Doctors for America
PO Box 53313
1921 Florida Ave NW
Washington, DC  20009-9997

March 10, 2023

Makena Statement

WASHINGTON, D.C. – This week, over a decade after accelerated approval and nearly three years since the Food and Drug Administration (FDA) recommended withdrawal, Covis announced that it will withdraw its application for FDA approval of its drug to prevent preterm birth, Makena, and enter into a 21 week wind-down from the market. Doctors for America’s FDA Task Force supports the decision to remove this drug from the market, as its manufacturer has not been able to demonstrate meaningful clinical benefit. Further, we hope this case will help reaffirm the need for continuous review of and modifications to the FDA’s accelerated approval process such that the agency can take timely action to prevent prolonged clinical uncertainty for clinicians and their patients.      

Last October, an independent expert FDA advisory committee voted that Makena should be removed from the market. Eight years after the treatment was granted accelerated approval by FDA based on the suggestion that it was “reasonably likely” to reduce the proportion of women delivering before 37 weeks, the post-approval confirmatory trial failed to verify any effect on this primary endpoint. Now after over ten years of profit during which the FDA has repeatedly requested the manufacturer voluntarily withdraw the drug from the market given the lack of evidence of improvement in maternal or neonatal outcomes, the manufacturer has finally agreed to do so. As the FDA also noted, such a withdrawal will enable the manufacturer to conduct additional robust, placebo-controlled trials should they wish to adequately verify clinical benefit in representative patient populations and resubmit an application. This arduous process to remove an unproven drug from the market has showcased the many challenges associated with the accelerated approval pathway. 

We hope that the reforms passed by Congress last year as part of the Food and Drug Omnibus Reform Act (FDORA) will strengthen FDA’s authority to streamline the withdrawal process and protect patients from drugs where meaningful clinical benefit has not been demonstrated. 

About Doctors for America:

Doctors for America (DFA) mobilizes doctors and medical students to be leaders in putting patients over politics to improve the health of our patients, communities, and nation. DFA is an organization of over 27,000 physician and medical student advocates in all 50 states, representing all areas of specialization. DFA teaches physicians and medical students advocacy skills and does advocacy at a state and federal level. Our impact areas focus on access to affordable care, community health and prevention, and health justice and equity. DFA focuses solely on what is best for our patients, not on the business side of medicine, and does not accept any funding from pharmaceutical or medical device companies, which uniquely positions DFA as the organization that puts patients over politics and patients over profits.

Find out more at and on Twitter @drsforamerica.

Prescription Drugs, FDA