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Sunday, December 3, 2023

Speeding up drug approvals

Rep. Fred Upton, R-Mich.  (AP Photo/Charles Dharapak)
Rep. Fred Upton, R-Mich.
(AP Photo/Charles Dharapak)

Pressed by industry and patients’ groups, the House is nearing approval of a bipartisan bill that would speed federal approval of drugs and medical devices and boost biomedical research.

Passage seemed likely Friday despite warnings from consumer organizations and others that the measure would weaken government safeguards against dangerous or ineffective products. 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.

Before stepping down as FDA commissioner earlier this year, Margaret Hamburg told Congress that her agency had approved the most new drugs last year in nearly two decades. She said two-thirds of the drugs approved by the FDA last year had gone through streamlined processes, the highest proportion ever, and that her agency’s typical time for approving drugs was significantly faster than Europe’s or Japan’s.

Public Citizen, a consumer group, said the bill would trade increased federal research for “perks to the pharmaceutical and medical device industries” and added, “Passage of this legislation would put lives at risk.”

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.

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, and hospitals could get extra payments as an incentive for using some new drugs.

The bill’s 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 buying certain medical equipment.

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.

Rep. Dave Brat, R-Va., was pushing an amendment under which the research money would not be guaranteed. Brat’s effort faced likely defeat, and among those sending emails supporting the original bill was former House Majority Leader Eric Cantor, whom Brat ushered from Congress by defeating him in a Republican primary last year.

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.


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