According to Politico, “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.
“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.”
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 back.
