The cost of preventing pre-term births: questions of ethics, public policy, and potential liability

Here’s the good news: a new drug called Makena manufactured by a company called KV Pharmaceutical was recently approved by the FDA for the treatment and prevention of pre-term births. But the approval has not come without controversy, as reported by media outlets all over the country. [For additional coverage, see here and here]. The problem? The drug, which must be administered by a shot once a week for about 20 weeks, was running about $20/dose prior to the approval. After the FDA gave the drug a nod, however, the price shot up to $1,500/dose. We’ll do the calculation for you: that’s $30,000 over the course of one pregnancy. [Note: the FDA has no control over pricing.] Now, the company has since reduced the price of each dose to $690, as reported by NBC, which would reduce the total price tag to $13,800.00. Nevertheless, the March of Dimes decided to end its relationship with the company.

This is not a new issue for drug companies, or for the people who need the drugs they manufacture. As KV Pharmaceutical pointed out to The Washington Post, the company is spending approximately $200 million developing the drug and having it approved by the FDA.

This is not atypical for the pharmaceutical industry; research and development are very expensive. In order for the company to stay in business and keep finding and manufacturing drugs that are of use to the public, the company should be entitled to recoup those costs and make a profit. But what duty do these companies have to the human race in general? This question can be posed not only to KV, but to the manufacturers of drugs used to treat cancer and other life-threatening conditions. What responsibility do these companies have to all people, and not just the people who have insurance that is willing to pay for these drugs, or others who can open their wallets and foot the bill themselves? It’s a chicken-and-egg problem that doesn’t seem to have a clear answer. For now, there are companies like Ther-Rx, a division of KV, which has developed a program for women who cannot afford the cost of Makena. The company also indicated it might be willing to develop a cheaper generic version.

Even more interesting from our point of view is the potential legal liability companies risk. The Washington Post indicated that “outside experts said the FTC could sue KV if it concludes the company is illegally impairing competition.” A Washington Post article on the subject interviewed an antitrust lawyer on the subject:

“It threatens to extract significant competitive harm on extremely vulnerable pregnant women, and it threatens to significantly inflate health-care costs at a time when controlling health-care costs is a critical national priority,” said David Balto, a Washington antitrust lawyer who worked at the FTC.

This is an issue that will continue to force some tough choices. And, cynical though it may seem, we are certain that litigation about this very issue is inevitable, if not with this drug than with the next one down the line.

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