FDA to Review Whether Allergy Meds Should Sell Over the Counter

Between 25 and 50 million Americans suffer from allergies, and this is one of the worst allergy seasons on record. The good news is that soon you may be able to get the newest prescription drugs over the counter (OTC). Our health correspondent Dr. Emily Senay explains.

On Friday, the US Food and Drug Administration (FDA) advisory committee will hold a meeting to discuss the possibility of three prescription antihistamines--Claritin, Zyrtec, and Allegra--becoming available over the counter.

Meetings like this usually take place when a patent is close to running out. In this case, a petition was filed by Blue Cross of California, which prompts this meeting to take place now. Three drug companies--Pfizer, Aventis, and Schering-Plough--are opposing this change, claiming the drugs need to be monitored by doctors for safety reasons.

The FDA advisory committee will make a recommendation on the safety of these drugs, but the agency is not expected to make a decision for some time, and the medications would not be available to consumers over the counter for nearly 3 years.

It began as a one-man campaign by California Blue Cross pharmacist Robert Seidman. Now he may end up forcing Pfizer, Aventis, and Schering-Plough to sell their allergy medications without a prescription.

The three companies are fighting to keep their products from being sold over the counter, which would likely to drive down their prices. Only once in the last 18 years has the FDA approved nonprescription sales of a drug without a petition or support from the manufacturer.

Now, the FDA is weighing just such a move. That would be a victory for Seidman, who has been pushing for the change for more than 3 years. "It's a big step for the FDA but I believe it's their responsibility to do it," says Seidman, now vice president of pharmacy development at Blue Cross California's parent company, WellPoint Health Networks, Inc. "It is clear that these drugs meet the criteria that's necessary for them to be OTC."

In March, FDA officials called Seidman to tell him the agency would convene a panel of experts to consider whether Claritin, Pfizer's Zyrtec, and Aventis's Allegra, can be safely used without a prescription. FDA documents prepared ahead of the meeting suggest that the agency considers the drugs safe enough for OTC use.

The FDA maintains it has the authority to compel a switch. "Drugs are by definition nonprescription unless they have particular attributes that would require them to be available only by prescription," says the director of the FDA office that oversees allergy drugs.

Seidman says Schering-Plough and other drug makers are helping make his case with advertising that touts the safety of their products. As Schering-Plough's ads point out, Claritin's side effects are no more frequent, or severe, than those for a sugar pill. "Prescription drugs are prescription drugs because they have the ability to do harm as well as good," Seidman says "These drugs are so safe that having to prescribe them trivializes the prescription system."

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