Eli Reshef MD
In February 2011, the FDA approved Makena for use in pregnant women to prevent premature labor. Premature delivery is a formidable health issue in the U.S., resulting in significant morbidity and mortality among babies and substantial health expenditure. Makena is the trade name given by its manufacturer, Ther-Rx, based in St. Louis, to a common form of progesterone injection called hydroxyprogesterone caproate (HPC).
HPC has been used for many years prior to its FDA approval for premature labor for other indications in pregnancy. A single injection cost $10-20. Upon approval of HPC, now known as Makena, by the FDA, Ther-Rx increased the cost of a single injection to $1500! This action sparked an outrage throughout the nation. Patients and physicians protested this price gouging via social, visual, and print media. In Oklahoma, we publicized the travesty on TV and newspapers; discouraged our colleagues from seeing Ther-Rx sales people; publicized available HPC from compounding pharmacies; and urged March of Dimes and scientific publications to refuse doing business with Ther-Rx. Not only did Ther-Rx created an outrageous price increase that would make a common medication unaffordable to many, but it aggressively tried to block production of generic HPC by compounding pharmacies.
The national protest against Makena worked. Under congressional pressure, the FDA refused to ban production of generic, far less expensive HPC. Ther-Rx dropped the price per injection to $690 but the damage was already done. This was a monumental public relations nightmare to Ther-Rx, who saw its stock tumble from over $13 to under $1 per share. On August 4, 2012, Ther-Rx filed for Chapter 11 bankrupcy.
The Makena story is a classic example of the power of the public when health care professionals and patients band together for a common cause.