Inside DDMAC: A Conversation with Thomas Abrams

Despite heightened scrutiny from industry advocates and the beginnings of self-imposed regulation, pharma companies' violations of DTC regulations have been getting worse, says Tom Abrams, director of FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC). Abrams has been on all sides of drug marketing, from receiving promotions as a pharmacist to creating promotions as a member of industry to regulating promotions as the head of DDMAC. As such, he's in good position to see the big picture. Pharm Exec recently sat down with Abrams to better understand his priorities, how DDMAC works, and a little more about FDA's Man of Letters.

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.'"

Red Flags

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.

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."

Warning Letters on the Rise

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.

$25 Billion a Year

Industry competition has grown fiercer and the money spent on promotions larger.

"[Promoting has] become more extensive," Abrams says. "Currently, industry spends $25 billion a year on promotion; I think it is going to continue to increase. It appears companies are more aggressive in competition with other companies. It's leading to more extensive promotion and more intense promotion. [But] I wouldn't be able to say that it's correlated to pushing it beyond what's permitted."

Instead, Abrams offers some advice: "I would encourage industry to do the right thing, and make promotion an asset to public health. That is, educate people rather than just trying to sell a product for the short term."

BACKGROUND: Fifty-year-old Abrams, a New Jersey native, has been with FDA since 1993. Before that, Abrams worked as a pharmacist and manager at an independent drug store in Edison, New Jersey while pursuing his MBA at Rutgers Business School. Abrams joined 3M in 1987 and then went to work at Merck in 1989. "It was very different from being a pharmacist," says Abrams. "I was in the sales and marketing side and I enjoyed my time there. I learned a lot from both companies. To this day, I admire the pharmaceutical industry for the drug discoveries they make."