US Senators today voted to pass the FDA’s Reauthorization Act of 2017 to reauthorize the FDA’s user fee program, sending the bill on to the President’s desk to sign.
The FDA Reauthorization Act renews an existing law that expires on Sept. 30 and which provides the majority of FDA funds used to regulate pharmaceuticals and medical devices and determine whether they are safe and effective. The Senate passed the bill by a vote of 94-1, with Sen. Bernie Sanders (I-Vt.) voting against it.
The US House of Representatives passed the bill last month.
Industry groups applauded the passage, including medical device group AdvaMed and biotechnology group BIO.
“AdvaMed commends the Senate for their vote today on the FDA Reauthorization Act. Passage of this important legislation will enable FDA to continue its critical mission of ensuring safe and effective medical devices and diagnostics remain available to patients everywhere. The robust FDA performance goals, process improvements, increased accountability and additional resources provided for under the new user fee agreement represent a victory for the agency, innovation and, most importantly, patients. The bill also includes pro-innovation provisions to improve the FDA inspections process and streamline device accessory classification. We urge the president to move swiftly in signing the bill into law, and we look forward to working with FDA to implement the legislation and continue to bring life-saving technologies to patients,” AdvaMed CEO Scott Whitaker said in a press release.
“The user fee program reauthorization package passed by the Senate today is an important victory for patients and for the next generation of medical innovation. This legislation will advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. It also 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 CEO James Greenwood said in a prepared statement.
Medical device and drug companies pay user fees to have the FDA review their products. The last Medical Device User Fee Act in 2012 doubled user fees from $295 million over 5 years to $595 million, in exchange for performance goals set for the FDA.
Although the parties hammered out the 4th MDUFA iteration last August, earlier this year the Trump administration proposed doubling the fees to $2 billion for calendar 2018. In return, the Trump budget would contain “a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products.”
The bill, 1st floated April 14 by the House Energy, Labor & Pensions and the Senate Energy & Commerce committees, would increase to total user fee program to $1.17 billion for fiscal 2017, which begins Oct. 1, adding about $400 million.
In June, the House committee approved a markup version, adding amendments on medical device servicing, the review process for imaging techniques that use contrast agents; a process for reclassifying medical device accessories; a voluntary pilot program on medical device safety and effectiveness; and a provision seeking to lower prescription drug prices. The House markup version also included technical corrections amending provisions for competitive generic therapies and a new 180-day exclusivity regime.
With the bill, medical device user fees rise from $130.2 million in fiscal 2017 to $183 million in fiscal 2018, topping out in the final year of the deal at $213.7 million for fiscal 2022, according to a summary. The bill also establishes a category for de novo applications, enabling a user fee for those product reviews, and create a pilot program across 5 device types to audit, certify and police medical device testing labs.
Material from Reuters was used in this report