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FDA Panel Supports Removal of Unproven Pregnancy Drugs

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WASHINGTON (AP) — Federal health advisers have concluded that a drug to prevent preterm births is not working, paving the way for US regulators to follow a long-delayed effort to get it off the market.

The Food and Drug Administration’s advisory panel voted 14 to 1 on Wednesday that the injectable drug Makena should be withdrawn, despite the manufacturer’s objections to keep it usable until further research.

The experts essentially agreed with the 2020 FDA decision that deemed the drug ineffective and called for its removal. Manufacturer Covis Pharma had appealed this decision by arranging this week’s rare public hearing.

An obstetrician, Dr. “If we let Makena stay on the market, that would mean that the FDA looked at a large study, found no benefit, and still allowed this drug to stay on the market,” said Margery Gass. “I think that’s a bad precedent.”

Gass and other panelists encouraged Covis to continue researching the drug to determine whether a subset of women might benefit.

University of South Alabama’s Dr. “I think our patients deserve a response and they deserve this well-designed clinical trial, and I think removing the drug from the market will allow for that,” said Mary Munn.

FDA Commissioner Dr. Robert Califf is expected to make a final decision on withdrawing the drug in the next few months. If he follows the panel’s advice, it will be the first time the FDA has officially withdrawn a drug it originally approved, based on promising early data.

The FDA granted accelerated approval to Makena in 2011 based on a small study that appeared to reduce the rate of preterm birth in women with a history of problems. Premature birth increases the risk of infant disability and death and affects approximately 10% of births in the United States.

FDA’s approval was conditioned on a larger follow-up study to confirm whether Makena provides healthier outcomes for babies.

But in 2019, results from an international study involving 1,700 patients showed that the drug neither reduced preterm births – as originally thought – nor produced healthier outcomes for babies.

The FDA has since taken action to revoke approval of the drug. But the long, bureaucratic process underscores the difficulty of removing a drug from the market when a manufacturer does not voluntarily do so.

Luxembourg-based Covis Pharma argued this week that Makena benefits women most at risk of preterm birth, including Black Americans, and suggested narrowing its approval to this group while conducting another study to confirm effectiveness. The company’s presentations included outside experts who said removing Makena would exacerbate racial disparities in prenatal care.

Obstetrician at Baylor University, Dr. Yolanda Lawson tells the FDA, “The FDA must do what is best for our patients; “This is to keep this drug available to those of us who manage these very high-risk patients every day.” panel.

But experts eventually sided with the FDA scientists, emphasizing that “they failed to identify a group of women who had Makena’s influence.” The FDA noted that the drug also carries risks, including blood clots and depression.

The FDA has faced pressure to crack down on unproven drugs approved under its accelerated approval program, which has allowed dozens of drugs to come to market based on early results since the early 1990s. The other side of the program is the removal of drugs if their initial promises are not confirmed by subsequent studies.

Makena has become a poster child for the downsides of the program, as the drug has remained on the market for over a decade without any confirmed benefits. According to a recent federal report, the United States has spent $700 million on Makena since 2018 through various government programs, including Medicaid.

According to Covis, about 350,000 women have used the drug in the last decade.

Even if the drug is discontinued, it is expected that some doctors will continue to prescribe its main ingredient as a specialty drug. Compounding pharmacies have long offered their own formulations of the drug. Both Makena and the combined drugs consist of a synthetic form of the hormone progesterone, which helps the uterus grow and maintain a pregnancy.

This story has been corrected to show that the panel member commenting on the potential for bad precedent was Margery Gass, not Margaret Gatz.

The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. Only AP is responsible for all content.

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