The House Energy and Commerce Health Subcommittee has scheduled a hearing for March 10 on "Drug Safety: An Update from the FDA." At the hearing, the FDA will detail its current challenges and successes in the area of drug safety. Joshua M. Sharfstein, M.D., FDA Principal Deputy Commissioner, is slated to testify.
This post was written by Paul Sheives.
The Food and Drug Administration (FDA) has published a proposed rule on “Reporting Information Regarding Falsification of Data,” which would require sponsors to self-report any “information indicating that any person has, or may have, engaged in the falsification of data” associated with study results (clinical or pre-clinical) relied upon by the sponsor. Under the new regulations, sponsors would be required to report any such information to FDA as soon as possible, but no later than 45 days after learning of the activity. FDA is accepting comments on the proposed rule until May 20, 2010. For more information, see http://edocket.access.gpo.gov/2010/pdf/2010-3123.pdf
This post was written by Paul Sheives.
FDA and the National Institutes of Health (NIH) have announced a new initiative aimed at improving efficiencies in translational science and regulatory science to close the gap in time between discovery of new technology and availability of therapies to patients. A new entity established under the initiative, the Joint Leadership Council, will seek to increase the consideration of regulatory issues early in the development of new technologies and therapies. In addition, the agencies jointly will issue grants totaling almost $7 million to develop better approaches to evaluating safety and efficacy for the development of new technologies and therapies. Additional information is available here.
This post was written by Paul Sheives.
On February 18, 2010, the FDA posted updated listings of specific drugs that are being evaluated for potential safety issues based on a review of reports in FDA's Adverse Event Reporting System. The postings, which are mandated by the Food and Drug Administration Amendments Act of 2007, reflect safety information through September 2009. The FDA cautions that the appearance of a drug on this list does not mean that FDA has concluded that the drug has or causes the listed risk, nor does it suggest that healthcare providers should not prescribe or patients should not take the drug. If the FDA determines after further evaluation that the drug is associated with the risk, FDA could require labeling changes, require development of a Risk Evaluation and Mitigation Strategy (REMS), or gather additional data to better characterize the risk.
This post was written by Paul Sheives.
On March 30-31, FDA is holding a public meeting on “Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging.“ The purpose of the meeting is to seek stakeholder input on how manufacturers of devices used in computed tomography (CT) and in fluoroscopy could alter medical devices or clinical practice to lessen exposure to unnecessary ionizing radiation during these procedures. FDA also is accepting public comment on this issue until April 15, 2010.
This post was written by Paul Sheives.
A draft guidance was issued by FDA to help institutional review boards (IRBs) fulfill their continuing review responsibility under FDA regulations by providing guidance on the criteria, process, and frequency ofcontinuing IRB review necessary to ensure that subjects in clinical trials are protected. Although directed primarily at IRBs, the draft guidance should also assist sponsors and clinical investigators to fulfill their responsibilities related to continuing review. The FDA is seeking comments on the draft guidance by March 15, 2010 for consideration when drafting the final guidance.
This post was written by Paul Sheives.
FDA published a guidance document aimed at sponsors that are developing drug products with the potential for abuse that may need to be scheduled by the Drug Enforcement Agency (DEA) under the Controlled Substances Act. Within the draft guidance document, FDA addresses both the definition of abuse potential and information on submitting an adequate abuse potential assessment and scheduling request – covering such topics as study design and administrative recommendations. Comments should be submitted by March 29, 2010 to be considered when the FDA drafts its final guidance.
This post was written by Paul Sheives.
In an effort to better streamline medical device clinical trials, FDA issued a guidance document that addresses the use of Bayesian methods in medical device clinical trials. FDA provides a general overview of Bayesian methods and discusses how they intersect with the design and analysis of medical device clinical trials. The advantages and challenges inherent when using Bayesian methods are discussed, and FDA offers some comparisons to more standard statistical methods. In particular, FDA notes that this methodology allows companies to combine data collected in previous studies with data collected in a current trial, and the combined data may provide sufficient justification for smaller or shorter clinical studies. The use of Bayesian methods in post-market studies is explored as well.
This post was written by Paul Sheives.
FDA recently issued a revision of an International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance document, M3(R2), that was published in 1997 and is intended to harmonize and recommend international standards for non-clinical safety studies conducted to support human clinical trials of a given scope and duration, and/or to be relied upon for marketing authorization for pharmaceuticals. In this revised guidance document, FDA includes a new discussion relating to exploratory clinical studies. Also included are recommendations to help sponsors determine when certain nonclinical studies should be performed, such as phototoxicity studies, immunotoxicity studies, juvenile animal toxicity studies, and abuse potential studies.
This post was written by Paul Sheives.
To maximize the agency’s efforts to process submissions for the evaluation of proprietary names within the deadlines under the Prescription Drug User Fee Act (PDUFA), FDA issued a guidance document to assist manufacturers in making a complete submission, which is required for the PDUFA review clock to begin. FDA discusses the collection of information that the agency requires to assess: (1) the safety aspects of a proposed proprietary name in order to reduce medication errors, and (2) the promotional implications of a proposed proprietary name, to ensure compliance with other requirements for labeling and promotion using traditional FDA review methods.
This post was written by Paul Sheives.
FDA recently announced an initiative seeking to minimize patient exposure to ionizing radiation associated with computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams. To further this goal, the agency is advocating the universal adoption of two principles of radiation protection: (1) appropriate justification for ordering each procedure, and (2) careful optimization of the radiation dose used during each procedure. FDA states that “each patient should get the right imaging exam, at the right time, with the right radiation dose.” The FDA released a white paper on the initiative along with a question and answer document.
