By Sam Baker - 04/25/12 04:21 PM EDT
The Senate bill would reauthorize user fees that the drug and medical device industries pay to the FDA. Companies pay a user fee when they submit new products for FDA approval, which some consumer advocates and congressional liberals see as a conflict of interest.
The measure also adds a new fee for companies that make generic drugs. The generics industry has complained about long backlogs at the FDA, but until now has not been willing to foot the bill for faster reviews.
The HELP Committee’s bill also seeks to improve the FDA’s oversight of potential safety issues while also helping to bring important products to market more quickly. The FDA is perennially torn between those two priorities — ensuring that drugs are safe without being too cautious and preventing patients from accessing life-saving treatments.
Under the Senate bill, FDA reviewers could fast-track products intended to treat rare or serious diseases.
The bill would also beef up record-keeping requirements throughout the supply chain for prescription drugs, making it easier for the FDA to track down contaminated products.