No, it's not your imagination: The FDA really has gotten tougher on drug promotions. Thomas Abrams, who heads up the FDA division that oversees drug marketing, freely admits it. His group sent 41 enforcement letters in 2009, up from just 21 the year before. And so far this year--just the month of January--it has dispatched another nine, with plans to continue that pace through 2010.
"We're trying to get the point across to industry that we want them to comply with the law because it affects public health," Abrams says in an interview with Reuters. "If you don't comply with the law, we are going to take action. We are not going to tolerate having consumers or healthcare professionals misled."
It's not unexpected, considering that FDA Commissioner Margaret Hamburg has pledged to increase the agency's enforcement presence. And she's promised to streamline processes that slowed down regulatory action. That streamlining has already had an effect at DDMAC, Abrams said; his division has changed its procedures so that warning letters go out more quickly. "We are inspired by Dr. Hamburg's enforcement initiative and have taken it to heart," he told the news service. "I personally am thrilled with it."
If you'd like to take a look at some ads that drew the FDA's ire last year, hop on over to Forbes, which has put together a list of 10. One thing the FDA is jumping on quickly: Downplayed side effects. The agency has raised the bar for risk disclosures, requiring them to be more complete and to take up a bigger share of ad time. See what you think.
- read the Reuters news
- get the ads from Forbes