Patient access to the emergency hormonal contraceptive “Plan B One-Step” has been one of the most combustible issues ever faced by FDA. It received more attention last week when FDA approved expanded access for adolescents under 17 and HHS Secretary Katherine Sebelius promptly overruled the agency because she found inadequate scientific support for the decision. (For my readers outside the US, here is a New York Times article that provides background).
FDA Matters wonders: has FDA’s scientific decisionmaking authority been thwarted in some lasting way, as some have claimed? Is it time to reconsider proposals for a new category of drugs for which pharmacists are the gatekeeper?
Under the Federal Food, Drug and Cosmetic Act and other laws, the Secretary of HHS has the legal authority to make virtually all decisions within the Department’s jurisdiction. Most of this authority has been delegated to subordinates, including the FDA Commissioner, although the delegation can be withdrawn at any time. No one remembers an instance in which the Secretary explicitly overruled FDA.
Was there a lapse in communications between FDA and HHS? Normally, the Secretary and the Commissioner (or their staffs) discuss controversial decisions before they are made and a compromise reached. Had this occurred, FDA would have announced that compromise as the agency’s decision and taken the heat for ignoring its advisors and staff.
The alternative explanation, which I hope is true, is that there was an understanding that FDA’s voice should be heard and its integrity preserved, while the Secretary would take the heat for the decision by overruling the agency. This would be consistent with an approach that Commissioner Hamburg has championed: that government should be more honest and transparent about disagreements, as long as everyone understands that someone with decisionmaking authority will actually make a decision.
Either way, it is important to recognize that Plan B has proven to be a “one-of-a-kind” controversy, presenting uniquely difficult issues that aren’t present in 99.9% of FDA’s decisions. I see no reason for commentators to be writing, as one did: “FDA’s medical and scientific integrity has been forever blighted by these frankly political decisions.”
Secretary Sebelius is not going to make a habit of questioning the scientific support for FDA’s decisions. Nor have we any reason to fear the death of FDA’s integrity or to conclude that it can no longer be a scientifically-driven regulatory agency.
Leaving aside the merits of either FDA or HHS’s position, the Plan B controversy provides an impetus to consider whether there should be a third class of drugs that are neither prescription-only (Rx) nor over-the-counter (OTC). The day after the HHS decision, John Jenkins, director of FDA’s Office of New Drugs, suggested just such a connection between Plan B and a potential third class of drugs known as “behind the counter” drugs (BTC).
BTC, which has been discussed for decades, relies upon pharmacists to dispense these drugs without a prescription and independent of a physician-office visit. Pharmacists are the most widely distributed of all health care professionals, as well as the most readily accessible. BTC would empower them to provide additional education, monitor appropriate use and discourage misuse for a wide variety of drugs.
Currently, OTC products containing pseudoephedrine are handled as BTC because of their potential use in making methamphetamine. According to Dr. Jenkins, statins are potential candidates for BTC status, as might other drug classes where petitions for Rx to OTC switches have been denied but there is still potential for safe patient self-treatment without a physician office visit.
In sum, accessibility to the emergency contraceptive Plan B continues to be a disruptive and controversial issue for FDA. However, this is a unique issue and there should be no continuing damage to FDA because the agency was overruled by HHS. A third class of drugs could evolve out of this that might be beneficial to patients across a number of diseases and drug classes, including hormonal contraceptives.