FDA to look at BTC drug class
WASHINGTON —The Food and Drug Administration earlier this month announced plans for a public advisory committee meeting Nov. 14 on the potentiality of a third class of drugs—a class of drugs that would be available without prescription, but not without a healthcare consultation with the neighborhood pharmacist—thus further evolving the pharmacist’s already-substantial role in the delivery of today’s health care.
As such, the initial reaction among pharmacy associations, including the National Community Pharmacists Association and the American Pharmacists Association, is bullish—anything that drives more patients to the pharmacy counter has got to be good. The National Association of Chain Drug Stores is a little more hesitant in issuing a gung-ho recommendation, however, it is nonetheless positive about the potential for pharmacy operators. But before weighing in on the subject, NACDS plans to ascertain the potential impact a BTC class of drugs would have on the industry, such as pharmacy reimbursement, pharmacist work-flow, potential supply chain issues and whether third-party payers would cover this new class of drugs.
“It impacts more than just the pharmacy [executives], it impacts operations, marketing, merchandising,” Mary Ann Wagner, NACDS senior vice president, policy and pharmacy regulatory affairs, told Drug Store News the day after the FDA announced the meeting. “We’re intrigued by the idea, but we don’t know exactly how [a third class of drugs] is going to be formalized.”
“The pharmacist is certainly capable of improving medication use with patients, but it does raise a lot of questions,” she added. How many drugs would be included in this class? Would pharmacists be compensated for their time? “Third-party coverage is another big issue, probably more from the patient’s perspective, but are third-party groups going to cover this third class of drugs? If not, will the patient pay out-of-pocket?”
NACDS currently is polling its membership on a BTC class of drugs and plans to testify at the public meeting, along with their cohorts at the NCPA and the APhA.
A little less enthusiastic about any proposed BTC class of drugs are consumer healthcare companies. While BTC drugs could mean expanded market opportunity for medicines like Merck’s Mevacor, a statin that has been before the FDA as a potential switch candidate two times now, there is some concern that nonprescription medicines already approved for sale over-the-counter might be reclassified as BTC. It could become a knee-jerk reaction to potential safety concerns, for example, such as concerns a few years ago over the heart-safety profile of such non-steroidal, anti-inflammatory drugs as ibuprofen (Advil) and even naproxen sodium (Aleve). OTC NSAIDs were found to be safe, after all, as they never have been recommended for chronic use. But there was some concern for a time that NSAIDs would follow in the wake of such cox-2 inhibitors as Vioxx or Bextra and be pulled from the market, or at least carry severe warnings on the packaging, like Celebrex does today.
Conversely, a third class could significantly curtail market opportunities, as evidenced by the plummeting sales of products containing pseudoephedrine, a decongestant that was legislated to behind-the-counter status by the Combat Methamphetamine Act last year.
“We still believe that the current two-class system [of drug distribution] is the best system for American consumers,” said Elizabeth Funderburk, director, of communications and media relations for the Consumer Healthcare Products Association. “Expanded access can be achieved under the current regulatory system,” she said, even for medicines either with complex protocols, such as GlaxoSmithKline’s Alli (Alli isn’t for everyone…), or requiring additional outreach resources, such as smoking cessation.
Limiting potential markets is as much a concern for retail pharmacy operators as it is for their manufacturer partners—drooping sales negatively impact everybody’s bottom line—but the bigger issues surrounding a potential BTC class of drugs lay in the business model that would develop in the wake of a third class of drugs, such as reimbursement and pharmacy workflow issues.
“Pharmacists should be compensated for the time they spend or the knowledge that they have, just like a physician or any other healthcare provider,” said Mitchel Rothholz, APhA chief of staff. “If the patient were to get this product in a physician’s office, the physician would charge for that consultation time. It’s no different from that perspective. The market, though, will dictate what happens in that situation.”
But increased patient interaction, at the end of the day, is where the pharmacy industry is heading, Rothholz said. “This is in line with the strategic vision of not just APhA, but all the pharmacy organizations have articulated [increased patient interaction] as the future for the profession,” he said. “The use of technicians, the use of technology supporting the pharmacist to be able to pull back from the hands-on product manipulation to work with the patient is where the profession is trying to go.”
“If you see where [medication therapy management] is going, where Medicare is going, we are depending more on the pharmacist,” added Colleen Brennan, NCPA director of professional education affairs. “You’re going to see pharmacy workflow having to change [anyway].… You’re seeing that already with more robotics in the pharmacy; you’re seeing that with licensed and certified technicians. You’re seeing more operational efficiencies.… So these kinds of [initiatives] are going to be worked into the operational workflow.”