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VOL. 39 | NO. 28 | Friday, July 10, 2015

House OKs bill to speed drug approvals, boost bio research

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WASHINGTON (AP) — Urged on by the medical industry and patients' groups, the House overwhelmingly approved a bipartisan bill that would speed federal approval of drugs and medical devices and boost biomedical research.

The measure's easy 344-77 passage on Friday came despite objections from consumer organizations and others arguing the measure would erode government safeguards against dangerous and ineffective products.

The bill's supporters said that with advances like genetic mapping and biologic medicines produced in living cells, it is time to streamline how federal regulators assess the safety of new treatments and let them reach markets.

Passage also marked the second time the two parties have worked together this year on health policy, following enactment of legislation changing how Medicare pays doctors. They remain deeply divided over President Barack Obama's health care law, which the GOP wants to erase.

"It showed we could come together," Rep. Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee, said after the vote. He and Rep. Diana DeGette, D-Colo., are chief authors of the bill.

The Obama administration has given the measure mixed reviews but has not threatened a veto. The Senate has yet to write its version of the legislation.

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" and called it "an assault on patient safety and science."

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 it was defeated easily. 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.

In a letter, the White House 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.

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