SENATE TO CONSIDER DRUG SAFETY LEGISLATION BEFORE MIDTERM ELECTIONS
The Senate will soon address a number of important pieces of healthcare legislation, with an eye toward addressing these bills before the midterm elections in November, congressional sources say.
The Senate is planning to vote on one drug safety bill this week and another before the end of the month, a spokesman for Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Mike Enzi (R-Wyo.) said. First up will be "The Dietary Supplement and Nonprescription Drug Consumer Protection Act," which would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to require OTC and dietary supplement companies to provide notice of serious adverse events to the FDA. The bill, which was placed on the legislative calendar Sept. 5, is expected to go to the Senate floor this week.
This action comes at a time when the FDA is increasingly targeting supplement manufacturers with enforcement actions.
The HELP Committee is also working to mark up Enzi and Sen. Edward Kennedy's (D-Mass.) drug safety bill by the end of the month, the spokesman said. The bill, "Enhancing Drug Safety and Innovation Act," is meant to improve the FDA's oversight of drugs once they are on the market and imposes on the industry new safety planning requirements before launching a drug. But the FDA has rejected the bill, arguing that the legislation's risk management plans are unrealistic and would unnecessarily delay drug reviews.