H.R. 2430 of the FDA Reauthorization Act (FDARA) has been signed into law. This bill extends the Federal Food, Drug, and Cosmetic Act through FY2022 and revises and renews four user fee agreements between industry and FDA for new drug applications.

PBOA president Gil Roth said, “A year ago, industry ratified the second iteration of Generic Drug User Fee Amendments (GDUFA II), and today I commend the White House for signing it into law via FDARA. GDUFA II will empower FDA and industry to work toward swifter approval of cost-lowering generic drugs.

“One of PBOA’s key goals was to bring CMOs to the table to help develop a fairer fee structure that better reflects the economic models of the various stakeholders. PBOA worked extensively with FDA and our industry partners to achieve that goal, and we are happy that GDUFA — along with its Prescription, Biosimilar, and Medical Device counterparts — has been authorized for a new five-year term.

“PBOA applauds the bipartisan efforts of the Senate Health, Education, Labor and Pension (HELP) Committee and House Energy and Commerce Committee to bring FDARA through Congress, and we look forward to working with FDA and our peers to bring safe, effective medicines to patients.”