Misleading Drug Ads on the Rise, FDA Officials Say

Pharmaceutical advertising increasingly includes unsubstantiated claims about the safety and efficacy of drug products while downplaying or even failing to completely discuss the risks associated with taking them, Thomas Abrams, the director of the FDA’s Division of Drug Marketing, Advertising and Communication (DDMAC), said.

As a result, DDMAC has sent unusually large numbers of warning letters to pharmaceutical companies regarding these and related issues — 15 in 2005, 14 in 2006 and six in the first five months of 2007, compared with an average of four or five warning letters a year in previous years, Abrams said. His remarks came June 19 at the Drug Information Association’s 43rd Annual Meeting in Atlanta.

“We’re hearing from the industry about increased competition, causing marketing to want to ‘push the envelope,’” Abrams said. As well as causing the FDA to take enforcement actions, drug advertising that overplays safety and efficacy while underplaying risks can also “tarnish the industry” over time, he added.

The surge in warning letters from DDMAC is also due to the division’s prioritizing its work load “to get to the most serious violations first,” Abrams said.

The Advertising and Promotional Labeling Branch (APLB) at CBER had a surge in enforcement actions in 2004 that has tailed off since then, but many of the issues are the same as those DDMAC has been dealing with, APLB Chief Ele Ibarra-Pratt said. “If you have to squint to read the risk information but not the efficacy information [on a biologic product label], it’s a problem,” she said.

APLB places a priority on reviewing direct-to-consumer advertising, Ibarra-Pratt added.
Other problems in drug advertising that DDMAC and APLB have recently found include promotion of products for broader indications than those for which they are approved, and unsubstantiated comparative or superiority claims, Abrams and Ibarra-Pratt said.

DDMAC has seen the “pushing the envelope” phenomenon “in a few cases, not many,” Abrams said, stressing that the problems he was talking about affect a minority of drug advertising.

Abrams and Ibarra-Pratt also discussed ongoing changes that impact their offices. For example, if the user fee legislation now before Congress becomes law, DDMAC will be expanding to take on the new work, Abrams said. If the law passes, a company that submits 150 proposed television ads for review in a year would pay approximately $42,000 per ad, he said.

Companies submitting applications to APLB should be aware that the FDA’s esubmission gateway has been up since August 2006, and that the new physician’s labeling rule for human prescription drug and biological products has been in effect since June 30, 2006, Ibarra-Pratt said. Her branch is still receiving submissions under the old format and these are no longer valid, she said. — Martin Gidron