Not everyone was as thrilled with the U.S. Senate’s passage yesterday of the latest iteration of the FDA user fee bill as were the lawmakers who repeatedly lauded the bipartisan amity that led to a swift decision.
At least 1 voice in the crowd said "nay" on the measure. Sen. Bernie Sanders (I-Vt.) was the only down vote in a 96-1 decision to pass a bill re-authorizing the FDA’s ability to charge fees for review of medical devices and pharmaceuticals.
Sanders, whose amendment to cut off drug marketing exclusivity for companies charged with fraud or other violations was rejected by a 9-88 vote earlier in the day, decried the FDA fee bill becauseit lacked sufficient controls on drug makers, he said.
"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 prepared 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."
Sanders was joined by consumer advocacy group Consumers Union in lamenting the lack of stronger controls in the FDA bill.
CU has played an active role in user fee agreements recently, especially with regard to review and clearance of medical devices.
The group earlier this year challenged the medical device industry’s calls for speedier clearance pathways at the FDA during a sometimes contentious U.S. House hearing on the user fee bill, arguing that device makers left device safety out of the negotiations with the FDA.
The latest user fee agreement between the FDA and the device industry, passed by the Senate yesterday, proposes to collect $595 million over 5 years, double the amount agreed to in the previous generation of the Medical Device User Fee & Modernization Act, but some say that’s not enough.
"Tens of thousands of patients have been seriously harmed by dangerous and defective medical devices in recent years because our current system fails to ensure they are safe and effective," CU Safe Patient Project director Lisa McGiffert said in prepared remarks. "The Senate bill makes some improvements in the law but fails to address some long-standing flaws in our medical device oversight system that endanger patient safety. Congress is missing the opportunity to fix a broken system that lets too many unsafe medical devices on the market and limits the FDA’s ability to protect patients when problems arise."
CU wants the FDA to have broader authority to require medical device makers seeking clearance to speak for failures in predicate devices. Under current law, the FDA has no power to force companies to prove that new devices are free from flaws that led to recalls or safety issues in prior products that are serving as a foundation for review.
The group had also called for enhanced post-market surveillance and a national registry for tracking medical implants, but it will have to take concerns to the U.S. House of Representatives, where lawmakers hope to have a final bill on President Obama’s desk by July 4.