On July 12, 2017, the Biotechnology Innovation Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) both issued statements in support of the passage of the Food and Drug Administration Reauthorization Act (FDARA) by the US House of Representatives. H.R. 2430 reauthorizes the Generic Drug User Fee Amendments (GDUFA), the Prescription Drug User Fee Amendments (PDUFA), the Biosimilar User Fee Amendments (BsUFA), and the Medical Device User Fee Amendments (MDUFA). The House passed the bill on July 12, 2017.
“This legislation ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, while advancing important patient-centered policies that will help streamline the clinical trial process—the most time-consuming, complex, and expensive step in the drug development process. It also takes important steps to advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. The reauthorization of the biosimilars user fee program, including steps to improve communication throughout application review, will move the needle on getting more affordable biosimilar products to patients in a timely way, once the IP protection expires for new biologics,” BIO President and CEO James C. Greenwood said in a statement.
PhRMA president and CEO Stephen J. Ubl issued the following statement:
“Timely reauthorization of the Prescription Drug, Biosimilar and Generic Drug User Fee Acts is crucial to patients in need of life-saving treatments and enhancing the competitive market in biopharmaceutical innovation. The House took an important step in reauthorizing the user fee programs and we look forward to swift action in the Senate on behalf of America’s patients.”