President Donald Trump has signed into law the FDA Reauthorization Act of 2017, which reauthorizes the US Food and Drug Administration (FDA) to collect user fees for prescription drugs, generic drugs, biosimilars, and medical devices. The law provides authorization for user fees for fiscal year 2018 to fiscal year 2022. Current user fees were set to expire on September 30, 2017.
The bill was a product of a bipartisan Congressional effort begun in mid-April 2017, when members of the US House and Representatives and the US Senate proposed a discussion draft of the FDA Reauthorization Act.
A key difference between the Congressional measures and an earlier budget proposal by the Trump Administration was the level of user fees. The President’s budget, released in May 2017, called for more than $1 billion in new user fees to replace budget appropriations for the FDA to fund premarket reviews 100% by user fees.
In fiscal year 2018, user fees are expected to generate over $878 million from prescription drugs, $493 million from generic drugs, and $45 million from biosimilar products, according to the FDA Reauthorization Act of 2017.
The new law also provides support for FDA activities related to medical product regulation. In FDA Voice, a blog of the FDA, Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, and Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health, highlighted key measures of the new law.
Some highlights of the new law include: (1) enhancing the FDA’s ability to capture the patient voice in drug development; (2) advancing and facilitating the development and timely approval of drugs and biologics for rare diseases, including for children (The new law includes a new authority to require a pediatric investigation into an adult cancer drug if that drug is directed at a molecular target that is relevant to a pediatric cancer); (3) additional resources for the breakthrough therapies program for drugs; (4) leveraging the use of “real-world” health data to inform regulatory decision-making, including enhancing the capabilities of FDA’s Sentinel System for drugs; (5) streamlining combination-product review to enhance coordination and transparency between the FDA and industry; (6) improving FDA hiring and retention efforts, including a dedicated unit for scientific staff and continuous independent assessment of the agency’s hiring and retention operations; and (7) allowing the FDA flexibility to inspect medical device facilities based on risk.
“The new law marks the culmination of two years of negotiations with industry and discussions with stakeholders. This is a compelling example of what can be achieved when FDA, industry, patients, Congress, and other stakeholders work together towards the same goal,” said the three directors in the blog post.
Source: White House and FDA Voice (FDA blog)