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Allergy sufferers who hope that Claritin will soon be available over the counter may well be waiting for many months, if not years.

On Friday, a committee of experts advised the Food and Drug Administration that Claritin and two other popular allergy drugs, Allegra and Zyrtec, were safe enough to be made available without a prescription.

But it is not clear that the F.D.A. has the authority to force the allergy drug manufacturers — Schering-Plough, Aventis and Pfizer — to make the products available over the counter.

And even if the government does order the change, the drug companies are almost certain to fight back in court. In fact, at the end of Friday's meeting, Pfizer delivered a 49-page legal brief to agency officials laying out why such a move would violate the companies' property rights and be illegal.

The advisory committee review of the status of the drugs was requested by Wellpoint Health Networks, an insurance company. Typically, pharmaceutical companies are the ones that ask for permission to sell their drugs without a prescription.

Analysts watching the case say that it is not clear that the Bush administration will even try to push ahead with a process that began while President Bill Clinton was in office.

 They also say that the F.D.A. is unlikely to make any decision until the White House appoints a new commissioner to lead the agency. The post has been vacant since President Bush took office.
But executives at Wellpoint said yesterday that they would continue to press their case.

Dr. Robert C. Seidman, Wellpoint's chief pharmacy officer, said that he planned to call Dr. Janet Woodcock, director of the F.D.A.'s Center for Drug Evaluation and Research, later this week. "I will ask when I will receive an official response," he said.

Dr. Seidman said he met on Monday with staff members of the House Energy and Commerce Committee, which deals with drug regulation.
Officials at the F.D.A. said yesterday that they could not predict when a decision would be reached.

Laura Bradbard, a spokeswoman at the agency, said that officials were reviewing the advisory committee's decision as well as information on the drugs' safety. The agency must consider each drug individually, she said, and decide whether each is safe enough to be used over the counter.

Ms. Bradbard said the agency had not yet spent much time researching the legal questions associated with forcing the companies to sell the drugs without a prescription. Further legal research will not be done, she said, until agency officials decide whether they agree with the advisory committee that the three drugs are appropriate for sale over the counter.
"It will be a little while," Ms. Bradbard said.

The companies would have full discretion to set prices on their over- the-counter drugs, just as they set prices on prescription drugs. But analysts say the proposal could substantially hurt their profits since prices for over-the-counter drugs are generally much lower than those charged for prescription medicines. 

The companies are also concerned that the challenge by Wellpoint might establish a precedent that would allow third parties to ask that the status of other drugs be changed, according to industry officials.

The three drug companies have argued that it would be risky for patients to diagnose their own allergy treatments.

"There were a lot of reservations made by members of the committee that we hope will make the agency hesitate," said Lisa Kennedy, a spokeswoman for Aventis, the French company that sells Allegra.

"If the agency moves forward," Ms. Kennedy added, "we would absolutely challenge it."

Without giving specifics, Schering- Plough, which sells Claritin, said yesterday that it planned to press its case that the drugs are inappropriate for over-the- counter use.

Pfizer, which sells Zyrtec, declined to comment yesterday. But in its legal brief, the company argues that under the law, the F.D.A. must have a formal public hearing before it can make the drugs available without a prescription. 

To do that, Pfizer's lawyers argue, the agency would be forced to disclose confidential information on the drugs that the companies have shared only with the agency. That disclosure, Pfizer argues, would deprive the companies of the use and economic benefit of their property and violate federal law.

Experts are divided on whether the government can force the companies to sell the drugs over the counter.

Dr. David A. Kessler, a former commissioner of the F.D.A., said that there are several procedures that the agency can use to switch a drug to over-the-counter use. "It appears the F.D.A. has the authority," he said.

But Ira S. Loss, a senior vice president at Washington Analysis, which monitors federal agencies for investors, said that he believed that the agency was uncertain about its legal authority to proceed because it has avoided discussing the issue, even at Friday's meeting.

"The statute does not prevent them from doing this," Mr. Loss said, "but it doesn't say they can either." He continued: "This is unprecedented. That makes trying to determine what will happen next speculative at best."

Dr. Kessler said that the drug companies were trying "to play both sides" with the allergy drugs. He said the companies are marketing the drugs directly to consumers but are now arguing that the medicines should be used only if consumers go to their doctors first.

"If you're marketing directly to consumers, it is one step closer to taking the physician out of the loop," Dr. Kessler said. "I wish it was the safety of these drugs that drove the companies' decisions, but we know it has a lot to do with their business models."