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 concerns from the National Institutes of Health (NIH) that the legislation would seriously disrupt the agency’s ability to review research proposals. At the same time, the bill’s Republican sponsor in the Senate chastised NIH’s parent body for “moving the goal posts” after legislators believed they had struck a compromise last fall to address NIH’s concerns about the bill’s impact on its 173 study sections.

“I’m not someone who likes to publicly admonish agencies, unless it’s warranted,” said Senator Rob Portman (R–OH), 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 (R–WI) postponed action on the transparency bill, H.R. 1608, after Portman said committee members needed more time to examine its provisions.

The bill, which passed the U.S. House of Representatives unanimously in March, is aimed at strengthening the 47-year-old Federal Advisory Committee Act (FACA). FACA sets rules for appointing members to the thousands of panels advising the U.S. government and governs how they operate, with open meetings the default mode. Good-government watchdog groups have long complained that some agencies have circumvented the rules in hopes of ginning up more favorable advice by appointing members that represent special interests or who have shown a clear bias.

Cautious support

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 change—they are now classified as consultants—would 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 government’s 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 (R–UT), noting that NIH had shared its concerns with him. “And while I’m 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 doesn’t impose too substantial a burden on our health and technology investments.”

Last-minute objections

H.R. 1608 is the latest version of legislation that Representative William Lacy Clay (D–MO) first introduced in 2008. It has passed the House three times—twice while Republicans were the majority party—but 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 (R–KY) saying the changes haven’t 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 NIH’s behavior.

Legislators are dumbfounded by HHS’s 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 HHS’s 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 NIH’s concerns and still close existing loopholes in FACA.

“So we’ll 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.”