Senator Lamar Alexander (R–TN)

Senator Lamar Alexander (R–TN)

AMSF2011/FLICKR (CC BY 2.0)

Senator offers tantalizing prospect of regulatory relief for biomedical researchers

Senator Lamar Alexander (R–TN) today told a National Academies panel examining federal oversight of academic research that he hopes to make reform happen as part of broader legislation to hasten medical advances. The catch: The panel must deliver its recommendations by the end of the summer. That’s a much shorter timetable than the panel had envisioned, but one that it now seems eager to meet.  

Alexander’s offer is not an empty promise: He chairs the Senate panel that oversees both the National Institutes of Health (NIH), the 800-pound gorilla for federally funded basic research, and the Department of Education, which monitors higher education, where most NIH-funded research is performed. The political stars are favorably aligned, Alexander told the Academies’ Committee on Federal Research Regulations and Reporting Requirements, which Congress has asked to look at ways to streamline the process by which institutions comply with federal rules governing research.

Alexander says he is eager to hear the committee’s views on rules affecting the entire scope of federally supported research. But a major driver is to clear the way for finding cures and treatments for dread diseases. “For example, I hear repeatedly that our conflict-of-interest rules [for NIH-funded research] prohibit participation in clinical trials by many of the people who know the most about what is going on,” he told ScienceInsider in comments after his presentation. “It doesn’t protect the public to spend money on administrative costs that would be better spent finding a cure for Alzheimer’s.”

A study of how to tweak federal research regulations may sound dry and trivial. But having to comply with those regulations is a perennial source of complaints from university administrators. Their list includes what they regard as unnecessary oversight of research, such as accounting for a scientist’s time on a grant; the high cost of documenting some rules, such as those governing financial conflicts of interest; and conflicting requirements from different federal agencies on the same subject. The system not only wastes money, they say, but it can also hinder scientific progress by stealing time and money from the research enterprise.

The Academies’ panel met for the first time in February, and it was expecting to finish its work next spring. Its draft report would then be vetted by internal reviewers in a process that often takes several months. But Alexander, a former governor, president of the University of Tennessee, and education secretary under President George H. W. Bush, urged them to move much more quickly.

“Here’s what I’d suggest you do: Make an interim report in September to Congress, especially the Senate, on the specific recommendations that you would like us to put into law, or make changes to existing regulations that would simplify and reduce the cost of federal regulations on university-based research. That would have the most impact,” Alexander said.

A few minutes later, in response to a question about how the panel should frame its recommendations, Alexander was even more explicit: “If you give me 12 recommendations, in priority order, I’m going to ask [staff] to draft them into law,” he explained. “Then we can decide whether we can pass it. The rationale is important, but frankly, what I’ve learned to do as a U.S. senator is to find people whose judgment I can rely upon. … There are a lot of ways to skin the cat, but first, I need the product.”

Larry Faulkner, the chair of the Academies panel, told Alexander that the committee will do its best to comply. “I think we will be in a position to deliver to you an interim report … a relatively short list of the 10 or 12 highest priority matters we feel need to be addressed,” said Faulkner, president emeritus of the University of Texas, Austin.

The Senate is drafting its version of the House of Representatives–passed 21st Century Cures Act to bolster federal support for biomedical research, Alexander noted, and he tipped his hand on how he thinks regulatory reform fits into his larger legislative strategy. “We’ve got a train that is coming into the station—we call it our medical innovation effort. We’ve asked the question: What can Congress do to better align federal policies so that discoveries can get through the investment and regulatory process and into the medicine cabinet more rapidly?”

“The House has already completed its work on a similar thing,” Alexander said. “And President Obama is interested in precision medicine. So in talking with the president, I said, ‘We’ll fold your precision medicine initiative into our innovation legislation. And while we’re arguing about other things, we’ll get this done. … While nothing’s certain in Washington, my guess is that we have a really good chance, early next year, of passing a new law built upon 21st Century Cures, or precision medicine, or changing policies that speed up treatments and cures. And if you give us X number of recommendations on simplifying and reducing the regulatory burden on universities, we can put it in there.”