At POGO, we've warned repeatedly about the dangers of loosening the Food and Drug Administration's (FDA) conflict of interest rules for expert advisors. But it looks like some in Congress are doing the bidding of industry anyway.
Last week, three U.S. senators introduced a bill that would allow experts with financial ties to drug or device manufacturers to serve on FDA advisory panels as long as they meet certain disclosure requirements.
The Medical Device Regulatory Improvement Act, which was introduced by Senators Amy Klobuchar (D-MN), Richard Burr (R-NC) and Michael Bennet (D-CO), makes many changes to the device approval process and reverses 2007 legislation that barred experts with conflicts of interest from serving on these panels without waivers.
Looking at how this legislation is being portrayed by the Senators has been an excellent lesson to me in how the other side writes about a bill it supports (a lesson that I'll keep in mind next time I cover a specific piece of legislation POGO supports.) According to the Senators,
"The legislation would help streamline the Food and Drug Administration’s (FDA) regulation of medical devices to continue to spur innovation and help get new, lifesaving products to the market quicker...the FDA is having difficulty finding qualified experts to serve on advisory committees [because of conflict of interest requirements], which can contribute to unnecessary delays for patients."
This is the precisely the opposite of what POGO has been saying. In fact, this claim ignores key information and fails to accurately portray the situation.
According to POGO, the number of waivers granted for FDA advisory members since the rules were tightened is around 5 percent—well below the legal cap of around 13 percent. The percent of vacancies on for Center for Drug Evaluation and Research advisory members continues to plummet. And as for the supposed “difficulty” in finding medical experts without conflicts of interest—a federally funded study of 2914 academics by Harvard University’s Eric Campbell found that almost 50 percent of research academics have no ties to industry.
“This legislation would roll back years of work by congressional leaders to protect patient safety and undermines findings by the Institute of Medicine that conflicts of interest should be guarded against in medicine,” said POGO Investigator Paul Thacker.
So there you have it--two very different views on the same piece of legislation. What do you think?