WASHINGTON, D.C. -- It's a giant business. But last year, for the first time since 1993, there were no true prescription to over-the-counter switches released to the market.
Given that fact, and the uncertainty at the Food and Drug Administration as it awaits the appointment of a new commissioner, supermarket retailers are wondering what they can expect in terms of new Rx-to-OTC products for 2001.
Over-the-counter products rang up $23.2 billion in food, drug and mass sales for the 52 weeks ending Jan. 27, 2001, according to ACNielsen, Schaumburg, Ill. Total OTC sales rose 2.3% for the period. Of that amount, the retail food industry generated $6.5 billion in sales, up 28.3%.
Major Rx-to-OTC switches introduced since 1976 accounted for approximately $2.67 billion in sales in 1999 and comprised 25.6% of overall OTC sales for the same period, according to Kline & Co., a Little Falls, N.J.-based consultancy. ACNielsen reported total OTC sales of $22.7 billion for the 52-week period ending Jan. 29, 2000.
SN asked R. William Soller, Ph.D, senior vice president and director of science and technology at the Consumer Healthcare Products Association here, for his views on the current environment for releasing prescription drugs to market. According to Soller, a true switch -- which he defines as the exact dosage amount, form, duration and indication -- is fairly rare. He pointed to Ibuprofen as an example. When it first went OTC, it wasn't formulated in 100-mg or 200-mg tablets, as it was under prescription.
"We have used the term as a catchall, rightly or wrongly. But it has been a way to rally support around a concept, which is really OTC new-drug introductions," he said.
Soller described the highs and lows of the Rx-to-OTC market over the past decade. He pointed to a high point from 1995 to 1997 and an era in the late '80s when switches were in a valley. "At the time, we had put forward a list of about 50 switch ingredients after a symposium to create a self-fulfilling prophecy. Once the FDA got through the approval process, we saw the H2 blockers, the nicotine replacement therapies, and so on," he said.
At the moment, some of the major drug companies appear to be holding off on the movement of prescription drugs across to the consumer shopping aisles. "They have their own specific reasons for doing so. They may believe their products would be better off Rx for the time being, presumably for them to get more Rx experience before it goes over-the-counter," Soller explained.
Another reason, which Soller didn't touch on, is a drug's patent expiration. Here, timing becomes everything, as drug companies seek to prolong revenues as long as possible by taking a prescription drug brand to the OTC side before generic versions are allowed to become available and erode the branded drug's sales base. In making the crossover, though, it becomes important to build consumer awareness and loyalty for the product on the OTC side.
Drug companies are doing this early by using direct-to-consumer advertising for their prescription drugs. Soller said he believes the drugs being touted as DTC products now are good candidates for future switches.
Another trend seen last year was the direct-to-OTC route with Abreva cream (docosanol 10%) from Avanir Pharmaceuticals for the treatment of cold sores and fever blisters. The company originally sought Rx status for Abreva, but was told by the FDA that it would be better as an OTC because the product is most effective when applied at the first signs of an outbreak. Most other OTCs launched last year were line extensions and not original drug products.
During the '90s, the FDA established a solid foundation for future switches by building a database and implementing a technical process for testing OTCs before they go to market. At the time, this work was greatly aided by the Nonprescription Drug Advisory Committee and by OTC and label-comprehension studies, Soller pointed out. Having the information and process for testing drugs in place has helped facilitate approvals for switches.
"If you think about the continuum of wellness to disease -- chronic diseases in a moment -- it's looking at that transition, that gray area between wellness and disease, that will be the future frontier for OTCs," Soller said.
According to media reports, retailers might expect to see new switches for products used to treat such chronic conditions as allergy, hypertension, high cholesterol, diabetes, osteoporosis, herpes and other lesions, stomach and intestinal ailments, asthma and bladder control. Birth-control contraceptives could go OTC as well.
In 2000, several companies have sought OTC status for breakthrough drugs. Most notably, AstraZeneca has applied for an OTC version of its antiulcerant Priosec (omeprazole). Merck & Co. and Bristol-Myers Squibb have sought OTC approval for their statin anti-hyperlipidemia agents (cholesterol-lowering drugs) Mevacor (lovastatin) and Pravachol (pravastatin), respectively.
Soller said he was optimistic that some of these drugs and others will win OTC status. "I'm hopeful for a switch next year," he said, citing positive feedback from the July FDA meeting on cholesterol-lowering agents.
Commenting on the future status of cholesterol-lowering drugs, Soller said: "I think we all left very optimistic after the July meeting. In fact, this could be a very significant milestone in switches, because it's an asymptomatic condition. There are no obvious symptoms to know that a person's cholesterol would be up or down, so it would have to be monitored. Not to adequately monitor it could have significant serious aquila like stroke, heart attack, and so on. This opens up the disease management area for OTC very significantly. It has moved people to think about hypertension. It has moved people to think about hormone replacement therapy and other types of long-term conditions/diseases that might be managed in a complementary way with OTC. In a way, that would allow OTC to complement, not take the place of, the kinds of Rx therapies that health practitioners would be providing to their patients."
Regarding the appointment of an FDA commissioner, Soller said, "Hopefully the new commissioner would give us the same confirmation of the importance of self-care and the importance of OTCness to enhance the management of long-term conditions that require monitoring."