Inside DDMAC: A Conversation with Thomas Abrams - Pharmaceutical Executive


Inside DDMAC: A Conversation with Thomas Abrams

Pharmaceutical Executive

Warning Letters on the Rise
He says straightforward information is the best course: "Give people factual information. I think the American public, whether they're consumers or healthcare professionals, are entitled to a complete picture of a drug. And that includes a candid representation of the risks associated with the use of the drug."

Because of the overwhelming amount of promotion out there, FDA looks for red flags that typically indicate violation:

  • Minimization of risks Even if a company presents risks, it might not display them as effectively as the benefits. Violations include speeding up the voiceover during risk information, quick cuts in video that distract viewers during fair balance, or—in the case of print ads—displaying risk information in a smaller font than benefit information.
  • Unsubstantiated claims Abrams says one company got into trouble with its hypertension drug because it made claims about the drug's effectiveness in preventing end-stage renal disease without having the clinical studies to back it up. "Drugs are effective for the uses that they are approved for—they wouldn't be on the market if they weren't—but be accurate as far as what you're conveying that drug can do," he says. "Don't claim beyond what has been proven about the drug."
  • Rationalization of side effects Abrams says FDA watches out for phrases like, "All drugs have side effects." Such phrases indicate rationalization of a drug's side-effect profile. Instead, Abrams advises pharma companies to simply state the side effects of the drugs they advertise.
  • Wrong population He says companies can also get slapped with a letter for marketing the brand in such a way that expands the population: "Let people know who the drug is appropriate for, who it's approved for," Abrams says. "If a drug is indicated for people over 60 years old, [the company] shouldn't claim that it's effective for someone who is 30 years old."

New Tech, Old Issues

Abrams says FDA is watching—no matter what vehicle companies choose to disseminate messages through. "I tell my staff: Don't just look at TV commercials," he says. "If people know we're just looking at TV commercials, they're not going to be as compliant. This would also result in FDA missing opportunities to address misleading promotion being disseminated through other vehicles. If they know we're taking a broad view—looking at TV commercials, sales rep activities, Internet, what's going on at medical meetings, exhibit halls, and in journal ads—it helps to make us more effective across the marketplace."

As companies change the technology they use, Abrams says FDA will continue to be vigilant. "Whether it's Internet, whether it's broadcast on your telephone, we have to be aware of it."

Video news releases (VNRs), for example, have been under increased scrutiny this year. FDA considers the medium, created by or on behalf of pharma companies, to be promotional and therefore, subject to regulation by DDMAC. Abrams says it's unrealistic to believe that stations will run VNRs that contain the entire brief summary. Therefore, companies should put major risk factors in the body of the story and then make the PI available to stations, either by enclosing a hard copy or scrolling it at the end of the tape.

Abrams says patient education videos present opportunities for communicating with patients, particularly because they can reach traditionally under-informed populations, such as those with language barriers or limited literacy. "But the people putting it out there need to ensure the information is being presented in a way that's understandable for patients without healthcare backgrounds," he says.


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