Industry cheers bipartisan FDA funding reauthorization
The fact that our fractured United States Senate has agreed on anything in a bipartisan way beyond a name for a new bridge or a resolution recognizing that Memphis originated soul music or the town of New Milford, Connecticut for, well, being the town of New Milford, Connecticut, is news.
But witty sarcasm aside, the Senate’s recent it’s reauthorization of S. 3187, or the Food and Drug Administration Safety and Innovation Act (FDASIA) is a pretty big deal. It will extend the user-fee programs for prescription drugs and medical devices, and establish new similar requirements for generic drugs and biosimiliars.
Eli Lilly was happy about it, lauding the lopsided vote as a “an important step forward for medical innovation.”
The Biotechnology Industry Organization shared the love, too. CEO Jim Greenwood said, “The legislation will enhance the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science and strengthened post-market review. It will also increase the FDA’s access to external expertise to improve the drug review process.”
The medical device industry weighed in positively on the earlier, similar House of Representatives version. Medical Device Manufacturing Association President and CEO Mark Leahey noted, “it represents a strong vision for medical technology innovation over the coming years, and addresses many of the challenges that face our dynamic industry.”
“It became abundantly clear during the course of negotiations and passage of this legislation that Congress and numerous stakeholders recognized just how important it is for the United States to retain our global leadership position in medical technology. A transparent and reasonable regulatory process is the key to accomplishing this goal.”
Everyone’s playing nice in the afterglow of passage. Now it’s time to make sure the FDA has the proper personnel and funding to update and make its regulatory process more consistent.