Friday, February 12, 2016

FDA funding is odd, angst-ridden and ... bipartisan

The funding process for the U.S. Food and Drug Administration is odd, no less so because it sometimes leads to rare Congressional bipartisanship and compromise.

FDA funding is odd, angst-ridden and ... bipartisan


The funding process for the U.S. Food and Drug Administration is odd, no less so because it sometimes leads to rare Congressional bipartisanship and compromise.

One odd part is that while the taxpayers pay some of the bill for FDA operations, user fees from drug and device companies pay for much of the rest in those realms.

In the latest bill (the FDA Safety and Innovation Act), that will amount to $6 billion over the five-year life of the newest incarnation of the law. The difference this time is that generic and biosimilar companies will have to kick in money for the first time.

The Senate this week passed the compromise bill, 92-4, so it moves to the White House for President Obama's signature. The House had passed the compromise bill on a voice vote earlier. The process to get there took more than a year.

All six senators from Pennsylvania, New Jersey and Delaware voted for the bill.

The four senators who voted against the bill were Richard Burr (R.-N.C.), Tom Coburn (R.-Okla.), Rand Paul (R.-Ky.) and Bernie Sanders (I-Vt.).

Paul, an eye doctor by trade, has advocated cutting government costs and reducing programs for the poor, but he recently proposed raising the pay for doctors through Medicare. He also objected to FDA efforts to oversee the largely unregulated supplements industry. His defeated amendment to the FDA legislation was "an attempt to end armed raids on natural food stores and Amish farmers, and stop FDA censorship of truthful claims of dietary supplements," Paul said in a statement posted on his web site in May.

Meanwhile, Sanders objects to prices that drug companies are allowed to charge in America.

"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," Sanders said in a statement posted on his official web site after an earlier vote on the bill. "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."

Staff Writer
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About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at or 215-854-4506.

David Sell Staff Writer
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