According to a letter obtained by FDA Week, “a coalition of patient, consumer and public health advocates is bypassing the Food and Drug Administration (FDA) and directly asking Health and Human Services (HHS) Secretary Kathleen Sebelius to include in the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA):
- Better monitoring of direct-to-consumer (DTC) advertisements,
- An expansion of the Sentinel Initiative, and
- Greater flexibility in the Risk Evaluation and Mitigation Strategies (REMS) program
The group argues that its ideas were dismissed with little debate during closed-door FDA-industry meetings, even though FDA faced new requirements during this PDUFA reauthorization cycle to include consumer and patient groups in the process.
Members of the Patient, Consumer and Public Health Coalition — which includes the National Research Center for Children and Families, Consumers Union and the Union of Concerned Scientists — said the FDA-drug industry agreement, which could be formally unveiled in the very near future, “places too little emphasis on improving the safety and efficacy of drugs, they wrote in the letter sent on August 22nd to Sebelius.
Consumer advocates said they have done all they could at the agency level to influence the negotiations and are appealing to the secretary to include their recommendations in the reauthorization. The 2007 reauthorization of PDUFA included a provision mandating that FDA regularly meet with patient and consumer groups during the negotiation process to solicit feedback.
“The big issue for us is that although we didn’t have major objections in the negotiations, it seemed much more geared toward what is going to benefit the companies,” said Diana Zuckerman, president of the National Research Center for Women and Families.
She said consumer groups do not oppose improving the drug approval process, but resources are being used for meetings, rather than safety and efficacy enhancements.
“We felt that the FDA had given away too much and gotten very little,” Zuckerman said. “We have heard that some of the things we asked for … industry said no, and that was the end of the discussion.”
The group said several initiatives it put forward were never discussed in the formal dialogue with industry, including reforms in DTC television advertising, the adverse event reporting program, and off-label drug use. In particular, the coalition is calling for greater funding to monitor drug promotion efforts, particularly with the growing use of the Internet and social media. It also wants improvements in the MedWatch system and for FDA to conduct research into the safety and effectiveness of off-label drug uses.
The coalition also asked Sebelius to urge Congress to include improvements in clinical trial oversight, which were not a part of the proposed recommendations, including FDA’s original proposal to build quality systems into trial oversight and increase inspection of trial sites, according to the letter.
Safety and efficacy can be undermined if there is a lack of clinical trial oversight, said Cindy Pearson, executive director of the National Women’s Health Network.
“If logic held, what would have the best chance (of getting into the final reauthorization) are things the FDA is openly admitting it proposed and had to give up in the negotiations,” she said. “We are holding out hope that the secretary might be able to use her power in the next phases to get that back in.”
Advocates said while they are pleased that the FDA-industry pact includes proposals to improve the Sentinel and REMS programs, they don’t “adequately describe the reforms that will be needed to implement the necessary changes successfully”, according to the letter.
The FDA-industry agreement does not explicitly commit FDA to scaling up from the Sentinel’s pilot stage to the full system and is more focused on anticipated risks rather than a broader approach that would allow the system to provide preliminary data on unexpected adverse reactions, the letter said.
“We had hoped it would be more of an early warning system that would look at everything” not just expected problems, Zuckerman said.
The group is also concerned that standardizing the REMS system to make it easier and less expensive for pharmacies could take away needed flexibility, and “unique features should be permitted in a REMS to deal with unique situations.”
The FDA-industry PDUFA agreement is expected to be presented to Congress in early January, after the agency holds a public comment period and considers revising the pact before its transmittal. However, the agreement — codified after months of closed-door talks — is reviewed by both the HHS policy shop and the White House before becoming the administration’s position. While elements of the pact are public, the precise language has not been released, which is expected to occur in the very near future.