Controversy Looms Over Cost Of Unique Drug To Prevent Premature Birth

After weeks of controversy, federal health officials announced last week that they would not stop pharmacies from making a cheaper alternative to a costly drug given to prevent premature birth. And separately, they investigated the deaths of nine Alabama hospital patients who received a nutritional supplement contaminated with bacteria.

The two events seemed unrelated, but both revolved around a century-old struggle between pharmacists and the government over who is best equipped to safeguard the nation’s drug supply. And both raise questions about what price the country is willing to pay for that protection. It is the drug industry equivalent of the battle between food trucks and restaurants.

The Alabama supplement was made by a so-called compounding pharmacy, a company that makes medicinal concoctions that are not otherwise available, like a liquid form of a drug sold only as a pill. But while the compounds are supposed to be made only for individuals, some compounding pharmacies operate in a legal gray area, making large batches of medicines and selling them widely.

Even though many patients over the years have died after taking these medicines, the F.D.A. does not subject compounding pharmacies to the strict controls that are routine for drug manufacturers.

The battle over the pregnancy drug, 17P, goes back at least to 2003, when demand soared after a landmark study confirmed its effectiveness in preventing premature births. First approved by the Food and Drug Administration in 1956, it was manufactured by Bristol-Myers Squibb until 2000; now the only makers are compounding pharmacies, which charge $10 to $20 per injection — $200 to $400 for the drug’s 20-week course.

There is no evidence that present supplies of 17P are unsafe, but the F.D.A. is always eager for crucial injectable medicines to be made under consistent and verifiable controls. Applying for manufacturing approval can be expensive, and companies generally go through it only if they can be assured of a high price and exclusive rights.

Since it was decades old, 17P had no patent protection. But a law called the Orphan Drug Act does provide seven years of exclusive sales rights to manufacturers who win F.D.A. approval for drugs that affect fewer than 200,000 people.

On Feb. 3, the F.D.A. approved an application from KV Pharmaceutical, a specialty-drug manufacturer based in St. Louis, and gave the company its exclusive orphan license. KV named the drug Makena. The March of Dimes, which has long been dedicated to preventing premature births (and has received more than $1 million in donations from KV and its partners), cheered the announcement.

Then, KV announced that the price for Makena would be $1,500 per injection, or $30,000 for an entire course. And the company sent letters to compounding pharmacies warning that they could run afoul of the F.D.A. if they continued to sell competing versions.

Last week, in the face of protests from outraged obstetricians, women’s advocates and lawmakers, the agency issued a statement asserting that KV’s letters were incorrect and that “at this time and under this unique situation, F.D.A. does not intend to take enforcement action.” On Friday, KV announced that it would slash its price for Makena, to $690 per dose. It defended the price by pointing out that the F.D.A. had insisted it conduct a long and expensive clinical trial.

But the controversy did not end. “This company took advantage of the system,” said Dr. Alan Fleischman, medical director for the March of Dimes.

Mary Dunkle, a spokeswoman for the National Organization for Rare Disorders, said the Makena controversy should not be “used to undermine the Orphan Drug Act, which we consider one of the most important pieces of legislation ever enacted.”

Dr. Janet Woodcock, director of the F.D.A.’s center for drug evaluation and research, said the incentives built into the legislation were crucial for its success. The F.D.A. is still eager for KV to complete its confirmatory clinical trial.

“There is a price that society has to pay for having quality drugs,” she said. “But that price should be reasonable,” she said.


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