Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

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

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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.

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On October 1, 2009, the Food and Drug Administration (FDA) published a proposed rule clarifying postmarketing safety reporting requirements that apply when regulated products (drugs, devices, and biological products) are combined to create a combination product. The FDA is accepting comments on the proposal until December 30, 2009.

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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).

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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.  

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The FDA is accepting comments on the following new draft guidance documents for industry:

• “Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation.” To be considered in drafting the final guidance, comments must be received by December 14, 2009. 
• “Microbiological Data for Systemic Antibacterial Drug Products Development, Analysis, and Presentation”; comments are due December 16, 2009. 
• “Clinical Considerations for Therapeutic Cancer Vaccines”; the comment deadline is December 17, 2009. 
• “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses”; comments are due December 8, 2009. 

In addition, the FDA recently has issued a number of final guidance documents, including the following:

• “End-of-Phase 2A Meetings”;
• “Considerations for Allogeneic Pancreatic Islet Cell Products”;  and
• “Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.”

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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. 

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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.

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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.

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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. 

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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. 

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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.  

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On July 28, 2009, the FDA published a final rule requiring holders of new drug applications (NDAs) to submit certain information regarding authorized generic drugs in an annual report. The FDA is taking this action as part of its implementation of the Food and Drug Administration Amendments Act of 2007, which requires the FDA to provide updated listings of all authorized generic drugs. The rule is effective January 25, 2010. 

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The FDA is opening a public docket to obtain public input on implementation of the Family Smoking Prevention and Tobacco Control Act. The agency is particularly interested in comments on the approaches and actions the agency should consider initially to increase the likelihood of reducing the incidence and prevalence of tobacco product use and protecting the public health. In the future, the agency intends to solicit public input on specific issues. Comments will be accepted until September 29, 2009. 

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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. 

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On May 27, 2009, the Food and Drug Administration (FDA) published a notice soliciting comments on a draft guidance document entitled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.”   The draft guidance proposes to use a “reasonable consumer” standard, similar to the Federal Trade Commission's standard, for assessing whether advertisements are misleading, a standard FDA already applies to labels on food and dietary supplements. In the draft guidance, FDA discusses the factors the agency would consider when evaluating prescription drug and restricted device promotional materials directed at healthcare professionals and consumers. The factors include: consistent and appropriate use of language, use of signals, framing of risk information, and the hierarchy of risk information. FDA also states that the agency will review content for both quantity of risk information, as well as materiality and comprehensiveness. Finally, FDA provides extensive factors it considers when evaluating the format of promotional materials.   Comments should be submitted by August 25, 2009; for information on submitting comments, click here.

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The Food and Drug Administration (FDA) has issued a direct final rule clarifying the regulatory procedures for notifying the public about the revocation of a biologics license to be consistent with current practices. The FDA also issued a companion proposed rule to provide a procedural framework to finalize the regulation in the event that the agency receives any significant adverse comments on the direct final rule. The final rule is effective September 17, 2009, unless FDA receives any significant adverse comments. Comments will be accepted until July 20, 2009.  If FDA receives no significant adverse comments within the comment period, it will publish a document confirming the effective date of the final rule; if timely significant adverse comments are received, the FDA will publish a document withdrawing the direct final rule.

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On April 7, 2009, the FDA announced the rates and payment procedures for generic new animal drug user fees for FY 2009. The notice is available here.

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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.

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The FDA published a notice on January 13, 2009 announcing a final guidance document 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 guidance, which finalizes a February 20, 2008 draft policy, is intended to provide manufacturers with the agency's views on permissible distribution by a company's sales representatives of medical journal articles and scientific or medical reference publications that discuss unapproved new uses for FDA-approved drugs or biologics or FDA-approved or cleared medical devices to healthcare professionals. As with the 2008 draft guidance, the final version notes the need to balance the law’s prohibition on distributing or promoting “unapproved uses of approved drugs and approved or cleared medical devices” with the “important public policy” of providing information that “may even constitute a medically recognized standard of care.” The FDA concludes that the touchstone for lawful dissemination of literature about unapproved uses is that the publications “are truthful and non-misleading.” To meet this standard, the FDA final guidance lists “principles of Good Reprint Practices” that include criteria for determining the type of publication and the manner in which the publication can be distributed. Although the final guidance closely tracks the draft guidance, it has some important clarifications, including revisions to the Good Reprint Practices and a specific reference encouraging manufacturers to seek approvals and clearance for new indications and intended uses for medical products.   A Reed Smith analysis of the final guidance is available here.

