House GOP proposes changes for NIH, FDA

By John Fritze, The Baltimore Sun. January 27, 2015.

House Republicans are considering significant changes to the way billions of dollars in National Institutes of Health grants are awarded to research institutions under a proposal intended to speed medical breakthroughs.

The proposal, which Republican lawmakers unveiled Tuesday, would require the Bethesda-based NIH to set aside more money for high-risk research and young, emerging scientists while also giving the director more power to shape the agency’s direction.

Nearly a year in the making, the proposal from the House Energy and Commerce Committee represents a political shift from the Republican Party’s persistent effort to undercut the Affordable Care Act toward a focus on medical research that might ultimately draw bipartisan support.

The 393-page document has implications for major research institutions such as the Johns Hopkins University and the University of Maryland, Baltimore, which are among the largest recipients of NIH money in the nation.

“If we want to achieve great things at the NIH, one of the things we have to do is empower younger investigators,” said Rep. Andy Harris, a Maryland Republican and Hopkins-trained anesthesiologist whom the panel gave credit for several provisions. “I don’t think these are Democrat or Republican ideas.”

The proposal also calls for changes at the Food and Drug Administration, such as the speeding of clinical trials and extending patents for drugmakers who develop therapies for complex diseases such as Alzheimer’s. Debate over those proposals is sure to set off a flurry of lobbying by universities, drug companies and medical device manufacturers.

Yet the draft drew a tepid response from some Democrats, including one of the lawmakers who has been most closely associated with its development. Colorado Rep. Diana DeGette said in a statement Tuesday that while she appreciated the public airing of ideas, she does not endorse the proposal.

Others said they were wary of significant new requirements for the National Institutes of Health, particularly since there islittle discussion of additional funding for the agency. Research groups have complained that federal money for research has been inconsistent and has not kept pace with medical inflation.

“The problem has been Congress,” said Diana Zuckerman, president of the National Center for Health Research. “When Congress tells the NIH to do something — when it tells any federal agency to do something, there are a lot of unforeseen consequences.”

Sen. Barbara A. Mikulski, a Maryland Democrat long considered a champion of the National Institutes of Health, said she is reviewing the proposal.

“Maintaining America’s innovation edge is a subject worthy of national discussion and debate,” she said.

Dr. Francis Collins, whom President Barack Obama named as NIH director in 2009, has frequently lamented the difficulty young scientists have in securing grants. The average age of first-time recipients of the agency’s most sought-after funding is 42, even as studies suggest that scientists are likely to come up with their best ideas in their mid- to late 30s.

The House proposal includes an idea pushed by Harris to dedicate an NIH fund specifically for young researchers.

Republicans also want the leaders of individual centers and institutes, such as the National Cancer Institute, to report to the NIH director instead of the secretary of health and human services. And they would give NIH leadership more power to transfer money from one institute to another and would require the head of each institute to personally sign off on research grants.

The proposal also includes a program to dedicate an unspecified amount to high-risk research, in which unexpected breakthroughs are often developed.

An NIH spokeswoman said that officials are reviewing the draft and that the agency urges Congress “to work in a bipartisan way to more rapidly translate scientific discoveries into therapies that will improve patient outcomes.”

Neither Hopkins nor the University of Maryland responded to requests for comment Tuesday. Hopkins President Ronald Daniels used an article in a scientific journal this month to call for reforms to increase opportunities for young researchers.

Several medical research groups applauded the announcement.

“The initiative could be a game-changer for the medical innovation ecosystem,” Research!America President and CEO Mary Woolley said in a statement.

The proposal also represents something of a political victory for Harris, Maryland’s only Republican in Congress, who has been expanding his reach on medical issues in recent years. Harris, who conducted NIH-funded research on cerebral blood flow during childbirth, influenced several provisions of the bill despite not serving on the Energy and Commerce Committee.

There is little discussion in the draft about overall funding for the National Institutes of Health, which has hovered around $30 billion for the past several years. Harris, a member of the House Appropriations subcommittee that approves health agency spending, said he believes the changes could make it easier for the new Republican majorities in both chambers to consider allocating more money for NIH.

“I’m not averse to increasing NIH funding,” Harris said. “If they’re willing to listen to some of these reforms … then I think Congress is going to be willing to consider an increase in funding.”