There has been a lot of debate surrounding Plan B One-Step® and the lessening of age restrictions. To summarize these recent discussions, Teva Women’s Health Inc., requested FDA approval to market its drug without age restrictions. Health and Human Services (HHS) Secretary Kathleen Sebelius rejected the request concluding, “…the data submitted for this product do not establish that dispensing requirements should be lifted for all ages”. She added, “…there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age”. In my opinion, this seems like a straight forward case of a pharmaceutical company seeking to sell more products and the government seeking to perform proper oversight.

This story became particularly interesting to me when several medical associations

  • American Academy of Family Physicians
  • American Academy of Pediatrics
  • American Congress of Obstetricians and Gynecologists
  • American Medical Association
  • American Society for Emergency Contraception
  • Association of Reproductive Health Professionals
  • National Association of Nurse Practitioners in Women’s Health
  • National Family Planning and Reproductive Health Association
  • Physicians for Reproductive Choice and Health
  • Planned Parenthood Federation of America
  • Society for Adolescent Health and Medicine

supported the position of Teva Women’s Health Inc., which essentially eliminates the need for a consultation by a physician to apprise the female of the risks and possible complications of Plan B One-Step®. In a joint letter to the HHS published December 7, 2012, the associations listed above petitioned the HHS to “respectfully ask that the age restrictions on this safe and effective drug be removed, enabling women of all ages to access Plan B One-Step®”. The letter goes on to state “…there is no evidence that ready access to Plan B encourages risky behaviors among teens”. This was shocking to me. This may be true within the context of birth control but what about overall patient safety? As I searched for the answers, two major questions arose. First, would the average teen choose this option over the use of other contraceptives? Second, why would physician groups advocate for relinquishing control over the physician-patient relationship in matters pertaining to sexual health?

Question 1
“Would the average teen choose this option over the
use of other contraceptives?”

This seemed like a simple “yes” answer to me. Nonetheless, in the spirit of seeking “empirical data”, a virtual family debate was initiated via flash group text message. The sample included a 21-year-old male, an 18-year-old female, and a 14-year-old male. The question was, “Would the average teen choose this option over the use of other contraceptives?” The result of this discussion was scientifically conclusive: “yea probably.” The discussion gravitated more toward safety concerns associated with sexually transmitted infections (STIs) and child abuse. Traditional contraceptives such as condoms offer some protection against STIs. Plan B does not. Having an over-the-counter pill of this nature could make it easier for abusers to harm children in secret.

The family panel concluded with a consensus on the need for across-the-board control of all contraceptives for adolescents with unrestricted access for older teens (driving, voting and drinking ages) for the purpose of safety. This supports the HHS position regarding the mental health and cognitive differences of young teens. This panel also agreed that Plan B is an easier and generally more pleasurable option making it reasonable to assume it would become the contraceptive of choice for teens provided that pricing is reasonable.

In summary, Plan B could be seen as an over-the-counter option that would:

  • Be an easier and more desirable option for birth control
  • Lead to an increase in STIs
  • Reduce child safety, as well as the ability to identify mental health issues and child abuse

Question 2
“Why would physicians advocate for the
patient - pharmaceutical company relationship”?

Why would medical associations reject  the HHS recommendation and advocate relinquishing control over the physician-patient relationship in this scenario? Why wouldn’t physician groups support the government’s position and maintain control in this area? Shouldn’t adolescents and young teens have access to a physician consultation, not a pharmaceutical company, for a matter this serious? Wouldn’t most parents of minors want at least a first opinion in decisions like this? As noted by the HHS secretary, psychological changes taking place during adolescence would merit concern over the patient’s mental and physical health prior to prescription.  A physician-patient consultation would help identify:

  • Mental health issues
  • Physical abuse
  • Drug interactions
  • Risks/complications associated with improper use
  • Better/less expensive alternatives for menstrual cycle management, birth control or pain management

To me, this issue appears to be fallout from the availability of direct-to-consumer marketing. Why would a pharmaceutical company want to eliminate the age restrictions? In my opinion, the answer is obvious -- to sell more product. But why would physician associations advocate for this? As a parent, my children would not see a physician who supported this position. I believe the physical and mental health of children far exceeds the need to learn about new drugs from the manufacturer. I would rather learn about new drugs from my physician within the context of my own personal health.

Update June 26, 2013: Age restriction ban was lifted June 20th. FDA clears the way for contraception

To help us understand “the why” question associated with the position of these associations, please comment below or email your comments to or login and join in the discussion. Responses sent via email will remain anonymous; however, they may be used in the aggregate in a future publication.

Randy Glick

Disclaimer: The views expressed here are solely those of the author in his private capacity and do not in any way represent the views of the Southern Medical Association or any of its Council members, officers, partners, vendors or subsidiaries. Furthermore, neither the Southern Medical Association nor any of its subsidiaries have approved, endorsed, or embraced anything associated with this post.

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