The Obama Administration has released its proposed federal budget for fiscal year (FY) 2011. In its budget documents, the Administration reaffirms its commitment to enacting health reform legislation, and it assumes $150 billion in federal savings attributable to health reform over the 2011-2020 period. The document states that the budget “supports health insurance reform” by expanding patient-centered health research on treatment effectiveness; increasing investment in health information technology, prevention, and wellness activities; and initiating Medicare payment reform demonstrations. Nevertheless, the budget does not outline comprehensive reform plans, nor does it repeat the sweeping Medicare and Medicaid budget savings proposals included in the Administration’s proposed FY 2010 budget. In other health policy areas, the budget would: expand funding for biomedical research, health centers for the medically underserved, and HIV/AIDS prevention and treatment; provide a six-month, $25.5 billion extension of the American Recovery and Reinvestment Act (ARRA) temporary increase in federal Medicaid matching funds; expand Medicare and Medicaid anti-fraud efforts; address high-risk billing activity associated with the Medicaid drug benefit; expand Food and Drug Administration (FDA) user fees; and fund an FDA to “provide regulatory pathways for new technologies such as biosimilars.” A separate FDA press release on the budget proposal announces that the Administration is seeking $4.03 billion for the FDA in FY 2011, which is a 23% increase over the agency’s current $3.28 billion budget. The following initiatives are the major components of the FDA's FY 2011 budget increase: transforming food safety ($318.3 million); Protecting Patients Initiative ($100.8 million); advancing regulatory science ($25.0 million); and tobacco-related initiatives ($215.0 million). Note that many provisions of the proposed budget would require Congressional approval to implement. To that end, Congress is holding a series of hearings on the proposal, including Senate Finance and House Energy and Commerce Committee hearings focusing on the health policy provisions of the budget. Several other budget hearings scheduled for the week of February 8 were postponed due to extreme weather conditions in the Washington, D.C. area.
This post was written by Paul Sheives.
On December 29, 2009, the Food & Drug Administration Act (FDA) issued a proposed rule that would amend the informed consent regulations to require the addition of an element regarding disclosure of information to the National Institute of Health (NIH) clinical trials database. Under the Food and Drug Administration Amendments Act of 2007, sponsors of “applicable clinical trials” are required to submit information for listing in the NIH clinical trial database. The proposed rule would require all informed consents for such “applicable clinical trials” – including specified drug, biologic, and device clinical investigations -- to include language informing the subject of the potential disclosure of the de-identified data to the clinical trials database (www.clinicaltrials.gov). FDA is accepting comments on the proposal until March 1, 2010.
This post was written by Paul Sheives.
The FDA has issued a guidance document seeking to encourage the creation of contingency production plans for the manufacture of medically-necessary drug products and their components during emergencies that result in high absenteeism at production facilities. Medically-necessary products are those used to treat or prevent a serious disease or medical condition for which there is no other adequately available drug product that is judged by medical staff to be an appropriate substitute.
This post was written by Paul Sheives.
An upcoming FDA public workshop will focus on safe and effective interoperable medical devices. The public meeting is intended to promote dialogue between FDA, industry, academia, professional societies, clinical investigators and other interested parties. The public workshop will be held in Silver Spring, Maryland on January 25 - 27, 2010.
This post was written by Paul Sheives.
FDA is holding a public meeting on February 9, 2010 to discuss measures for incorporating new science (i.e., novel technologies or novel uses of existing technologies, evolving information and knowledge, or new methods to support decisionmaking) into the FDA Center for Devices and Radiological Health decision-making processes. The meeting notice lists specific questions posed by FDA for discussion and public comment. The comment period closes on February 24, 2010.
This post was written by Paul Sheives.
On March 3-4, 2010, FDA is cohosting a public workshop in Orlando, Florida entitled "FDA Clinical Trial Requirements, Regulations, Compliance and GCP."
This post was written by Paul Sheives.
A recent GAO report points to improvement in FDA’s postmarket drug safety oversight, but the agency expresses concern over continued gaps in particular areas. The GAO recommended that FDA develop a plan and timeline for transferring additional regulatory authorities from the Office of New Drugs to the Office of Surveillance and Epidemiology. FDA comments regarding the report were generally supportive, but the agency is hesitant to commit to any timelines.
On December 7, 2009, HHS published its semiannual regulatory agenda outlining the Obama Administration's planned regulatory initiatives in a number of health policy areas. Note that discussions of certain major regulatory initiatives (health information technology, drug and device reporting requirements, and Medicare physician, inpatient hospital, and outpatient hospital rules, among others) are highlighted in an introduction to the regulatory plan.
This post was written by Paul Sheives.
FDA is hosting a one-day public workshop on January 25, 2010 to seek constructive input from experts in the field of genetic toxicology on proposed changes to the International Conference on Harmonisation (ICH) guidance ‘‘S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use’’ from March 2008.
This post was written by Paul Sheives.
FDA recently released two guidance documents (one in draft form) concerning hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C), which provide information to manufacturers seeking licensure and potential sponsors for Investigational New Drugs Applications (INDs). FDA announced that it no longer intends to exercise enforcement discretion regarding IND and Biologics License Application (BLA) requirements for these products. The final guidance document is entitled “Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications,” and the draft guidance is entitled “Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications.” Other recent FDA guidance documents include the following:
This post was written by Paul Sheives.
FDA is authorized to approve applications based on clinical trials that demonstrate a new drug’s impact on a “surrogate endpoint,” or laboratory measure or physical sign used as a substitute for a clinical endpoint. When FDA approves a drug based on a surrogate endpoint under an accelerated approval process, a sponsor must, as a condition of approval, conduct postmarketing confirmatory studies to validate that a drug’s impact on a surrogate endpoint also leads to clinical benefits. Responding to concerns raised about FDA’s reliance on surrogate endpoints and its oversight of postmarketing studies, the GAO issued a report that (1) identified drugs approved based on surrogate endpoints; (2) obtained the status of related postmarketing studies; and (3) reviewed FDA’s oversight of a sample of 35 studies it required under its accelerated approval process, selected to include studies at varying levels of completion. According to the GAO, although FDA has authority to expedite the withdrawal of a drug from the market if a sponsor does not complete a required confirmatory study with due diligence, or if a study fails to confirm a drug’s clinical benefit, it has not specified the conditions that would prompt it to do so. The GAO notes that this authority has never been exercised by the agency, even when such study requirements have gone unfulfilled for nearly 13 years. The GAO report recommends that FDA clarify the conditions under which it would utilize its authority to expedite the withdrawal of drugs under its accelerated approval process, but FDA disagreed with the need to develop such clarifying guidance.
