GOVERNMENT & MEDICINE

Suit targets Paxil ads, tests FDA authority

The question arises from a case that claims that patients have experienced severe withdrawal symptoms after discontinuing their use of the antidepressant.

By Tanya Albert, AMNews staff. Sept. 16, 2002. Additional information

In what legal experts have said is a rare move, a federal judge in August challenged the Food and Drug Administration's approval of drug advertising.

U.S. District Court Judge Mariana R. Pfaelzer told GlaxoSmithKline, the drug's manufacturer, that it would have to stop airing television commercials that said Paxil (paroxetine hydrochloride) is "non-habit-forming."

Her order was set to take effect on Sept. 1, even though the FDA had already approved the medication and the ad language.

Pfaelzer, who serves in the Central District of California, quickly put a stay on her order while the FDA prepared information on why it gave GlaxoSmithKline the go-ahead to advertise that the antidepressant is non-habit-forming.

Regardless of the case's outcome, the order raises questions: Should a court be allowed to overrule the authority of a government agency charged with being the expert on a subject? And what happens when a court intervenes?

The answer depends on whom you ask.

Karen A. Barth, a California attorney representing the patients in the lawsuit against GlaxoSmithKline, said the judge's action offered important checks and balances on the FDA's powers.

"Patients are oftentimes using these advertisements to make health care decisions," Barth pointed out. "She [the judge] is well within her jurisdiction."

Barth noted that courts in the past have ruled on false advertising cases.

But others oppose the judge's intervention and say that the ruling could hurt the system the government established to ensure that medication is safe and drug advertising is accurate.

"The U.S. Food and Drug Administration -- and not the courts -- has the expertise and responsibility for reviewing and regulating pharmaceutical ads," said David Stout, president of U.S. Pharmaceuticals at GlaxoSmithKline. "The Paxil television ad was submitted for FDA review prior to use, and the agency raised no objections to the language at issue."

The FDA also has concerns about the judge's ruling in this case, said Crystal Rice, an FDA spokeswoman. "This is not a concern about a single product or single company, but a concern about the FDA's authority over prescription drug advertising," she said.

The agency would not elaborate on what specifically its concerns are. Peter S. Reichertz, a Washington, D.C., lawyer, said the FDA likely would not want to see its work second-guessed by the courts.

"If a case like this became case law, it would play havoc with the whole system," said Reichertz, who counsels companies that manufacture FDA-regulated products. "It would be very troubling."

He said he would be surprised if the court did interfere. Traditionally, courts have deferred to an agency's expertise. For example, in one case involving insecticides, the court defaulted to the Environmental Protection Agency.

"Generally, the courts don't feel they have the scientific background," Reichertz said.

The FDA was scheduled to file papers with the court Sept. 5 explaining why it decided to allow Paxil to be advertised as non-habit-forming. Lawyers representing the patients were scheduled to file their response by Sept. 12.

The judge is expected to rule after those papers are filed. Any decision is likely to be appealed.

Patients' complaints

The case raising this question of judicial authority stems from patients' concerns that Paxil is habit-forming. In their proposed class action suit, the patients allege that they have experienced or continued to experience dependency and severe withdrawal symptoms after they reduced the amount of Paxil they were taking or after they stopped using the drug.

They say that is contrary to GlaxoSmithKline's advertising claim that Paxil is non-habit-forming.

The patients asked the court to force the company to change its ads because they fear that employers, family members, friends and some physicians would believe that their symptoms aren't attributed to the Paxil withdrawal, according to court documents.

"My biggest concern is misleading information getting out," said Barth, who added that her firm had heard from about 5,000 people with concerns about side effects from Paxil.

GlaxoSmithKline spokeswoman Mary Anne Rhyne said there was no scientific evidence that Paxil is habit-forming and that the company had submitted its ads to the FDA and received FDA approval. She also noted that several mental health organizations, including the American Psychiatric Assn., say that antidepressants are not habit-forming.

"We strongly disagreed with the judge's ruling" that advertising the drug as non-habit-forming should stop, Rhyne said.

"We are in a wait-and-see mode now while the judge takes a look at the information."

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Paxil litigation

Venue: U.S. District Court for the Central District of California
At issue: Whether the court will step in and require GlaxoSmithKline to stop advertising Paxil as non-habit-forming, even though the Food and Drug Administration has already approved the advertising.
Potential impact: Some say the court offers positive checks and balances on a government agency. Others say the court is overstepping its bounds, and judicial second-guessing could create problems with the FDA's advertising approval system.

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Copyright 2002 American Medical Association. All rights reserved.