FDA issues draft guidances on DTC advertising and more

The Food and Drug Administration has issued three draft guidance documents designed to improve communications to consumers and health care providers about health conditions and medical products, according to a press release from the FDA.

The guidances cover three areas: how manufacturers should disclose risks associated with their drugs in direct-to-consumer print advertisements; how manufacturers can use advertisements to make consumers aware of diseases that may be undertreated; and how manufacturers of devices under FDA control can provide the public with accurate information on those devices.

“Our new regulatory guidance provides new direction to sponsors on how to provide higher-quality health information to the public, based on recent evidence of what works and what doesn’t in drug promotion,” said FDA Commissioner Mark B. McClellan, MD, PhD, in the press release.

The guidances are a culmination of FDA research and policy development, according to the release. They were influenced by public reaction at an open meeting on consumer-directed advertising held by the FDA last September.

According to the FDA, most physicians feel that direct-to-consumer advertising increases patient awareness and involvement and improves compliance. An FDA study showed that visits to physicians stimulated by these types of ads can help to identify previously undiagnosed conditions. The study found that, of patients who visited doctors because of a DTC ad, and asked for a brand-name drug by name, 87% actually had the condition the drug treats, according to the release.

The FDA is encouraging comment on these draft guidances. To see the text of the guidances in a downloadable form, go to http://www.fda.gov/cder/guidance/5669dft.pdf.

For more information about the September meeting, go to http://www.fda.gov/cder/ddmac/DTCmeeting2003.html.