FDA Demands to be the Final Authority

October 1, 2002
Jill Wechsler, Pharm Exec's Washington Correspondent

Jill Wechsler is Pharm Exec's Washington Corespondent

Pharmaceutical Executive

Pharmaceutical Executive, Pharmaceutical Executive-10-01-2002,

Acting on the belief that states should respect agency rulings involving labeling and advertising, FDA filed legal briefs challenging judges that second-guess its authority.

Acting on the belief that states should respect agency rulings involving labeling and advertising, FDA filed legal briefs challenging judges that second-guess its authority. The agency's top lawyer, Daniel Troy, maintains that FDA is entitled to "deference" by state governments in scientific and regulatory issues, as seen in three important cases now before the courts:

Need for a black-box warning about suicide for Zoloft (sertraline). FDA recently filed an amicus brief in the Ninth Circuit Court of Appeals in a case involving a California woman claiming that her husband committed suicide after taking Zoloft and that Pfizer was negligent in failing to provide adequate warning. FDA says it weighed information about the need for stronger warnings on anti-depressants for that effect and decided that the evidence did not support such a finding. A federal district court ruled that FDA's regulation of drug labels does not preempt all state court actions, but FDA maintains that the judge did not adequately review all the evidence.

TV ad claims for Paxil (paroxetine). In August, FDA challenged a federal court ruling regarding DTC ad claims that GlaxoSmithKline's Paxil (paroxetine) is not "habit forming." The judge had agreed with plaintiffs that GSK ads were misleading and ordered them off the air. FDA counters that it reviewed the issue and determined that GSK's claim is legitimate and different from the adverse events arising from discontinuing the therapy too quickly.

Stop-smoking product use by pregnant women. FDA also is arguing against a court ruling-Dowhal v. SmithKlineBeecham-that California's Proposition 65 requires manufacturers of anti-smoking therapies to warn pregnant women not to use them. That ruling contradicts FDA experts' finding that such a warning might deter pregnant women from making efforts to stop smoking, which would do even more harm to a fetus. A coalition of manufacturer associations is asking the California Supreme Court to review and overturn the lower state court decision.

Troy told attendees at the Food and Drug Law Institute marketing conference last month that those court actions pose a serious challenge to FDA's control over pharma labels and marketing materials. The agency can't have 50 states setting different standards for drug ads, commented the chief counsel. Troy says such issues could end up before the Supreme Court.

In the meantime, he noted that the same thinking applies to first amendment rights cases. If FDA deserves deference from the courts on scientific and regulatory decisions, it similarly should not have to collect new patient comprehension data to defend its decisions on DTC advertising against charges of violating marketers' right to free speech.

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