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. 

FDA will hold a public meeting on September 23, 2010 to seek input on the manufacturing, characterization, and biocompatibility evaluation of medical devices containing or utilizing nanomaterials and nanostructures, including diagnostics. Meeting participants may either make a short oral presentation or participate in a round-table discussion. Registration for the meeting closes on September 15, 2010. The deadline for submitting written comments to be considered at the meeting is September 15, 2010, and all other comments will be accepted until October 22, 2010. 

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This post was written by Paul Sheives and Areta Kupchyk.

The FDA and CMS have entered into a Memorandum of Understanding (MOU), effective June 25, 2010, to promote collaboration and enhance knowledge and efficiency by sharing information and expertise. In particular, the MOU highlights the agencies’ “common needs for evaluating the safety, efficacy, utilization, coverage, payment, and clinical benefit of drugs, biologics, and medical devices.” Included among the action items in the MOU are the appointment of a liaison for each agency, the establishment of a joint agency meeting to discuss implementing the MOU, an agreement to set reasonable expectations on responses to requests for information, and the implementation of certain safeguards to protect the transmittal and use of trade secret and confidential information. 
 

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This post was written by Paul Sheives and Areta Kupchyk.

FDA announced the medical device user fees for FY 2011, which covers October 1, 2010 – September 20, 2011. The standard fee for a premarket application—or the “base fee”— in FY 2011 will be $236,298. The establishment registration fee for FY 2011 will be $2,179. The FDA has issued a chart listing all of the user fees associated with each type of submission.  The FDA also has announced a September 12 public meeting on the reauthorization of the medical device user fee program.
 

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This post was written by Paul Sheives and Areta Kupchyk.

FDA has made available for comment two reports from internal agency workgroups, one from the Center for Devices and Radiological Health (CDRH) 510(k) Working Group, and another from the Task Force on the Utilization of Science in Regulatory Decision Making. The recommendations proposed in the documents are preliminary. Among the proposed changes are providing information on how FDA will review 510(k)-regulated devices for the true intended use (compared to solely the labeled indication), and fragmenting the categorization of Class II devices for more appropriate data requirements for devices that present similar risk profiles. FDA is accepting written comments on the proposed changes until October 4, 2010. 
 

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This post was written by Paul Sheives and Areta Kupchyk.

As Reed Smith previously reported, FDA issued a direct final rule and a corresponding proposed rule requiring sponsors of premarket approval applications (PMA), humanitarian device exemptions (HDE), and product development protocols (PDP) to submit data on pediatric populations for which the device is intended to treat diagnose, or cure, and the number of affected pediatric patients. FDA noted at the time that the regulation was promulgated based the mandate in the Food and Drug Administration Amendments Act of 2007. A direct final rule must be withdrawn if the Agency receives significant adverse comments. Because significant adverse comments were submitted, FDA has withdrawn the direct final rule and is considering the comments. 
 

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This post was written by Paul Sheives and Areta Kupchyk.

The CDRH has released its 2010 Compliance Strategic Plan. As part of the plan, CDRH intends to implement six goals relating to risk-based strategic compliance planning. Among other things, CDRH will create a database to assist staff to identify “compliance targets” based on weighted factors. Also among the initiatives is a goal to streamline the Warning Letter clearance process. 
 

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This post was written by Paul Sheives.

FDA issued a guidance document entitled “In Vitro Diagnostic (IVD) Device Studies -Frequently Asked Questions,” which is intended to help manufacturers and investigators regarding the development of IVD devices and IVD studies.  The guidance includes information on general regulatory issues, investigational studies, human subject protection, and data considerations. 

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This post was written by Paul Sheives.

FDA and FCC will hold a joint public meeting to discuss regulatory issues arising from the convergence of wireless technology and healthcare devices on July 26 and 27, 2010. The meeting is formally entitled: "Enabling the Convergence of Communications and Medical Systems: Ways to Update Regulatory and Information Processes." The purpose of this meeting is, among other things, to discuss ways to promote investment and innovation in health technology by streamlining government processes. With public input, the agencies hope to identify the challenges and risks posed by the emergence of medical implants and other devices that use radio communications to function. The information gathered will be used to enhance coordination between the FDA and the FCC for healthcare devices and applications and clarify the respective areas of expertise and jurisdiction between the agencies. A list of specific topics on which the agencies are seeking input can be accessed online. Registration to attend the meeting (and to make an oral presentation, if desired) closes July 19, 2010. FDA is also accepting written comments on issues relating specifically to the meeting agenda until June 25, 2010, and general comments until August 16, 2010.

