Letter: FDA Panel for Hearing to Evaluate Makena Removal Must Be Fairly Balanced To Ensure Independent Judgment

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) must ensure that the advisory committee for a planned agency hearing that will consider whether the drug hydroxyprogesterone (Makena), which is approved to reduce the risk of preterm birth, should be withdrawn from the market must be fairly balanced to ensure the integrity of the hearing process and public trust in the committee’s advice, Public Citizen said today in a letter to the agency.

“It is imperative that the FDA reject the proposal from Covis Pharma GmbH, the manufacturer of Makena, to essentially stack the jury in its favor by significantly expanding the advisory committee roster for the hearing with individuals whom the company believes will be sympathetic to its view that Makena should remain on the market,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group.

The FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) will be convened as part of a to-be-scheduled hearing to provide advice and recommendations on the FDA’s proposal to withdraw approval of Makena, which was approved in 2011 under the agency’s accelerated approval pathway. Public Citizen originally petitioned the agency in October 2019 to take Makena and related generic products off the market because a large FDA-mandated post-approval clinical trial showed the drug is not effective in reducing the rate of preterm birth.

In its letter, Public Citizen emphasized that the panel must be fairly balanced in terms of the points of view represented; constituted in a manner to ensure independent judgment; and the members must have both relevant expertise and diverse professional education, training and experience.

Public Citizen endorsed the position of the FDA’s Center for Drug Evaluation and Research that the composition of the committee for the upcoming hearing should include multiple members with expertise in biostatistics — including at least one member with expertise in meta-analysis — as well as members with expertise in epidemiology, neonatology, understanding real-world evidence and the regulation of pharmaceuticals. Public Citizen further recommended that no more than one-third of the voting committee members be practicing obstetricians.

The letter is available here.