FDA faces fight with drug companies over use of funds from user fees
The Food and Drug Administration faces a fight this year with drug companies over how the agency uses the money it collects from user fees levied on pharmaceutical firms.
Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America (PhRMA) said at a briefing Friday that negotiations over renewal of legislation known as the Prescription Drug User Fee Act "have not gone as smoothly as last time."
PDUFA, which expires in September, directs the industry to pay a user fee to the FDA that has enabled the agency to hire hundreds of new employees to review new drug applications. Renewal of PDUFA without the addition of controversial FDA reforms is one of PhRMA's top goals this year, and it has been working with the agency to develop a proposal to send to Capitol Hill.
The FDA has expressed interest in using user fee money for its activities outside of application review--such as beefing up its adverse event reporting database, improving post-market surveillance and increasing its vigilance over companies' direct- to-consumer advertising.
But PhRMA's Russ Bantham said funding the FDA's post-marketing activities were not intended as part of the original law and could pose conflicts of interest.
"Citizens need to have total confidence in FDA's enforcement role," he said. However, "these items are part of the discussion," Bantham added.
Several Democrats, including House Energy and Commerce Health Subcommittee ranking member Sherrod Brown of Ohio, have expressed interest in expanding the user fee program. The committee plans to begin hearings on the legislation soon, a Republican aide said.
PhRMA officials said their negotiations with the FDA have been made more difficult by the fact that the agency has been without a commissioner for nearly a year. "For our individual companies, there have been significant challenges without leadership at the top," said Holmer.
PhRMA officials declined to offer support for any particular FDA commissioner nominee, including one of the top candidates, Alistair Wood of Vanderbilt University.