Advocates: FDA deal with drug makers ‘opaque’

Consumer advocates are blasting the FDA for the process it has used to renegotiate the terms of the drug approval process following news that a deal has been reached with industry on proposed changes to the process.

The FDA had been holding two sets of meetings in working out an agreement on the Prescription Drug User Fee Act, which Congress must reauthorize in 2012. One set has been held with representatives of PhRMA and the Biotechnology Industry Organization, the other with stakeholders including patient groups, consumer advocates and provider organizations.

According to an email obtained by POLITICO, industry accepted an FDA proposal “shortly before Memorial Day weekend” and forwarded an agreement to HHS last week. But stakeholders did not receive details on the deal until Wednesday morning. The email, which was forwarded to POLITICO by a source, was sent by Theresa Mullin, the Director of the Office of Planning and Informatics in the FDA Center for Drug Evaluation and Research.

The slides provided by the FDA to stakeholders also did not include all aspects of the deal, including the dollar amount set for user fees for the 5-year reauthorization window. An industry source confirms to POLITICO that fees will increase only $100 million over their current level, from $2.9 billion under the last reauthorization to $3 billion — an amount that keeps pace with inflation. These fees are paid by drug companies when they submit new products for review and help finance the approval process.

“I was not surprised that we were left in the dark,” said one rueful consumer advocate participating in the stakeholders’ meetings on background. “We went through the motions but the real deal was over there with industry and the process was opaque.”

“The whole process is very questionable,” said another stakeholder participant, Diana Zuckerman, president of the National Research Center for Women and Families.

Though Zuckerman said the stakeholder meetings gave a chance for input that was not available during the 2007 reauthorization, they have not fundamentally changed the process.

“We say what we want, then the FDA is supposed to reflect that [in negotiating with industry]. But as you can see from this apparent agreement, that hasn’t happened,” she said.

Many provisions of the deal respond to industry concerns that approval timelines have been slipping due to new requirements placed on the process by Congress. Mullin wrote that the FDA rejected a demand for new review deadlines, instead taking steps to “increase communication the FDA and sponsors during review.”

There is no plan to add new personnel to speed the core review process, which may have required additional user fees to pay their salaries. However, the agency will create a dedicated liaison unit to help companies navigate the review process.

Additional personnel would better be used to do scientific work, said Zuckerman, instead of doing “customer service” for drug makers. And much greater resources are needed to cover the cost of guaranteeing patient safety.

“Basically in these negotiations, because it’s industry money, FDA’s never negotiated as a full partner. They’ve negotiated as a supplicant,” she said.

Another consumer advocate echoed the sentiment that the reliance on user fees places far too heavy an emphasis on the approval timeline rather than patient safety, remarking, “The process is too much about the idea that industry needs to be serviced in exchange for these fees.”

Some elements of the deal did have support among stakeholders, however. Cynthia Bens, director of public policy at the Alliance for Aging Research praised the FDA for “taking to heart comments from the patient community about how they could improve the [approval process],” including reconfiguring the risk/benefit calculation to be more “sensitive to the needs of patients” awaiting treatments.

Bens also defended the two-track process.

“I think there can always be more [stakeholder involvement], but ultimately patients aren’t the ones who are putting the money forward, so I see why the [stakeholder] process is separate” from industry’s negotiations, she said.

The FDA’s Mullin highlighted provisions of the deal as reflecting stakeholder input when writing to stakeholders.

“Throughout this negotiation process, your identified priorities for strengthening regulatory science and patient safety have played a critical role in our success in getting these enhancements included in the PDUFA V package of proposed recommendations,” she wrote.

PhRMA would not comment on details of the agreement, but Senior Vice President for Scientific and Regulatory Affairs Dr. David E. Wheadon praised the process in a statement for being “characterized by unprecedented transparency, including the FDA holding the first of its two planned public meetings and posting minutes from industry negotiating sessions and stakeholder meetings on its website.”

BIO’s Sara Radcliffe, executive vice president of health, provided POLITICO a statement that said, “FDA, BIO and PhRMA have agreed on a package of proposed technical recommendations that will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance.”

FDA spokeswomen Karen Riley declined to comment on any of the specific details of this process.

“The package of proposed recommendations is currently undergoing further administration review and that we cannot comment on the details of the package,” Riley wrote in an email.

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