The OIG has issued a report entitled “Adverse Event Reporting for Medical Devices.” According to the OIG, the FDA’s Center for Devices and Radiological Health (CDRH) does not use adverse event reports in a systematic manner to detect and address safety concerns about medical devices. Specifically, CDRH has not documented follow-up on adverse events, it does not consistently read adverse event reports for the first time in a timely manner, and it rarely acts when manufacturers and user facilities submit reports late. The OIG recommends that FDA develop a clear protocol for reviewing adverse event reports, including: documenting follow-up on adverse events, documenting that CDRH is meeting its own guidelines for reviewing high-priority adverse event reports, following up with manufacturers who routinely submit reports late or with incomplete information, and enhancing outreach strategies to reduce user facility underreporting. The OIG also recommends that FDA seek legislative authority to eliminate the requirement that user facilities submit annual reports. The FDA agreed with the OIG’s recommendations.
This post was written by Paul Sheives.
The GAO issued a report entitled "Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Medical Product Investigators." Among other things, the report raises concerns about the length of time associated with FDA disqualification proceedings. The GAO also found that FDA rules allow an investigator who is disqualified for conduct related to drugs or biologics to serve as an investigator for medical devices; likewise, an individual disqualified for conduct related to medical devices still may serve as a clinical investigator for drugs and biologics. In the report, the GAO recommends that the FDA Commissioner: pursue extending FDA’s debarment authority; extend disqualification to include drugs, biologics, and medical devices; and ensure the timely completion of debarment and disqualification proceedings. FDA agreed with GAO’s recommendations.
The FDA Transparency Task Force is holding its second public meeting on November 3, 2009. This meeting will focus on: early communication about emerging safety issues concerning FDA-regulated products; disclosure of information about product applications that are abandoned or withdrawn by the applicant before approval; and communication of FDA decisions about pending product applications. The registration deadline is October 27, 2009, and comments will be accepted until November 6, 2009.
On September 23, 2009, the FDA published a proposed rule to codify current good manufacturing practice (cGMP) requirements that apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule sets forth what the FDA characterizes as a “transparent and streamlined” regulatory framework for demonstrating compliance with cGMP requirements for “single-entity” and “co-packaged'” combination products. The FDA is accepting comments on the proposed rule until February 5, 2010 (extended from December 22, 2009).
The FDA is seeking public input on the promotion of FDA-regulated medical products (including prescription drugs and biologics and medical devices) using the internet and social media tools (e.g., blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis). To that end, the FDA is hosting a public hearing in Washington, D.C. on November 12-13, 2009 to discuss this topic, and the agency is soliciting public comments through February 28, 2010. In particular, the FDA is requesting input on questions such as: (1) for what online communications are manufacturers, packers, or distributors accountable; (2) how can such entities fulfill regulatory requirements in their internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications; (3) what parameters should apply to the posting of corrective information on web sites controlled by third parties; (4) when is the use of links appropriate; and (5) how do adverse event reporting requirements apply to these formats.
The FDA is accepting comments on the following new draft guidance documents for industry:
In addition, the FDA recently has issued a number of final guidance documents, including the following:
The FDA is announcing an extension of the deadline for submitting requests to participate in a pilot program involving the submission of quality (chemistry, manufacturing, and controls) information for biotechnology products in an Expanded Change Protocol consistent with the principles of quality-by-design and risk management in pharmaceutical manufacturing. FDA also is extending the application submission deadlines and increasing the number of applications being accepted into the pilot program. Requests to participate in the pilot program are due September 30, 2010, and investigational new drug applications and postapproval supplements are due March 31, 2011.
The FDA has released its annual report on the status of drug and biological product postmarketing studies and clinical trials, as required by the Food and Drug Administration Modernization Act of 1997.
On October 29 – 30, 2009, the FDA is hosting a forum entitled “Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes.” Comments regarding the public workshop will be accepted through November 30, 2009.
On August 21, 2009, the FDA published two proposed rules that would require manufacturers and other covered entities to report adverse drug, biological, and device events electronically. The FDA expects that the proposed changes would help it “more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission.” In the first rule, the FDA is proposing to amend its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. Likewise, with regard to devices, the FDA is proposing to amend its postmarket medical device reporting regulation to require that manufacturers, importers, and user facilities use an electronic format to submit mandatory reports of individual medical device adverse events. Comments on both rules will be accepted until November 19, 2009, and comments on related information collection issues are due September 21, 2009. Separately, the FDA released a draft guidance document that provides recommendations on how to prepare and submit electronic medical device reports to FDA in a manner that satisfies the proposed rule; comments on the draft are requested by November 19, 2009.
The Food and Drug Administration (FDA) has reopened its public comment period on ways the agency can enhance the transparency of FDA activities and decisionmaking. Specifically, the FDA will accept comments on this topic until November 6, 2009 in preparation for a second meeting of the FDA’s Transparency Task Force planned for this fall.
On September 9-10, 2009, the FDA is holding a public workshop on “Methodologies for Post-Approval Studies of Medical Devices.” The target audiences for this workshop are Epidemiologists, Statisticians, Clinicians, and Regulatory Affairs Specialists. Preregistration is required.
The Food and Drug Administration (FDA) has issued two final rules designed to further expand access to investigational drugs for treatment use and clarify when patients can be charged for investigational drugs. The rules are effective October 13, 2009. The first rule, “Expanded Access to Investigational Drugs for Treatment Use,” clarifies existing regulations and makes access to investigational drugs for treatment use easier for individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The FDA intends for the rule to “improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies.” The second final rule, “Charging for Investigational Drugs Under an Investigational New Drug Application,” clarifies the circumstances under which charging for an investigational drug in a clinical trial is appropriate; sets forth criteria for charging for an investigational drug for different population categories; and clarifies what costs can be recovered. The final rule will permit charging for a broader range of uses than was explicitly permitted previously.
On August 11, 2009, the FDA published a notice announcing a program to establish a deadline for inspected establishments to submit post-inspection responses to FDA 483 inspectional observations for the FDA's consideration in deciding whether to issue warning letters. According to the FDA, delayed and multiple responses to an FDA 483 have resulted in delays in the issuance of warning letters while these responses are reviewed and addressed. Under the program, the agency will not ordinarily delay the issuance of a warning letter in order to review a response to an FDA 483 that is received more than 15 business days after the FDA 483 was issued. The purpose of this program is to optimize resource utilization, facilitate the timely issuance of warning letters, and promote prompt correction of violations. FDA will assess the program after approximately 18 months to determine whether to make it permanent. The program will begin on September 15, 2009.
