FDA Enters Fight To Switch RX To OTC

When should a drug be sold over the counter instead of by prescription only? Historically, the decision to apply for such a change has almost always been left up to the manufacturer.
The motivation to switch a drug from Rx to OTC status is supposed to be determined by the compound’s safety and ease of use. But money may play a vital role.
When a prescription product is about to lose its patent and face generic competition, drug companies may try to take the drug to the masses to maintain brand name loyalty and bolster sales. That is what happened with heartburn products like Tagamet and Zantac and with pain relievers such as Motrin and Aleve.
But two years ago an insurance company, WellPoint Health Networks, changed the rules for Rx-to-OTC switches, and the game may never be the same again. Wellpoint asked the FDA to switch prescription allergy medications like Allegra, Claritin and Zyrtec to over-the-counter status.
Wellpoint believed it might be able to save almost $100 million annually by not having to pay for doctor visits and pricey allergy pills. That’s because patients pay for OTC products out of their own pockets.
To support its request, Wellpoint also pointed out that non-sedating medications such as Allegra, Claritin and Zyrtec are probably safer than traditional OTC allergy drugs. Antihistamines like diphenhydramine (Benadryl) may make people drowsy and impair driving ability.
Initially, the maker of Claritin balked at the idea. The company objected that patients might not be able to diagnose allergies themselves and suggested that, “self-care and self-treatment by patients may often be inappropriate.”
But faced with generic competition and granted the opportunity to sell prescription Clarinex, Schering did an about-face. The company embraced the opportunity to sell Claritin OTC.
Claritin is now one of the priciest OTC products on pharmacy shelves, at around $30 for a month’s supply. This makes nonprescription Claritin more expensive for some insured people than when it was available only with a doctor’s prescription. Then, many patients had to come up with just a modest $10 or $15 monthly co-pay. But for the uninsured, the price has dropped.
Following the Claritin conversion, the FDA is about to announce a bold new policy. Instead of leaving it up to drug companies to decide whether they want to request an Rx-to-OTC switch, the FDA is planning to take a more pro-active role. The agency believes it can force certain products over the counter.
Senior FDA officials believe they have the legal horsepower to move other prescription antihistamines like Allegra and Zyrtec to off-the-shelf status. Not surprisingly, the manufacturers of these products oppose this action.
Neither Allegra nor Zyrtec faces generic competition any time soon. Such drugs are far more profitable when they remain prescription only than when they must compete with other OTC products.
If the FDA wins this fight, other types of drugs may also become available over the counter. In an attempt to hold down the ever-rising cost of drugs and increase patient access, medications for asthma, emergency contraception, heartburn and high cholesterol may follow other allergy medications to non-prescription status.