Far-Fetched FDA Claims

In the last year, the FDA has more than tripled the number of warnings about misleading ads that it sends to drug companies. In the 12-month period between August 2004 and 2005, the FDA sent 17 warnings; in the same period from August 2003 to 2004, five warnings were issued. I think we’re expected to pat the agency on the back for its tremendous efforts to increase enforcement of drug advertising laws.

In 2003, drug companies spent $3.2 billion on such ads. There were only five warnings issued from August 2003 to August 2004? Figures for 2004 expenditures have yet to be issued, but the trend indicates that the amount continued to rise. We’re supposed to believe that increasing the number of warnings by 12 made a difference?

The FDA division that regulates the ads is responsible for reviewing 30,000 to 40,000 ads each year, according to the Washington Post. Only 17 of these ads were out of line? I don’t think so. More significant, though, is that the FDA is almost powerless in enforcing drug advertising requirements. An article in the Seattle Times‘ Suddenly Sick series makes this pretty clear:

“The FDA has the task of making sure that drug companies do not make misleading claims in their ads, whether in medical journals or in mass-market Parade. But the regulatory agency, with part of its budget dependent on drug-company funding, has little firepower.

“When the FDA reviewed drug ads between 1997 and 1999, it found that more than half were inaccurate. It asked companies to change them, and in most cases they did.

“When companies refused and the FDA took them to court, the agency lost eight out of 10 court challenges on grounds of free speech.

“The FDA doesn’t have the authority to fine companies, either. The agency can go to court and ask a judge to fine them, but it has never done so, FDA spokeswoman Laura Alvey said last week.”

Unless major changes to the FDA’s authority accompany new legislation, tightening direct-to-consumer ad laws is a patch that will fail before it adheres.

What’s the motivation drug companies to clean up their acts? Even on the off chance that FDA cites a company, it’s after the first round of ads have already run, and the message is out to millions of people.

When I worked in communications for the government, a supreme spin master held the reins. He crafted messages that glorified our agency’s activities. No one believed the rhetoric because it wasn’t true. Neither he nor the FDA official who spoke today understand that to convince the public that you’re involved in spectacular activities requires engaging in spectacular activities.