Both the House E&C subcommittee and Senate HELP committee advanced legislation to reauthorize the user fees for the next five years, but President Trump is looking to increase the user fees signficanlty to make up for reduced FDA funding.
The House Energy & Commerce subcommittee advanced a bill for the reauthorization of user fee agreements for drugs, generics, medical devices and biosimilars, with amendments on generic competition, device inspections, the supply chain and OTC hearing aids.
One amendment, introduced by Rep. Kurt Schrader (D-Ore.) and Rep. Gus Bilirakis (R-Fla.), would provide 180-day exclusivity for the first generics that enter a market with limited competition. Per the amendment, a drugmaker would be able to request designation as a competitive generic therapy and the FDA would be required to make a decision within 60 calendar days. The agency would also be required to publish draft guidance on the generic therapy designation within 18 months. A second amendment, introduced by Rep. Larry Bucshon (R-Ind.), Rep. G.K. Butterfield (D-N.C.) and Rep. Mo Brooks (R-Ala.), would require risk-based medical device inspections. It would require the FDA to publish guidance on a risk-based inspection schedule and establish a time frame for such inspections. A third amendment addresses protecting the supply chain while a fourth relates to over-the-counter hearing aids.
The Senate Committee on Health, Education, Labor & Pensions also advanced the user fee reauthorization with amendments. The first amendment, introduced by Sens. Orrin Hatch (R-Utah), Michael Bennet (D-Colo.), Richard Burr (R-N.C.) and Bob Casey (D-Pa.), would require the FDA to establish guidance on methodological approaches that may be leveraged to expand eligibility for trials and to develop eligibility criteria that more accurately reflect the patients likely to receive the treatment. It would also remove a requirement under the Federal Food, Drug and Cosmetic Act that licensed physicians must determine the person has no comparable or satisfactory alternative therapy available and the likely risk to the person from the investigational agent is not greater than the risk from the disease. The second amendment, introduced by Sens. Al Franken (D-Minn.) and Susan Collins (R-Maine), would establish a more competitive generics market and set in place a time line of eight months for the FDA to review generics entering markets with inadequate competition.
Despite the advancements, however, President Donald Trump is seeking a renegotiation of the deals to make up for a nearly 30 percent decrease in the FDA’s budget. In a FY2018 budget proposal, the President is calling for more than $1 billion in additional user fees to replace reduced appropriations. At present, the user fees cover about 60% of FDA premarket review costs. The proposed budget would see industry take responsibility for all the premarket review costs, with $2.4 billion in user fees in 2018, an increase of $1.2 billion over 2017.