Pharma’s Cutting Edge

PDUFA H.R. 3580 (2007)

In a 405-7 vote, the U.S. House passed legislation reauthorizing PDUFA.  The full-text link to the approved legislation is above.  Here are some highlights of the bill focused on amendments to laws affecting regulation of drugs (devices are also covered under the bill), which must now be passed by the Senate without further amendment (as early as this afternoon) and signed by the President before becoming law.

1. Fees: Total revenues from fees comparable to prior fees are set at $392.8M during FY 2008-2012, a 51% increase over FY 2007 expected revenues. In addition, fees are set aside specifically for drug safety, beginning at $25M for FY 2008, and progressively increasing to $65M by FY 2012.  Congress eliminated the orphan-drug exception to fee collection from companies with more than $50M in gross worldwide revenues for the preceding 12 months prior to the exemption request. Congress authorized collection of an advisory review fee for DTC ads submitted for advisory purposes to FDA prior to their public dissemination. The fee may not exceed $83,000 per advisory review and may not increaase more than 50% year over year. Total revenues from such fees are set at $6.25 M for FY 2008-2012.2. Drug Safety Surveillance: The expected scope and performance of drug safety surveillance supported by FDA is increased, with Congress explicitly authorizing use of “improved adverse-event data-collection systems…and improved analytical tools.”

3. Pediatric Research:  The Pediatric Research Equity Act and The Best Pharmaceuticals for Children Act are reauthorized with minor modifications.

4. FDA Modernization: The Reagan-Udall Foundation is authorized.  This non-profit foundation’s purpose is to advance FDA’s mission to modernize development of medicines, foods, and cosmetics, accelerate innovation, and enhance product safety.  The Office of The Chief Scientist is created to “oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs…” of FDA.  Public-private partnerships between FDA and non-profit institutions to advance FDA’s Critical Path Intiative is established.

5. Conflicts of Interest: Waivers allowing financially conflicted experts to participate in advisory committee meetings are expected to to drop by 5% per year from the base year waiver percentage of 2007 (set as 100%) from 2008 through 2012, such that the percentage of meeting exceptions granted in 2012 will be 75% of that in 2007.

6. Clinical Trial Databases: The amount of information captured for the U.S. trial registry is significantly expanded to include more data pre-trial and links to results from trials, including results that are written in language comprehensible by lay audiences.  Result updates are to be made annually. HHS has three years after passage of PDUFA 2007 to implement this expansion fully.

7. Postmarket studies and surveillance:  Entire sections are added regarding postamarket studies and risk evaluation and mitigation strategies.  Probably the most important new addition is the requirement that sponsors respond to FDA notice of a postmarket safety issue with a supplemental label change.  FDA decides unilaterally when to make such notifications.  The sponsor’s proposed label change change is subject to review and discussions.  However, such discussions may last only 30 days following FDA notification, and within 15 days after conclusion of discussions, FDA may issue an order directing the labeling change. Within 5 days of this order, an appeal may be made using normal dispute resolution procedures.  Similar rules regulate notifications of a need for risk mitigation strategies.  Should sponsors fail to respond appropriately to FDA postmarket safety or risk mitigation notifications, drug products would no longer be qualified for sale in the U.S.

Congress has also authorized development of postmarket risk identification and analysis methods that includes linkages among multiple sources of data, with goals of at least 100,000,000 patients [under analysis] by 2012. FDA is authorized to seek public-private collaborations to improve its postmarket risk identification and analysis methods.

8.  Television and other DTC ads: FDA is given authority to require submissions of TV ads no later than 45 days before they are aired. FDA will establish standards in the next 30 months that will be used to determine whether a major statement relating to side effects or contraindications is presented appropriately. First-offense fines for false or misleading DTC ads are $250,000, with $500,000 per each subsequent violation.  A report on DTC ads and their benefits to subsets of the general population will be filed within 24 months of PDUFA 2007 passage.  A schedule for payments of fines, including fines for recurring violations, has been added to the enforcement rules.

9.  Citizens Petitions:  FDA may now deny a Citizen Petition whose primary purpose is to delay approval of an application and if it does not raise valid scientific or regulatory issues.  The 30-month exclusivity period for generics is extended if a Citizen Petition was filed against its approval and is denied.  The length of extension equals the time period between filing of the Petition and the Agency action on the Petition.  An annual report to Congress describing Petitions that resulted in delayed approvals of generics will be submitted.

10.  Postmarket drug safety information for patients and providers:  FDA must improve its procedures for internet-based dissemination of drug information to include a central clearinghouse of safety data and label information and enabling “patients, providers and drug sponsors to submit adverse event reports thrugh the Web site.” FDA will also establish an advisory committe on risk communication.

_________________________________________________

There’s lots of well-intentioned stuff here, although one has to wonder how well some of the “wish list” items for FDA future operational improvements can be encouraged into action by legislation.  It seems to me as if  Congress is trying to substitute itself for effective FDA and HHS leadership, and that will never work.  Indeed, the best potential FDA leaders will be discouraged from taking the job if Congress is viewed as their micromanager.  That said, at least this Congress has made it known explicitly what it overwhelmingly believes are the top priorities for this Agency, and its hard to argue against their priorities.