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.

While the Secretary of HHS possesses the power to overturn FDA’s decision to approve Zohydro, I don’t think she’ll do that for several practical reasons.  First, Zohydro is not as politically controversial as Plan B.  Plan B One-Step is an emergency contraceptive that, when taken within 72 hours of unprotected intercourse, can prevent pregnancy.  Given its use, making Plan B available over-the-counter to women and girls of all ages raises politically contentious questions about minors’ access to contraception, and access to abortion (to the extent that some believe Plan B can terminate pregnancies, despite a lack of scientific evidence supporting that belief).  Although Zohydro is somewhat controversial because of its potential for abuse, the controversies associated with Zohydro simply are not as politically loaded as those associated with Plan B.  I suspect it would take more significant political controversy, and associated pressure on Administration leadership, for the Secretary to meddle with FDA’s decision-making.

Second, if the Secretary disagreed with FDA’s decision to approve Zohdryo, I think that she likely would have acted before FDA’s approval of the drug, as then-Secretary Sebelius did with Plan B.  It is much easier for the government to refuse to approve a drug in the first place, than it is to withdraw approval of a drug that is already on the market.  Among other reasons, FDA regulations require that FDA provide a drug manufacturer with an opportunity for a hearing before withdrawing approval of its drug.

Finally, a minor point.  The states’ letter and the media (see, e.g., here, here, and here) have emphasized that the relevant FDA advisory committee recommended against approval of Zohydro.  But that doesn’t quite tell the whole story.  The minutes for the meeting at which Zohydro was discussed show that a majority of the advisory committee members voted “no” in response to a question about whether the efficacy, safety, and risk-benefit profile of Zohydro supported approval.  However, a majority of the committee members also voted “yes” in response to a question about whether Zohydro is effective, and “agreed that [Zohydro] met the safety standards set forth by the Agency and stated that Zohdryo ER is as safe as other long-acting and extended release opioids that have previously been approved.”  So, it appears that the advisory committee may have recommended against approval despite thinking that the drug met the legal standards for approval—meaning, the advisory committee’s recommendation was not necessarily as straightforward as it has been made out to be.  (And, of course, even if the recommendation from the advisory committee was inarguably clear, FDA is not required to follow the recommendations of an advisory committee—such committees, as their name suggests, merely provide advice and do not make decisions.)

In sum, I think this latest development in the Zohydro saga is unlikely to amount to much.  But it’s certainly interesting, and I’ll be interested to see how the Secretary responds to the states’ letter.