NATIONAL NEWS

FDA to offer faster drug reviews to companies promoting ‘national priorities’

Jun 17, 2025, 10:32 AM

FILE - Food and Drug Administration (FDA) commissioner Marty Makary speaks during a news conference...

FILE - Food and Drug Administration (FDA) commissioner Marty Makary speaks during a news conference at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, file)
Credit: ASSOCIATED PRESS

(AP Photo/Jose Luis Magana, file)

WASHINGTON (AP) — U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting “the health interests of Americans,” under a new initiative announced Tuesday.

Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA’s long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to “challenge assumptions” and rethink procedures. In a published last week, Makary suggested the agency could conduct “rapid or instant reviews,” pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed.

For the new program, the FDA will issue a limited number of “national priority vouchers” to companies “aligned with U.S. national priorities,” the agency said in a statement. The special designation will give the selected companies access to extra FDA communications, streamlined staff reviews and the ability to submit much of their product information in advance.

Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews.

Many aspects of the plan announced Tuesday overlap with older programs. But the broad criteria for receiving a voucher will give FDA officials unprecedented discretion in deciding which companies can benefit from the fastest reviews.

“The ultimate goal is to bring more cures and meaningful treatments to the American public,” Makary said in a statement.

Makary previously said the FDA should be willing to ease its scientific requirements for certain drugs, for instance, by not always requiring randomized studies in which patients are tracked over time to track safety and effectiveness. Such trials are generally considered the gold standard of medical research, though the FDA has increasingly been willing to accept smaller, less-definitive studies for rare or life-threatening diseases.

In several recent cases, the FDA has faced criticism for approving drugs based on preliminary data that didn’t ultimately show benefits for patients.

The push to rapidly accelerated drug approvals is the opposite approach that Makary and his boss, Health Secretary Robert F. Kennedy Jr., have taken on vaccines.

Promising a “return to gold-standard science,” Kennedy previously announced that all new vaccines would have to be compared to placebo, or a dummy shot, to win approval. Kennedy and Makary also have announced a stricter policy on seasonal updates to COVID-19 shots, saying they will have to undergo new testing before they can be approved for use in healthy children and most adults.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

National News

FILE - A border wall section stands on July 14, 2021, near La Grulla, Texas, in Starr County. (Delc...

Associated Press

Texas stops providing new funding for border wall construction

AUSTIN, Texas (AP) — Texas has stopped putting new money toward building a U.S.-Mexico border wall, shifting course after installing only a fraction of the hundreds of miles of potential barrier that Republican Gov. Greg Abbott set out to construct four years ago. State lawmakers this month approved a new Texas budget that does not […]

41 minutes ago

Associated Press

Childhood friend says Minnesota suspect had ‘darkness inside of him’

Hours after the shootings of two Minnesota lawmakers over the weekend, authorities asked David Carlson to identify his lifelong friend in a harrowing photograph. Carlson says he had known and trusted Vance Boelter from the time the two played together as children. But he barely recognized the 57-year-old in the surveillance image police showed him […]

45 minutes ago

FILE - Cuban doctors arrive at the Jose Marti International Airport in Havana, Cuba, June 8, 2020, ...

Associated Press

Cuban diplomat defends foreign medical missions under pressure from US

UNITED NATIONS (AP) — A senior Cuban diplomat has accused the Trump administration of trying to discredit the thousands of Cuban doctors working around the world and deprive the country of an important source of income. Deputy Foreign Minister Carlos Fernandez de Cossio, who was at U.N. headquarters this week for a debate on sanctions, […]

51 minutes ago

Michael Beach protests President Donald Trump's proposed cuts to health services outside the Center...

Associated Press

Trump administration blocked from cutting local health funding for four municipalities

A federal court has temporarily blocked the Trump administration from clawing back millions in public health funding from four Democrat-led municipalities in GOP-governed states. It’s the second such federal ruling to reinstate public health funding for several states. U.S. District Judge Christopher Cooper in Washington, D.C., issued a preliminary injunction Tuesday sought by district attorneys […]

1 hour ago

Associated Press

Judge says government can’t limit passport sex markers for many transgender, nonbinary people

BOSTON (AP) — A federal judge expanded a ruling Tuesday that blocked the Trump administration from enacting policy changes to sex markers on passports for many transgender and nonbinary Americans. In an executive order signed in January, the president used a narrow definition of the sexes instead of a broader conception of gender. The order […]

1 hour ago

Associated Press

Jury finds leading proponent of ‘The Big Lie’ defamed former voting equipment employee

DENVER (AP) — A jury found Monday that MyPillow founder Mike Lindell defamed a former employee of a prominent voting equipment company by calling him a traitor, telling Lindell and his online media platform to pay $2.3 million in damages. The decision came after a two-week trial involving one of the biggest proponents of the […]

1 hour ago

FDA to offer faster drug reviews to companies promoting ‘national priorities’