Health Care & Prescription Drugs News

New Report says FDA’s Enforcement Policies Ineffective

WASHINGTON, D.C.– Prescription drug marketers made deceptive claims to doctors and consumers about 150 different drugs including Vioxx and OxyContin, according to a new report released today by U.S. Public Interest Research Group and the NJPIRG Law and Policy Center.

“Powerful prescription drugs can improve or save lives, but if they’re marketed to the wrong people, they can cripple or even kill,” said NJPIRG Law and Policy Center Consumer Advocate Abigail Caplovitz, the report’s author.

The report, “Turning Medicine Into Snake Oil: How Drug Marketers Put Patients At Risk,” analyzes five years of regulatory letters from the FDA to prescription drug companies. The report called false and misleading prescription drug advertising “common and dangerous.”

Among the report’s key findings:

Drug marketers make unsupported or misleading claims.
• Thirty-eight percent of deceptive messages to doctors and consumers made unsupported or misleading claims.
• Thirty-five percent misrepresented risks or side effects of taking the drugs.
• Twenty-two percent promoted unproven drug uses.

FDA policies to stop deceptive advertising are ineffective.
• About one-third of the drug marketers receiving FDA enforcement letters received more than one letter declaring their ads false or misleading.
• Many of those drug marketers received more than one letter addressing the same problem.

Deceptive marketing aimed at doctors.
• Physicians were inundated with 38 different types of dangerous and misleading marketing tactics.
“Doctors are targeted because they’re the ones who write the prescriptions,” said U.S. PIRG Consumer Advocate Paul Brown. “Drug companies know who they have to influence, if they want to jack up sales and profits.”

Deceptive marketing aimed at consumers.
• Print ads, TV ads and website ads make up almost 80 percent of deceptive marketing aimed at consumers. These direct-to-consumer ads potentially mislead millions of people, far more than the marketing aimed solely at doctors.
Deceptive marketing includes clinical trials.
• Drug companies have suppressed unfavorable clinical trials.
• They use public relations firms to write favorable research reports and then list a doctor’s name on the report as the “author.”
• The FDA highlighted marketing materials that used false footnotes to “support” claims about their products—the over 82 clinical trials in those footnotes didn’t support the claims being made.

“If we can’t rely on clinical trial reports, the very foundation of pharmaceutical medicine is destroyed,” Caplovitz said. “Medicine, not marketing must drive clinical trial designs.”

The report recommends that Congress:
• Pass The Food and Drug Administration Safety Act, Senate Bill 930, which requires the FDA to review prescription drug advertising materials before consumers see them.
• Require that clinical trials used to support advertising claims be approved by the FDA.
• Authorize the FDA to levy stiff fines against drug marketers who use deceptive tactics.

“The FDA’s current enforcement isn’t even a slap on the wrist,” Brown said. “A slap on the wrist would be an improvement.”

The report recommends that individual states:
• Pass laws to make it easier for consumer to sue drug marketers for deceptive advertising.
• Create a comprehensive, searchable database of clinical trials, which would make it harder for drug marketers to suppress or misrepresent data.

“States can protect consumers now from the dangers of deceptive drug marketing,” Caplovitz said. “There’s no need to wait for Congress or the FDA.”

The report includes six case studies of deceptive marketing: Vioxx, OxyContin, Paxil, Accutane, Neurontin and Tindamax. The report’s numbers are derived from FDA letters to drug marketers.