SENATE DEMOCRATS MOVE TO POSTPONE DRUG SAFETY BILL
Democrats on the Health, Education, Labor and Pensions (HELP) Committee are urging Chairman Mike Enzi (R-Wyo.) to delay the markup of his drug safety bill until there has been a hearing on the bill and time to consider the recommendations in a recent report by the Institute of Medicine (IOM).
The National Academies' IOM report, which reviewed the FDA's drug safety practices, is an important tool in understanding problems with the regulatory system and how to address those problems, Sen. Chris Dodd (D-Conn.) and other Democrats on the HELP Committee wrote in a letter to Enzi. This new information, along with the lack of any hearings to consider Enzi's bill, the "Enhancing Drug Safety and Innovation Act," gives the lawmakers pause.
"We believe it would be a mistake to move drug safety legislation through the HELP Committee before Congress and the public have an opportunity to consider [the report's] findings," the Sept. 26 letter said. "Too much is at stake to rush legislation that has not had a single hearing through the HELP Committee."
IOM's Sept. 22 report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public," blasted the agency's handling of drug safety issues and recommended legislative action to fix these failings. The report recommended that Congress give the FDA the authority to require whatever postmarketing risk assessment and risk management programs are needed to monitor and ensure the safe use of drug products.
Meanwhile, Enzi and cosponsor Sen. Edward Kennedy (D-Mass.) have used the report to herald the need for the bill. The report "adds new urgency for Congress to act on reform legislation to give the [FDA] better tools to protect and promote the public health," the senators said in a Sept. 22 statement. Their bill would require the FDA to approve drugs and biologics, as well as new indications for these products, under a risk evaluation and mitigation strategy, a mechanism to acquire and adapt to new safety information about a drug.