House panel announces user fee hearings

{mosads}The hearings follow months of negotiations between the drug industry and federal health officials. Lawmakers have also weighed in, notably with hearings into the FDA regulations and their impact on getting new drugs to market quickly and safely.

The FDA struck a preliminary agreement with drugmakers in May over the prescription drug fee reauthorization, which is expected to sail through Congress. The deal calls for a $100 million increase in fees to pay for more than 100 extra staff members, two more meetings with sponsors during the drug review process and a two-month extension of the review time for new drugs.

The medical device fee is shaping up to be a tougher sell. Device makers want a revamp of the expedited approval process for low-risk devices, but patient advocacy groups say the current system is already too lax and allows dangerous products to get to market with little to no oversight.