FDA May Ask for Rescission Authority for 510(k) Clearances

CDRH Director Jeffrey Shuren has stated that, as the agency considers proposed changes to the 510(k) process, it may request additional authority from lawmakers, including 510(k) rescission authority. The agency has said that it is challenged by a lack of robust ability to rescind device clearances. Industry officials argue that any new powers should be limited and restrained, while patient advocates praise rescission authority as an important step towards strengthening the safety of devices cleared through the 510(k) process.

Devicemakers Worried About Bayh’s Retirement

Devicemakers with facilities in Indiana, including Boston Scientific, DePuy Orthopaedics, Medtronic and Zimmer, have expressed concern about losing support in the Senate following Sen. Evan Bayh’s retirement at the end of this year. In announcing his decision to step down, Bayh touted his advocacy for device companies as a major accomplishment; the industry employs more than 45,000 in the state.

FDA Appoints Two to Tobacco Panel

Reports are stating that the FDA has selected Jack Henningfield, VP for research and health policy at Pinney Associates, which works on behalf of GlaxoSmithKline, and Neal L. Benowitz, a UC San Francisco professor who has consulted for GlaxoSmithKline and Pfizer, to a panel responsible for regulating the tobacco industry.

China Health Reform Spending Benefits Device Manufacturers

The $125 billion in spending by the Chinese government to start a national health insurance system is benefiting manufacturers of medical devices, including makers of imaging and diagnostic equipment. $41 billion of this amount is being spent to build 31,000 hospitals and equip them with diagnostic and imaging equipment.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

The past several months have brought forth numerous bits of news, pronouncements, expressions of concern and general uncertainty about the device regulatory regime, but also about FDA’s regulatory paradigm in general.  The recent piece in the New York Times regarding disagreement about the diabetes drug Avandia and the controversy involving accusations of conflict of interest by CDER head Janet Woodcock in the consideration of competing applications for enoxaperin, in the wake of last year’s resignation of Dan Schultz at CDER has led many to wonder where FDA is going under Dr. Margaret Hamburg.

Clearly, the new leadership at FDA is now acutely aware of the number and scale of the issues confronting FDA.  In their overwhelming majority, the scientists and technical specialists at FDA are dedicated and committed individuals.  At the higher levels, however, FDA has suffered from a series of problems, none more troubling in its long-term implications for the future of the industries it regulates, than its absence of imagination.

The FDA’s approach to science is rooted in statistical models, and those models and the people who analyze their results are wholly unwilling (as a matter of culture) to do finely tuned, meaningful risk-benefit analysis.  Several years ago, FDA’s own internal assessment cautioned that this blind reliance on statistical analysis will render it entirely incapable of assessing a new generation of complex devices, medications and combinations. The FDA is earning a reputation for inability to approve a product either safely or accurately, because it evaluates products in a statistical vacuum, without regard to societal benefit, need or even real-world safety variables.

There is some hope to be found in the fact that CDRH recently admitted that it needed new methods and new thinking, precisely along these lines.  That represents a refreshing start, but it will only make a difference if it is inculcated in FDA’s culture as a whole. Dr. Hamburg has quite a challenge ahead of her.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

FDA Seeks Comments on Proposed Information Collections

The FDA has announced an opportunity for public comment on several proposed collections of information. The agency is seeking comment on information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking. The agency is also seeking comments on a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency also seeks comments on its Guidance for Industry on How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine. Comments are due by April 19, 2010.

In addition, the agency is seeking comments on Antimicrobial Animal Drug Distribution Reports and on its Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff: Humanitarian Device Exemption Regulation: Questions and Answers. Comments are due by March 22, 2010.

FDA Seeks Comments on Proposed Data Falsification Rule

The FDA is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. Comments on the proposed rule are due by May 20, 2010. More information is available here.

Court of Appeals Agrees to Delay E-Cigarette Decision

A federal court of appeals has agreed to stay the decision of the U.S. District Court for the District of Columbia that lifted FDA restrictions on e-cigarettes. The court ruled last month that the FDA misused its authority when it classified e-cigarettes as a drug-device combination and placed the products under an import alert.

Drug Companies May Have to Wait Longer for REMS Final Guidance

It is being reported that the final guidance on risk evaluation and mitigation strategies (REMS) may be delayed, as the CDER staff developing the recommendations must also review all proposed REMS from drugmakers.

Companies Comment on Proposed Combination Products Rule

Manufacturers of combination products, including Johnson & Johnson, have submitted comments on the FDA’s proposed rule on good manufacturing practices (GMPs) for combination products, saying that the rule needs more guidance and should better address legacy products.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

CDRH Publishes Strategic Priorities for 2010

CDRH has published its 2010 Strategic Priorities. The four major identified priorities of CDRH include: fully implementing a total product life cycle approach, enhancing communication and transparency, strengthening the workforce and workplace, and facilitating innovation and addressing unmet public health needs. Within these priorities, CDRH has set forth a timeline, in which it states that it intends to begin implementation of the recommendations of the 510(k) Working Group by September 30, 2010. Director Jeffrey Shuren has indicated that he plans to review public comments from a meeting this month and the findings of an internal review, to be completed this summer, before making any proposals. In its notice announcing this month’s meeting on the 510(k) process, the FDA stated that it is seeking comments pertaining to four areas: predicate devices; new technologies and scientific evidence; practices for managing the high volume of 510(k) submissions; and post-market surveillance.

