Mark Mansour, Partner, Bryan Cave, LLP

Industry, Consumer Advocates Differ in Views of MDUFMA User Fee Negotiations

While consumer advocates are pushing the FDA to increase user fees as part of its next round of negotiations under the Medical Device User Fee and Modernization Act (MDUFMA), industry has indicated that it does not support an increase in such user fees because the FDA has thus far failed to meet its goals put forward in the last round of negotiations. The Medical Device Manufacturers Association has indicated that it is not pleased with the FDA’s progress in meeting its goals, including increased collaboration, predictability, and timeliness, under the MDUFMA and is calling on the agency to work harder toward meeting those goalsbefore it further increases user fees. The agency has indicated that it intends to release draft recommendations regarding user fee reauthorization in about a year’s time and then hold another public meeting. Final recommendations are due to Congress by January 2012. Agency officials have indicated that the changes that the agency is considering with regards to the 510(k) process will also have implications for user fees.

Members of Congress Introduce Bill for Inspection Parity

Four House Democrats in the House of Representatives have released draft legislation that aims to create parity in foreign and domestic inspections of drug manufacturing sites. The legislation would also provide the FDA with mandatory recall authority over drugs.

FDA Seeks Comments on Parallel Review of Medical Products

The FDA and the Centers for Medicare and Medicaid Services (CMS) have indicated that they are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review. This process is intended to reduce the time between FDA marketing approval or clearance decisions and CMS national coverage determinations (NCDs). The agencies are seeking public comment on what products would be appropriate for parallel review by the two agencies, what procedures should be developed, how a parallel review process should be implemented, and other issues related to the effective operation of the process. The agencies also intend to create a pilot program for parallel review of medical devices. More information is available here.

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

Mark Mansour, Partner, Bryan Cave, LLP

Senate Appropriations Committee Funds FDA at Level Requested by President
The Senate Appropriations Committee voted July 15 to approve FDA funding at the President’s requested level, to the dismay of certain stakeholders who had hoped that the agency would be funded at the same level as that recently afforded by the House. The funding includes an additional $2 million for the Office of Generic Drugs and an offset of $5 million, to be determined by the Commissioner. The Committee also expressed its general support for generic drug user fees, for an electronic drug pedigree system that would track drugs as they move through the supply chain, and for guidance from the agency on limiting antibiotics in animal feed.

Mandatory Recall Authority Bill Introduced in Congress
Representative Edolphus Towns has introduced a bill that would give the FDA mandatory recall authority for drugs posing a risk to human health. The bill would permit the agency to order that distribution of a drug stop immediately and be the subject of a recall where the drug posed a risk of serious harm to humans or animals

FDA Withdraws Rule on Pediatric Medical Device Information
The FDA has announced that it has withdrawn a direct final rule that would have required the submission of readily available pediatric medical device information as a part of premarket approval applications, requests for humanitarian use device exemptions, and any product development protocols. The agency decided to withdraw the rule due to significant adverse comment received. More information is available at here.

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

Mark Mansour, Partner, Bryan Cave, LLP

House Committee Votes to Increase FDA Funding
A House Appropriations subcommittee has voted to increase the FDA’s budget by $55 million over the President’s request. The panel passed by unanimous consent the first proposed FDA spending bill for the 2011 fiscal year, funding the agency at $2.57 billion.

Administration Releases Plan Requiring Reporting of Counterfeit Products
The Obama administration has released a plan requiring device makers to report counterfeit products and to submit lists of their products to the FDA twice a year so the agency can better track legitimately marketed devices.

FDA Seeks Comments on Recordkeeping Requirements for Medical Devices
The FDA is seeking comments from the public regarding recordkeeping requirements related to the medical devices current good manufacturing practice quality system regulation. Comments are due by August 23, 2010. More information is available here.

FDA Issues Notice of Termination of EUAs for Certain in vitro Diagnostic Devices
The FDA has issued a notice of the termination of the declarations of emergency justifying Emergency Use Authorizations (EUAs) of certain in vitro diagnostic devices, personal respiratory protection devices, and antiviral products that were issued in response to the public health emergency involving 2009 H1N1 Influenza.

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

Mark Mansour, Partner, Bryan Cave, LLP

FDA: Genetic Testing Kits are Medical Devices

The FDA has sent letters to five manufacturers of genetic testing kits stating that the agency is considering the kits to be medical devices. As such, the agency has said that they need to receive approval from the agency before they can be marketed. The House Energy and Commerce Committee has announced that it too is looking into the tests.

FDA Requests Notifications of Intention to Participate in Meetings on PDUFA Reauthorization

The FDA has issued a notice requesting that public stakeholders notify the agency of their intent to participate in periodic consultation meetings on reauthorization of the Prescription Drug User Fee Act (PDUFA). After the statutory authority for PDUFA expires in September 2012, the FDA will consult stakeholders to develop recommendations for the next PDUFA program. Notifications of intention to participate must be submitted by June 25, 2010. The first stakeholder meeting will be held on July 1, 2010, from 9 a.m. to 11 a.m. More information is available here.

FDA Corrects Dental Device Final Rule

The FDA has issued a notice that it is correcting an error in its Final Rule on dental devices, published on August 4, 2009. More information is available here.

FDA Seeks Comments on Labeling Requirements, Premarket Approval, Drug Co-Development

The FDA is seeking comments on the standardized format and content requirements for the labeling of over-the-counter (OTC) drug products. Comments are due by August 2, 2010. More information is available here.  The FDA is seeking comments on requirements for premarket approval of medical devices. Comments are due by August 9, 2010. More information is available here. The FDA also seeks comments on methods to co-develop two or more distinct investigational drugs intended to be used in combination to treat a disease or condition. FDA is planning to develop guidance for industry and other affected parties on the co-development of two or more novel drugs intended to be used in combination (but not as not fixed-dose combinations) and is seeking public input to identify the affected parties’ information needs concerning such co-development. Comments are due by September 7, 2010. More information is available here.