On August 7, 2009, the FDA announced its enhanced procedures for debarment and clinical investigator disqualification with, among other things, increased staffing and centralized coordination, to ensure more rapid, transparent and consistent actions. The FDA notes that in the short time these measures have been in effect, the number of debarment actions has risen considerably while the times for resolving disqualification and debarment actions have been reduced significantly. The FDA also is posting disqualification and debarment proceeding information on its website to provide clinical study sponsors with ready access to information about FDA's actions. These policy changes are in response to concerns expressed by members of Congress that the FDA has not adequately used its debarment and disqualification authorities.
On August 3, 2009, the FDA published a number of notices setting forth the fiscal year 2010 user fee rates for prescription drugs, medical devices, animal drugs, and generic animal drugs.
The FDA has published a notice announcing the availability of a draft guidance entitled “E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions.” The FDA is requesting comments on the guidance by September 28, 2009.
According to a recent Government Accountability Office (GAO) report, the FDA faces challenges fulfilling its growing medical product oversight responsibilities, particularly those not funded by industry user fees. While FDA reports that funding levels allow it to address the most urgent needs and priorities, the agency did not receive enough resources to meet some statutory requirements, such as biennially inspecting certain manufacturing establishments. The GAO recommends that the FDA establish a comprehensive and reliable basis for substantiating the agency’s resource needs; the FDA concurred.
On September 24-25, 2009, the FDA is holding a public workshop entitled “Providing Effective Information to Consumers About Prescription Drug Risks and Benefits.” Comments on workshop documents (including a series of prototypes on different written approaches to conveying prescription drug information to consumers) will be accepted until November 25, 2009.
On June 22, 2009, the FDA announced a public comment opportunity on its “Experimental Study of Presentation of Quantitative Effectiveness Information to Consumers in Direct-to-Consumer (DTC) Television and Print Advertisements for Prescription Drugs.” The study will examine: (1) various ways of communicating quantitative efficacy in DTC print ads and (2) whether the findings translate to DTC television ads. Comments will be accepted until August 21, 2009.
On June 22, 2009, President Obama signed into law H.R. 1256, the “Family Smoking Prevention and Tobacco Control Act,” as amended. The law gives the Food and Drug Administration (FDA) authority to regulate the advertising, marketing, and manufacturing of tobacco products under the Federal Food, Drug, and Cosmetic Act, funded through user fees on tobacco product manufacturers.
On June 8, 2009, House Energy and Commerce Committee Chairman Henry Waxman wrote to President Obama asking "the Administration to consider what steps can be taken under existing authority to prepare and even begin to use a pathway for generic biologics." The letter also requests that the "Administration provide an analysis of long-term savings generated from generic biologics not only for Medicare and Medicaid, but also for businesses, insurers, and families."
The Government Accountability Office (GAO) has issued a report entitled “Privacy and Security: Food and Drug Administration Faces Challenges in Establishing Protections for Its Postmarket Risk Analysis System.” The report focuses on the FDA’s Sentinel Initiative, a postmarket risk identification and analysis system based on electronic health data. Although the Sentinel system is still in the early planning stages, the GAO believes that the system will pose significant privacy and security challenges, including among other things: ensuring that appropriate legal mechanisms are established to protect privacy and implement security consistently across the Sentinel system; effectively informing the public of the program’s planned uses of their personal health information; ensuring that de-identified information is not re-identified; establishing adequate security controls to protect the personal health information associated with Sentinel; and establishing sufficient oversight and enforcement mechanisms to ensure that privacy and security requirements are consistently implemented. In the report, the GAO recommends that the Commissioner of FDA develop a plan, including milestones, for developing the Sentinel system and for addressing these privacy and security challenges.
The FDA is holding a meeting June 24, 2009 to solicit recommendations on ways the agency can make useful and understandable information about FDA activities and decisionmaking more readily available to the public. Among other things, the FDA is seeking comments on specific ways to announce FDA activities (e.g., enforcement actions, product approvals, and recalls), and what information should remain confidential in order to promote key internal and external policy goals.
On May 18, 2009, the Senate unanimously confirmed Dr. Margaret "Peggy" Hamburg as FDA Commissioner. Dr. Hamburg was sworn in as the FDA Commissioner by HHS Secretary Kathleen Sebelius on May 22, 2009.
On May 20, 2009, the Senate Health, Education, Labor and Pensions (HELP) Committee approved an amended version of S. 982, the "Family Smoking Prevention and Tobacco Control Act,” which would provide the FDA with certain authority to regulate tobacco products.
On June 4 and 5, the FDA is holding a public workshop on Implementation of Post-Approval Studies for Medical Devices.
On May 12, 2009, the Senate Committee on Health, Education, Labor and Pensions has scheduled a markup of the Family Smoking Prevention and Tobacco Control Act.
On May 7, 2009, the Senate Health, Education, Labor, and Pensions has scheduled hearings to examine the nomination of Margaret A. Hamburg to be Commissioner of Food and Drugs.
On June 1 and 2, 2009, the FDA is holding a public workshop on the use of computational modeling in the design, development, and evaluation of cardiovascular medical devices. Issues to be discussed may include: multi-scale modeling; imaging for cardiovascular device modeling; physiologic input data for cardiovascular device modeling; device-specific issues related to modeling, including a focus on heart valves, drug-eluting and bare metal stents, endovascular stents, cardiac rhythm management, and mechanical and circulatory support devices; and regulatory issues with implementation of computer modeling.
On April 2, 2009, the House approved H.R. 1256, the “Family Smoking Prevention and Tobacco Control Act.” The bill, which was approved on a 298 to 112 vote, would authorize FDA regulation of tobacco products, including allowing for the adoption of tobacco product standards to protect public health, and establish labeling, inspection, and record keeping requirements related to tobacco, among other things. The bill now moves to the Senate.
The GAO has issued a report entitled “Nonprescription Drugs: Considerations Regarding a Behind-the-Counter Drug Class.” This report examines the pros and cons of establishing an additional class of nonprescription drugs that would be held behind the counter (BTC) but would require the intervention of a pharmacist before being dispensed, and issues that must be addressed before establishing such a drug class.
