November 14, 2014

The Commission has voted (5-0 and 4-1) to delay enforcement of our requirement for child-resistant (CR) packaging for imidazoline medications. I was pleased to join in this vote.

Imidazolines are used as decongestants in products like eye drops and nasal sprays. Their misuse can cause significant negative effects on the cardiovascular and central nervous systems.

In 2012, the Commission issued a rule to require CR packaging as of December of 2013. Because of the challenges of developing such packaging (including industry’s obligations to comply with rules from the Food and Drug Administration), we stayed enforcement for one year.

Despite substantial progress, the industry has been unable to develop CR-packaging that can be manufactured on the necessary scale, but assures us that a solution is near. To keep these products available, our staff proposed that the Commission grant another 6-month stay and delegate authority to our Office of Compliance to give companies additional time if their good-faith efforts have not yet succeeded. I was glad to join in our unanimous vote for the 6-month stay and in our vote to give our compliance officers the freedom to do what they do best.

I applaud our staff’s tireless efforts to work with industry to improve safety. Ensuring that these medications are available to those who need them – while putting their potential latent harm out of kids’ reach – has proven challenging, and we need to help companies strike the right and responsible balance.

I am fully confident in our staff's ability to continue its diligent, professional work and keep the industry moving toward compliance.