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

Mark Mansour, Partner, Bryan Cave, LLP

Court Says Patent Settlements May Violate Antitrust Laws

A federal appeals court in New York indicated that patent settlements reached by drug companies may violate antitrust laws when they include payments to rivals to delay the introduction of generic products. The Justice Department has previously asserted that those types of payments may be illegal and the FTC has called on courts to consider the merits of the patents at issue when determining whether such settlements should be valid. FTC Chairman Jonathan Leibowitz has stated that these settlements cost consumers $3.5 billion per year through higher drug prices.

House Committee: FDA Didn’t Pursue Leads on Heparin Contamination

Members of the House Energy and Commerce Committee have stated that they have concluded an investigation into the FDA’s handling of the contaminated heparin crisis and found that the FDA failed to pursue certain leads which could have uncovered those responsible.

Speakers at Conference Advise Companies Not to Wait for FDA Guidance to Use Social Media

Speakers at a recent FDLI annual conference encouraged companies not to wait until after the FDA issues guidance on the use of the internet and social media to use those mediums. They did recommend that companies use caution when using social media or developing certain websites, including not promoting specific products and monitoring the sites and postings regularly.

FDA Seeks Comments on Proposed Collections of Information

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of information on administrative procedures for the Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization. Comments on the collection of information are due July 6, 2010. More information is available here.

The FDA is also seeking comments on for research entitled “Experimental Study of Patient Information Prototypes.” This study is designed to determine, based on different prototype testing, whether consumers are able to comprehend serious warnings, directions for use, drug indications and uses, contraindications, and side effects in the material that is presented. Comments are due July 6, 2010. More information is available at here.

The FDA has also announced that it has submitted a proposed collection of information regarding requirements for submission of labeling for human prescription drugs and biologics in electronic format to the Office of Management and Budget (OMB) for review and clearance. Comments on the collection of information are due June 3, 2010. More information is available here.

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

Mark Mansour, Partner, Bryan Cave, LLP

FDA Launches New Initiative to Measure Performance

The FDA announced the launch of its newest initiative, FDA-TRACK, this week. The initiative is designed to help measure the agency’s performance through using a series of quantifiable benchmarks that would give congressional appropriators a clear understanding of how well the FDA uses its money.

PREDICT Rollout Delayed Indefinitely

The nationwide rollout of the FDA’s PREDICT electronic ranking system, designed to help uncover adulterated and misbranded imports, has been delayed indefinitely, due primarily to issues relating to IT infrastructure.

FDA Issues Final Rule on Device Pre-Market Submissions

Under the FDA’s final rule published on March 31, pre-market approval applications, beginning in August, will be required to include additional data on pediatric patients who suffer from diseases or conditions treated by the sponsor’s device. The rule requires MA applications, humanitarian device exemption (HDE) applications and PMA supplements for new intended uses to include “readily available” information on any pediatric subpopulations that suffer from the disease or condition addressed by the sponsor’s device, as well as information on the number of pediatric patients who might be treated with the device.

FDA to Release UDI Database Proposed Rule

CDRH has indicated that it expects to release a proposed rule for a unique device identifier (UDI) database this summer and is aiming at having a final rule in place by April 2011. Once the final rule is out, manufacturers of Class III devices will have one year to comply.

FDA Announces New Process for Approval of Radiotherapy Equipment

The FDA has announced that it will strengthen its approval process for new radiotherapy equipment and will no longer allow new radiotherapy equipment to use the streamlined approval process, in an effort to reduce overdoses, underdoses and other errors in radiation therapy.

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

Mark Mansour, Partner, Bryan Cave, LLP

Industry Submits Comments on 510(k) Review, Use of DeNovo Process

Reports are predicting that, as the FDA considers changes to its 510(k) review process, it will face difficulties in expanding or creating a vehicle for the review of novel medical devices without requiring those technologies to go through the more cumbersome premarket approval process. Although some industry groups have called for the increased use of the DeNovo process for novel technologies, industry experts are indicating that the use of that avenue is complicated by a lack of resources and by the requirement that the FDA develop specific guidance documents for each approved device, a process that consumes agency resources and may make the agency more hesitant to such expansion.

Others are also submitting comments on the 510(k) review process, as it undergoes reevaluation from the FDA. Comments include that the database requiring manufacturers to enter exact keywords to locate a predicate device is ineffective. In addition, industry has submitted comments regarding whether the FDA should have rescission authority for its 510(k) substantial equivalence decisions. Industry lobbyists have commented that such rescission authority should be limited to extreme cases of fraud. These groups state that the agency can make use of other means to remove problematic devices from the market, such as banning the product, mandating a recall, or ordering a product seizure.

FDA Amends Public Hearing Regulations

The FDA is amending its regulations on public hearings before public advisory committees to reflect an internal change with respect to the staff that handles the nomination and selection process for nonvoting members representing consumer interests for standing technical advisory committees. The FDA is also revising the address where the nominations for nonvoting members representing consumer interests should be submitted. For more information click here.

FDA Proposes Amendments to DTC Advertising Regulations

The FDA is proposing to amend its regulations concerning direct-to-consumer (DTC) advertisements of prescription drugs. Specifically, the proposed rule would implement a new requirement of the Federal Food, Drug, and Cosmetic Act, added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that the major statement in DTC television or radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. Written comments are due by June 28, 2010. For more information click here.

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

Mark Mansour, Partner, Bryan Cave, LLP

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

Mark Mansour, Partner, 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

Mark Mansour, Partner, 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