Healthy Skepticism Library item: 17808

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Edwards J
The Activist FDA: Warnings to Drug Companies Up 50% From Bush Era
BNet 2010 May 12
http://industry.bnet.com/pharma/10008115/under-obama-fda-warnings-to-drug-companies-increased-50-from-bush-era/

Full text:

The FDA’s new Bad Ad program – in which doctors are urged to call the feds if they hear or see a drug pitch they don’t like – is the latest example of the FDA’s renewed activism under President Obama. FDA warning letters – which cite drug companies for misleading advertising or bad manufacturing practices – have increased 31 percent since 2008, and 50 percent since 2007.

This year to date, the FDA has issued 186 warning letters, a rate that indicates 2009 will be another big year for drug company discipline. Last year the FDA issued the most warning letters in years – 570. In 2008, the last year of George W. Bush’s administration, the FDA only sent 436 letters. The year before just 381 were sent:

Source: FDA.

The Obama FDA has also looked at new types of advertising. In 2009 it cited 14 companies for using Google search ads to promote their products. Bayer (BAY)’s erectile dysfunction drug Levitra and Pfizer (PFE)’s anti-smoking pill Chantix were caught in that push.

More recently, the FDA cited Novartis (NVS) for two unbranded Web sites that it claimed were misleadingly promoting the company’s cancer drug, Gleevec. Neither site actually mentioned the drug, but the FDA said the material on them hinted heavily that Gleevec was recommended and thus the site were drug ads and not the more lightly regulated category of health information “help-seeking” ads.