FDA Reauthorization Act heads to Trump’s desk after Senate passage

WASHINGTON — The Senate on Thursday voted to pass the Food and Drug Administration Reauthorization Act of 2017, sending the bill to the desk of President Donald Trump following the House’s passage of the legislation in June. The bill contains the reauthorizations of the FDA’s Prescription Drug, Biosimilar, and Generic Drug User Fee Acts.

“Working together, House and Senate Republicans and Democrats brought forth a bill to reauthorize these important programs, putting patients first and their hope for new treatments within reach,” said Senate Energy and Commerce Committee chairman Greg Walden, R-Ore.; ranking member Frank Pallone, Jr., D-N.J.; Health Subcommittee chairman Dr. Michael Burgess, R-Texas; and Health Subcommittee ranking member Gene Green,D-TX).“This bill is a win for patients and the millions of Americans working to develop our next generation of cures and therapies. We applaud the Senate’s swift action in passing this vital bill, and urge President Trump to sign it into law.”

The bill’s passage immediately drew praise from the industry, including Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America.

“PhRMA applauds the Senate for passage of the Prescription Drug, Biosimilar and Generic Drug User Fee Acts,” Ubl said. “PDUFA VI better incorporates real-world evidence and patient perspectives into the drug development and approval process, while also providing the [FDA] with new tools and resources to keep up with the latest scientific advances. By strengthening the FDA and improving efficiency in the drug review process, we can bring safe, innovative medicines to patients faster, which will enhance competition and lower costs. This is a major victory for medical innovation, the FDA and patients.”

The Biotechnology Innovation Organization also weighed in, saying that the bill contained provisions that would help accelerate and incentivize the entry of generics and biosimilars to the market.

“[The bill] ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, and takes steps to modernize and improve the clinical trial process, which remains the most time-consuming, complex and expensive stage of drug development,” BIO president and CEO James Greenwood said. “The reauthorization of the biosimilars user fee program, including steps to improve communication between the FDA and Sponsors throughout application review, will create a more robust and competitive marketplace for biosimilar therapies, following an appropriate period of exclusivity for innovator biologic products.”