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House clears medical research bill with wide margin

Democrats and Republicans find rare common ground on health care.

In an unusual display of bipartisanship on an issue that has divided Congress for years, the House overwhelmingly approved a biomedical research bill Friday that would change how the National Institutes of Health grants money to institutions like the Johns Hopkins University.

The measure, approved on a 344-77 vote, would provide $1.75 billion in additional annual funding to the Bethesda-based NIH in exchange for the agency's placing a greater emphasis on young scientists — who often struggle to win grants — and requiring more accountability in grant making.

"Thousands of chronic and deadly diseases, for which we have no treatments or cures, cost billions of dollars and claim millions of lives every year," said Rep. Andy Harris, the Baltimore County Republican and Hopkins-trained anesthesiologist who crafted many of the bill's provisions. "This bill is our chance to invest in promising breakthroughs and real cures."

After years of squabbling over President Barack Obama's health care law, the vote marked the second time this year that the GOP-led House has secured a wide, bipartisan margin on a health-related bill. The chamber also approved legislation this spring to "fix" the way Medicare pays doctors — an issue that had long confounded lawmakers in both parties.

The Senate is not expected to take up its version of the bill until this fall, and some House Republicans raised concerns that could foreshadow difficulties in the other chamber. Some conservatives objected to making new NIH funding mandatory — and therefore not subject to congressional review as part of the annual appropriations process.

The legislation, known as the 21st-Century Cures Act, also includes provisions to speed the approval of new medicine at the Food and Drug Administration. It would allow the pharmaceutical industry to rely more on "real-world evidence," to determine the efficacy of drugs for new treatments.

Supporters said that with the industry rapidly creating new treatments, it is time to modernize how the federal agency assesses the safety of new products and allows their use by patients. The bill was backed by the pharmaceutical, biotechnology and medical device industries and research universities.

But consumer groups and some doctors said some provisions sacrificed sound science for speed and could be dangerous.

"The bill is a bad deal for patients," said Vijay Das with the Washington-based watchdog group Public Citizen. "At its core, this legislation is a horse trade: In exchange for increased funding for the world-renowned National Institutes of Health, lawmakers added perks for the pharmaceutical and medical device industries."

Research groups have complained for years that NIH funding has remained essentially stagnant at around $30 billion a year even though medical costs have consistently grown faster than inflation.

If approved, the legislation could have significant implications for Maryland, where research institutions received $1.3 billion in NIH funding in 2014 — the fifth-largest share in the country.

The Johns Hopkins University is the state's largest beneficiary of medical research money, and one of the largest in the country.

"Today's strong bipartisan vote puts us on an exciting path to address critical NIH funding needs and fuel innovation in medical research," Hopkins President Ronald J. Daniels said in a statement. The bill, he said, "reflects a shared belief in the crucial role of NIH-supported research."

Johns Hopkins Medicine issued a separate statement noting the "broadly bipartisan vote," which officials hope "bodes well for moving legislation through the Senate and to the president's desk before the end of the year."

The legislation drew support from Maryland's entire congressional delegation —Harris and seven Democratic lawmakers.

Rep. Steny Hoyer, the Southern Maryland lawmaker and No. 2 Democrat in the House, called the bill "the most significant investment in biomedical research in more than a decade."

Harris, the only current member of Congress who has conducted NIH-funded research, drafted several of the provisions, including the creation of an innovation fund that would be targeted at investing more money in young investigators and high-risk projects that can lead to breakthroughs.

Studies suggest that scientists often develop their career-defining ideas in their mid- to late 30s. But the average age of first-time recipients of the most sought-after NIH funding is 42.

Harris also wrote provisions Republicans said would increase accountability at the NIH. Institute directors would be appointed by the director of the NIH, instead of the secretary of the Department of Health and Human Services.

Directors also would be responsible for approving grants at their institutes, rather than being permitted to delegate that oversight. And the bill calls for the NIH to develop a five-year strategic plan to formalize the agency's goals.

The legislation contains numerous ways for FDA regulators to accelerate clinical trials of products, including allowing the use of data from case studies, patients' experiences, other countries and medical journals.

Procedures would be streamlined for approving some new antibiotics and medical devices considered breakthrough technologies. Producers of existing drugs would get an extra six months of protection from competition if their drug is approved for use against rare diseases.

In a letter to lawmakers, the White House embraced the measure's added research funds and efforts to accelerate drug development. It criticized its extension of competition-free periods for some drugs and said some therapies would be available before their safety was proven. But it but did not threaten a veto.

Democrats lost an effort to delete language that applied existing restrictions on the use of federal money to pay for abortions.

The Associated Press contributed to this article.

john.fritze@baltsun.com

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