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FDA panel supports the removal of unproven drugs for pregnancy

Federal health advisors concluded that the drug meant to prevent premature births had not been proven to work. This opens the door for U.S. regulators who will now pursue a long-delayed effort at getting it off the marketplace.

Wednesday’s vote by the Food and Drug Administration advisory panel was 14-1. The panel rejected appeals from the manufacturer to keep Makena available for further research.

Experts essentially agreed to a 2020 FDA decision declaring the drug ineffective and calling for its elimination. Covis Pharma, the manufacturer, had opposed that FDA decision and set up this rare public hearing.

“If we allow Makena on the market, it means that the FDA looked at large studies, found no benefit, and allowed this drug to continue on the market,” Dr. Margery Gass, an obstetrics specialist, said. “I believe that this is a bad precedent.”

Gass and the other panelists encouraged Covis not to stop studying the drug to determine if there is a subgroup that could be benefited.

Dr. Mary Munn, University of South Alabama, stated that “I believe that our patients deserve an explanation and that they deserve a well-designed clinical study and that taking the drug off of the market will allow that to happen.”

The FDA Commissioner, Dr. Robert Califf, is expected to make the final decision regarding the withdrawal of the drug within the next few months. It would be the first time that the FDA has officially pulled the drug it approved initially based on promising early data.

Based on a small study that showed Makena could reduce premature births in women who have had the problem in the past, the FDA granted Makena accelerated approval in 2011. Preterm birth increases the risk of death and disability in infants. It affects approximately 10% of U.S. deliveries.

FDA approval was conditional on larger follow-up studies to verify that Makena had better outcomes for babies.

However, the 2019 results of this international study with 1,700 patients showed that the drug did not reduce premature births as initially thought or result in healthier infant outcomes.

Since then, the FDA has been trying to revoke approval for the drug. The lengthy, bureaucratic process highlights the difficulty in removing a drug from the market if a manufacturer refuses to do so.

Covis Pharma, a Luxembourg-based company, argued that Makena is beneficial to women at greatest risk of having early delivery, including Black Americans. It proposed that it be approved for this group, while another study was conducted to verify its effectiveness. The presentations of Covis Pharma included experts from outside who claimed that removing Makena could worsen racial disparities when it comes to prenatal care.

Dr. Yolanda Yolanda, an obstetrics expert at Baylor University, stated that the FDA should do what is best for patients. She suggested that this medication be kept available for those who care for high-risk patients.

The FDA scientists won the support of experts, but they said that they couldn’t identify any women for whom Makena was effective. FDA also noted that the drug has risks, such as blood clots or depression.

FDA is under pressure to stop unproven drugs from being approved under its accelerated program. This program has allowed many drugs to be launched based on early results from the early 1990s. However, the program can also be used to remove drugs from the market if they don’t prove promising in later studies.

Makena is a symbol of the program’s shortcomings, as the drug has been on the market for over a decade with no evidence of any benefit. A federal report shows that the U.S. spent $700 million on Makena between 2018 and 2018. This includes Medicaid.

According to Covis, 350,000 women used the drug over the past decade.

Some doctors will continue to prescribe the drug’s key ingredient as a specialty medicine even if it is discontinued. For long, compounding pharmacies have offered their versions of the drug. Makena as well as compounded medications contain a synthetic version of the hormone progesterone that helps to maintain and grow a pregnancy.

This story has been corrected so that Margery Gass was the one who spoke out about the possibility of bad precedent and not Margaret Gatz.

Howard Hughes Medical Institute’s Department of Science Education provides support to the Associated Press Health and Science Department. All content is the sole responsibility of the Associated Press.

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