FDA Considers Behind-the-Counter Medication Availability

Key Points

BTC medications are only available at pharmacy counter and require a green light from a pharmacist, but not a physician, before they are purchased. Barr Laboratories' emergency contraceptive product known as Plan B, some smoking cessation drugs that have age limits on the labeling, as well as some pseudoephedrine and codeine cough syrups also are sold BTC.

"There's been a collection of changes over the years, and I think most recently they're really driven by an increased trend toward consumer involvement and patient empowerment in their decisions and responsibilities that they take for healthcare," FDA Deputy Commissioner for Policy Randall Lutter, MD, said at a public meeting in November. "What you have therefore is the phenomena with the Internet [and] of increased consumer and patient awareness and the need for information about their own decisions. Given that new technology, it seems like an appropriate time to ask now whether or not there are ways of improving public health through increased access by behind-the-counter availability."

However, industry experts raise some key issues regarding eligibility, physician involvement, reimbursement and liability. First, how will eligibility for this designation be defined, asks Clive Riddle, president and founder of MCOL, a provider of business-to-business health management and managed care resources in Modesto, Calif.

Based on practices in countries that already have a BTC class in use, "requirements for BTC status typically include products used to treat conditions that can either be self-diagnosed with the assistance of a licensed pharmacist and/or those that have an excellent side-effect profile and low potential for overdose," according to Pharmaceutical Sales and Marketing Expert Didi Discar, executive vice president, Access Communications-West, San Diego, Calif.,

The FDA seems to be following this model, according to Discar, and is considering whether to make some drugs available without a prescription "given that the consumer has a discussion with a licensed pharmacist prior to receiving a BTC medication. Some products that may be included in their consideration might be routine products such as birth control and migraine medications," she says.

Second will BTC availability affect a patient's decision to seek treatment from a physician for certain medical conditions?

Perhaps, according to Discar. "Making such products BTC status may serve to facilitate access for those patients who perhaps can't afford to visit a doctor or have a preference not to see a doctor," she says.

Third, there are varying opinions in the managed care arena about reimbursement for BTC products, based on the cost of the treatment versus prescription and over-the-counter alternatives, says MHE Editorial Advisor Perry Cohen, president of the Pharmacy Group in Glastonbury, Conn.

While no plans seem to have made a final ruling on the topic, many of the large insurers indicate that they'll need to see how the FDA decides to move forward. They likely will make reimbursement decisions on a case-by-case basis.

"It's possible some managed care plans would cover patient costs because of a history of doing so in the past with OTC products," Discar says. "Some of the large plans-Premera Blue Cross, Medica, HealthPartners, WellPoint and Aetna-have been reported saying that they will await FDA plans. However, most mentioned they stopped covering costs for other products, such as Claritin when it went OTC, and there may be similarities in how they treat BTC status conversions."

In addition, with reimbursement from consumer-driven HSA and HRA accounts, coverage should not be an issue, as OTC drugs already are classified as reimburseable, Riddle says.

Finally, experts wonder if the potential for lawsuits from patients suffering adverse drug reactions will affect the willingness of some pharmacies or of some states to offer the agents BTC.

"Any drugs ultimately reclassified from regular prescription products to behind the counter generally would have reduced liability, as there is more implied consumer involvement in the purchase decision for a BTC product than for a regular prescription," Riddle says. "However, new products or products ultimately reclassified from OTC to BTC would, conversely, have greater potential liability."