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This post was written by Areta Kupchyk.

The Institute of Medicine (IOM) has issued a report recommending that Congress grant FDA greater authority to require post-market surveillance of medical products approved primarily on the basis of surrogate endpoints. In the May 12 report entitled “Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease,” the IOM also recommends that FDA better harmonize its approach to evaluate biomarkers across the drug, device, biologic, and food centers, as well as convene expert panels to evaluate biomarkers and biomarker tests intended to have a regulatory impact.

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This post was written by Paul Sheives.

FDA has issued draft guidance on the implementation of section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). This provision allows a device manufacturer that has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) using ISO 13485:2003 “Medical devices – Quality management systems – Requirements for regulatory purposes,” to submit the audit report to FDA. If FDA determines there is minimal risk that the establishment will produce nonconforming and/or defective finished devices, FDA may elect to remove the manufacturer’s establishment from FDA’s routine work plan for one year. FDA is accepting written comments on the draft guidance until August 18, 2010.

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FDA is hosting a meeting June 29 and 30 on “FDA Review and Regulation of Articles for the Treatment of Rare Diseases.” The hearing is intended to provide stakeholders, including the pharmaceutical industry, with an opportunity to present their views on the way FDA regulates the scientific evaluation of, marketing authorization for, and postmarket surveillance of, articles pertaining to drugs, biological products, and devices used for rare diseases. Written comments on this topic also will be accepted. 

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On June 9-10, 2010, the FDA is holding a public meeting on "Device Improvements to Reduce the Number of Under-doses, Over-doses, and Misaligned Exposures from Therapeutic Radiation." The purpose of this meeting is to discuss steps that could be taken by manufacturers of linear accelerators, radiation therapy treatment planning systems, and radiation therapy simulators to help reduce misadministration and misaligned exposures. FDA is seeking input on this topic and requests comments on a number of related questions.

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This post was written by Paul Sheives.

FDA has announced changes in the procedures for advisory committees considering medical devices under review for premarket approval, effective May 1, 2010. The changes address staffing issues, voting procedures, and other items related to information presentation and flow of discussion. Among other things, rather than focusing on whether a device should be approved, which is solely in FDA’s discretion, the panels will now vote on only the safety and effectiveness of the device. FDA believes that this change is intended to narrow the focus of the advisory committees and prevent confusion regarding complicated regulatory nuances.

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This post was written by Paul Sheives.

FDA has published two draft guidance documents relating to requests under section 513(g) of the Federal Food, Drug, and Cosmetic Act, which provides a means to obtain the FDA’s views about the classification and regulatory requirements that may apply to a particular device. In the first draft guidance, FDA discusses procedures for submitting, reviewing, and responding to requests for information under Section 513(g). The second draft guidance document discusses the user fees associated with requests under Section 513(g). FDA is accepting comments on these guidance documents until June 28, 2010. 

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This post was written by Paul Sheives.

FDA is hosting a public meeting on May 18, 2010 entitled “Town Hall Discussion With the Director of the Center for Devices and Radiological Health (CDRH) and Other Senior Center Management.” At the meeting, which will be held in Bloomington, MN, CDRH Director Jeffrey Shuren, MD, JD, will present the Center’s FY 2010 priorities and discuss other topics of interest to industry. Registration for the meeting closes May 5, 2010. 

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This post was written by Paul Sheives.

FDA is holding a public workshop entitled “Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device Technology Migrating into the Home,” on May 24, 2010 in Silver Spring, MD. The purpose of the workshop is to seek input from interested parties regarding the issues raised by the use of medical device technology in the home environment. More specifically, FDA seeks input on: (1) the agency’s definition of “home use”; (2) the unique risks of the home environment; (3) the unique characteristics of end users in the home environment; (4) issues with tracking home use devices for the purpose of safety notices and recalls; and (5) device labeling issues for home use. FDA is accepting comments relating to the workshop until June 30, 2010, and registration for attendance closes May 17, 2010. 

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Now that the Patient Protection and Affordable Care Act of 2010 (PPACA) and the companion Health Care and Education Reconciliation Act of 2010 (Reconciliation Act) have been enacted, attention shifts to analysis and implementation efforts. Reed Smith has prepared a number client alerts analyzing various aspects of the new health reform legislation, including a major alert concentrating on those PPACA provisions we believe are of most interest to health care providers and medical device and pharmaceutical manufacturers, along with summaries of major tax-related provisions of the PPACA, PPACA provisions impacting health plans, and the PPACA’s new tax incentives for small biotech companies. Future publications are planned, and will be available here.   

