On Friday August 18, President Trump signed FDARA (FDA Reauthorization Act 2017) into law. H.R. 2430 was passed by the House of Representatives on July 12, and the Senate passed the bill on August 3. This bipartisan legislation essentially reauthorizes the MDUFA (Medical Device User Fee Amendments), PDUFA (Prescription Drug User Fee Act), and other user fees that make it possible for the FDA to review the effectiveness and safety of new and innovative treatments in an efficient, timely manner, without compromising the Food & Drug Administration’s high standards.
In the passing of FDARA, BsUFA (Biosimilar User Fee Act) and GDUFA (Generic Drug User Fee Amendments) were included for the first time. FDARA allows the FDA to collect these medical product user fees for the next five years, through fiscal year 2022.
While the impact to medical products and patients is far-reaching, some of the FDA activities supported by the new law in regards to medical product regulation include:
- Making affordable hearing aids available to patients in need by creating a lower cost category to be available over-the-counter.
- Providing resources for the popular, successful, and resource intensive breakthrough therapies program for drugs.
- Improving transparency and coordination between the FDA and industry by making combination product review more efficient.
- Establishing a more efficient and flexible path to market for certain new medical device accessories, to enable new and innovative accessories to come to market more rapidly and enable accessories to be used with a wide range of devices – creating important options for patients.
- Advancing approval for drugs that treat rare diseases, including requiring a pediatric investigation into the development of new drugs designed to treat cancers in adults that, if directed at a molecular target, may be relevant to the progression or growth of a pediatric cancer treatment.
Other key provisions from FDARA include pediatric product development reforms, prescription drug reforms, generic drug access reforms, and medical device reforms.
FDARA, which reauthorizes PDUFA, MDUFA, BsUFA and GDUFA, will ultimately make it possible for the U.S. Food & Drug Administration to enhance the established successes of these programs which will not only uphold the standing of the U.S. as a global leader in biomedical innovation, but most importantly expand patient benefits.
Following the President’s signing of FDARA, Health and Human Services Secretary, Tom Price, said that the president is “ensuring that safe and effective, life-saving treatments will continue to reach American patients, from innovative new drugs to generic drugs, biosimilars, and medical devices.”
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