Dr. Joshua M. Sharfstein has been appointed by President Obama to be the FDA principal deputy commissioner. On March 30, 2009, Dr. Sharfstein began serving as Acting Commissioner for Food and Drugs, replacing previous Acting Commissioner Frank Torti, until the U.S. Senate confirms a new Commissioner of Food and Drugs (President Obama’s nominee for that post is Dr. Margaret Hamburg).
On March 11, 2009, President Obama signed into law H.R. 1105, an omnibus spending bill that completes work on the remaining FY 2009 appropriations bills, including funding for the Department of Health and Human Services (HHS). Among other things, the law (PL 111-008) increases funding for the Food and Drug Administration (FDA) by $335 million above 2008 levels to help FDA improve the safety of domestic and imported food and medical products. The measure also includes increased funding compared to FY 2008 levels for the National Institutes of Health (NIH), the Centers for Disease Control and Prevention, community health centers, health professions training, childhood immunizations, and rural hospital programs. Moreover, the act funds a new initiative to reduce hospital and clinic infections and requires national and state plans to combat infections.
The FDA is seeking comments on a draft guidance document entitled “User Fees and Refunds for Premarket Approval Applications'' (PMAs). The draft document outlines the types of PMAs subject to user fees, as well as those that do not have an associated user fee, and identifies industry and FDA actions on these submissions that may result in a refund of the fee. Comments on the draft guidance will be accepted through April 15, 2009. The FDA also has released “Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files,” which is designed to simplify the preparation and evaluation of submissions in support of new animal drug applications. Comments will be accepted until June 1, 2009.
On March 14, 2009, President Obama named Dr. Margaret Hamburg as Commissioner of the Food and Drug Administration, and Dr. Joshua Sharfstein as the Principal Deputy Commissioner. The following profiles were supplied by the White House:
Margaret "Peggy" Hamburg
Dr. Hamburg is a nationally and internationally recognized leader in public health and medicine, and an authority on global health, public health systems, infectious disease, bioterrorism and emergency preparedness. She served as the Nuclear Threat Initiative's founding Vice President for the Biological Program. Before joining NTI, she was the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. Prior to this, she served for six years as the Commissioner of Health for the City of New York and as the Assistant Director of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
Joshua "Josh" Sharfstein
Dr. Joshua M. Sharfstein is Commissioner of Health for the City of Baltimore. He also serves as chair of the board of four affiliated nonprofit agencies. He has been recognized as a national leader for his efforts to protect children from unsafe jewelry and over-the-counter medication, and ensuring Americans with disabilities have access to prescription drugs. He is a member of the Board on Population Health and Public Health Practice of the Institute of Medicine.
The FDA has published a rule confirming the March 27, 2009 effective date for its November 12, 2008 direct final rule regarding CMPs prescribed by the Food and Drug Administration Amendments Act of 2007.
The Government Accountability Office (GAO) has issued a report entitled “Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding.” The GAO found that while FDA has taken some steps to identify and act upon safety concerns related to dietary supplements, several factors limit the agency’s ability to detect concerns and remove products from the market, including lack of mandatory recall authority and the difficult process of demonstrating significant or unreasonable risk for specific ingredients. The GAO recommends that the FDA request additional authority to oversee dietary supplements, issue guidance on new dietary ingredients and clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements. The FDA generally agreed with GAO’s recommendations.
On March 31, 2009, the Food and Drug Administration (FDA) is cosponsoring a public workshop with several medical societies regarding scientific issues in clinical trial design for hospital-acquired pneumonia and ventilator-associated pneumonia.
On April 30 and May 1, 2009, the FDA Risk Communication Advisory Committee is meeting to discuss the FDA’s draft risk communication strategic plan and strategic priorities for research on effective risk communication.
The HHS Office of Inspector General (OIG) has issued a report on “The Food and Drug Administration's Oversight of Clinical Investigators' Financial Information,” which concludes that clinical investigators may not be disclosing all financial interests. The OIG found that only 1% of clinical investigators disclosed a financial interest, and the FDA cannot determine whether sponsors have submitted financial interest information for all clinical investigators. Further, FDA's oversight of such information is lacking, since: almost half of marketing applications were missing financial interest information; FDA reviewers did not document a review of financial interest information in almost one-third of marketing applications; and neither FDA nor sponsors took action to minimize potential bias in 22% of marketing applications with a disclosed financial interest. The OIG recommends that FDA ensure that sponsors submit complete financial information for all clinical investigators; use a review template and provide reviewer training; and require sponsors to submit financial information as part of the pretrial application process. While the FDA generally agreed with the recommendations, it did not agree to require sponsors to submit the financial information during the pretrial application process.
The Government Accountability Office (GAO) has issued a report entitled “High-Risk Series: An Update,” which identifies areas where federal programs are at risk of fraud, waste, abuse, and mismanagement. This biennial report highlights areas of continuing concern, including Medicare and Medicaid program management. While the GAO points to certain improvements in Medicare program operations, it recommends further actions, such as monitoring beneficiary grievances; eliminating inappropriate payment incentives; safeguarding the program from payment errors; and addressing deficiencies in oversight of care quality in nursing homes and hospitals. The GAO also identified continued weaknesses in oversight of state Medicaid claims and supplemental payments, review of the budget neutrality of Medicaid demonstrations prior to approval, and the overall level of improper Medicaid payments. The GAO also adds a new high risk area this year focusing on the FDA’s ability to ensure the safety and efficacy of drugs, biologics, and medical devices. The GAO recommendations in this area address, among other things, foreign drug inspections, review of promotional materials, and presentation of clinical trial results by drug sponsors.
