A bill aimed at tightening up the Food and Drug Administration's oversight of prescription drug safety moved one small step closer to the statute books late last week after it passed the Senate Health, Education, Labor and Pensions (HELP) Committee by a 15 to five vote.
Among the measures included in the bill are commitments for the FDA to review the safety of new medicines after they have been on the market for 18 months and three years, as well as giving the agency the power to fine companies that don't meet their commitments to carry out post-market safety studies.
The FDA has already started measures to implement this risk-benefit appraisal system, and will assess a number of different types of data, including adverse event reports, data mining systems and epidemiological findings.
The withdrawal from the market of Merck & Co's painkiller Vioxx (rofecoxib) in 2004 prompted criticism of the FDA over its handling of the affair, as well as a prolonged period of introspection into its role and regulatory processes.
The architects of the bill, Senators Edward Kennedy and Mike Enzi, said that it is a key step towards "enhancing drug safety, providing key resources to review new drugs and medical devices, and ensuring that drugs and devices for children are safe and effective."
In addition to the risk-management element, which gives the FDA the right to choose which new products to assess at this higher level, the bill also would give the agency greater authority over advertising and labeling, and includes a provision that would grant three months' additional patent protection for companies that conduct pediatric studies on drugs with more than $1bn in annual sales.
Some of these elements have not found favour among the pharmaceutical industry.
For example, the Pharmaceutical Research and Manufacturers of America (PhRMA) said that measures to ban advertising in the first two years after a new drug is launched "is not in the best interest of patients and physicians who every day make important healthcare decisions".
But the bill, known as the Food and Drug Administration Revitalization Act, still has to move onto the Senate floor, and both Enzi and Kennedy acknowledge that it is unlikely go through that wringer and emerge unchanged.
The Senate bill backs up the premise of the Prescription Drug Users Fee Act (PDUFA), up for renewal by Congress in September. This provides some of the FDA's annual funding through fees paid by companies, but the Kennedy/Enzi model would apportion more of that money toward drug safety monitoring.
The FDA wants to raise fees by around $100m to $393m in 2008, while the Revitalization Act would raise that by an additional $30m earmarked for drug safety.
Some argue that the user fee system makes the FDA too reliant on industry, however. Consumer group Public Citizen, for example, believes all the agency's functions should be funded out of the public purse.