A judge in the U.S. District Court for the District of Columbia has dismissed KV Pharmaceuticals suit against the FDA over the company's preterm birth drug Makena hydroxyprogesterone caproate.
After developing an FDA approved version of a drug that was in danger of becoming obsolete, KV promptly – and without warning – decided to charge $1500 per dose. The company was rightly criticized for the sudden jump in price and did the right thing by cutting the retail price of the drug to $680 and offering the drug at a reduced price to a wide range of organizations.
And yet the FDA decided to allow pharmacists to continue compounding even though KV developed the drug to put an end to the risk associated with compounding products. (FYI -- The FDA is currently Investigating bacteria that sickened 19 people at Alabama hospitals and may have killed nine and has turned up at compounding pharmacy in Alabama. And there are many other examples.)
Is this a victory for the public health?
KV filed suit against the FDA, alleging that the agency's policy of non-enforcement for compounded hydroxyprogesterone caproate products violated KV's right to market exclusivity for Makena under the Orphan Drug Act.
Judge Army Berman said KV's allegations relate to FDA's discretionary enforcement activities and are therefore "unreviewable claims." She said in her ruling that the "case is fundamentally an effort to get the court to direct and oversee the FDA's enforcement activities, and that it cannot do." We agree with Judge Berman -- but it's a dangerous precedent.
Last month, KV filed for Chapter 11 bankruptcy because it has been "unable to realize the full value" of Makena, citing FDA's lack of enforcement of the market exclusivity.
Is this a victory for pregnant women?
Certainly the FDA has the authority to ensure the availability of products and indirectly considers affordability. It did so when it kept generic asthma inhalers on the market for several years rather than forcing them off to comply with an EPA requirement to remove inhalers powered by CFCs. I was at the agency at the time and the issue of inner city access was hotly debated.
That was (IMHO) a considered and organized action based on much thought and many meetings with stakeholders. The KV action (IMHO) was a reaction to media hype and political pressure. The FDA even got involved in a little demagoguery when it cited the fact that the NIH had provided KV with support to conduct clinical trials as the agency’s reason to allow the compounding. Given that logic, should every drug developed in cooperation with the NIH or based on NIH research be denied market exclusivity?