The GAO has issued a report entitled "Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process." The GAO found that in fiscal years (FY) 2003 through 2007, as part of its premarket review, the FDA: (1) reviewed 13,199 submissions for class I and II devices via the 510(k) process, clearing 11,935 (90%) of these submissions; (2) reviewed 342 submissions for class III devices through the 510(k) process, clearing 228 (67%) of these submissions; and (3) reviewed 217 original and 784 supplemental PMA submissions for class III devices and approved 78% and 85%, respectively, of these submissions. Although Congress envisioned that class III devices would be approved through the more stringent PMA process, and the Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III device types, the GAO concluded that this process remains incomplete. GAO found that in FYs 2003 through 2007, FDA cleared submissions for 24 types of class III devices through the 510(k) process. As of October 2008, four of these device types had been reclassified to class II, but 20 device types could still be cleared through the 510(k) process. FDA said it is committed to issuing regulations either reclassifying or requiring PMAs for the class III devices currently allowed to receive clearance for marketing via the 510(k) process, but it did not provide a time frame for doing so. The GAO recommends that FDA expeditiously take steps to issue regulations for class III device types currently allowed to enter the market via the 510(k) process by requiring PMAs or reclassifying them to a lower class. HHS agreed with the GAO’s recommendation.
HHS published a rule January 15, 2009 imposing registration requirements on institutional review boards (IRB) that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federal-wide use by the HHS Office for Human Research Protections (OHRP). The registration information will include contact information, numbers of all active protocols and active protocols involving research conducted or supported by HHS, and staffing for the IRB. The rule is effective July 14, 2009. Initial registration must be submitted by September 14, 2009, while IRBs currently registered with OHRP must comply by the three-year expiration date assigned by OHRP or within 90 days of certain IRB personnel changes. The FDA also issued a parallel rule to require IRBs to register through the HHS system and provide contact information and information on the number of active protocols involving FDA-regulated products and types of products reviewed. The rule is effective July 14, 2009, with a September 14, 2009 deadline for compliance with the initial registration requirement. In connection with the rule, the FDA released final guidance entitled “Adverse Event Reporting to IRBs -- Improving Human Subject Protection,” which is intended to help the research community interpret requirements for submitting reports of unanticipated problems, including certain adverse events reports, to IRBs. The document seeks to address concerns raised by the IRB community that increasingly large volumes of individual, unanalyzed adverse event reports are inhibiting the ability of IRBs to adequately protect human subjects.
On February 12, 2009, the FDA is hosting a public workshop to obtain input on issued involved in the establishment of a unique device identification (UDI) system. The Food and Drug Administration Amendments Act of 2007 requires the establishment of a UDI system requiring the labeling of devices through distribution and use (subject to certain exceptions). The registration deadline for the workshop is January 30, 2009.
The Food and Drug Administration Amendments Act of 2007 (FDAAA) expanded the public reporting requirements for “applicable clinical trials” involving certain drugs, biologicals, and devices. In December 2008, the Food and Drug Administration (FDA) issued a draft guidance document proposing, among other things, definitions that would affect who would be required to register certain clinical trials under the FDAAA. In some cases, FDA's proposal would require manufacturers who make grants to investigators to be the responsible party required to register. In addition, FDA elaborates on the circumstances under which clinical investigations designed to demonstrate bioequivalency would be subject to reporting. Additional background information is available at the clinicaltrials.gov web site. Reed Smith is reviewing the draft guidance. Please contact Areta Kupchyk at akupchyk@reedsmith.com for more information.
The FDA has released final guidance on “Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act,” which discusses the amount, type, and quality of evidence that FDA recommends a dietary supplement manufacturer have to substantiate a nutritional deficiency, structure/function, or general well-being claim. FDA has adopted the FTC standard for substantiation and, among other things, will expect statistically significant clinical studies to support structure/function claims. For more information, contact Areta Kupchyk at akupchyk@reedsmith.com.
The FDA has issued final guidance on “Labeling OTC Human Drug Products—Questions and Answers.” This document is intended to assist manufacturers, packers, and distributors of over-the-counter (OTC) drug products in complying with the agency’s regulation on standardized content and format requirements for the labeling of OTC drug products, including the use of toll-free numbers and compliance with adverse event reporting requirements.
The FDA has released draft guidance entitled “Assay Migration Studies for In Vitro Diagnostic Devices,” which is designed to present a least burdensome regulatory approach to gaining FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously-approved assay is migrating to a new system for which the assay has not been previously approved or licensed. FDA will accept comments on the draft guidance until April 6, 2009.
The FDA is inviting pharmaceutical companies to participate in the FDA’s Regulatory Project Management Site Tours and Regulatory Interaction Program, through which FDA personnel observe operations of pharmaceutical manufacturing and/or packaging facilities, pathology/toxicology laboratories, and regulatory affairs operations. The goals of the program are to provide FDA regulatory project managers with first-hand exposure to industry’s drug development processes, and to offer a venue for sharing information about project management procedures (but not drug-specific information) with industry representatives. Interested companies may submit proposed agendas to FDA by March 6, 2009.
FDA is soliciting comments on the paperwork burden associated with its plan to require drug establishment registration and drug listing submissions in electronic format. Comments will be accepted until February 9, 2009.
The Food and Drug Administration (FDA) is seeking comments on a planned "Experimental Study of the Impact of Coupons Embedded in Direct-to-Consumer Prescription Drug Print Advertisements." According to the FDA notice, the study will examine the impact of the presence of coupons offering price incentives or rebates on consumers' perceptions of product risks and benefits in direct-to-consumer (DTC) print ads. The FDA acknowledges, however, that "it does not actually regulate the dollar or other incentive amount of coupons, price incentives, or rebate offers with respect to how they affect the price of prescription drugs or biological products." Comments will be accepted until February 13, 2009.
The FDA Office of Orphan Product Development has announced grants to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. Grants are available for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Of the estimated FY 2010 funding ($14.1 million) for this program, approximately $10 million will fund noncompeting continuation awards, and approximately $4.1 million will fund 10 to 12 new awards, subject to availability of funds.
The FDA has released revised draft guidance entitled “Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1.” This guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. In an earlier version of the guidance issued January 2, 2008, the FDA stated that it intended to begin enforcing the labeling requirements for OTC drug products marketed without an approved application that are labeled on or after January 1, 2009; because the agency is still finalizing the guidance, the revised draft extends the enforcement date until January 1, 2010. Separate guidance regarding compliance with the labeling requirements for dietary supplements also has been released.
