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House bill would speed drug approvals, boost research

By ALAN FRAM
Associated Press

WASHINGTON (AP) - Backed by medical industry and patients' groups, the House neared approval Friday of a bipartisan bill that would speed federal approval of drugs and medical devices and boost biomedical research.

Passage seemed likely despite warnings from consumer groups and others that the measure would weaken government safeguards against dangerous or ineffective products. Conservatives also complained angrily about the multibillion-dollar cost of the legislation, and Democratic lawmakers raised concerns about language on funding for abortions.

Supporters said that with genetic mapping, biologic medicines produced in living cells and other advances, it was time to streamline how federal regulators assure the safety of new treatments and let them reach market.

"We have a chance to do something big, and this is our time," said Rep. Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee. He and Rep. Diana DeGette, D-Colo., were chief authors of the bill.

Defenders of the current system said the Food and Drug Administration, which regulates drugs and medical devices, already has an efficient approval process. Public Citizen, a consumer group, said the bill would trade increased federal research for "perks to the pharmaceutical and medical device industries."

The House bill would increase spending for the National Institutes of Health, which finances much of the country's biomedical research, by $8.75 billion over the next five years. FDA would get an additional $550 million over that period.

The new spending would be paid for, mostly by selling $7 billion worth of oil from the Strategic Petroleum Reserve, the government's emergency oil stockpile. Another $2.5 billion would come from trimming federal Medicaid reimbursements to states.

Conservatives were unhappy because the NIH and FDA would get their additional research funds automatically and because that money would be on top of - not part of - the amounts Congress spends annually on domestic programs.

"If you want a cure, go to the doctor, but if you want to clean up the U.S. economy, please consult an economist or two," said Rep. Dave Brat, R-Va., a former economics professor who defeated former House Majority Leader Eric Cantor in a Republican primary last year.

By 281-141, the House rejected an amendment by Brat under which the research money would not be guaranteed. Republican leaders urged their colleagues to vote it down. Cantor, no longer in Congress, was among those urging lawmakers to support the original bill.

The abortion issue came up as Republicans sought to extend existing prohibitions on abortion funding to the legislation. Rep. Barbara Lee, D-Calif., called that "outrageous" and offered an amendment to undo the provision, but Democrats indicated they would not oppose the underlying bill over the issue given that the abortion funding restrictions already are in place in federal law.

Other provisions would speed how many drugs and devices reach consumers, such as letting regulators approve some medical equipment with shorter studies using fewer people. New uses of existing drugs could be based partly on case studies and other processes that are less rigorous than traditional clinical trials.

In a boon for pharmaceutical companies, the bill would give producers of existing drugs an extra six months of protection from competition if their drug is approved for use against rare diseases. There would be a streamlined process for approving new antibiotics for patients with resistant infections.

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

Similar legislation has yet to be introduced in the Senate.

___

AP Health Writer Matthew Perrone contributed to this report.

Copyright 2015 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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