At safety hearing, Dems lament lack of resources

Many congressional Democrats are uneasy about the fact that pharmaceutical companies pay fees to the Food and Drug Administration (FDA) to get medicines reviewed but are not committed to replacing the industry’s money with new federal funding.

The House Energy and Commerce Committee’s Oversight and Investigations Subcommittee held a hearing yesterday on drug safety, during which lawmakers lamented that the FDA lacked resources in the form of money and staff to improve its performance in drug safety reviews.

Subcommittee members, including full committee Chairman John Dingell (D-Mich.), decried the “cozy ties” between the FDA and drug makers, which pay user fees to the agency to get their applications for new medicines processed.

Nevertheless, the Energy and Commerce Committee will move ahead in coming months with legislation to reauthorize the law that created such user fees, the Prescription Drug User Fee Act (PDUFA). User fees paid by drug and medical-device companies have become an increasingly large share of the FDA’s budget over the years.

Congress enacted PDUFA in 1992 to address the twin problems of funding shortages and a lag in the drug-approval process. Current and former FDA officials, along with many lawmakers from both parties, agree that the program has succeeded in accomplishing these goals. But some are uncomfortable with the real or perceived conflicts of interest the fees perpetuate.
The pharmaceutical industry strongly supports the reauthorization of PDUFA because of its importance to the drug-review process. Nevertheless, healthcare-industry and consumer groups joined together with former federal health officials last year to form the Coalition for a Stronger FDA, which advocates more appropriations for the agency.

Subcommittee Chairman Bart Stupak (D-Mich.) and other Democrats agreed that user fees put the FDA’s credibility as a public-health agency at risk.

“You’re under pressure because of PDUFA and the user fees from manufacturers to push for faster approval of the drug, not to slow down and require more studies be done,” Rep. Henry Waxman (D-Calif.) said.

Committee Democrats, along with full committee ranking member Joe Barton (R-Texas), agreed that the agency is under-funded. In addition to promoting new drug-safety authority for the agency, Waxman said, “We also need to do what it takes to get FDA adequate funding.” Said Barton, “The overwhelming need … is additional resources.”

While authorizing committees are calling for more resources and legislating new responsibilities for the FDA, appropriators do not appear poised to pump enough money into the agency to make the user fees unnecessary.

Rep. Rosa DeLauro (D-Conn.), who chairs the agriculture appropriations subcommittee that funds the FDA, said Tuesday that the balance between federal funds and user fees must be reconsidered. DeLauro would not say whether she would push the Budget Committee or the full Appropriations Committee to set aside more money to achieve that goal.

Rep. Diana DeGette (D-Colo.) suggested that the agency’s reputation and performance might be improved if the user fees are eliminated and supplanted with new federal dollars, citing the recommendations of the Institute of Medicine (IOM).

“Would it be better, as the IOM and [former] FDA commissioners said, just to eliminate that [user fee] portion, which creates a conflict of interest, and go to direct congressional appropriations?” DeGette asked FDA Commissioner Andrew von Eschenbach at the hearing.

Von Eschenbach replied to DeGette that it is only fair that drug makers pay into the review process.

“The issue there is that it puts an even further burden on the American taxpayer and when there’s an opportunity for others to contribute or participate and support this, I think it’s appropriate,” von Eschenbach said.

There are numerous ways to get the right amount of funding for the FDA, von Eschenbach said. “PDUFA happens to be one of the options that’s in place. I think it’s an option that has served us well,” he said.

Von Eschenbach emphasized his view that the FDA can accept fees from the companies and still “be vigilant and rigorous” in the drug-review process.

At an event last month hosted by George Washington University, FDA commissioners from the Carter, Reagan, George H.W. Bush and Clinton administrations endorsed direct federal appropriations for the FDA as preferable to the user fee program.

“The Congress has let the agency down,” Frank Young, FDA commissioner from 1984 to 1989, said in the February meeting. Jane Henney, commissioner from 1999 to 2001, added that presidents share the blame because they do not ask for more funding.

One major institutional obstacle is that the FDA continues to receive its money from the agriculture appropriations subcommittees, Henney said. “There’s very limited resources that the agency can ever hope to receive out of that process,” she said.

“Agriculture appropriators care about farms and food stamps,” former FDA official William Hubbard said this week. Hubbard was associate commissioner for policy and planning from 1991 to 2005 and now serves as a senior adviser to the Coalition for a Stronger FDA.

The rest of the Department of Health and Human Services (HHS) is funded through the Labor-HHS-Education subcommittees. FDA remains under the agriculture panels’ jurisdiction because, when it was founded a century ago, it focused more on foods than drugs.

The agency wouldn’t fare better under HHS appropriations, however, Hubbard said. “Regulatory agencies are never popular for money,” he said.