Full Article Reprinted from The Pink Sheet - September 17, 2008
Find out why the Department of Justice's level of interest in drug industry promotional issues seems to be increasing, FDA Division of Drug Marketing, Advertising & Communications Director Tom Abrams told the Food & Drug Law Institute advertising and promotion conference Sept. 8.
Full Article Reprinted from The Pink Sheet - September 17, 2008
The Department of Justice's level of interest in drug industry promotional issues seems to be increasing, FDA Division of Drug Marketing, Advertising & Communications Director Tom Abrams told the Food & Drug Law Institute advertising and promotion conference Sept. 8.
"There is a lot of interest from DoJ," Abrams observed. "That interest ... has even grown as of late."
DDMAC works with the Justice Department on investigations and settlements of cases involving promotional issues - often in the context of multi-million dollar Medicare or Medicaid fraud cases.
[Editor's note: For an analysis of recent settlements of marketing related cases, see "1Off-Label Sales in Jeopardy," The RPM Report, December 2007.]
Abrams' comment was one of several from FDA's top ad officials at the conference that suggest more enforcement activity is coming in the promotional arena.
There is pressure from Congress. "What we are hearing mostly from the Hill is they want effective and close oversight of drug promotion," Abrams said.
There is pressure from competitors. The number of complaints about promotions "seems to be increasing," Center for Biologics Evaluation & Research Advertising & Promotional Labeling Branch Chief Ele Ibarra-Pratt said.
There is a sense within FDA that maybe not everyone is trying hard enough to play by the rules. "I must say there have been a number of egregious cases, and it makes you wonder why these push the envelope so much," Abrams said.
Last but not least, FDA is expanding its advertising oversight staff - and those new reviewers are likely to generate more enforcement activity. "We have a growing staff ... so that may be contributing to higher numbers of compliance letters this year," CBER's Ibarra-Pratt said.
Together, those comments suggest the potential for a swing back towards more aggressive enforcement by FDA of its advertising regulations in the years ahead.
The agency's most recent statistics on advertising letters, released in CDER's 2report to the nation, show the sustained drop in notices of violation issued by the agency during the Bush Administration.
Abrams opened the two-day FDLI conference with an appeal for voluntary compliance, emphasizing the tie-in between marketing and FDA's overriding emphasis on drug safety.
"I believe that promotion can be and should be used as a vehicle to convey risk information," he said. "We need to make sure we do this right."
Abrams offered three reasons for industry to use promotion more effectively as a risk communication tool: First, "it is beneficial to the public health. Second, if you don't do it right, the company can be potentially liable for product liability. And third, if you do it right, it is really good for the overall image of industry."
And the consequences of not doing things right? "The egregious campaigns we are seeing" are "a minority of what is going on in promotion, but these are the things that stick out," Abrams said.
"People see egregious campaigns. I think that has stimulated the interest of DoJ, the interest of Congress, and also has caused some new initiatives," such as steps by hospitals and medical groups to prohibit sales reps from making detailing calls in their facilities.
"So, my opinion alone, I think it behooves industry to make sure that that promotion is compliant with the regulation. I think it's a win-win if it's done right."
As if to underscore the point about the importance of using promotion the right way as a risk communication tool, FDA issued a warning letter to Forest Labs regarding its Bystolic launch materials on the eve of the FDLI conference (see 3following story).
Abrams, however, did not discuss the Bystolic letter, focusing instead on four older examples of recent compliance actions from DDMAC.
Avinza: The Perils of the Pain Market
FDA issued a warning letter to King Pharmaceuticals in March, objecting to a 22-page file card for the extended-release morphine brand Avinza. King acquired the product from Ligand in 2007, and says it never actually used the promotional piece (4"The Pink Sheet" DAILY, March 28, 2008).
Abrams highlighted several elements of the brochure that prompted the warning letter. First, it "failed to present any risk information in 22 pages," except for a brief description of common adverse events. The piece did repeatedly describe Avinza as "proven to be safe and well-tolerated" and included the advice "For unacceptable side-effects, reassess/reduce the dose."
"I wish treatment with a drug with these fatal side effects could be so easily managed that you could just reduce the dose," Abrams said.
The piece also does not include the complete indication for the drug, which is "for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time."
"It is not just for pain," Abrams said. So the agency objected to the description of Avinza as "continual 24-hour pain relief to get back to active living."
"Remember, these limitations are for safety reasons, so when you promote a drug for an unapproved use, or promote it in a way that causes this to be used in a broader population than might be appropriate, it is really quite concerning," Abrams said.
The pain market is clearly an area of focus across CDER in the current "safety first" climate. FDA is considering a range of new restrictions on controlled substances, particularly in the context of concerns about ongoing off-label use (5"The Pink Sheet," Aug. 4, 2008, p. 10).
Provigil, Clindesse And Formulary Communications
Two other promotions cited by Abrams came in the context of managed care formulary decisions.
One, a May 2007 letter to KV Pharmaceuticals for its bacterial vaginosis treatment Clindesse (clindamycin), focused on a promotional e-mail touting the drug's status as a "tier 2" brand on the UnitedHealth formulary (6"The Pink Sheet" DAILY, May 25, 2007).
The second involved a handout used by a physician during a presentation to a P&T committee about Cephalon's narcolepsy product Provigil (modafanil) (7"The Pink Sheet" DAILY, March 2, 2007).
The Provigil letter may be a first for the agency: it holds Cephalon accountable for a handout prepared independently by a physician speaking on its behalf to a P&T committee.
The situation is not much different than holding companies accountable for "home-made" pieces created by sales reps, but the context of a presentation by a physician to a formulary committee is certainly different in the minds of most pharma companies.
Abrams, though, stressed that the physician was "speaking on behalf of the company," and the handout made claims that "were quite contrary" to the approved indications.
The Clindesse letter raised issues that are more typical in DDMAC correspondence - and, other than the e-mail format and headline focusing on formulary status, the promotion itself was similar to traditional professional brochures.
However, FDA is clearly spending more time monitoring communications via the Internet, including looking at outlets like YouTube for potential violations.
The final letter cited by Abrams was one objecting to Novartis promotional material for the Alzheimer's drug Exelon (rivastigmine) for making superiority claims based on open-label extension studies (8"The Pink Sheet" DAILY, Aug. 14, 2007).
Abrams closed his presentation by noting that DDMAC is almost done with a huge recruitment effort, filling 13 new positions. The division has moved to bigger offices, and "you will see a lot of new people come on board," Abrams said.
It seems logical to expect more letters to follow.
- Michael McCaughan
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