President Obama Signs FDA Bill into Law

President Obama has proven a friend to the medical device industry this week, or at least in terms of U.S. Food and Drug Administration (FDA) regulatory reform. He signed the bipartisan Food and Drug Administration Safety and Innovation Act into law, which reauthorizes user fees as well as renovates many criticized aspects of FDA operations.

Most changes to the older Medical Device User Fee and Modernization Act (MDUFMA) were made to speed up approval and clearance times for devices, partly by raising fees paid to the FDA (to which the industry did not balk, provided that speed and predictability from the agency are forthcoming). The House and Senate moved the reauthorization bill with little squabbling, and the bill was an encouraging example of bipartisan agreement.

“The [increased] user fees will improve FDA’s ability to provide timely and expedited review and approval of applications for prescription drugs and medical devices,” said David L Gollaher, Ph.D., president and CEO of the California Healthcare Institute. “The legislation extends and modifies FDA authorities related to drugs intended for use by children, improves the drug and device approval processes and offers new incentives for innovators to develop antibiotics.”

Lawmakers has set a goal of getting the bill to the President’s desk before Independence Day recess, and they succeeded. More importantly, lawmakers were able to avoid possible renegotiations triggered by the Supreme Court decision on the Affordable Care Act on June 28. President Obama signed the Act on July 9.

“S. 3187 is the culmination of the work of the administration and Congress, in partnership with patients, the pharmaceutical and medical device industries, the clinical community, and other stakeholders, to provide the Food and Drug Administration with the tools needed to continue to bring drugs and devices to market safely and quickly and promote innovation in the biomedical industry, and to help secure the jobs supported by drug and device development,” U.S. Department of Health and Human Services Secretary Kathleen Sebelius said in a statement.