FDA Marketing Police Cannot Keep Up With $4.8 Billion Pharma Drug Advertising Budget
You can buy a lot of ads for $4.8 billion. That’s how much money the pharmaceutical industry spends each year marketing its products directly to consumers (DTCA).
The problem is, the U.S. Food and Drug Administration (FDA) can’t keep up with their job of policing the ads. Not even close. It’s the FDA’s job to ensure ads are fair, do not mislead, and warn about side effects.
The U.S. is the only developed country other than New Zealand that allows direct-to-consumer advertising for drugs and other medical products – a huge point of contention among consumer groups.
The special report by Reuters that outlines the inability of the FDA’s oversight is about 4,000 words long, so let’s stick to the highlights. It won’t take long for you to be unimpressed…
- The FDA is charged with reviewing about 75,000 pharmaceutical marketing items per year. The agency recently received “a handful” of new staffers for these duties, bringing the total to 57 officials. FDA officials say they review thousands of ads but simply cannot get to them all. Many misleading ads, they admit, are already in the media before they are discovered.
- The antiquated FDA does not have the technology that would allow pharma companies to upload streaming files. This means the FDA must look at storyboards for commercials and other video files. These are not the actual advertisements themselves, of course.
- The number of FDA warning letters sent to pharma companies for violations of FDA marketing standards has increased over the years. It was just 21 in 2008, 41 in 2009, and 45 this year through late August.
- The FDA has yet to release a standardized set of requirements for the pharma industry with regard to advertising medications such as viagra online and through social media. Yahoo and Google have also been clamoring for some direction, and the FDA says it hopes to release a draft document by the end of 2010.
- The FDA has recruited doctors to help them with the watchdog duties. The agency’s “Bad Ad” campaign trains physicians to recognize questionable promotions and statements, and the program has generated about 100 complaints from medical professionals since its inception.
- Pharmaceutical companies continue to push the envelope with their advertising. Allergan used “Twilight” movie actor Michael Welch to promote its Aczone medication for acne, and stuffed animals, games and children’s books have been used to target teens and young adults.
In this advertising tug of war, pharma companies have a limited amount of time to sell their products while presenting risk information – all in a way that’s understandable and not misleading. A tough balancing act. The disconcerting thing, however, is that pharma’s resources are way out of balance with the FDA’s.