The Food and Drug Administration Safety and Innovation Act is intended, in part, to speed up the approval process for drugs and medical devices. (Image: Brian Brown/iStockphoto.com)
In a rare display of bipartisanship, the Senate has passed legislation that is expected to give the US Food and Drug Administration (FDA) about $6 billion in user fees from brand-name drug and medical device companies over the next 5 years. The legislation, the Food and Drug Administration Safety and Innovation Act (S 3187), which passed yesterday in a 92-4 vote, reauthorizes current law. It was approved earlier by the House, and President Obama is expected to sign it into law.
Historically, these user fees have funded the FDA’s approval process for drugs and medical devices. Under the legislation approved Tuesday, the fees will also be used to bolster the agency’s safety oversight, in return for a speedier drug and medical device approval process. Additionally, the act allows the FDA to begin collecting user fees from companies making generic and biosimilar medicines (biological products that are demonstrated to be “biosimilar” to or interchangeable with an FDA-licensed biological product).
The Pew Charitable Trusts commended Congress for passing the legislation. “This legislation will, for the first time, enable the FDA to: regularly inspect foreign drug manufacturing facilities, which supply 80 percent of the ingredients in our medications; spur the development of new antibiotics specifically to treat serious and life-threatening infections; and actively monitor the safety of high-risk medical devices already on the market and promote innovation by streamlining the review process for new low- and medium-risk devices,” said Allan Coukell, director of medical programs at the Pew Health Group, in a release.
Although the legislation’s passage was being hailed by most, including the prescription drug and medical device trade associations, not everyone is pleased. “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,” said Sen Bernie Sanders (I, Vt), one of the senators who voted against the bill, in a statement. “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.”
Categories: Health Policy
