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Bloomberg Law – Fears of Slow Research Halt Federal Advisory Panel Bill

Bloomberg Law – Fears of Slow Research Halt Federal Advisory Panel Bill

NIH concerns slammed the brakes on a bill May 15 seeking more transparency about people serving on federal advisory boards.

 

The Senate Homeland Security and Governmental Affairs Committee agreed to postpone voting on the Federal Advisory Committee Act (H.R. 1608) to address any negative impact on medical research.

 

The National Institutes of Health said the legislation would slow down new discoveries by burying the grant selection process in paperwork. The NIH funds more than 50,000 competitive grants to more than 300,000 researchers at more than 2,500 universities, medical schools, and other research institutions.

 

“The chairman is right to postpone it to make sure we’re dealing with NIH’s concerns,” Sen. Rob Portman (R-Ohio) said during the markup.

 

At issue is a provision in the bill that requires anyone who’s a member of a federal advisory group to be classified as a special government employee, which would boost the criteria for participating in the peer review process.

Peer Review Thwarted

The proposed change caused protest in the research community. It would place a choke hold on peer review, the NIH’s process for selecting which grant applications to fund, Research!America and Friends of Cancer Research wrote in a May 14 letter to committee leaders. Peer review relies in part on experts within each scientific field appearing at one-day meetings and assessing applications.

 

The NIH peer review system uses about 30,000 to 35,000 peer reviewers annually, according to an April letter from the HHS. Changing participation requirements would increase the administrative burden by 30 to 35-fold, the HHS said. Each special government employee must complete and notarize 13 forms totaling 94 pages.

 

“Increasing transparency and accountability across government is a laudable goal, but burying NIH peer review under reams of additional paper would be a tragic mistake,” Ellie Dehoney, Research!America’s vice president of policy and advocacy, said.

 

The bill sailed through the House by a voice vote in March but appears to have stumbled since then. Portman said lawmakers worked with the Department of Health and Human Services on its concerns, but they didn’t reach closure.

“We made those changes and then at the last minute, they moved the goal post on us, frankly,” he said.

 

Sen. Mitt Romney (R-Utah) said he would vote to send the bill to the Senate floor but vote against it there if it hampers medical research.

 

Slowing down medical progress runs counter to the goals of 21st Century Cures, the bipartisan 2016 law to spur new drugs and devices.

 

The research community also said the bill would also increase the burdens on the Food and Drug Administration’s advisory committees, which make recommendations on whether to approve new drugs and devices.

 

It could also hamper the Centers for Disease Control and Prevention’s ability to use outside experts to get at issues like opioid crisis, Dehoney said.

 

https://news.bloomberglaw.com/pharma-and-life-sciences/fears-of-slow-re…