FDA's Experts Recommend Over-the-Counter Status for Popular Allergy Drugs

From the WebMD Archives

May 11, 2001 (Gaithersburg, Md.) -- An FDA panel of experts recommended today that three popular prescription allergy drugs are safe enough to use as over-the-counter medications. The move bolsters a petition from a large health plan to make the antihistamines available at your local supermarket.

If the FDA goes along with the recommendation of its advisory panel, it will be good news for health plans but bad news for companies making prescription drugs.

Schering-Plough's Claritin, Pfizer's Zyrtec, and Aventis' Allegra, known as 'second generation' antihistamines, are prescription-only drugs in the U.S. But they have been available without a prescription for years in Canada and western European countries.

The FDA panel, which comprised a combination of its Nonprescription Drugs Advisory Committee and its Pulmonary-Allergy Drugs Advisory Committee, voted 19-4 on the safety of Claritin and 19-4 for Zyrtec. It backed safety for Allegra by 18-5; that drug has had less use in pediatric populations.

Wellpoint/Blue Cross of California, a large health plan that has seen high increases in its drug spending, petitioned the FDA in 1998 to switch the status of the allergy drugs to over the counter.

There are dozens of 'first-generation' antihistamines, such as Benadryl and Tavist, that are already available without prescription for similar uses as the three drugs in question. But the prescription drugs may be safer, Wellpoint said, since they appear less likely to cause sleepiness or sedation.

The plan noted that direct-to-consumer advertising for the three prescription drugs asserts that their safety is comparable to a sugar pill. The FDA itself said that the medications appear to be effective and have a favorable safety profile.

The agency often follows the lead of its advisory committees, but is not bound by their votes.

Indeed, approval of the petition raises legal issues, the drug companies said today.

Wellpoint had contended that the FDA has the authority, under a 1951 law, to switch the drug's status from prescription to over the counter, if consumers can take the drug safely by following its label. But customarily, it is a drugmaker that asks the FDA for a switch in drug status.

Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America, tells WebMD, "Granting the switches proposed over the [drug companies]' clear objections would mark a major change in current practice. If the FDA agrees to these switches, the changes discussed today will be the tip of the iceberg. What classes of drugs will be next?"

If the FDA OKs a switch, "The only one to benefit will be lawyers," said Steve Francesco, an expert on drug status switch cases.

Eric Brass, MD, chairman of the Nonprescription Drugs Advisory Committee, tells WebMD, "The agency has its work cut out for it to try to address the petition, based on the scientific advice they got today. The issues raised by the petition go well beyond the scientific questions. I think they have a very difficult job."

It's unclear how, or when, the FDA will act on the Wellpoint petition. FDA's Robert Meyer, MD, director of its division of pulmonary and allergy drugs, tells WebMD, "We do not have a set time frame. But we have our experts' advice, and it's an important step. We'll take it under internal consideration." He acknowledges that "there are process issues, and we have a number of factors that need to go in consideration of the petition."

Robert Seidman, PharmD, chief pharmacy officer for Wellpoint, tells WebMD, "I'm hoping that at the end of the day, everyone will recognize that a societal need will be met by these drugs being made available over the counter. Forty million allergy sufferers will be better served."

If the drugs were switched away from prescription status, the HMO would be saving itself tens of millions each year, since it does not -- and would not -- cover over-the-counter drugs.

But the drug companies would face serious dents in their profits -- and stock prices -- if the medications were moved off prescription, says Francesco.

The bottom line for consumers and a switch isn't so clear. The health plan claimed that opening access wouldn't increase costs for consumers, because they must already make co-payments for covered prescription drugs. But the drug companies said that insured patients would face higher costs.

"I think a lot of statements were made about health care costs that were unsubstantiated by data," Brass tells WebMD. "To conclude what the overall impact would be, I think people are just guessing."

With the lack of a compelling argument either way for consumers, the groups Public Citizen and Consumer Federation of America have not yet weighed in on the debate.

The drug firms emphasized that switching the drugs could mean that consumers could mistakenly self-diagnose themselves as only having allergies, when in fact they had colds, sinusitis, and asthma. That could bring complications and increased health costs down the road.

Many doctors agreed, noting that physicians are crucial in correctly identifying and managing conditions like allergies. "Keeping a doctor in the loop is in the patient's best interest," said Michael Parker, MD, an ear, nose, and throat specialist in Syracuse, N.Y.

Andrea Apter, MD, a member of the pulmonary advisory committee, recommended today that over-the-counter labeling for the allergy drugs carry the following messages to consumers: not to use the drugs if they are running a fever; to see a doctor if they have no response after a certain timeframe; and to consult a physician before taking it during pregnancy.