NIH and FDA: Less red tape, more research investment will drive medical innovation

In a U.S. Senate Health, Education, Labor and Pensions Committee hearing Tuesday, National Institutes of Health (NIH) Director Francis Collins and outgoing Food and Drug Administration (FDA) Commissioner Margaret Hamburg each outlined how Congress could help their agencies speed up medical innovation.

Sen. Lamar Alexander (R-Tenn.), who chairs the committee, said he and his colleagues want to "take a look at what we can do as a Congress, working with the president, to reduce the amount of time it takes to go from discovery of a medicine or a treatment or a medical device and take it all the way through to the medicine cabinet or the doctor's office."

Furthermore, "it's an area that we ought to succeed in," because the issue isn't partisan, he said, citing the parallel aims of President Barack Obama's recently announced Precision Medicine Initiative and the House of Representatives' "21st Century Cures" proposal.

"This is an unusual opportunity to get a result in a town that doesn't that often see the president and the Republican Congress on the same train headed in the same direction toward an important station," Alexander later added.  

Since both the FDA and NIH will play major roles in these efforts, Alexander asked both Collins and Hamburg to identify the top two ways Congress could help them streamline their regulatory and research roles, particularly in reference to reducing the significant amount of time the NIH spends on administrative tasks, currently estimated as 42 percent of its time.

To improve his agency's efficiency, Collins highlighted the following top issues:

  • The NIH wants Congress to fix the excessive oversight of attendance at scientific meetings, on which Collins said the government spends $16 million and uses hundreds of employees in response to other agencies abusing their power by holding conferences in places like Las Vegas. The NIH shouldn't have to pay the price for others' excesses, he said, adding, "Scientists going to conferences is a critical part of how new things emerge, and it is very much being inhibited by this heavy-handed oversight."
  • The NIH also would like to be able to carry funds over into next year, as other agencies such as the Department of Energy are allowed to do, Collins said. The current policy forces the agency to rush to spend excess funding at the end of the year, and the ability to roll over funds would mean "we could be more flexible in how we spend the taxpayers' money," he added.

Hamburg's requests, meanwhile, focused less on oversight and more on big-picture issues, including:

  • The FDA wants Congress to invest more money in regulatory science to develop tools and strategies that will enable it to better assess the safety, efficacy and quality of a product, Hamburg said. It's an area that's has not received enough attention, though it's "proving to be really essential as we are trying to take that last set of steps from research and development into a product that will really make a difference in people's lives," she said.
  • Along similar lines, the government must recognize that the FDA "has a huge amount to contribute to the overall process of product development" as well as its responsibility to review products and medicines, she said. Congress needs to take steps to allow the FDA to be able to engage in a consistent way earlier in the product development process so that it conducts the right studies and return on investment in research drives toward a product that works.

Both the FDA and NIH will to play major roles in Obama's Precision Medicine Initiative, with the former slated to receive $10 million to transform its framework for regulating genome-based treatments and the latter set to get $130 million to invest in a large-scale effort to gather "a million or more" Americans' health data to advance researchers' understanding of the genetic causes of disease, FierceHealthcare reported. Both agencies have already begun work on the project, as the FDA recently authorized the first direct-to-consumer genetic test and the NIH has enlisted the help of an array of experts to produce a serious of whitepapers related to the initiative.

To learn more:
- watch the first, second and third videos of the hearing

Related Articles:
Consumer-driven precision medicine gets boost from FDA
Privacy must be at forefront of precision medicine initiatives
Legislators aim to send 21st Century Cures bill to Obama by year's end
Will the promise of precision medicine live up to the hype?
Priority Health to cover comprehensive genetic testing
What will 'precision medicine' mean for providers?
Obama to request $215M for precision medicine plan
Moores Cancer Center among precision medicine pioneers
Obama touts cybersecurity, personalized medicine efforts in State of the Union address