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The FDA published a notice January 15, 2009 announcing the launch of a voluntary Secure Supply Chain pilot program to help promote the safety of imported drugs and active pharmaceutical ingredients (APIs). According to the FDA, the program would enable the FDA to focus its resources on imported drugs that fall outside the program and that pose a risk of being adulterated, misbranded, or unapproved, while increasing the likelihood of expedited entry for specific finished drug products and APIs into the U.S. that meet the pilot’s criteria. The FDA plans to select 100 applicants to participate in the program, and each applicant may designate up to five drugs for selection in the pilot program. To qualify, applicants will need to meet the pilot's criteria, including a requirement that they maintain control over the drugs from the time of manufacture through entry into the U.S.  The FDA will accept comments on the program through March 16, 2009.

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On January 13, 2009, the FDA published a notice seeking comments on issues related to the enrollment of certain populations in clinical drug trials. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA) section 901, which requires the FDA to report to Congress on best practice approaches to increasing participation of elderly populations, children, racially and ethnically diverse communities, and medically-underserved populations in clinical drug trials. FDA requests comments from medical product manufacturers, IRBs, patient groups, researchers, and other interested parties on possible approaches to increasing participation of these groups in clinical drug trials. Comments will be accepted until February 27, 2009.

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On January 16, 2009, the FDA published a final rule requiring an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets bioequivalence criteria in order for FDA to approve the ANDA, but have not typically submitted additional BE studies conducted on the same drug product formulation, such as studies that do not show that the product meets these criteria. The FDA now believes that additional BE study data may be important in determining whether the proposed formulation is bioequivalent to the reference listed drug, and will increase FDA’s understanding of how changes in components, composition, and methods of manufacture may affect product formulation performance. The rule is effective July 15, 2009.

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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.  

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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. 

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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. 

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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.   

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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.

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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.

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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. 

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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). 

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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.

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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. 

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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.

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On August 22, 2008, the FDA published a final rule amending its regulations regarding changes to an approved new drug application, biologics license application, or medical device premarket approval application.  Specifically, the rule provides that a labeling change to an approved product to reflect "newly-acquired information" that adds or strengthens a contraindication, warning, precaution, or adverse reaction, may be made prior to FDA approval upon the submission of a "Changes Being Effected" or "CBE" supplemental only if there is sufficient (reasonable) evidence of a causal association with the use of the drug, biologic, or device.  In a change from the January 16, 2008 proposed rule, CMS is revising the definition of “newly acquired information” to clarify that data, whether derived from reports of adverse events or from new clinical studies or new analyses of previously submitted data (e.g., meta-analyses) needs to be of a “different type or greater severity or frequency than previously included in submissions to FDA.”  This standard could limit the circumstances under which a company can make changes without prior FDA approval.  The rule is viewed by many as FDA's attempt to address preemption questions raised in state product liability lawsuits against holders of marketing applications for their failure to amend labeling before or without FDA's approval.  The rule is effective September 22, 2008.

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On August 4, 2008, the Food and Drug Administration (FDA) released a series of final guidance documents designed strengthen its management of FDA advisory committees. Among other things, the new policies include stricter limits on financial conflicts of interest for committee members (including a $50,000 cap on the personal financial interest an advisor may have in all companies potentially affected by a meeting), revised voting procedures, strengthened processes for disclosing information regarding advisory committee members’ financial interest information; and procedures for developing and distributing briefing materials considered at advisory committee meetings. The FDA also released draft guidance regarding factors the FDA considers in deciding whether to refer a matter to an advisory committee for consideration.  Notices regarding the guidance documents also were published in the Federal Register.

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On August 1, 2008, the FDA posted its FY 2009 prescription drug user fee rates and medical device user fee rates. 

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On August 6, 2008, the FDA published a notice soliciting comments on its plan to conduct an “Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Broadcast Advertisements.”  Specifically, the FDA will create a variety of television ads for a fictitious medication and study whether visual or other distractions impact a viewer’s comprehension of the ad’s risk and benefit information. The FDA may use this data to determine, among other things, whether additional guidance is needed on how broadcast ads present a prescription drug’s risks and benefits. Comments on the study will be accepted until September 5, 2008.

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On July 16, 2008, the House Energy and Commerce Committee approved amended versions of H.R. 6432, the "Animal Drug User Fee Amendments of 2008," and H.R. 6433, the "Animal Generic Drug User Fee Act of 2008." 

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On July 15, 2008, the Food and Drug Administration (FDA) published a final rule amending the current good manufacturing practice (CGMP) regulations for human drugs and biological products to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements.  FDA will continue to exercise oversight of the manufacturing of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications. In addition, FDA is announcing the availability of a guidance document on "CGMP for Phase 1 Investigational Drugs," which sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs.  FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality.  This action will also streamline and promote the drug development process, according to FDA.

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 On July 15, 2008, FDA is publishing a final rule amending the current good manufacturing practice (CGMP) regulations for human drugs and biological products to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacturing of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, FDA is announcing the availability of a guidance document on "CGMP for Phase 1 Investigational Drugs," which sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action also will streamline and promote the drug development process, according to FDA.

