House Passes FDA User Fee Bill

The 387-5 vote by the U.S. House of Representatives on May 30 means a conference committee will reconcile the two versions of the bill, which supporters say will help to reduce drug shortages.

Nearly unanimous approval by the U.S. Senate last week of S. 3187, the Food and Drug Administration Safety and Innovation Act, sent it on to the House of Representatives with a fair amount of momentum. The bill reauthorizes several FDA user fees, which the chairman and ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee consider vital.

The House passed its own version May 30 by a vote of 387-5, and now a conference committee will reconcile the two versions that have passed so it can be sent to the president for his signature.

One of the user fees is a new user fee program for generic drugs that will require all foreign and domestic drug production facilities to be inspected. "Our goal when we negotiated this legislation with FDA last year was to hold all players contributing to the U.S. generic drug system to the same inspection standards and enhance the agency"s ability to identify and track registration and contributors involved in each drug product sold in the U.S.," said Patty Benson, who is quality assurance director of SAFC and chair of the Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA). "We are pleased that the Senate has recognized this need and passed this crucial piece of legislation with overwhelming bipartisan support," she said.

According to SOCMA, the generic drug industry will pay approximately $1.5 billion over five years under the program in return for faster and more predictable review of generic drug applications, and this will help to reduce drug shortages and bring drugs to market faster.

A joint statement by HELP Chairman Tom Harkin, D-Iowa, and Ranking Member Mike Enzi, R-Wyo., said the bill will preserve America's global leadership in biomedical innovation. "This bill can literally save lives," they said, "ensuring that Americans have access to crucial medicines and medical devices. It will keep patients safer by modernizing the FDA's inspection process for foreign manufacturing facilities while also improving access to new and innovative medicines and devices. It will also reduce drug costs for consumers by speeding the approval of lower-cost generic drugs and help prevent and address drug shortages. Finally, by improving the way FDA does business, increasing accountability and transparency, U.S. companies will be better able to innovate and compete in the global marketplace. This bill's passage is a victory for the millions of Americans who need medicines or medical devices and for the kind of bipartisan cooperation that we see all too rarely in Washington."

S. 3187 passed the Senate 96-1 on May 24, with the lone dissenting vote coming from Sen. Bernie Sanders, I-Vt. He issued a statement afterward: "The most pressing prescription drug issue in our country today is that Americans pay, by far, the highest prices in the world for their medicine and millions of people cannot afford the medications their doctors prescribe. I voted against this bill because it does far too little to address this crisis while it perpetuates a prescription drug system that continues to fail the American people."

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