Comments on: Is HHS Using Scientific Standards?

By: Erik

Erik — Thu, 29 Dec 2011 15:35:36 +0000

Thanks to Bill and Steven for commenting on my post. In his comment, Bill mentions illegal narcotics and alcohol. These drugs are not used for medical purposes, so I don’t think it’s relevant to compare them with Plan B One-Step.

To an extent, social concerns do matter when it comes to drug approvals, as Bill wrote. Secretary Sebelius’s action cannot be justified on social grounds any more than it can be justified on scientific grounds.

Less than 1% of 11-year-old girls, the population about which Sebelius expressed concern, are sexually active, according to the Guttmacher Institute. But almost half of girls have had sex by their 17th birthdays, and most of these begin at age 15 or 16, according to the Institute. Birth control methods sometimes fail, and Sebelius’s decision will increase the number of 15- and 16-year-olds who face unintended pregnancy. Having children at an early age can limit the educational achievement of both mother and child, can contribute to large family sizes, and can increase reliance on public assistance.

Bill or Sebelius may be uncomfortable with the idea that teenagers are having sex, but this discomfort should have no bearing on whether Plan B One-Step is available over the counter to girls under the age of 17. No evidence suggests that making contraceptives available to teenagers encourages them to have sex. The availability does help them to avoid unintended pregnancies, though. Considering the ramifications of early childbirth for the mother, child, and society at large, Sebelius has made the wrong decision.

By: Steven Grossman

Steven Grossman — Thu, 15 Dec 2011 22:42:56 +0000

In my weekly blog on FDA regulation and policy, http://www.fdamatters.com, I have explored whether there is lasting impact on FDA’s decisionmaking authority. Contrary to many commentators, I believe that Plan B is unique in the issues it raises. Secretary Sebelius is unlikely to insert herself into the process again.

In the same blog column, I examine FDA’s Office of New Drugs Director John Jenkins suggestion that it might be time to formalize behind-the-counter drugs as a third category of drugs alongside Rx and OTC. Drugs containing pseudoephedrine are now handled this way. Statins might be moved there. Plan B might also be a good fit.

The column, “Beyond Plan B: Scientific Integrity and a Possible Third Class of Drugs” can be found at: http://www.fdamatters.com/?p=1599.

By: Bill Cooney

Bill Cooney — Thu, 15 Dec 2011 14:24:08 +0000

Scientific facts should play a leading role, but not an exclusive role, in determining what drugs are available to whom. Social issues also matter and cannot be simply swept away as unscientific. For instance, the debate on legalization of various narcotics clearly involves both medical and social considerations. Is the legal age for drinking alcohol based on medical considerations or social ones? The answer is obvious. Issues of human reproduction have long been an area of serious controversy on social grounds.

You certainly may disagree with the recent decision by HHS, and argue your case based on science. But you cannot ignore the serious social aspects of this issue, nor should you discredit the legitmate, but “nonscientific,” concerns raised by those who agree with HHS. This is a debate worth having, not dismissing.