Pharmacists again making preterm labor drug

Most stopped after Feb. FDA decision

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Local compounding pharmacists say they will again start making a less costly version of a drug that helps prevent preterm labor, after the U.S. Food and Drug Administration said it would not take action against them if they do.

"I'll be making it again," said Joe Bettinger, owner of Hieber's Pharmacy in Oakland, which made the drug known as 17P for years until the FDA in February gave exclusive marketing rights to one company, K-V Pharmaceutical.

After that, K-V Pharmaceutical of suburban St. Louis sent cease-and-desist letters to pharmacists, including Mr. Bettinger.

But after hearing the FDA statement this week, and getting clarification from the International Academy of Compounding Pharmacists in a conference call on Thursday, "I feel comfortable making it now," he said.

The FDA on Wednesday said it wouldn't take any action after criticism was heaped upon the government and the company when K-V Pharmaceutical last month said it was going to charge $1,500 per dose of the drug it calls Makena, when compounding pharmacies typically charged $10 to $20 for 17P.

On Friday, K-V Pharmaceutical responded by saying it would cut the price of Makena by nearly 55 percent to $690 per dose.

Even with that cut in price, though, Mr. Bettinger and others doubted it would do much to persuade insurance companies to use Makena, or prevent doctors from prescribing 17P from compounding pharmacies.

"Still, at $690 a shot, it's still orders of magnitude more than what women were paying before," said Hyagriv Simhan, the division chief for maternal-fetal medicine at Magee-Womens Hospital of UPMC, where 200 to 300 women use the drug annually. "If there's a compounded alternative, I can't imagine [insurance companies] would cover the FDA-approved Makena. Why would they?"

The dramatic increase in cost last month created a torrent of anger from women's health organizations, congressional representatives and thousands of women, who started Facebook pages and sent letters and emails to the FDA and the company to protest the move.

They feared the dramatic price increase wouldn't be covered by insurance companies or that the co-pays would be so high that it would prevent many women from taking a drug that has been shown to reduce premature births by one-third when taken weekly for up to 21 weeks during pregnancy by high-risk mothers.

When the original price was announced last month, with compounding pharmacies about to stop making the drug, and most insurance companies saying they were reviewing coverage of Makena, many women scrambled to either stock up or find alternatives that wouldn't cost them thousands.

Janice Watkins, a Pittsburgh teacher who is pregnant with twins, said she rushed to get a second stock of her prescription, which finally arrived this week in the mail, her sixth week on the drug.

She was happy to hear the news this week, but said: "I still think the company is completely wrong. You just shouldn't be able to do this."

In response to such criticism, on Wednesday, the FDA released a statement saying, in part: "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 hydroxyprogesterone caproate," also known as 17P and Makena.

Pharmacists were surprised that the FDA took such action.

"I'm shocked, quite frankly. But it's great for the patients and their care," said Amy Belcastro, a compounding pharmacist at Jeffrey's Drugstore in Canonsburg, which just stopped making 17P this week but has since restarted.

K-V Pharmaceutical on Friday said that by dropping its price to $690, 85 percent of women would pay $20 or less per dose for the drug, based on co-pays.

In a statement, Greg Divis, chief executive officer of K-V Pharmaceutical Co., and president of Ther-Rx Corp., the subsidiary that will market Makena, said: "We understand the concerns that key stakeholders raised under our original pricing structure. We also recognize the current budget challenges facing state Medicaid programs and other payers."

One gray area in this debate, however, remained unclear.

Though the FDA said it would not take enforcement action against pharmacies, some pharmacists questioned whether K-V Pharmaceutical might come after them in civil court, claiming intrusion on their exclusive right.

The company did not help clear up the confusion, saying in a statement: "Because of the importance of Makena to women with a prescription, we will vigorously support the exclusivity of this FDA-approved, FDA-regulated treatment. The Company looks forward to discussing this further with the FDA."

Ronald Thomas, director of the division of maternal fetal medicine for West Penn Allegheny Health System, said he doubts the company will try anything.

"They could" try to sue individual pharmacies, he said. "But it has become such a political hot potato, I'd be surprised if they'd grab the public attention again by going after individual pharmacists."

If it did, it would be another bad publicity move, said Dr. Simhan, who notes K-V Pharmaceutical's first mistake was not realizing it was dealing with perhaps the most cherished segment of our culture: babies, and premature babies at that.

"It's an incredibly vulnerable segment of society and it's our responsibility to care for them as best we can," he said. "That is truly what has rubbed people the wrong way in this."

Sean D. Hamill: or 412-263-2579.


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