Democratic leaders eye FDA reforms

Officials at the Food and Drug Administration (FDA) and representatives of the pharmaceutical industry can expect to spend a lot of their time next year testifying before congressional committees.

One of the Democratic minority’s most frequent criticisms of Republican stewardship of Congress during the Bush administration has been that the GOP has neglected its oversight responsibilities, leading to a lack of reform at some troubled agencies.

The Federal Emergency Management Agency’s response to last year’s Gulf Coast hurricanes and the Defense Department’s contracting practices have attracted particular scrutiny.

But congressional Democrats have also been highly critical of the FDA’s record on the safeguarding of new medicines when they reach the market.

Draft bills are already circulating, said one aide to a Democratic lawmaker who is active on FDA issues.

A senior FDA official acknowledged this week that the agency anticipates drug safety coming under the Democratic microscope.

“These issues are likely to be front and center when the new Congress convenes next year,” Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb said this week in a speech to the Manhattan Institute in New York, according to his prepared remarks.

To be sure, Republican committee chairmen have also gone after the FDA in recent years.

The Senate Health, Education, Labor and Pensions (HELP) Committee, for example, plans to hold an oversight hearing today on drug-safety issues. Also in the Senate, Finance Committee chairman Chuck Grassley (R-Iowa) has been one of the agency’s harshest critics despite his panel’s lack of jurisdiction over the agency itself.

HELP Committee chairman Mike Enzi (R-Wyo.) and ranking member Edward Kennedy (D-Mass.) have co-sponsored a bipartisan drug-safety bill, while Grassley and HELP Committee Democratic Sen. Chris Dodd (Conn.) authored a competing bipartisan bill.

Kennedy plans FDA oversight hearings early in the year and will reintroduce his and Enzi’s bill, a spokeswoman said.

The House Energy and Commerce Committee also staged hearings on drug-safety issues.

But the Republican majority failed to enact new legislation to bolster the agency’s oversight of the safety of drugs and other medical products, to the consternation of leading congressional Democrats.

Congressional attention to drug safety and the FDA’s performance has centered on the 2004 withdrawal of Merck’s popular prescription painkiller Vioxx after evidence emerged linking it to heart problems.

In addition, the Bush administration’s difficulty filling the position of FDA commissioner has kept the agency in the spotlight. The nomination of acting Commissioner Andrew von Eschenbach has languished in the Senate, mostly over individual holds threatened by senators unhappy with the agency’s actions on emergency contraception and the abortion pill and its opposition to expanded importation of drugs from other countries.

Former Commissioner Lester Crawford resigned his position just months after securing a hard-won confirmation and recently pleaded guilty to charges that he failed to comply with federal rules regarding his financial holdings.

In addition to lingering dissatisfaction among Democrats about the agency’s performance, the new Democratic majority has an obvious legislative vehicle to use to advance its plans for the FDA.

The Prescription Drug User Fee Act expires at the end of 2007 and a reauthorization of the statute was expected on the agenda regardless of which party controlled Congress.

The last Democratic majority enacted this law, known as PDUFA, in 1992 to require pharmaceutical companies to pay fees to the FDA to offset the costs of reviewing their drug-approval applications and monitoring the safety of drugs already on the market. The Republican Congress reauthorized the statute in 1997.

The reauthorization this time around will be managed by some of the key figures who drafted the original legislation: Reps. John Dingell (D-Mich.) and Henry Waxman (D-Calif.) and Sen. Kennedy.

Presumptive Energy and Commerce Committee chairman Dingell sponsored the original legislation when he last chaired the committee. One of his chief allies was Waxman, then chairman of the committee’s Health Subcommittee and now slated to be chairman of the Government Reform Committee. Kennedy, the once and future chairman of the HELP Committee, shepherded the measure through the Senate.

The FDA and the drug companies are engaged in ongoing talks about how to restructure the program and how to set the fees beginning in 2008. Gottlieb suggested yesterday that the agency might seek higher fees from drug companies and direct the new money to improving its monitoring of drugs on the market.

The FDA and the industry hope that Congress will use any eventual agreement as a starting point for legislation, but congressional Democrats may have other plans.

The PDUFA reauthorization process is expected to serve as a platform for other FDA reform initiatives, such as a proposal to create an independent office of drug safety. The debate “will provide a big opportunity for the entire Congress to get into this issue” of FDA reform, the Democratic aide said.

Some Democrats and consumer groups have argued that the user-free program has made the FDA too dependent on — and too cozy with — the industry. At least one congressional Democrat plans to propose that the fees no longer go directly to the FDA but instead be diverted into general revenues to be doled out in the appropriations process.

The outcome of the PDUFA debate also could determine whether appropriators seek to allocate additional funding for the FDA from the treasury. House Democratic appropriators such as Agriculture Subcommittee ranking member Rosa DeLauro (Conn.) and Rep. Maurice Hinchey (N.Y.) have been vocal in their complaints about the agency. The FDA is funded under agriculture appropriations, separate from the other agencies in the Department of Health and Human Services.

In addition to drug safety and funding issues, congressional Democrats have highlighted their plans to speed cheaper generic drugs to the market, expressed concerns over alleged repression of dissenting scientific opinions at the FDA and complained about the people the administration chooses to sit on influential advisory committees.

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