FDA opens up competition for pregnancy drug

The Food and Drug Administration took the unusual step Wednesday of inviting specialty pharmacies to make an end run around a company that obtained exclusive rights to a pregnancy drug and promptly raised the price from $20 a dose to $1,500.

The drug, a synthetic form of progesterone trade-named Makena, is recommended as a weekly injection for women at high risk of delivering prematurely, beginning between 16 and 18 weeks’ gestation until 36 weeks. The action by K-V Pharmaceutical Co. boosted the total cost of the drug during a pregnancy from about $400 to $30,000, igniting a firestorm of objections.

Then K-V sent letters to pharmacies threatening that the FDA would punish them if they compounded their own versions of the drug. On Wednesday, the FDA declared it would do no such thing.


In its statement, the FDA noted that the drug was important and K-V “received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness.”

Until early this year, women obtained the drug from so-called compounding pharmacies, which produced it on a made-to-order basis. Although custom-made for each patient, it sold for about $20 a dose.

But in February, the FDA granted St. Louis-based K-V exclusive rights to make Makena for seven years, ending, at least in theory, the need for made-to-order versions.

But the company’s pricing announcement this month, coupled with the warning letters K-V sent to pharmacies, aroused a strong reaction from several members of Congress, including Sens. Sherrod Brown (D-Ohio) and Amy Klobuchar (D-Minn.), as well as patients and medical groups. Critics called the huge increase unfair to patients, private insurers and Medicaid.

In response, the FDA said it had no intention of blocking pharmacies from selling their own versions of Makena.

“In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound [Makena] based on a valid prescription,” the agency said in a statement.

Although the FDA has the authority to crack down on compounding pharmacies when they offer products competing with FDA-approved drugs, it is not obligated to do so.

In a statement after the FDA’s announcement, K-V said it would do more to make the drug affordable, but did not say it would lower the price.

“Based on feedback the company has received, we are currently exploring additional ways to help provide affordable access for all patients who are prescribed Makena,” K-V’s statement said.

Compounding pharmacists undergo additional training to make drugs tailored for individuals. Their versions should be safe and effective, experts said.

“It’s a non-issue,” said James Moran, chairman of the OB/GYN department at St. John’s Health Center in Santa Monica. “There are plenty of really good compounding pharmacies we deal with all the time.”

Since 2003, the American Congress of Obstetricians and Gynecologists has recommended that Makena be offered to high-risk women — those who have had at least one previous pre-term delivery.

An estimated 500,000 babies are born prematurely in the U.S. each year, and those births are associated with a range of health and developmental problems, as well as with billions of dollars in additional medical costs.

K-V’s Makena application was approved under the Orphan Drug Act, which expedites evaluation of medications needed by relatively small populations of patients and gives companies seven years of protection from generic competition. But that protection does not apply to competition from compounding pharmacies, whose products are not FDA-approved.

“Orphan-drug exclusivity only prevents approval of another application for the same indication. Pharmacy compounding is not done under an approved application,” FDA spokesman Jeffrey Ventura said.