With almost zero fanfare, President Donald Trump signed the FDA Reauthorization Act (FDARA) of 2017 into law on Aug. 18, approving the user fee agreements paid by pharmaceutical and medical device companies to the Food and Drug Administration (FDA).
While the legislation passed both houses with only one recorded no vote—coming from Sen. Bernie Sanders, I-Vermont—it didn’t match what Trump had proposed. His 2018 budget proposal called for doubling FDA user fees to $2 billion, even after several years of increases since the fees were last negotiated in 2012. The law will require pharma companies to put up $8 billion total for these review, while making other changes which could speed up approvals. Those include requiring the FDA to set up an electronic submission system for 510(k) clearance and pre-market approval bids, modifying how the agency evaluates and approves applications and how they track device safety.
Supporters of the legislation in Congress said those changes match the spirit of the 21st Century Cures Act.
“Throughout the 21st Century Cures process, we heard about cutting-edge medical innovations that were on their way, but just out of reach,” House Energy and Commerce Committee Chairman Greg Walden, R-Oregon, said in a statement. “Ensuring these user fee programs are reauthorized will help connect the dots, bringing those innovations to light.”
The Medical Imaging and Technology Alliance (MITA) also praised the signing of FDARA. Among its favorite provisions were requirements for the FDA to produce, within 270 days of being signed into law, a report on device servicing quality and safety, which MITA said would address risks created when unregulated, third-party groups service devices improperly.
“We are confident that this legislation will be a critical component in ensuring that all patients have timely access to life-saving medical technologies,” said Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare.