New FDA Safety and Innovation Act Extends Pay to Play for Drug and Device Makers

The Food and Drug Administration Safety and Innovation Act which was signed into law July 9, is intended to fasttrack FDA approval of drugs and other treatments for certain diseases and medical conditions. Its chief purpose is to extend rules passed in 1992 that made drug and medical device makers pay the FDA to test its products. That rule was about to expire and without extension, FDA funding would plummet. The bill also includes provisions of a bill, originally, known as the TREAT act (Transforming the Regulatory Environment to Accelerate Access to Treatments), which was sponsored by Sen. Kay Hagan, D-N.C. Those provisions are intended to spark innovation and investment in biotechnology, and help bring jobs to North Carolina, by shortening the current time frame to bring new medicines and therapies to market.

Cynthia Powell, division chief of genetics and metabolism at North Carolina Children's Hospital, said that while the TREAT provisions in the law promise to maintain the FDA's high standards for safety and effectiveness, it is too early to tell if this will happen. "It's definitely going to be a fine balance between expediting things while ensuring that treatments are still safe," she said in a Fayetteville Observer article recently.

According to the Union of Concerned Scientists, the drug and device industry spent $700 million lobbying for the latest bill and that it doesn't do enough to ensure the independence of FDA scientists.
Despite concerns, the bill passed with few dissenters and drew praise from patient advocacy groups as well as big pharma and even the American Medical Association.
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