Did Judge Go Too Far on Plan B Pill?

Did Judge Go Too Far on Plan B Pill?

May 2nd, 2013 // 3:55 pm @

Updated Daily – Read our latest FDA, cGMP Compliance News

A month after a US federal court mandated that FDA has to make the morning after pill available for sale without a prescription within thirty days, the Obama administration has now filed a motion to suspend the ruling until a ruling can be made on an appeal. The administration thinks that the judge went too far. Their view is that such an important issue needs to be decided by FDA rulemaking and not by a judge.

The judge on the case, US District Court Judge Edward Korman, ripped the White House for not letting FDA approve broader distribution of Plan B. In 2011, the administration did not allow FDA to do this, right before the 2012 election. Some think the White House was trying to mollify conservatives and swing voters.

In the ruling, Korman said that the White House was acting in bad faith and was causing long delays in the availability of Plan B. The White House states that the judge is going about this in the wrong way. DOJ has stated that the right thing to do is to vacate the agency decision and to mandate that the agency reconsider the decision, or give a more complete answer or explanation.

The administration states that the way to change Plan B distribution is for the drug maker to turn in the right paper work that is looking to ease restrictions. If this is not done, there would be great harm to public interest and the US government. The public relies on FDA deliberations for safety and efficacy and not court rulings.

For now, FDA has approved Plan B for women who are 15+ and without an Rx.

Korman definitely got the White House’s attention, but the outcome in this case is cloudy. The approval for Plan B distribution to those 15 or older with no prescription means that the US government will likely argue that its methodical approach is a better way of action in this delicate public policy matter.


Subscribe Now

Testimonial

"ExpertBriefings.com always selects excellent speakers – some of the best I have ever heard. Their messages are direct, clear, timely, and relevant."

Anon A. Mouse

Featured Partner