Senate panel delays good-government bill, scolds HHS for ‘moving the goal posts’

Senate panel delays good-government bill, scolds HHS for ‘moving the goal posts’
A Senate panel delayed action today on a bipartisan bill to improve government transparency among advisory bodies in deference to (NIH) that the legislation would seriously disrupt the agencys ability to review research proposals. At the same time, the bills Republican sponsor in the Senate chastised NIHs parent body for moving the goal posts after legislators believed they had struck a compromise last fall to address NIHs concerns about the bills impact on its 173 study sections.

Im not someone who likes to publicly admonish agencies, unless its warranted, said Senator Rob Portman (ROH), referring to the Department of Health and Human Services (HHS). But we did work with them, and I thought we had reached a compromise. And then they moved the goal posts.

Without debate, the Senate Homeland Security and Governmental Affairs Committee (HSGAC) unanimously approved 15 bills and four nominees to senior positions at agencies it oversees during a 20-minute business meeting this morning. But its chairman, Senator Ron Johnson (RWI) postponed action on the transparency bill, H.R. 1608, after Portman said committee members needed more time to examine its provisions.

FACA applies to all federal research agencies, and the bill would put into statute what are now executive branch rules on how it should be implemented. One key change would require NIH to designate study section members as special government employees. The National Science Foundation already does that, with little disruption to its merit review system. But NIH officials say the changethey are now classified as consultantswould add months to the appointment process, generate massive amounts of additional paperwork, and discourage scientists from volunteering to serve.

Senators on the HSGAC panel were clearly torn between their support for greater transparency and their fear of jeopardizing the governments investment in biomedical research.

I would be happy to vote to move [H.R. 1608] forward so that it can be reviewed on the floor before we take a vote, said Senator Mitt Romney (RUT), noting that NIH had shared its concerns with him. And while Im willing to vote for it at this stage, I reserve the right to vote no if further analysis suggests that we need to make further adjustments to get the support of NIH so that it doesnt impose too substantial a burden on our health and technology investments.

H.R. 1608 is the latest version of legislation that Representative William Lacy Clay (DMO) first introduced in 2008. It has passed the House three timestwice while Republicans were the majority partybut it was only last year that HSGAC also embraced it. That step set off alarm bells at NIH and HHS, which led to negotiations last fall with both House and Senate members.

Supporters say they tweaked the bill to exempt NIH study sections and address other HHS concerns. But last month, HHS wrote to Senate Majority Leader Mitch McConnell (RKY) saying the changes havent solved the problem. Specifically, HHS said the fix only applied to when NIH study sections meet, not how their members are appointed or the rules governing their operations. It suggested exempting all study sections covered by the Public Health Service Act that governs NIHs behavior.

Legislators are dumbfounded by HHSs interpretation. At the eleventh hour HHS raised some additional concerns, Portman says. Going forward, he adds, We hope the standard of reasonableness will apply.

At the same time, supporters of the legislation say HHSs proposed fix is a nonstarter because it would also apply to regulatory agencies like the Food and Drug Administration, where potential conflicts of interest among advisory committee members are rife.

With no markup looming, both sides are hoping to resume negotiations in the next few weeks. The goal is to find a way to address NIHs concerns and still close existing loopholes in FACA.

So well go back and work with them again, Portman says. We want to make sure that NIH can continue to carry out its job of reviewing grant proposals. But we believe that transparency in advisory committees is very important, too.
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