One patient group created a Facebook page specifically to shame the manufacturer. Sarah Vandermeulen, age 30 years, of Paducah, Ky., was quick to join up. Ms. Vandermeulen said that in 2000, she had delivered a 1 lb 3oz baby at 23 weeks’ gestation who did not survive. In 2009, she became pregnant again and had heard about 17P from members of an online support group "I promptly asked my doctor if this was for me, and she agreed I may benefit from taking 17P," she said in an interview. Ms. Vandermeulen delivered a healthy baby at 37 weeks’ gestation.
"I obviously have no comparison or scientific data, but I do believe that 17P at the very least delayed preterm labor," said Ms. Vandermeulen. "I know that other women are scared for their current and future pregnancies. Many swear they wouldn’t have carried to term without 17P and are terrified that they will be denied this treatment option. I can tell you that there are discussions taking place on what we can do to help change the price increase."
The same question is also vexing clinicians. Dr. Harman, whose university clinic handles about 1,500 high-risk babies per year and whose referring hospitals deliver a total of about 9,000, said that he was concerned that local compounding pharmacists would not make the medication now that it is FDA-approved. "We’re investigating our possibilities," he said. "We may end up a producer ourselves," he said, adding that this was only "anxious conversation" in the near term.
The compounding pharmacies for now are striking a defiant pose. On March 14, the International Academy of Compounding Pharmacists issued a statement to patients and providers saying that, although many pharmacies had received a warning letter dated Feb. 17 from Ther-Rx that they could no longer compound an FDA-approved medication to which Ther-Rx had exclusive marketing rights, "In our estimation, the letter is nothing more than a ‘scare tactic.’ ... Pharmacists can legally compound FDA approved products when a prescriber determines that the compounded preparation is more clinically appropriate for an individual patient."
David G. Miller, R.Ph., the group’s chief executive, said in an e-mail that the answer to the question of whether 17P can legally be compounded, in light of an FDA-approved product with market exclusivity, was "clear and simple."
"If a prescriber determines that a compounded preparation of a medication is in the best clinical interest of his or her patient and discusses the available options with a pharmacist, there are no statutory or regulatory prohibitions on that professional decision," Mr. Miller said.
One criticism raised by Mr. Miller and others was that Makena had received FDA approval in part as a way to offer 17P with guaranteed consistency across the market. However, Ther-Rx’s parent company, KV Pharmaceutical Company, has recently faced legal trouble over active-ingredient inconsistencies and false labeling of its FDA-approved products.
Just last week, KV Pharmaceutical Company’s former chief executive pleaded guilty to breaching federal food and drug statutes by selling oversized morphine tablets.
Dr. Harman said he had no relevant financial disclosures.