FDA Allows De Facto Generic of Pricey Preemie Drug Makena


It wasn't always easy to find places that made the medication, however, said Dr. Michael Lindsay, division director of Maternal-Fetal Medicine at Emory University School of Medicine.

"We were excited at first to hear it be FDA-approved," he said. "My mind-set was that now everyone could get it, but no one is going to be able to afford [the price KV Pharma is putting on it]."

Menard agreed, adding that "this financial barrier, we see it as insurmountable."

Several letters have been sent to the company by leading maternity advocates and public officials voicing concerns that the price will prevent many women in need from receiving the drug and put a heavy burden on the health care system as a whole, especially Medicaid.

The March of Dimes, American College of Obstetrics and Gynecology, the American Academy of Pediatrics and the Society for Maternal Fetal Medicine today took their concerns directly to KV.

"[KV] wanted to listen to our concerns. They apologized sincerely for the way this was handled, said they were working with incomplete information. Basically, they're going to take all that listening and go back to the board and make a decision," Menard reported from the meeting.

Company's Financial Assistance Program Questioned

KV Pharmaceutical respond to the price controversy by announcing a Comprehensive Patient Assistance Program for Makena in which households, both insured and uninsured, making less than $100,000 a year will be subsidized.

In a statement to ABC News, KV Pharmaceuticals and partner company Ther-Rx, wrote: "We are committed to taking the appropriate steps to help ensure that all clinically-eligible patients have access to Makena."

This translates into providing the drug for free to households making less than $60,000 annually that "apply for and are eligible for patient assistance." Those making $60,000 to $100,000 will be able to obtain it "at a cost that is comparable to the average copay assigned by commercial insurance," and those who are insured and make less than $100,000 will have a copay of $20 or less guaranteed to them, according to a company statement.

This contingency plan raises concerns for doctors, however. Those households making more than $100,000 a year cannot necessarily afford to devote as much as a third of their income to pay for Makena if their insurance does not cover the procedure, Lindsay said.

In addition, those receiving financial assistance will need to go through an approval process that could delay treatment, possibly resulting in preterm birth for many patients, Menard says.

ABC News' Lisa Stark contributed on this report

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