The FDA has released draft guidance on “Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.” The document reflects the agency's views on genotoxic and carcinogenic impurities in drug substances and drug products, including biologic products regulated by the Center for Drug Evaluation and Research. It also provides recommendations on how to evaluate the safety of these impurities during clinical development and for marketing applications, including additional testing and exposure threshold recommendations when genotoxic or carcinogenic impurities are present. The draft guidance addresses synthetic impurities and degradants in drug substances, but not the genotoxicity or carcinogenicity of actual drug substances or intended drug product ingredients. This draft guidance also applies to known starting materials or anticipated reaction products. The FDA will accept comments on the guidance through February 17, 2009.
The FDA has issued guidance on “Modifications to Devices Subject to Premarket Approval (PMA)--the PMA Supplement Decision-Making Process,” which is designed to help industry determine the type of regulatory submission that may be required when a device subject to PMA is modified.
The FDA has released guidance for manufacturers of new and generic pharmaceutical products on the definition of an orally disintegrating tablet (ODT). The FDA notes that manufacturers have developed products that can be ingested simply by placing them on the tongue, eliminating the need to chew the tablet, swallow an intact tablet, or take the tablet with liquids. As new products have been developed using different technology and formulations, many of these later products exhibited wide variation in product characteristics from the initial products. Because this shift in product characteristics can affect suitability for particular uses, the agency developed this guidance for industry.
On December 1, 2008, the HHS Office for Human Research Protections (OHRP), Office of Public Health and Science, announced it is requesting public comments on a draft guidance document entitled “Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.” The draft document is intended primarily for institutional review boards (IRBs), investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by HHS. OHRP will accept comments on the draft until January 30, 2009. In a related development, the FDA released guidance on “Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials,” which clarifies FDA's position that it is critical that data be retained from trial participants who decide to discontinue participation in a clinical study of an investigational product, who are withdrawn by their legally authorized representative, as applicable, or who were discontinued from participation by the clinical investigator. This Level 1 guidance is being issued for immediate implementation to prevent the potential loss of important clinical trial data.; if comments are received, the agency will review the comments and revise the guidance if appropriate.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on a planned FDA study examining consumer comprehension of inclusion of a toll-free number to report side effects in direct-to-consumer (DTC) prescription drug television advertisements. Comments will be accepted until January 26, 2009.
The FDA has released for public comment draft guidance entitled “Submission of Patent Information for Certain Old Antibiotics.” The document describes the agency's current thinking on the implementation of certain provisions of the Q1 Program Supplemental Funding Act (the Q1 Act) that concern old antibiotics and addresses which sponsors of new drug applications must submit patent information under the Q1 Act by December 5, 2008. Comments on the guidance will be accepted until February 2, 2009.
The FDA has announced the availability of a document entitled “Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics.” The guidance, which applies to biological products subject to licensure under the U.S. Public Health Service Act, describes the licensing strategies for meeting the increased need for flexible manufacturing arrangements, such as short supply arrangements, divided manufacturing arrangements, shared manufacturing arrangements, and contract manufacturing arrangements.
On December 3, 2008, the FDA announced it is teaming with WebMD to expand consumer access to FDA safety alerts and other public health information. Among other things, the partnership includes a new online consumer health information resource on WebMD.com where consumers can access information on the safety of FDA-regulated products.
On November 24, 2008, the Food and Drug Administration (FDA) announced the availability of a draft guidance document entitled “Contents of a Complete Submission for the Evaluation of Proprietary Names.” The document is intended to help prevent medication errors by assisting industry in the submission of complete product information that will enable FDA to evaluate the safety of proposed proprietary drug and biological product names. In addition, FDA intends to use this information in the assessment of promotional aspects of proposed proprietary names. The FDA will accept comments on the draft until January 23, 2009.
Separately, on November 18, 2008, the FDA announced the availability of draft guidance entitled “Process Validation: General Principles and Practices.” The FDA is revising related May 1987 guidance to promote a “lifecycle approach” to process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients. Comments will be accepted until January 20, 2009.
On November 24, 2008, the Department of Health and Human Services (HHS) published its semiannual regulatory agenda, outlining planned regulatory initiatives in a number of health policy areas. A separate document listing major Administration regulatory initiatives and priorities, including health policy priorities, also is available.
On November 12, 2008, the Food and Drug Administration (FDA) issued a direct final rule to adjust for inflation the maximum civil money penalty (CMP) amounts for the various CMP authorities under FDA jurisdiction, as required by the Federal Civil Penalties Inflation Adjustment Act. The rule does not adjust new CMPs enacted by the Food and Drug Administration Amendments Act of 2007. The FDA is using direct final rulemaking for this action because the agency expects no significant adverse comment on the rule. However, the agency also is concurrently issuing the rule in proposed form and soliciting comments on the direct rule. If significant adverse comments are received, the FDA will withdraw the final rule and address the comments in a subsequent rulemaking. The rule is effective March 27, 2009, unless the FDA receives significant adverse comment by January 26, 2009. Comments will be accepted on the proposed rule until December 26, 2008.
The FDA published a notice November 13, 2008 requesting written notification of any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on Center for Biologics Evaluation and Research (CBER) public advisory committees. The FDA also is soliciting nominations for nonvoting industry representatives to serve on the following CBER public advisory committees: the Cellular, Tissue and Gene Therapies Advisory Committee; the Vaccines and Related Biological Products Advisory Committee; and the Transmissible Spongiform Encephalopathies Advisory Committee. Notifications of interest and nominations are due December 15, 2008.
On October 28, 2008, the Food and Drug Administration (FDA) published a final rule requiring a statement to be included on certain human drug product labeling that provides a toll-free number for reporting side effects and specifies that the number is not intended to be used for medical advice. The rule, which confirms a January 3, 2008 interim final rule on this issue, implements provisions of the Best Pharmaceuticals for Children Act and the Food and Drug Administration Amendments Act of 2007. The compliance date for the final rule is July 1, 2009 (rather than the January 1, 2009 compliance date anticipated under the interim final rule).
HHS announced it is preparing to open FDA offices in China, India, Europe, and Latin America before the end of 2008 to beef up efforts to ensure the safety of imported food and medical products. FDA personnel overseas will be tasked with providing technical advice to local authorities and industries, conducting additional inspections, and working with government agencies and private sector entities interested in developing certification programs. This initiative is part of the federal government’s Import Safety Action Plan.
