Congress Expands FDA User Fee Program, Reforms Drug Safety Process

Congress has passed legislation which will reauthorize a program allowing the U.S. Food and Drug Administration (FDA) to collect fees from pharmaceutical companies in order to conduct drug approvals. The bill will also dramatically expand FDA's regulatory authority in response to recent controversy. President George W. Bush is expected to sign the bill into law soon.

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.

The Food and Drug Administration Amendments Act of 2007 (H.R. 3580) will renew and expand the user fee program. FDA will increase the amount of user fees it collects to almost $400 million, up from approximately $300 million. User fees will 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, the reauthorization bill was considered must-pass legislation.

In addition to reauthorizing PDUFA, the bill will expand the regulatory authority of the FDA. Recent controversies concerning the safety of the food and drug supply have subjected FDA to increased public and congressional scrutiny. PDUFA reauthorization provided a vehicle for lawmakers to address public concerns and to begin 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 drug recalls, the bill includes provisions to strengthen FDA's regulatory authority for drugs already on the market. The legislation will 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 bill will also give FDA more authority to regulate direct-to-consumer advertising of pharmaceuticals, an arena over which FDA has held scant regulatory authority. However, the bill does not go as far as some drug safety advocates desired because it will not give FDA the authority to ban direct-to-consumer advertisements found to be false or misleading.

The legislation will also allow FDA to promptly order drug companies to change the labeling for a drug, a process which industry has been able to delay. The bill will also expand FDA's ability to assess civil penalties if drug companies violate any of these provisions.

Other post-marketing provisions include the creation of a publicly-available clinical trials database. Under the bill, the National Institutes of Health will administer a database where the public can search the results of clinical trials of drugs and medical devices. Drug safety advocates believe — by allowing individuals to examine separate studies of the effects of individual drugs or medical devices — the database will facilitate the ability of medical researchers to detect adverse effects.

While the primary focus of the bill is on improving FDA's regulatory regime for drugs, the bill includes some provisions related to food safety. The bill will give FDA the authority to better regulate, and recall if necessary, pet food. This comes in response to the contaminated pet food outbreak which occurred in March 2007.

On May 9, the Senate had passed its version of the PDUFA renewal and FDA reform legislation (S. 1082). The House had passed its version (H.R. 2900) June 21.

However, negotiations between the two chambers stalled, and Congress did not form a conference committee to reconcile the two bills. Because of the need to finalize the legislation by Sept. 30, Rep. John Dingell (D-MI) introduced Sept. 19 the Food and Drug Administration Amendments Act of 2007, which was based on the two original bills. The House and the Senate voted favorably on an identical version of Dingell's bill. On Sept. 19, the House approved the bill 405-7. On Sept. 20, the Senate approved the bill by unanimous consent.

Two provisions proved contentious during the final days of negotiations. One provision concerned conflicts of interest on FDA advisory panels. Advisory panels are composed of governmental and non-governmental experts and provide recommendations on a variety of topics such as the safety of a particular drug. Federal law prohibits individuals with conflicts of interest from serving on FDA advisory panels; however, the FDA commissioner may grant waivers allowing individuals to serve regardless of the degree or nature of the conflict.

A provision in the original House bill would have capped at one the number of waivers the commissioner could grant per advisory panel. The Senate voted on a similar provision but, in a 47-47 tie vote, did not adopt it. Lawmakers could not reconcile the issue. Instead, the final bill includes language which will limit conflicts by assessing the sum of conflicts on all FDA advisory committees. FDA will reduce by five percent each year the number of waivers granted. Currently, about 25 percent of panel members receive waivers, according to the Center for Science in the Public Interest.

The other contentious provision would have required pharmaceutical companies to receive FDA approval before changing a drug's labeling. Currently, companies may make changes without FDA approval and often do so when discovering new information about a drug's side effects.

The American Association for Justice and some congressional Democrats opposed the provision which Sen. Richard Burr (R-NC) introduced. Those critics said, if the bill forced drug companies to receive FDA approval for label changes, companies may be able to avoid liability in cases where victims of a drug's negative side effects would seek damages. The bill would have preempted state tort law, the critics argued. The provision was not included in the final bill.

President Bush is expected to sign the bill into law in the coming days. If the bill does not become law by Sept. 30, FDA will face funding shortfalls and may be forced to begin reducing staff levels.