With the U.S. Food and Drug Administration (FDA) cracking down on manufacturing irregularities at Johnson & Johnson, Genzyme, and others, increasingly strict provisions to the Physician Payment Sunshine Act being discussed, and a Congress looking desperately for a way out its budget troubles (see Trimming the Fat, page 8), the message is clear: the tenuous congeniality between regulators and the biopharmaceutical industry is slipping away.
Despite what might be construed as a hostile environment, the playing field was always level for individual drug makers. Each had the right to present the case for their treatment and explain why it should be approved. I use the past tense, because last Dec. 7, the Secretary of Health and Human Services (HHS), Kathleen Sebelius, took the unprecedented step of intervening in the future of Plan B.
The controversial emergency contraceptive was originally made available without a prescription in 2009 for women 17 and older. A subsequent application from manufacturer Teva Pharmaceuticals in early 2011 sought to eliminate the age restriction entirely. The FDA’s Center for Drug Evaluation and Research (CDER) examined years of studies and, based on this data, FDA Commissioner Margaret Hamburg stated her belief that Plan B was safe and effective for adolescent females and should be made available without a prescription for all women of reproductive age.
Shortly after this announcement, Sebelius sent a memo directing Hamburg to send a Complete Response Letter to Teva rejecting their application. She stated that she did not "believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age." More specifically, the studies did not include data from the youngest 10% of girls who could possibly become pregnant.
The usual patient advocacy and policy groups were all either outraged or overjoyed. But except for a boilerplate expression of disappointment in HHS’ intervention by Teva, little was heard from the drugmakers. Perhaps this is self-censorship as a result of the currently unfriendly atmosphere or maybe in these times of declining sales it is an anathema to rise to the defense of a potential competitor. Either way, it should be unthinkable to the industry as a whole to allow Sebelius to couch what is essentially a politcal maneuver behind a thin veneer of science.
As with all exceptional decisions it is difficult to not begin looking down that slippery slope. While any drug dealing with reproductive health is going to be a hot-button issue, who’s to say that the controversy stops there? What happens when legislators or pressure groups decide that an HIV vaccine encourages reckless sexual behavior or that an expensive lung cancer drug shouldn’t be covered for former smokers? Can anyone truly feel safe investing the enormous sums of money and countless years needed to bring a potential treatment to market if, in the name of political expediency, they can be turned away at the 11th hour?
Regardless of your position on the morality of emergency contraception, there can be little argument as to the chilling effect of political appointees contradicting the nation’s pharmaceutical watchdog on matters of drug safety.