Regular readers of this blog will know that for some time I’ve been following state reactions to FDA’s October 2013 approval of Zohydro, an extended-release oral formulation of hydrocodone that has sparked concerns about abuse because, among other reasons, it lacks abuse-deterrent properties. To recap, last spring Massachusetts banned Zohydro, becoming the first state that I know of that has banned an FDA-approved drug (see our April 2014 podcast and my blog post here). After a federal judge enjoined the Massachusetts ban on preemption grounds, Massachusetts joined Vermont in imposing restrictions on the use of Zohydro that fall short of an outright ban (see a second blog post here). Well, the saga continues. Now the Governors of Massachusetts and Vermont, along with the Governors of Connecticut, New Hampshire, and Rhode Island, are taking a new tack: they wrote to the Secretary of the Department of Health and Human Services (HHS) to ask that she “overturn” FDA’s decision to approve Zohydro.
Although we typically think of FDA as the ultimate decision-maker when it comes to a drug’s safety and effectiveness, the Federal Food, Drug, and Cosmetic Act (the Act), in fact, assigns drug approval authority to the Secretary of HHS (see section 505 of the Act). The Secretary, in turn, has delegated her authority under the Act to FDA. This means that the Secretary has the power to overturn FDA’s decision to approve Zohydro, as the state Governors have requested. And, at least once, the Secretary has invoked her power to overturn FDA’s decisions. In 2011, the Secretary disagreed with FDA’s determination that Plan B One-Step was safe and effective as an over-the-counter drug for women and girls of all ages, and directed FDA not to approve the drug for that use.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.