On May 9, the Senate ended weeks of debate and passed S. 1082, the Food and Drug Administration Revitalization Act. The two primary aims of the bill are to renew the Prescription Drug User Fee Act and to generally strengthen the regulatory authority of the U.S. Food and Drug Administration (FDA).

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). PDUFA gives the FDA the authority to collect fees from pharmaceutical companies for the safety review and approval of new drugs. Under the original legislation, Congress must reauthorize PDUFA every five years. PDUFA is set to expire Sept. 30.

If signed into law, the Food and Drug Administration Revitalization Act would renew and expand the user fee program. FDA would increase the amount of user fees it collects to almost $400 million, up from approximately $300 million. User fees would fund approximately half of the agency's drug review program and a fifth of the agency's overall budget.

While user fees account for a significant portion of FDA's funding, critics say the program ties the interests of FDA's drug approval office too closely to those of the pharmaceutical industry. In an open letter, the public interest group Public Citizen tells Congress "the agency has become dependent for its funding upon the very industry over which it has regulatory authority." Due to the dependence on user fees, the letter says, "pharmaceutical companies are increasingly seen as stakeholders, customers or even clients."

However, because user fees account for such a large portion of FDA funding and expiration of PDUFA is looming, a reauthorization bill is considered must-pass legislation. FDA has indicated it will notify drug review employees of potential layoffs if reauthorization is not signed into law by July.

In addition to reauthorizing PDUFA, the Senate bill proposes expanding the regulatory authority of the FDA. Recent controversies concerning the safety of the food and drug supply has subjected FDA to increasing public and congressional scrutiny. PDUFA reauthorization provided a vehicle for senators to address public concerns and to attempt to solve FDA's problems. Subsequently, the legislation morphed into a broad-based FDA reform measure.

In response to controversy over the arthritis drug Vioxx and other high-profile FDA missteps resulting in recalls, the Senate bill includes provisions to strengthen FDA's regulatory authority for drugs already on the market. The legislation would expand FDA's ability to require drug companies to perform post-market safety studies and perform "risk evaluation and mitigation" for drugs exhibiting adverse effects.

The legislation would also allow FDA to promptly order drug companies to change the labeling for a drug, a process which industry is now able to delay. Other post-marketing provisions include the creation of a database allowing FDA to collect information on adverse health effects and the expansion of a program rewarding drug makers who study adverse effects of drugs on pediatric health.

The legislation would expand FDA's ability to impose civil penalties on drug manufacturers. One measure would give FDA the authority to fine drug companies for false or misleading direct-to-consumer advertising. One of the bill's amendments inserts language that would allow FDA to impose fines of up to $2 million on delinquent pharmaceutical companies. Sen. Charles Grassley (R-IA) introduced the amendment, and the Senate agreed to it.

Another measure would expand FDA's regulatory authority on pet food. The recent controversy over melamine contamination exposed the inability of FDA to adequately regulate or recall pet food. Sen. Richard Durbin (D-IL) sponsored an amendment inserting language which would require FDA to promulgate better standards for pet food ingredients, improve labeling and make it easier for FDA to conduct recalls. The Senate agreed to the amendment without a dissenting vote.

Much of the debate on the Senate floor centered on controversial amendments related to drug importation. Sen. Byron Dorgan (D-ND) led the charge in attempting to insert language which would allow the importation of drugs from Canada and the European Union. Dorgan cited a Congressional Budget Office study claiming drug importation would generate savings of $50 billion over ten years.

Sen. Thad Cochran (R-MS) introduced an amendment to Dorgan's amendment. Cochran's provision would require the Department of Health and Human Services, of which FDA is a part, to approve all imported drugs. Due to the substantial burden the requirement would impose on the agency, the measure essentially nullifies Dorgan's amendment. The Dorgan amendment passed by voice vote, but only after the Senate attached the Cochran amendment by a vote of 49-40.

Several amendments the Senate failed to approve proposed expanding the scope of the bill. Moments before the final vote on the bill, Durbin introduced an amendment that would have inserted language making it more difficult for scientists with financial conflicts of interest to serve on FDA advisory panels. The Senate did not agree to the amendment in a 47-47 vote. Grassley introduced a provision which would have involved the Office of Surveillance and Epidemiology in post-market safety reviews, a responsibility currently left to the Office of New Drugs. The amendment was rejected 47-46.

The Senate voted 93-1 on the final bill, with Sen. Bernie Sanders (I-VT) voting "nay," citing dissatisfaction over the nullified drug importation provision. The House is in the early stages of developing companion PDFUA reauthorization legislation, which is expected to contain similar regulatory expansion measures.

On May 1, the White House released a statement saying President Bush would veto the bill if it contained the Dorgan drug importation amendment. However, since the Cochran amendment has eliminated the chance of mass drug importation, prospects of a presidential signature have significantly improved.