While Some Provisions are Positive, Congress Emphasized Speed over Safety in New Law

WASHINGTON (June 26, 2012) – Major Food and Drug Administration (FDA) legislation approved by the Senate this afternoon misses many opportunities to protect patient health and may jeopardize the scientific independence of the agency, all to satisfy industry concerns, the Union of Concerned Scientists (UCS) said today.

The Food and Drug Administration Safety and Innovation Act, which the House passed last week, ratifies the fees drug and medical device manufacturers pay the agency to review its new products. Congress must approve these fees every five years, and this legislation is often used as a vehicle for other congressional mandates on the FDA.

Sen. Tom Harkin (D-Iowa) and Reps. Frank Pallone (D-NJ) and Henry Waxman (D-Calif.) fought to protect scientific integrity at the agency, but special-interest priorities largely prevailed. The drug, device, and biotech industries spent more than $700 million lobbying Congress and the administration between 2009 and the end of 2011, according to UCS analysis issued in March. 

“This bill shows what hundreds of millions of dollars in special interest lobbying can buy,” said Celia Wexler, senior Washington representative for UCS’s Scientific Integrity program. “The public wants the FDA to be independent and to make its decisions based on the best available science, but this bill largely stresses speed over safety and special interests over the public interest.”

Some of the bill’s industry-friendly provisions include relaxed conflict-of-interest rules at the FDA, which are intended to prevent medical professionals with ties to drug and device manufacturers from wielding undue influence over the approval process. In 2007, lawmakers placed limits on the number of experts on FDA advisory panels who could have financial ties to the companies they were overseeing. In the new legislation, Congress eliminated those limits on conflicted experts, though it did retain public disclosure of these conflicts.

UCS recently demonstrated that that the FDA could recruit qualified candidates to fill these panels without loosening conflict-of-interest rules. More than 100 of the 620 positions on FDA advisory committees are vacant, but with one email to its scientist network, UCS was able to find enough candidates to fill more than half of the vacant positions with experts who have no declared conflicts of interest.

The legislation also allows medical device makers to challenge any significant FDA decision and ask for it to be evaluated by a supervisor, a move that could increase industry influence on device reviews. It also would allow medical devices modeled after unsafe devices that have been recalled to remain on the market despite the threat they may pose to patients’ health.

The bill does include some positive reforms. It will help speed up the approval of generic drugs and take steps to address shortages of life-saving drugs. Further, it will make it easier for the FDA to ensure that high-risk devices receive more scrutiny and will give the agency the power to halt a clinical trial of a device it believes poses “an unreasonable risk” to trial participants. Finally, the legislation directs the agency to implement a rule that will—for the first time—track and identify devices so that patients with recalled devices can be more easily notified. 

But the legislation could have done much more to strengthen FDA’s scientific foundation. For instance, even a modest proposal to support the disclosure of more accurate and comprehensive clinical trial data failed to make it into the bill.

“At the very least, the bill is a missed opportunity to protect the public,” Wexler said. “This bill is one more sign of the climate on Capitol Hill that would sacrifice scientific integrity to industry interests, and the willingness of many lawmakers to jeopardize the science-based missions of our federal agencies.”

The Union of Concerned Scientists is the leading U.S. science-based nonprofit organization working for a healthy environment and a safer world. Founded in 1969, UCS is headquartered in Cambridge, Massachusetts, and also has offices in Berkeley, Chicago and Washington, D.C.