Drug industry debates BTC category at FDA meeting

WASHINGTON —While the establishment of a third class of drugs is by no means imminent, several pharmacy organizations advocated the creation of a new behind-the-counter class of drugs last month before a panel of Food and Drug Administration executives.

Opposed to a third class of drugs were the American Medical Association and the Consumer Healthcare Products Association, the former over concerns that a pharmacist lacks adequate training to diagnose and treat disease and the latter with misgivings that a BTC class of drugs could potentially restrict access to medicines currently available without a prescription as well as open access to medicines presently requiring a doctor’s prescription.

Increased access to comprehensive patient medical records was one need identified by pharmacy if pharmacists were to be intimately involved in the dispensing of a BTC class of drugs. Also addressed was the need for a business model that rewards pharmacists’ additional time counseling patients, though requiring a reimbursement as part of the BTC model seemed to be beyond the purview of the FDA.

Much of pharmacy’s support of BTC was centered around the increased access to medications a BTC class of drugs would create. For example, vaccines can be administered by the pharmacist in some 46 states, testified Michael Hogue, speaking for the Institute for Public Health and Pharmacy, but those pharmacists cannot prescribe those vaccines. A BTC class of drugs that included vaccinations would therefore increase access to those vaccines through convenience to the consumer.

Some of the pharmacy organizations expressed a concern that OTC medicines might be inappropriately moved to BTC, limiting access. BTC should be a clinical encounter as opposed to a “policed” dispensing of certain medicines, noted Ed Webb, speaking on behalf of the American College of Clinical Pharmacy, setting the stage for an argument that those clinical consultations ought to be reimbursed, whether by third-party payers or by the patients themselves. That consultation is of some considerable value—increasing compliance and thereby decreasing future hospital expenditures—and should be reimbursed as such.

The AMA also was concerned over the potential reimbursement of those clinical consultations with pharmacists, worrying that managed care might create incentives for patients to pursue a cheaper BTC treatment regimen before consulting their general practitioner, a factor that might delay treatment of an undiagnosed condition in some cases.

Along those lines, the AMA challenged the notion that pharmacists would even be capable of adequately consulting with patients because their expertise and training is in medicines and not the diagnosis of disease.

The relationship between a patient’s pharmacist and a patient’s physician ought to be collaborative rather than adversarial, countered Bill Soller of the UCSF School of Pharmacy. “The pharmacist is a coach [in the healthcare paradigm],” he said. “This [role] is something doctors should support rather than oppose.”

AMA also stated emphatically that the whole question of a BTC class of drugs was moot without a change in the [Food, Drug and Cosmetics Act].

CHPA stated its belief that a BTC class of drugs might, in fact, restrict access and increase costs—the current OTC market system helps keep costs down through competition reported CHPA’s David Spangler. The switch of cough-cold products in the 1970s and 1980s resulted in 100,000 fewer doctor’s visits per year by the end of the 1980s, Spangler said. When nicotine-replacement therapies switched—use of those products increased three- to four-fold, he added.

And consumers favor access to those medicines appropriate for the self-care market, he added. According to surveys, 3-in-4 consumers would rather treat themselves when they’re sick than see a doctor, and 3-in-5 want more medicines available on an OTC basis as opposed to a prescription-only basis.

And if a BTC class of drugs were created, CHPA charged, that may both become the default channel into which prescription-only drugs may switch and the channel into which any OTCs with a hint of controversy may be pushed. Indeed, Maria Sulli of St. John’s University’s College of Pharmacy suggested that kids cough-cold medicines indicated for children under age 6 may be ideal candidates for BTC placement, reinforcing the notion that controversial OTCs—pediatric medicines and dextromethorphan with its teenage abuse potential to name two—could follow the example of pseudoephedrine, a medicine pushed behind the pharmacy counter last year through legislation because of the concern that drug dealers may be buying the decongestant as a core ingredient in the home-laboratory manufacture of methamphetamine and not because of any safety concerns with the nonprescription medicine itself.

Spangler also noted that the FDA has all the necessary flexibility to realize any benefits a BTC class of drugs would bring within the current two-drug system. Spangler cited the switch of fluoride in the 1960s as an example of a switch of a medicine for chronic use in the prevention of an asymptomatic condition (comparable with the proposed switch of statins today), and both the switch of Plan B and NRTs as examples of switches addressing concerns over adequate patient counseling.

Eileen Harley, speaking on behalf of the Food Marketing Institute, advised the FDA panel that the creation of a BTC class of drugs would necessitate considerable capital costs throughout the retail pharmacy arena. Retail pharmacy would need to expand its behind-the-counter shelf space to incorporate this new class of drugs and, in many environments, also would need to reorganize the overall pharmacy layout to incorporate private screening areas where pharmacists could consult with their patients.

And William Vaughan, senior policy analyst of the Consumers Union, who was in favor of a BTC class of drugs, recommended that the FDA might apply a tried-and-true marketing tool—the test market—before rolling out any BTC model nationwide. “BTC raises such conflicting issues—possible cost savings versus increased safety problems—that it may be wisest to try a one- or two-state demonstration of the concept so that the FDA can monitor, for a year or two, the pros and cons,” he said.

At the beginning of the meeting, Randall Lutter, deputy commissioner for policy of the FDA, emphasized that the FDA has not set any BTC agenda, but rather conducted the meeting to help define the issues and concerns that would be raised if the FDA did pursue the creation of a third class of drugs. “Our own stance at this time…is to solicit public views and public input,” Lutter said during a press conference following the meeting. “We will review the comments that we received today,” he said, as well as comments submitted electronically through Nov. 28, before evaluating any further steps.

Two factors are driving the FDA’s interest in a BTC class of drugs to date, noted Douglas Throckmorton, deputy director of the FDA Center for Drug Evaluation and Research—the new and developing technology that aids healthcare professionals in managing disease states and a growing interest in health care among consumers.