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On July 9, 2008, the House Energy and Commerce Subcommittee on Health approved H.R. 6432, the "Animal Drug User Fee Amendments of 2008," and H.R. 6433, the "Animal Generic Drug User Fee Act of 2008." Additional information is available here.

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On July 2, 2008, the Food and Drug Administration (FDA) announced that it is inviting pharmaceutical companies to volunteer to participate in a pilot program designed to facilitate agency review of quality-by-design, risk-based approaches for manufacturing biotechnology products. The pilot involves the submission of quality (e.g., chemistry, manufacturing, and controls) information for biotechnology products in an Expanded Change Protocol, focusing on products reviewed by FDA's Office of Biotechnology Products (OBP) within the Center for Drug Evaluation and Research. The pilot is open to original submissions of and supplements to biologic license applications or new drug applications reviewed by OBP. Requests to participate in the pilot program must be submitted by September 30, 2009, and comments on the program can be submitted through 2008.

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The FDA has released its “Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan,” which describes the FDA’s vision for improving the automation of business processes and maintaining information systems that support the review process of human drug applications. Comments on the plan may be submitted at any time. Details are available here.

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The FDA has released final guidance to industry on individual product bioequivalence recommendations. 

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On June 19, 2008, the House of Representatives approved a modified version of emergency Iraq and Afghanistan appropriations legislation (H.R. 2642) that also includes funding for a number of domestic priorities. Among other things, the bill would extend a current moratorium on implementation of certain Medicaid regulations and block additional rules through April 1, 2009. The rules affected by the legislation involve: payments to public safety net institutions; coverage of rehabilitation services; school-based administrative and specialized medical transportation services for children; graduate medical education payments; case management services; and state provider tax laws. To finance the repeal, the bill would extend an electronic asset verification demonstration for Medicaid applicants and beneficiaries, and reduce balances in the Physician Assistance and Quality Improvement (PAQI) Fund. The bill also provides an additional $150 million for Food and Drug Administration food and medical product safety efforts, and $25 million annually for Medicaid anti-fraud activities.  The bill does not include restrictions on physician ownership of hospitals, as had been included in an earlier Senate version of the measure. The White House has announced its support for the House bill, although it is unclear at this time whether the Senate will adopt this version or propose additional revisions.

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On June 13, 2008, the Food and Drug Administration (FDA) published a direct final rule removing a requirement for medical device baseline reports that the agency deems no longer necessary. Currently, device manufacturers provide baseline reports when they submit the first adverse event report for a device model.  Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is removing the requirement for baseline reports to streamline reporting requirements.  The rule will become effective October 27, 2008, unless a comment is submitted within 75 days raising a significant objection to the change.  Therefore, FDA also has published a companion proposed rule to provide a procedural framework to finalize the rule in the event the agency withdraws the final rule in response to adverse comments. The FDA will accept comments on both documents through August 27, 2008.

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The OIG has released a report entitled "The Food and Drug Administration's Generic Drug Review Process". The OIG found that FDA disapproved 96 percent of original Abbreviated New Drug Applications (ANDA) under review in 2006 because they did not meet FDA review standards, and that many reviews exceeded the statutory review timeframe. In response, the FDA stated that it is implementing process improvements to address these areas.

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On May 29, 2008, the Food and Drug Administration (FDA) published a proposed rule to make major revisions to drug label requirements related to the use of a drug during pregnancy and breast feeding. Among other things, the agency is proposing to require that labeling include a summary of the risks of using a drug during pregnancy and lactation and a discussion of the data supporting that summary. The labeling also would include relevant clinical information – presented in sections on fetal risks, clinical considerations, and data – designed to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and/or lactation. Current letter categories would be removed from the pregnancy section of drug labeling. Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling requirements for previously approved drugs will be phased-in. The FDA is accepting comments on the proposal until August 27, 2008. Additional information is posted here.

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On May 22, 2008, the Food and Drug Administration (“FDA”) announced plans for what it is calling the “Sentinel System” -- a new, national electronic health information surveillance system to track the performance and safety of medical products once they are on the market. According to the FDA, the Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort. A Reed Smith bulletin discussing this initiative in greater detail is posted here.

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The FDA has published a final rule modifying the requirements for acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or application for marketing approval for a drug or biological product. The rule abandons the requirement that sponsors use the Declaration of Helsinki as the standard for ensuring protections for human subjects and, in its place, requires foreign studies to be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee. The rule is effective October 27.

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The FDA has released a final guidance document entitled “Interactive Review for Medical Device Submissions: 510(k)s, Original Premarket Approval Applications (PMAs), PMA Supplements, Original Biologic License Applications (BLAs), and BLA Supplements”.

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The FDA has released two draft guidance documents regarding the labeling of dietary supplements and the labeling of nonprescription human drug products marketed without an approved application, as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Comments will be accepted on both documents until March 3, 2008. For more information on the first draft, click here.  For more information on the second draft, click here. 

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