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This post was written by Paul Sheives.

The Food and Drug Administration (FDA) has issued a direct final rule requiring sponsors of premarket approval applications (PMA), humanitarian device exemptions (HDE), and product development protocols (PDP) to submit data on pediatric populations for which the device is intended to treat diagnose, or cure, and the number of affected pediatric patients. These regulations are promulgated based the mandate in the Food and Drug Administration Amendments Act of 2007. In the absence of any adverse written comments received by FDA before the June 15, 2010 deadline, the agency will publish the effective date of the final rule to be 30 days after the comment period ends. 

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This post was written by Paul Sheives.

The FDA, the National Heart Lung and Blood Institute, and the National Science Foundation will host a public workshop in Rockville, Maryland on June 10-11, 2010. The meeting is intended to foster discussion between FDA and industry on the use of computational modeling in the design, development, and evaluation of cardiovascular medical devices. 
 

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On March 26, 2010, FDA issued a proposed rule to implement its statutory mandate under the Food and Drug Administration Amendments Act of 2007 (FDAAA), as well as other legislation, regarding device registration and listing requirements. The amended regulations would require domestic and foreign device establishments to submit all registration and device listing information electronically, not by paper, to FDA. The regulations also expand the information required to be submitted by foreign establishments, as required under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

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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. 

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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.

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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.

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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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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. 

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This post was written by Paul Sheives.

The FDA recently held a hearing to help the agency determine how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the internet and newer technologies. Although the hearing was only an information gathering exercise for FDA, FDA acknowledged the industry’s concern that the Internet is a different medium with unique concerns that must be addressed. 

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This post was written by Paul Sheives.

On November 19, 2009, FDA completed a coordinated and collaborative international effort intended to curb illegal actions involving medical products sold via the internet. The agency issued 22 warning letters to the operators of these web sites and notified internet service providers and domain name registrars that the web sites were selling products in violation of U.S. law. FDA noted that, in many cases, because of these violations, internet service providers and domain name registrars may have grounds to terminate the websites and suspend the use of domain names. 

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This post was written by Paul Sheives.

FDA released a number of final and draft guidance documents in November, including the following:

• Draft Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins;
• Draft Guidance for Industry: Factors That Distinguish Liquid Dietary Supplements From Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods;
• Draft Guidance for Industry on Dosage Delivery Devices for Over-the-Counter Liquid Drug Products;
• International Conference on Harmonisation; Draft Guidance on E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers;
• Guidance for Industry on Residual Solvents in Drug Products Marketed in the United States; and
• Several final and draft guidance documents on tobacco products, including guidance on listing of tobacco ingredients, applications for modified risk tobacco products, and registration of owners and operators of tobacco product establishments.

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CMS is hosting a town hall meeting on February 10, 2010 to discuss FY 2011 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS).  Also on February 10, CMS is hosting a workshop on the application process and criteria for new medical services and technologies under the IPPS and on the outpatient prospective payment system (OPPS) transitional pass-through payment for drugs, biologicals, and devices and new technology Ambulatory Payment Classification assignment for new services application processes.

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The Agency for Healthcare Research and Quality (AHRQ) has released a "Horizon Scan" entitled "To What Extent do Changes in Third-Party Payment Affect Clinical Trials and the Evidence Base?" The analysis examines the extent to which payment policies may be influencing clinical trial participant recruitment, participation, and retention rates   The report found that several large-scale clinical trials have encountered substantial difficulties due to the deterrent effect of payment policy on participation, with a bigger impact on medical device trials than drug trial. The report called for better coordination among all parties involved in trials, including a strategy covering which costs will be covered and which party will be responsible for such costs.

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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.

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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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The FDA has issued a final guidance document for industry on “Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007.” The FDA also is soliciting comments on a number of draft guidance documents, including the following:

• Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications; to be considered by the agency in developing the final guidance, comments should be submitted by December 30, 2009.
• The Scope of the Prohibition Against Marketing a Tobacco Product in Combination With Another Article or Product Regulated Under the Federal Food, Drug, and Cosmetic Act;  comments are due January 4, 2010.
• Mammography Quality Standards Act Final Regulations; comments will be accepted until January 7, 2010.

