53,000 Promotional Pieces a Year
It's not exactly a small job. FDA regulations state that pharma companies must submit promotional materials to the Agency at the time of first use. That means Abrams and the DDMAC staff of just 35 receive an average of 53,000 promotional pieces a year.Abrams says the biggest misconception is that DDMAC screens and approves all promotional items before they're released to the public. While FDA does provide comment on certain materials, Abrams says most ads are launched without the agency reviewing them first.
"We get complaints from consumers and physicians who call us up and say, 'Tom, how can you allow that TV ad to be on?'" Abrams says. "They're flabbergasted when we say, 'We didn't approve it before it went on TV.' Often, we're seeing it at the same time as the American public. DDMAC has limited resources and we use our limited resources as effectively as we can to do our job."
DDMAC doesn't have enough resources to go after all the companies known to violate DDMAC guidelines. Instead, it ranks them in order and decides which to pursue. "We prioritize it according to risk to public health, with close attention to the promotion of drugs with significant risks and newly introduced drugs, as well as DTC advertising," Abrams says.
DDMAC also goes after certain ads if it thinks the ad will affect other companies' actions—and prevents companies from taking the same chances that got their competitor into trouble.
More Warning Letters
When FDA goes after a company, it issues two types of letters: notice of violation letters and warning letters. Notice of violation—or untitled—letters are issued for less serious violations. "They pretty much tell companies, 'Stop what you're doing and don't do it again," says Abrams. Warning letters request that a company stop its promotion and disseminate corrective messages, and are reserved for more serious or repetitive violations.
Abrams says FDA tripled the number of letters it sent in the last year. Of 23 letters issued in 2004, 12 were warning letters. By October 2005, FDA had already issued 14. "We typically used to issue about four or five a year, so 12 was a big increase," he says. "And this year, we're even seeing more serious violations." (See "Warning Letters on the Rise".)
Abrams says it's hard to point to exactly where the increase is coming from. "We have asked, 'Is any one [therapeutic] area getting more of them? Are the violations occurring in any one media or vehicle such as sales rep activities or TV commercials? When we do those analyses, the answer is 'no.'"
The most common violation is minimization or omission of risk. Indeed, Reuters reports that about 82 percent of FDA's warning letters cited companies for not including adequate risk information. "If you want to get our attention, minimize or omit a serious risk," Abrams says.