Considering a behind-the-counter option for drugs.

Should the United States follow the lead of most of the rest of the world and allow pharmacists to distribute some drugs without the involvement of physicians or other prescribers? Are there some drugs that don't need to be kept under doctors' control even though they don't meet the safety standard for over-the-counter distribution? In November 2007, the Food and Drug Administration (FDA) held a meeting to gather public input on these and other questions about the creation of a new class of drugs, usually called behind-the-counter (BTC) drugs. Drugs that might be considered for such classification potentially include statins, as well as certain hormonal contraceptives like oral contraception, patches, or rings.

The National Women's Health Network (NWHN) spoke at the meeting in support of creating a BTC category for medicines that can be safely used with screening, counseling, or other interventions that a pharmacist can do as well as another trained provider. A number of physician groups came to the meeting and spoke in opposition to the idea, but the NWHN was not alone in supporting the change. Pharmacist groups attended and advocated strongly for the reform, and some other consumer groups--including Consumers Union and the National Consumers League--spoke positively about it as well.

An important difference emerged, however, between the NWHN and some of the other supportive speakers. Many presenters repeatedly referred to the recent U.S. experience with Emergency Contraception (EC) as evidence that BTC distribution can work; in contrast, the NWHN specifically warned against replicating the EC example, and cautioned the FDA not to draw lessons about BTC distribution from the distorted policy that the Bush Administration created to manage the political problems it faced with this birth control method.

There are critical differences between the way the EC process was handled and effective implementation of a BTC designation. The NWHN supports the creation of the BTC class of drugs because we believe that a well-executed change can resolve some of the problems that women currently face in their ability to access certain drugs and use them consistently. But, this potential will only be realized by deliberate and thoughtful reform that prioritizes these goals. To be successful, a BTC drug distribution system will have to include a mechanism for reimbursement of drug costs; to establish a clear process that consumers can easily follow to get BTC products, including their interactions with pharmacists; and to encompass strengthened and diversified pharmacist training.

A poorly executed BTC system could make existing problems worse and create new barriers for women. If BTC products aren't covered by insurance, if pharmacies don't establish a way to allow confidential conversations between women and the pharmacist, if pharmacists are not well-informed and up-to-date about the latest research on BTC drugs, women's compliance and access could actually be reduced.

The NWHN statement noted that EC is not technically a BTC product, although the dual label that FDA imposed on it (continuing the prescription requirement for women 17 and younger while making it OTC for women 18 and older) creates a situation that may resemble BTC distribution. But, there are critical differences. Most importantly, the restricted distribution of Emergency Contraception was a political compromise that the FDA's own scientists and the medical community at large agree isn't necessary for its safe and effective use. The NWHN warned that, if the FDA creates a BTC class of drugs for the United States, it must not use the EC model: drugs that meet the medical and scientific criteria for OTC distribution should not be restricted to BTC distribution due to political concerns. Rather, the FDA must set a science-based standard with the best results for patients as the deciding factor for determining whether a drug will be sold over-the-counter or dispensed by pharmacists from behind it.

Amy Allina is the NWHN Director of Programs