Pharmaceutical companies hoping to boost their marketing efforts with misleading ads that overlook the risks and overstate the effectiveness of drugs won't be getting a free ride anymore thanks to the FDA.
In its latest push to keep drug makers honest, the U.S. Food and Drug Administration will soon begin asking doctors to pay special attention to drug advertisements and report those that violate FDA rules. Such violations include sales pitches that tout drugs' benefits but understate their risks, exaggerate how well drugs work, or suggest off-label uses not approved by regulators.
"False or misleading promotion can have a negative public health impact for a variety of reasons," said Shelly Burgess, an FDA spokeswoman. "It can negatively impact prescribing decisions and safe use of the drug by failing to disclose key risks, or by representing that a drug is more effective or useful in a broader range of conditions than it has been shown to be."
By enlisting the support of health-care providers, the agency aims to curb abuses that occur beyond TV screens and the public eye, such as direct sales pitches at doctors' offices and medical conventions. Physicians will be able to report such violations anonymously.
Currently, the FDA relies on drug companies to voluntarily submit their ads, brochures and presentations for review, or on tips or industry complaints. The agency issues warning letters to companies that use misleading ads, but because of backlogs and the sheer volume of submissions, those letters often don't reach their destinations in a timely manner.
"We don't have the resources to review all of the tens of thousands of prescription drug promotional pieces that are produced each year," said Burgess, adding that regulators use a risk-based enforcement approach to act on the most serious violations first.
This year alone, the FDA has cited Novartis, Genentech, Sanofi-Aventis, GlaxoSmithKline, Pfizer, Biogen, and a number of other pharmaceutical companies for marketing drugs in a misleading or untruthful manner.
Regulators have recently ratcheted up pressure on the pharmaceutical industry to steer clear of deceptive practices such as illegally promoting drugs for unapproved uses and continuing to sell defective medical devices that risk patient safety.
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