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.

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. [...]