Teva, the company that makes the morning-after pill Plan B One-Step, recently submitted an application to the FDA to make the drug available over-the-counter for women of all ages. Sound like a good thing? Well, it is and it isn’t.
Certainly any efforts to bring Plan B out from behind pharmacy counters and onto drugstore shelves – so women of all ages can purchase it – is positive, but the problem is… the FDA should have made emergency contraception fully available over the counter a long time ago.
Here’s some background explaining why and why you should care:
The FDA’s been playing games with Plan B for almost a decade
Let’s not forget the Plan B-FDA saga started back in 2001 when the Center for Reproductive Rights filed a Citizen Petition with the FDA on behalf of over 70 medical and public health organizations to make Plan B available over-the-counter. In 2003, the drug’s manufacturers filed their own application for over-the-counter status. But the FDA, under the Bush administration, proceeded to drag out making a decision for years. The agency employed numerous stall tactics from missing application deadlines to requesting public comments. It wasn’t until the Center for Reproductive Rights filed a case against the FDA in 2005 for failing to make a decision, that the agency finally made a move… sort of. In 2006, the agency agreed to make the drug available without a prescription – but only to women 18 and older, only behind pharmacy counters and only when a woman showed photo I.D.
For years, the FDA allowed politics to trump science
The Center’s case continued after the FDA’s unprecedented decision to place these restrictions on an over-the-counter drug. The lawsuit revealed that the FDA was not operating in its typical manner. The age restriction on Plan B had not been applied to any other drug. The FDA’s own scientists recommended Plan B be sold over-the-counter to every age, but the top officials ignored the advice. And it turns out that the Bush White House had been consulted during the decision-making process – one high-level FDA official even told colleagues that he was afraid he’d lose his job if he approved Plan B for over-the-counter status. As a result, in 2009, the court ruled that the agency had acted in "bad faith and in response to political pressure," not science, when it repeatedly and unreasonably delayed making a decision on Plan B, and that the agency had departed in significant ways from its normal procedures.
The court ordered the FDA to make a decision, but the FDA keeps stalling
The court specifically ordered the FDA to do two things – one, extend the restricted over-the-counter access, which had been limited to 18-year-olds and over, to 17-year-olds. Two, reconsider the Citizen Petition seeking true over-the-counter status for emergency contraception. The FDA followed the first part of the judge’s order. But it has failed to take any meaningful action on the second. This—despite the court expressing trust that this time around, the new administration, under President Obama, would “conduct a fair assessment of the scientific evidence.”
If the FDA ignores the court order, it sets a dangerous precedent
This past November, the Center took further legal action against the FDA, arguing that it is in contempt of court for ignoring the judge’s order. The FDA has had enough evidence before it to make a decision on the Citizen Petition since before the lawsuit started. There was no need to wait for another application. The Teva application may get the ball rolling on a final decision on Plan B, which will likely result in increased access for teens. The prospect of a good outcome after all of these years, is a step in the right direction. But the FDA must still be held responsible for the fact that it has ignored the court’s order. If it isn’t, it opens the door for the agency to treat other politically controversial drugs differently and to favor politics over science.
And that’s why you should care.