Law Reauthorizes FDA Fees and Increases Access to Generics/Biosimilars

A bill that just passed in the U.S. Senate and is expected to be signed by President Donald Trump will significantly increase access to generic and biosimilar drugs, said the Association for Accessible Medicine (AAM).

AAM praised the Senate for passing the FDA Reauthorization Act of 2017 (FDARA) by a vote of 94 to 1, a rare bipartisan vote. The act reauthorizes key user fee programs, which were set to expire on September 30.

The U.S. House of Representatives passed FDARA in late July by a voice vote.

“As the country grapples with the high price of health care, the strong bipartisan vote in the Senate recognizes the most effective and efficient way to contain prescription drug costs is to enhance competition by increasing the number of generic and biosimilar medicines available to patients,” said Chester “Chip” Davis, Jr., President and CEO of AAM.

The new law will put in place a framework for using the best processes and science available to approve new safe, effective, and affordable generic and biosimilar medicines, AAM said in a statement on its website.

It makes way for FDA’s  Generic Drug User Fee Amendments (GDUFA), which will promote safety, access, and transparency in the generic pharmaceutical industry,  the AAM statement said. GDUFA is one of the user fee programs in FDARA. The others are the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA), and the Medical Device User Fee Amendments (MDUFA).

“The program [GDUFA] holds all foreign and domestic companies to consistently high-quality standards, speeds the availability of low cost, high quality generic drugs through more predictable review processes for ANDAs, and increases transparency between manufacturers and the FDA by requiring the identification and registration of all facilities involved in the manufacturing of generics and their active ingredients,” according to AAM.

“AAM and our members look forward to the President swiftly signing FDARA; working with the FDA to increase the number of applications reviewed and approved; and to ensuring a sustainable and competitive market for generics and biosimilars that will serve the best interests of patients moving forward,” AAM said.

In addition to user fees, the law reforms application timelines and various drug and device clinical testing requirements.       

The Senate Energy and Commerce Committee issued a statement. “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,” it said. “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.”

In addition, the administration questioned how some of the act’s provisions may impact market competition.