This could be another watershed year for Rx-to-OTC switches.
The probable conversion of ulcer treatment Prilosec is expected to bring big-time sales, while the possible changeover of emergency contraceptive Plan B is likely to generate big-time controversy.
Prilosec is a top-selling ulcer treatment from drug maker AstraZeneca, London, and the company expects over-the-counter approval by the Food and Drug Administration this summer. It has already received preliminary sanction by an FDA advisory panel. Prilosec is a type of drug called a proton pump inhibitor, which blocks the production of acid by the stomach. This purple pill produces $4 billion in sales, according to published reports, and its move from prescription status to OTC would make it the biggest OTC switch to date, according to retailers polled by SN. It is a top-selling pharmaceutical product, "and a lot of people would switch from Tagament and Zantac to Prilosec, a highly effective second-generation drug with few side effects," said John Fegan, vice president, Ahold USA, Chantilly, Va.
"The Prilosec approval could potentially be the largest in terms of dollar sales," said Tim Covington, Bruno professor of pharmacy, McWhorter School of Pharmacy, Samford University, Birmingham, Ala., and director of the Managed Care Institute. This blockbuster drug approval would "expand the pharmacy professional prerogatives as professional advisors. We trivialize these kinds of relationships, but they are significant business opportunities," he noted.
The U.S. market for prescription drugs transferring to OTC status is accelerating on the heels of the allergy remedy Claritin from Schering-Plough, Kenilworth, N.J., which was a big success when it went on store shelves last December. Among the products that will see the most dramatic growth in the future are other allergy and gastrointestinal products, according to Kalorama Information, an imprint of MarketResearch.com, New York. In its study, "The Market for Rx-to-OTC Switches," Kalorama said the $5 billion OTC market will see double-digit growth, particularly in the gastrointestinal segment.
Medications and remedies totaled $7.34 billion in the combined food, drug and mass channels, excluding Wal-Mart Stores, Bentonville, Ark., according to the Strategic Planner of ACNielsen, Schaumburg, Ill., during a 52-week period ending April 19, with a small 0.9% increase from the previous year. Total pain remedies rang up $2.5 billion in the three retail channels during the same 52-week period, a 1.6% decrease from 2002. Total cough and cold remedies climbed 4.6% to $3.2 billion in sales.
Another prescription medication looking for OTC standing could produce more than strong sales; it could result in an entirely new way to sell certain OTC drugs. Women's Capital Corp., Washington, recently applied to the FDA for permission to switch its emergency contraceptive, Plan B, from prescription to OTC status. Pharmacists in Alaska, California, Washington and most recently, New Mexico, can already sell this controversial "morning-after pill" without a physician's prescription.
There is some confusion about these products. Some refer to the even more controversial RU-486 as "the morning-after pill," but this designation is better applied to emergency contraception products. While RU-486 triggers an abortion up to 12 weeks after conception, emergency contraception like Plan B prevent conception by either delaying ovulation or preventing a fertilized egg from attaching to the uterus. RU-486 is the drug mifepristone, while emergency contraception contains a high dose of birth control medication. RU-486 is not being considered for OTC.
Pharmacists and analysts gave a wide spectrum of opinions on the prospect of OTC emergency contraceptives.
"There will be a lot of retailers scratching their heads," said Jim Wisner, president, Wisner Retail Marketing, Libertyville, Ill. "If [retailers] carry it, how will consumers view the appropriateness of it?"
Greg Jones, director, pharmacy and whole health, Harmons, West Valley City, Utah, said he was uneasy about providing this medication to young women.
"Those drugs are not without side effects, and I'd hate to see any young girl who thinks she's pregnant taking this drug every time," he said.
This particular type of drug prompted retailers to advocate a new third class of medicines: ones that consumers can purchase without a prescription, but must be displayed behind the pharmacy counter so pharmacists can provide more information and guidance about the product at the time of purchase.
"Emergency contraceptives are a classic example of a drug that is suited for this third class of drugs," said Covington. "I'm supporting an Rx-to-OTC initiative for emergency contraception through America's pharmacies."
But Fegan said that retailers "are not ready" for emergency contraceptives to switch to OTC, even if kept behind the counter. If that were the case, it would be difficult to remain consistent in providing the medication to consumers when it would be a pharmacist-administered product open to pharmacist subjectivity, he said.
"It's a serious health treatment decision, and it should be made by a knowledgeable prescriber," he said. "In this category, we're still better off working with the physician community."
Sharon L. Camp, founder and chief executive officer, Women's Capital Corp., said in a prepared statement, "We look forward to working with the FDA over the next 10 months as they review the safety and efficacy of OTC status for Plan B. We believe that removing the prescription requirement is critical to giving women timely access to backup birth control."
While it is routine for drug manufacturers like Women's Capital Corp. to take the initiative to obtain FDA permission on Rx-to-OTC switches, that ritual may soon change. The FDA is considering a more proactive approach to the switch process, forcing drug makers to switch some of the prescription drugs to OTC as a way to make them less expensive and more easily available to consumers.
"While this issue is being actively considered, the agency's first mandate is that the drugs on the market are safe and effective," said Crystal Rice, spokeswoman, FDA Center for Drug Evaluation and Research. "The agency believes that it has the authority to determine whether or not a product is Rx or OTC, but the agency is being very careful to consider the policy implications, for this is a policy setting agency."
Donna Edenhart, director, public affairs, Consumer Healthcare Products Association, Washington, which represents over-the-counter drug manufacturers, told SN, "A switch is best determined by the manufacturer of the product because they have the best information to determine whether or not a product is safe for the masses."
"Why fool with the process that thus far has been working just fine, thank you?" she added.
Retailers would support these forced switches as long as the drugs were safe and effective for OTC use.
"When you look at the safety and risk, a lot of the [prescription drugs] are probably more safe than the ones already on the market," said Wisner.
"My only concern is the safety of our patients," said Joe Lahovich, director, pharmacy operations, the Fred W. Albrecht Grocery Co., Akron, Ohio, which operates under the Acme banner. "Pharmacy can play a big role in managing prescription drug therapy, and if patients allow us, we can play a role in OTC therapy as well."
Wherever the road takes OTC in the near future, it's headed in the right direction for greater sales potential and more pharmacist involvement to promote OTCs, said retailers.
Drugs like Claritin give a boost to OTCs, said Jones of Harmons' pharmacies. "It's a big win for the OTC department and not a huge loss for the pharmacy department," he said. While Claritin has cannibalized other anti-histamines in the allergy remedy category, "it more than evens out because Claritin is a higher ring." The retailer really "pushes" pharmacists to be seen as an OTC resource for patients, Jones said. Harmons places newspaper ads that promote pharmacists as good resources to answer OTC questions.
"Rx-to-OTCs keep getting bigger and bigger," said Wisner. "More OTCs expand the market and bring more people who should have drug therapy to the market."