Lawmakers develop FDA reform

In conjunction with the Food and Drug Administration, the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization are developing FDA legislative reform recommendations for Congress to consider. The proposed changes may further streamline the drug-regulatory process.

High on their agenda is a reauthorization of the 1992 Prescription Drug User Fee Act, due to expire at the end of September this year. The law - which was developed jointly by Congress, the FDA and industry professionals - generated $327 million in user fees between 1993 and 1997. That revenue enabled the FDA to hire 600 additional reviewers and reduce mean approval times for new drugs (for which user fees were paid) from 29.9 months to 15.5 months. As a result, the number of approved new medicines increased from 26 in 1992 to a record 53 in 1996.

PhRMA, BIO and the FDA have banded together to propose a framework for Congress that would extend PDUFA for another five years, increase user fees and reduce drug development and review time by 10 to 16 months. They are also asking members of the House Commerce Committee to negotiate a bipartisan agreement on FDA improvement proposals that would supplement the legislative concepts set forth in the renewed PDUFA, or PDUFA II. "It's a new opportunity for approaching FDA reform," said Jeff Trewhitt, assistant vice president, communications, at PhRMA.

According to industry experts at PhRMA, the user-fee proposals would specify quantifiable, measurable timelines and performance goals for FDA actions; the proposed improvements would provide the means for structurally changing some FDA practices and procedures. In both cases, the aim is the same: Make the FDA more efficient so that patients may receive new medicines as quickly as possible.

Reform provisions

So far, three major FDA reform provisions have been negotiated and accepted by both the agency and the industry as part of PDUFA II: Resolving holds on clinical studies, creating formal provisions for meetings management and establishing a more effective appeals process. Other issues still being negotiated concern efficacy data, manufacturing changes, dispute resolution, establishment of policy guidance and administrative and procedural reforms.

Industry lawmakers have also dropped their request for several items that proved too controversial during last year's FDA reform debate, such as regulatory "hammers" that could trigger approval decisions or third-party reviews if the FDA does not act within mandated timeframes. Although information dissemination regarding the off-label uses of drug products remains high on PhRMA's agenda, the industry is waiting for Senators Connie Mack (R-FL) and Bill Frist (R-TN) to reintroduce a separate bill to deal with the dissemination process before pressing ahead on the issue.

The industry's other legislative priority is to restore the FDA's baseline funding for 1998. The Clinton Administration's proposed budget would cut about 8% of the public funding provided by Congress. PhRMA has been lobbying both the appropriations and budget committees in the two houses of Congress to keep the FDA budget at its current 1997 level with only an inflationary increase. Although Congress has adjusted the FDA's budget to reflect inflation, Trewhitt said it has not provided the agency with a significant annual increase in the last 15 years. He said the renewal and ultimate success of PDUFA II is contingent upon level funding being maintained.

Focusing on the issue

"It's difficult to get lawmakers to focus on this as a major issue or to show their hand if they have focused on it," said Trewhitt. "They are preoccupied with big ticket items like Medicare and Medicaid. But even though this is only an $820 million regulatory agency, it has dramatic impact on the quality of life of millions of people in this country." To increase awareness of the situation, Trewhitt and other PhRMA press officials have been meeting with the editorial boards of major newspapers around the country to try and garner support for more FDA funding and passage of PFUDA II.

"Everything is on the table and we're confident that our negotiations with the FDA will bear some fruit," said one congressional source close to members of the House Commerce Committee. PR