CDRH has also announced that it intends to launch a “Unique Device Identification” (UDI) system by Sept. 30, 2013.

FDA Moves Radiological Devices Branch to OIVD

FDA Commissioner Margaret Hamburg has signed orders to officially move the Radiological Devices Branch to the Office of In Vitro Diagnostic Device Evaluation and Safety, a result of long-term discrepancies between how in vitro and in vivo diagnostics have been regulated by FDA. OIVD will now house four product divisions – the division of chemistry and toxicology devices; immunology and hematology devices; microbiology devices; and radiological devices.

FDA Enforcement Letters on Marketing Campaigns Doubled in 2009

An FDA official has stated that the agency sent 41 enforcement letters in 2009 related to questionable drug-marketing campaigns, almost twice as many as it issued in 2008.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

Some Concerned that New FDA Chief Counsel Lacks Food, Drug Law Experience

Although many stakeholders praised the selection of Maryland’s insurance chief to serve as the FDA’s top lawyer, some have expressed concern that he lacks experience with food and drug law. Still, many see his litigation background as beneficial and complementary to the FDA’s increased emphasis on enforcement.

FDA May Revise Guidance on Medical Device Approvals

The FDA has indicated that it may review its current guidelines on medical device approval and may issue a revised guidance that would require medical device manufacturers to notify the agency of any alterations to approved products. The change would occur as part of a larger agency review under Commissioner Margaret Hamburg and her chief deputy, Joshua Sharfstein.

CDRH Officials to Make 501(k) Process More Predictable

Officials at CDRH have stated that they want to break from what they acknowledge are questionable prior decisions and make the 501(k) process more predictable but are warning that this may mean that companies will need to be wary of relying primarily on past 501(k) clearance requirements or determinations.

FDA Announces Meeting to Identify Strategies for CDRH

The FDA is announcing a public meeting entitled: “Incorporation of New Science Into Regulatory Decisionmaking Within the Center for Devices and Radiological Health.” The purpose of the public meeting is to identify strategies and means for incorporating new science into the regulatory decisionmaking process within the agency’s Center for Devices and Radiological Health (CDRH). The meeting will be held on February 9, 2010, from 8 a.m. to 5 p.m. in Gaithersburg, Maryland. More information is available here.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

Trade Groups Urge FDA to Extend Compliance Period for eMDR Rule

The Advanced Medical Technology Association and other trade groups have called on the FDA to extend from one year to two years the period for complying with a proposed rule that would require device firms to electronically file adverse event reports with the agency.

DOJ Prosecutors Turn Attention to Manufacturing, Safety Issues

Recent cases suggest that the Department of Justice is increasingly pursuing cases related to device manufacturing, adverse event reporting and even product labeling. While the Food, Drug & Cosmetic Act does not have whistleblower provisions, Eugene Thirolf, director of DOJ’s Office of Consumer Litigation, has stated that he predicts that future qui tam cases will cite FDC Act violations, such as manufacturing controls or adverse event reporting issues, as evidence of fraud against the government in False Claims cases.

House Bill Would Let FDA Debar Device Researchers

The Strengthening of FDA Integrity Act, H.R. 3932, introduced by Rep. Joe Barton (R-TX), would grant the FDA authority to debar device clinical trial researchers convicted of felonies. The bill also would require the FDA to send annual debarment reports to Congress and would reduce the time it has to debar a researcher from five years to one.

Submitters Still Confused on Adverse Event Reporting to ClinicalTrials.gov

Device and drug firms that submit details about their clinical trials to ClinicalTrials.gov are still having problems reporting adverse events data, Deborah Zarin, the Web site’s director, told the FDA Risk Communication Advisory Committee on Nov. 12.

Third Parties Could Train Auditors for AP Inspection Program, AdvaMed Says

Janet Trunzo, executive VP of technology and regulatory affairs at AdvaMed, has suggested that the FDA allow FDA-certified, third-party auditing firms train their own investigators.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

The medical device industry is pushing back against calls for the FDA to release data from unsuccessful clinical trials, and has stated that, because the agency’s decision not to approve or clear a device often does not constitute final agency action, the FDA lacks the authority to release that data.

In addition, the FDA’s transparency task force is considering publishing the so-called complete response letters sent to drug companies outlining the outstanding issues, in the hope that the publication of the letters will ultimately speed the review process. Some companies, however, have concerns that the agency’s complete response letters contain trade secrets that would compromise their research if shared.

Mark Mansour is a partner in the firm, Bryan Cave, LLP