The Complete Pharm Exec Guide to PDUFA - Pharmaceutical Executive


The Complete Pharm Exec Guide to PDUFA
What Congress's grand plans for the "revitalization' of FDA really mean...besides more red tape

Pharmaceutical Executive

5 Safety Information

Both bills would provide $25 million in funding for FDA to do "routine active surveillance" of postmarket drug safety. The Senate bill aims for a public–private partnership in which the agency would pool data from federal and private health databases and hire private research groups to investigate priority safety signals. The House bill, by contrast, would direct the agency to consult with experts to develop methods of integrating and analyzing data from multiple sources and then require it to enter into partnerships to allow the analysis of available data from various sources to support identification of safety signals.

Under either approach, the key will be ensuring that the methodologies are sound and that the information emerging from these analyses is properly communicated. A loosely controlled data-mining effort could raise a stream of drug safety "concerns," with little context provided for physicians or patients. Of significant concern is the fact that neither bill is explicit about whether drug sponsors—presumably the best source of information on the safety of products—would have a significant role in developing these data-mining efforts. Although industry involvement would undoubtedly be met with allegations of a conflict of interest, it is in fact essential to ensuring full information and rigorous analyses.

The Senate bill also would establish, one year after enactment, a Web site devoted to pharmaceutical data and risk communication. The House bill would again go much further, requiring FDA to collect, analyze, and publish an array of "emerging" safety information, including: a summary analysis of the adverse-drug-reaction reports received for recently approved drugs; a biweekly report based on a screening of the Adverse Event Reporting System (AERS) database; a report to Congress on the Office of Surveillance and Epidemiology recommendations and consultations on postmarket safety activities; an annual review of the entire backlog of postmarket safety commitments to determine which require revision or elimination; and the development of "postmarket safety performance measurable and rigorous as the ones already developed for premarket review." Many in the industry are concerned that such use of the AERS database will whip up unwarranted, premature panics among patients and in the media regarding possible drug dangers.

6 DTC Advertising

An earlier attempt in the PDUFA IV legislative process to authorize FDA to impose moratoria on DTC advertising as part of a REMS failed, partly as a result of intense advertising-industry lobbying and constitutional concerns. The House bill would require every DTC ad to include the following statement: "You are encouraged to report adverse effects of prescription drug medication to the FDA. Log onto or call 1-800-FDA-1088." Moreover, as part of the new REMS framework, FDA could also demand specific risk disclosures in DTC advertising. Both bills include civil penalties for running a false or misleading consumer ad.

7 Pediatric Research

Both bills would reauthorize the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). However, in a provision that could create a dangerous precedent and weaken pediatric-research incentives, the Senate bill would cut pediatric exclusivity to three months if US sales of the drug exceed $1 billion annually. This so-called blockbuster provision, which grew out of accusations that companies were being unjustly enriched for their pediatric-research efforts, was stricken from the House bill. The Senate bill also includes a five-year sunset on the changes to PREA, while the House bill makes the provision permanent.

8 Clinical Trials Database

While both bills would require the public registration of clinical trials post–Phase I, they differ over publicizing clinical trial results. The House bill would establish a registration-and-results database within one year of enactment, spelling out specific requirements for the content of results submissions; the Senate bill provides for a negotiated rule-making, with a final rule issued within two and a half years of enactment. Although many believe the creation of this national database is a laudable step toward increasing the transparency in industry research efforts, it will almost certainly fuel further public drug safety debates—some constructive, others alarming to patients.

9 Conflicts of Interest

While the Senate bill would largely codify current FDA practices for granting waivers for advisory committee members with a "financial interest," the House bill would limit advisory committee meetings to one financial conflict-of-interest waiver per meeting. This rigid requirement could deprive FDA of critical advice from the best experts in the field.


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