Initiatives announced by the US Food and Drug Administration to improve drug safety programmes have generally disappointed critics, and lawmakers are pushing ahead with efforts to reorganise the agency and tighten controls through legislative means. But there are fears about proposals to tie these and other moves in with the bill needed to reauthorise the Prescription Drug User Fee Act (PDUFA), which expires this year.

Last week, Senator Edward Kennedy, chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, and the panel’s ranking member, Republican Senator Mike Enzi, re-introduced bill S 484, the Enhancing Drug Safety and Innovation Act. Its provisions include:

- requiring drugs and biologic products to be approved with risk evaluation and mitigation strategies (REMS) which would be reviewed at least annually for three years;

- establishing a non-profit entity, the Reagan-Udall Institute for Applied Biomedical Research, which would lead collaborations between the FDA, academic research institutions and industry to improve the process of drug development and evaluation;

- establishing a publicly-available database of all clinical trials; and

- improving the FDA’s process of screening advisory committee members for financial conflicts of interest.

“We need a more effective system to identify and assess the serious risks of drugs, inform health care providers and patients about such risks, and manage or mitigate these risks as soon as they are detected, and our bill will make that happen,” said Sen Kennedy. Sen Enzi added that S 484 “will raise the bar to ensure that drug safety is not an afterthought, but an integral part of the process throughout the life of a drug.”

Also in the Senate, Republican Chuck Grassley and Democrat Christopher Dodd last week sponsored moves to reorganise the FDA in order to create a centre for oversight of drug safety post-approval. And in the House, Representative Henry Waxman says he will introduce a bill similar to S 484 plus legislation to permit the approval of generic versions of biotechnology products, while Democrat John Dingell, chairman of the House Energy and Commerce Committee, plans to hold a hearing on drug safety some time this month.

The Senate HELP Committee proposes to take up the drug safety issue in early spring when it considers PDUFA reauthorisation, and Sens Kennedy and Enzi say they hope to report out a bill addressing PDUFA, drug safety and three other FDA reauthorisations by shortly after Easter. In addition, Senators Hillary Clinton and Charles Schumer are reported to be planning to link the Senate version of Rep Waxman’s biogenerics bill to the PDUFA reauthorisation, while other initiatives - such as moves to permit prescription drug imports and curb direct-to consumer advertising - could also be loaded on. Sens Kennedy and Enzi say they are aiming for the bill to pass before Congress’ August recess, but some legislators have misgivings that all these different elements could seriously slow the down the bill’s progress, Moreover, the Wall Street Journal has warned that if Congress fails to pass the PDUFA legislation by late summer, it risks shutting down much of the FDA’s drug regulation activity.

The FDA’s new drug safety initiatives are its response to a study published by the Institute of Medicine (IoM) on September 22, 2006, which was conducted to assess the US drug safety system and to make recommendations to improve risk assessment, surveillance and the safe use of drugs. The report was highly critical of both the FDA and the industry and made 25 recommendations for change. According to the Pharmaceutical Research and Manufacturers of America, many of the IoM’s concerns were fully addressed last month in the FDA’s recommendations to Congress for PDUFA’s reauthorisation, which included an agreement with industry to raise user fees almost 30% to $392.8 million. This would “provide the resources necessary to strengthen and modernised the agency’s already robust drug safety monitoring system,” said PhRMA deputy vice president Alan Goldhammer.

However, a leading consumer spokesman said the fee funding proposal was “woefully inadequate” and that the agency’s response to the IoM's criticisms fell dramatically short of what was needed. “If we’re serious about protecting consumers from unsafe drugs, Congress has to give FDA the authority to hold drug companies accountable and perform the safety studies,” said Bill Vaughan, senior policy analyst with Consumers Union Lynne Taylor.

Interested in dedicated news from the global clinical arena? Go to and register for free