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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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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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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.

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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.

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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.

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On August 4, 2009, the Senate Health, Education, Labor and Pensions Committee is holding a hearing "Protecting Patients from Defective Medical Devices." 

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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.

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A number of Congressional panels have held hearings recently on health policy issues, including the following:

• An Energy and Commerce Oversight and Investigations Subcommittee hearing on "Terminations of Individual Health Policies by Insurance Companies.”
• A Senate Homeland Security and Governmental Affairs Subcommittee on Oversight hearing on S. 372, the "Whistleblower Protection Enhancement Act of 2009."
• An Energy and Commerce Health Subcommittee hearing entitled "Medical Devices: Are Current Regulations Doing Enough for Patients?"

In addition, on June 24, 2009, the House Small Business Regulations and Healthcare Subcommittee is holding a hearing on "Health Information Technology and the New Challenges Faced by Solo and Small Group Healthcare Practices." Also on June 24, the Senate Homeland Security and Governmental Affairs Committee is holding a hearing on "Type 1 Diabetes Research: Real Progress and Real Hope for a Cure."

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A number of Congressional panels have held hearings recently on health policy issues, including the following:

• A House Small Business Committee hearing on “Common Ground: Finding Consensus on Health Reform, the Small Business Perspective.”
• A Special Committee on Aging hearing on the value of long-term care insurance.
• A House Judiciary Courts and Competition Policy Subcommittee hearing on "Pay to Delay: Are Patent Settlements That Delay Generic Drug Market Entry Anticompetitive?"

In addition, the following hearings are scheduled this month:

• A June 10 House Education and Labor Subcommittee on Health hearing on “Examining the Single Payer Health Care Option."
• A June 11 the Senate Health, Education, Labor and Pensions Committee hearing on health care reform.
• A June 11 House Energy and Commerce Health Subcommittee hearing on "Emerging Health Care Issues: Follow-on Biologic Drug Competition." 
• A June 11 Senate Homeland Security and Governmental Affairs Subcommittee on Oversight hearing on S. 372, the "Whistleblower Protection Enhancement Act of 2009." 
• A June 18 House Energy and Commerce Health Subcommittee hearing entitled, "Medical Devices: Are Current Regulations Doing Enough for Patients?"

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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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A number of Congressional panels have held hearings recently on health policy issues, including the following:

• A Senate Judiciary Crime Subcommittee hearing on “Criminal Prosecution as a Deterrent to Health Care Fraud.” 
• A HELP Committee hearing on "Delivery Reform: The Roles of Primary and Specialty Care in Innovative New Delivery Models." 
• A House Oversight and Government Reform Committee hearing on H.R. 1507, the "Whistleblower Protection Enhancement Act of 2009."
• A House Energy and Commerce Health Subcommittee hearing on H.R. 1346, the "Medical Device Safety Act of 2009," which is discussed in greater detail at Reed Smith’s Life Sciences Legal Update blog. 

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The FDA has released a draft guidance document providing technical and scientific information for sponsors to consider in developing information to support a marketing application for a pen, jet, or related injector device intended for use with drugs or biological products. The agency is accepting comments on the draft through July 27, 2009. 

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On June 4 and 5, the FDA is holding a public workshop on Implementation of Post-Approval Studies for Medical Devices. 

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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.

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The FDA has issued an order requiring manufacturers of remaining preamendments class III devices for which regulations requiring submission of premarket approval applications (PMAs) have not been issued to submit to FDA certain safety and effectiveness information. Specifically, these manufacturers must submit a summary of, and a citation to, any available information respecting such devices, including adverse safety or effectiveness information, which has not been submitted under the Federal Food, Drug, and Cosmetic Act. The FDA is requiring the submission of this information to determine whether the classification of each device should be revised to require the submission of a PMA or a notice of completion of a Product Development Protocol, or whether the device should be reclassified into class I or II. The deadline for information submission is August 7, 2009.  

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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.

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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.

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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 Agency for Healthcare Research and Quality's Centers for Education and Research on Therapeutics (CERTs) has launched a new educational web site offering clinicians and consumers expert information on drugs, biological products, and medical devices from a federally-sponsored network of leading research centers. The Clinician-Consumer Health Advisory Information Network (CHAIN) also provides access to informational resources developed from research conducted by CERTS and intended for use in improving health care quality, safety, and effectiveness.

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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. 

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