Posted by Phillipa on May 12, 2010, at 20:47:11 [reposted on May 12, 2010, at 22:58:48 | original URL]
Maybe no more freebies from Drug Companies no mugs, pads etc. Phillipa
From Medscape Medical News
FDA Urges Physicians to Report Misleading Drug Promotions
Robert Lowes
May 11, 2010 For years, physicians have been able to report adverse drug events to the US Food and Drug Administration (FDA) through a program called MedWatch.Now they also can report misleading or inaccurate promotions of prescription drugs to the FDA through its new "Bad Ad Program," which might as well be called "RepWatch."
The Bad Ad Program, unveiled today, is aimed in particular at "curtailing inappropriate promotional activities" of pharmaceutical company representatives who visit physician offices and give presentations at events sponsored by their industry, according to the agency's Web site. Common FDA violations include:
Omitting or downplaying a drug's risks
Overstating a drug's effectiveness
Promoting off-label or unapproved uses
Making misleading drug comparisons
Physicians can report such infractions to the Division of Drug Marketing, Advertising, and Communications in the FDA's Center for Drug Evaluation and Research by sending an email to BadAd@fda.gov, calling 877-793-3622, or writing a letter to FDA/CDER/DDMAC, 5901-B Ammendale Road, Beltsville, Maryland, 20705-1266.Anonymous complaints are welcome, but those accompanied by names and contact information help the FDA in any needed follow-up work. The agency also encourages clinicians to send along evidence of misleading spiels, such as a pamphlet or documentation of oral statements made by drug company representatives.
If it decides that the drug promotion violates FDA regulations, the Division of Drug Marketing, Advertising, and Communications will go into enforcement mode. It can send the pharmaceutical company either an official warning letter or an "untitled letter" for less serious cases, or seek criminal prosecution.
FDA Initiative Another Blow to the PhysicianDrug Rep Relationship
The new program, which urges physicians to report potential FDA violations, is another blow to the once cozy, gift-laden relationship that medicine has had with pharmaceutical companies. In recent years, some medical schools and academic medical centers have admitted pharmaceutical representatives by appointment only and prohibited them from handing out drug samples and pizza alike. In turn, the pharmaceutical industry has instituted new rules for its sales force that restrict the kind of freebies such as pens, mugs, and restaurant meals that it can bestow on physicians.
Not surprisingly, one critic of the pharmaceutical industry, who considers it a source of biased information about its products, is applauding the FDA initiative.
"The FDA should be congratulated," said Adriane Fugh-Berman, MD, who helps run PharmedOut, a group seeking to eliminate the role that the pharmaceutical industry plays in medical education. "It's not uncommon for a drug rep to promote an off-label use or minimize a drug's side effects."
Dr. Fugh-Berman, an associate professor of physiology at Georgetown University School of Medicine, said that even if only 1% to 5% of physicians report dubious drug pitches to the FDA, "it could make a huge difference." She noted that less that 1% of all adverse drug reactions are reported to MedWatch.
"The FDA is chronically understaffed," Dr. Fugh-Berman added. "They can't possibly monitor all the promotional activities of drug companies. So it's a great idea to recruit prescribers to help."
Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America, said in a written statement today that his group is committed to "truthful, scientifically accurate information in all direct-to-consumer advertising and interactions with healthcare professionals." The Bad Ad Program is "another step to help educate and receive feedback from healthcare providers about prescription drug advertising and promotion."
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