On October 22, 2008, the Government Accountability Office (GAO) issued a report entitled "Drug Safety: Better Data Management and More Inspections Are Needed to Strengthen FDA's Foreign Drug Inspection Program." Among other things, the GAO found that: FDA databases contain inaccurate information on foreign establishments subject to inspection; FDA inspects relatively few foreign establishments each year to assess the manufacturing of drugs currently marketed in the United States; and FDA’s identification of serious deficiencies has led foreign establishments to take corrective actions, but inspections to determine continued compliance are not always timely. The GAO recommends that FDA improve the data that it uses to manage its foreign inspection program, conduct more inspections of foreign establishments, and ensure more timely inspection of foreign establishments where FDA has identified serious deficiencies. HHS agreed that FDA should conduct more foreign inspections, and discussed other FDA oversight initiatives, such as database improvements.
The Food and Drug Administration (FDA) has released a draft guidance document on “Potency Tests for Cellular and Gene Therapy Products.” The document is designed to provide manufacturers of cellular and gene therapy products with recommendations for developing tests to measure potency to support an Investigational New Drug Application (IND) or a Biologics License Application (BLA). FDA will accept comments on the guidance through January 7, 2009.
The Government Accountability Office (GAO) has issued a report examining the FDA’s advisory committee processes. Specifically, the GAO examined: (1) how FDA recruited individuals for membership and evaluated candidates for potential conflicts of interest, (2) barriers that were reported to recruiting qualified individuals to serve on committees, and (3) the proportion of standing and temporary members, and the frequency with which members with conflict of interest determinations participated in meetings.
The FDA released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals. Among other things, the guidance requires producers to demonstrate that food from the GE animal is safe to eat if the GE animal is intended for food use. The guidance also describes a sponsor's responsibility in meeting the National Environmental Policy Act’s environmental assessment requirement. The draft guidance also describes how the FDA may exercise enforcement discretion with regard to GE animals. The FDA will accept comments on the guidance through November 18.
On September 29, 2008, the Food and Drug Administration (FDA) published a direct final rule requiring holders of a new drug application (NDA) to submit certain information regarding authorized generic drugs in an annual report . The rulemaking is part of the agency’s implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly. The agency is publishing the requirement as a direct final rulemaking because it does not expect significant adverse comment on the rule. As part of the administrative requirements for a direct final rule, the agency is concurrently issuing a proposed rule and soliciting comments and, if any significant adverse comment is received, the FDA will withdraw the direct final rule and address the comments in a subsequent rulemaking. If there is no significant adverse comment, the direct final rule will automatically become effective February 11, 2009. Comments will be accepted until December 15, 2008, although comments on related information collection provisions are due October 29, 2008.
On October 1, 2008, the HHS Office of Inspector General (OIG) released its FY 2009 Work Plan, which discusses planned OIG audit, inspection, and investigative initiatives affecting virtually every type of health care provider and supplier.
The Food and Drug Administration (FDA) has published a notice announcing animal drug and generic animal drug user fee rates and payment procedures for fiscal year 2009.
On September 8, 2008, the Food and Drug Administration (FDA) published a final rule amending its current good manufacturing practice (CGMP) requirements for finished pharmaceuticals, effective December 8, 2008. In particular, the rule revises CGMP requirements concerning aseptic processing, verification of performance of operations by a second individual, and the use of asbestos filters.
The FDA has announced the availability of additional draft and revised draft product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). FDA will accept comments on the recommendations until December 4, 2008. Separately, the FDA has released draft guidance entitled “M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The document, which discusses the types of nonclinical studies and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals, is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources. The FDA is requesting comments on the draft guidance by October 20, 2008.
On September 5, 2008, the FDA posted its first quarterly report listing 20 specific drugs that are being evaluated for potential safety issues based on a review of reports in FDA's Adverse Event Reporting System, as mandated by the Food and Drug Administration Amendments Act of 2007. The FDA cautions that the appearance of a drug on this list does not mean that FDA has concluded that the drug has or causes the listed risk, nor does it suggest that healthcare providers should not prescribe or patients should not take the drug. If the FDA determines after further evaluation that the drug is associated with the risk, FDA could require labeling changes, require development of a Risk Evaluation and Mitigation Strategy (REMS), or gather additional data to better characterize the risk.
On July 30, 2008, the House of Representatives approved by a 326 to 102 vote an amended version of H.R. 1108, the “Family Smoking Prevention and Tobacco Control Act,” which would give the FDA the authority to regulate tobacco products. The bill now moves to the Senate. Note that the President has threatened to veto the House version of the bill.
On August 1, 2008, the Senate approved H.R. 6432, the “Animal Drug User Fee Amendments of 2008,” which would to revise and extend the FDA’s animal drug user fee program, establish a program of fees relating to generic new animal drugs, and make certain technical corrections to the Food and Drug Administration Amendments Act of 2007. The House approved the measure on July 30, and it now awaits the President’s signature.
On February 20, the Food & Drug Administration (FDA) proposed guidelines for manufacturers of drugs and devices who would like to distribute scientific and medical articles that discuss off-label uses of approved products. The draft guidance is entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices." The document proposes that distribution be limited to peer-reviewed scientific or medical articles that are published by an with an editorial board that has a policy of disclosure of conflicts of interest. The publication should not be written for, edited by, or funded by the manufacturer, and it cannot be false or misleading or pose a significant risk to public health. Letters to the editor, abstracts of a publication, reports of Phase 1 trials in healthy subjects, or reference publications that contain insufficient substantive discussion of the data would not be acceptable. The draft guidance also proposes guidelines on the manner in which companies should distribute scientific and medical information. For instance, a company should not abridge, highlight, or summarize the article. In addition, FDA would expect that the article be accompanied by numerous disclosures and addendums, including: the approved labeling of the drug or medical device; a comprehensive bibliography of related information; a disclosure about the unapproved use being discussed, a disclosure of the manufacturer's interest in the product, a disclosure of any financial interest held by the author, and, a representative publication of any articles that call into question the conclusions of the article being disseminated. The journal article should also be distributed separately from promotional materials. Comments on the guidance are due April 21, 2008. The draft guidance document is posted here; details regarding comment submission are available here. Reed Smith has prepared a bulletin analyzing the draft; the bulletin is available here.
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