FDA Pondering New Internet Rules For Drug, Device Makers

The U.S. Food and Drug Administration (FDA) is looking into whether or not revised regulations are called for regarding how information is delivered on <"http://www.yourlawyer.com/practice_areas/defective_drugs">medicines and <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">medical devices via the Internet, says Reuters. The meeting is entitled “Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media,” and was announced in September.

Companies and consumer groups will be voicing opinions in a two-day meeting that began today. The focus of the meeting is on if Internet drug advertising requires “special oversight,” said Reuters. To start, the Pharmaceutical Research and Manufacturers of America, an industry group, is working to have the FDA agree to a safety logo that would appear on Internet information and would also be linked to FDA-approved information about the device or medication, said Reuters.

The topic is not without controversy and some 900 guests attempted to register for the meeting, which is being held in a room in Washington, D.C. that can only accommodate 350 people, reported Reuters. Pfizer, Eli Lilly, Google, and Yahoo are among the planned presenters. “How most consumers collect and interpret health information has changed,” said James Heywood, chairman and co-founder of PatientsLikeMe.com, a patient networking site, quoted Reuters.

The agency asked presenters to discuss criteria, for instance, to determine when “third-party conversations are subject” to “substantive influence” by companies advertising products being discussed, reported Reuters. “How do you control that advertising disguised as consumer information or consumer opinion?” asked Diana Zuckerman, president of the National Research Center for Women and Families, quoted Reuters. Zuckerman is slated to speak at the meeting.

In May we wrote In May we reported that the FDA released proposed guidelines for drug and medical device television ads meant to reduce diversion tactics. USA Today reported at the time that the $4.3 billion advertising sector was facing strong opposition from lawmakers hoping to put a stop to the advertising trend.

Lawmakers argued that direct-to-consumer (DTC) advertising, is responsible, in part, for the rising cost of health care and that the ads, described as “complicated,” discuss illnesses about which consumers might not even be aware.

DTC ads have long been criticized. Earlier this year GlaxoSmithKline was cited by the FDA when it ran an ad for the prostate drug Avodart that featured a man working on a model of the solar system and who must stop painting to “make frequent trips to the bathroom,” said the Star Tribune in a prior report. A colleague suggests Avodart, saying, “other medicines, they don’t treat the cause, because they don’t shrink the prostate.” FDA regulators, reported the Star Tribune, said the claim is bogus and in a letter to Glaxo’s U.S. officials, wrote that Merck’s Proscar reduces prostate size, and “has a similar indication…. Nothing in the labeling for Avodart suggests any specific advantage.”

Earlier this year, Consumer Reports questioned the ethics of a Chantix (varenicline) ad that, while never mentioning Chantix, appeared to market the drug while seeming to be a public service announcement. The commercial focused on a smoking cessation Website entitled MyTimeToQuit.com that presented information in a public service format, said Consumer Reports, pointing out that it is only at the ad’s end that hints about the ad’s origin—Pfizer—are discreetly revealed. The FDA approved Chantix in 2006; side effects may include suicidal ideation, depression, and violent behavior.

As part of a settlement with 27 states, Bayer had to change how it advertises birth control medication Yaz. Late last year, the FDA sent Bayer a warning letter over two Yaz televisions ads that misled consumers into believing Yaz could help relieve symptoms associated with Pre-Menstrual Syndrome (PMS) and could help in the treatment of specific types of acne. The FDA has never approved Yaz for either of these medical issues.

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