The Washington Legal Foundation (WLF), a conservative watchdog group funded by businesses (including drug companies), last week launched the "FDA/DDMAC Watch" program to "scrutinize" FDA advertising regulations. DDMAC is the FDA's Division of Drug Marketing, Advertising, and Communications, which oversees drug ads.
DDMAC Watch's first action challenged an FDA warning letter regarding a TV ad for Eli Lilly & Co.'s adult ADD therapy, Strattera (see "Watchdog Group Blasts FDA").
According to the WLF, the FDA is acting "outside its legal authority" when its writes such letters, and shows "disregard for the First Amendment by alleging that materials are misleading with no evidence of how consumers understand them." (See the WLF Letter to DDMAC).WLF is to the first amendment what the NRA is to the second amendment. That is, every argument by WLF begins and ends with the first amendment as it applies to a special interest group -- i.e., businesses like the pharmaceutical industry.
In short, the Washington Legal Foundation claims, the FDA "invented" much of its power to police drug advertising. ("Watchdog Group Blasts FDA").
The House(s) That Troy Built
What's really interesting, however, are the ties that bind WLF, FDA, and the Pharma industry.
One of the main ties is Daniel E. Troy, former chief counsel to the FDA who joined WLF's board of directors just 4 days before the DDMAC Watch letter. According to the WLF Web site, Troy was "the first appointee to the Food and Drug Administration made by President George W. Bush."
"Troy managed to restrict FDA's ability to use its statutes creatively, and this in turn deterred mid-level managers from advocating new approaches to emerging scientific issues, leaving the agency looking - and feeling - weak." (See "FDAers Think Troy Weakened Them, Worry About Masoudi").Before his stint at the FDA, Troy repeatedly sued the FDA. He argued that the FDA had only limited ability to regulate drug companies. Troy filed those suits through --- you guessed it -- the WLF! He also did legal work for Pfizer. Oh well, just another case of "What goes around, comes around."
What About Those Warning Letters?
The WLF criticism of the Strattera warning letter, which I will get to in a moment, comes at a time when the FDA is sharply increasing the number of warning letters sent to pharmaceutical companies.
The FDA issues two types of letters: untitled letters or Notices of Violation and warning letters. The warning letter goes to the CEO and essentially says "we think you have really screwed up and in a way that we think is important to the public health and we expect you to put out some kind of additional information to correct the misinformation you sent." (I quote here John Kamp, Executive Director, Coalition for Healthcare Communication. Kamp was speaking at a CME conference in Princeton, NJ.)
An untitled letter is sent to the head of marketing and says "we think you have a problem, let's sit down and work something out." This type of letter is much less serious and effective than a warning letter. In fact, I've heard it said that untitled letters are considered rites of passage by pharma product managers, who frame them and hang them on their office walls. That's what I've heard some people say.
According to the Philadelphia Inquirer ("Deluge of drug ads has FDA struggling to stop the hype"):
In January 2002, the Office of the FDA Chief Legal Counsel, Daniel Troy, began reviewing the evidence behind all proposed enforcement letters with an eye toward scuttling any that might not hold up in court. Claude Allen, the deputy secretary of the Health and Human Services Department, the FDA's parent agency, ordered the change in policy.Troy effectively hobbled the issuance of warning letters by the FDA.
An October 2002 study by the General Accounting Office, the investigative arm of Congress, said that, before Troy's reviews began, FDA notices went out within days after a problem ad was spotted. Under the new policy, clearing the letters took 13 to 78 days, the report said. "Some regulatory letters may not be issued until after the advertising campaign has run its course," the GAO found. (Phila Inquirer)While the number of total enforcement letters sent by the FDA has hovered around 23-25 in the last three years, the number of warning letters increased dramatically in 2004 (before Troy left the FDA but during the VIOXX debacle). In that year the FDA issued 12 warning letters compared to 5 in 2003 and 1 in 2002. 2005 promises to be a record year -- already nine warning letters have been issued.
The FDA may be getting the impression that the drug industry is not listening. According to Kamp, "DDMAC is saying the same things over and over again [in warning letters], but the industry is just not getting it. FDA is turning up the heat. How much higher, might I add, does it have to get before we start paying attention?"
If the WLF represents the pharma industry -- and with Troy involved it's hard to dispute that it does -- then the industry is paying attention, but responding by criticizing the FDA. There has been some more positive response as well. Recent DTC policy changes by J&J and BMS come to mind (see "DTC Straight Talk" and "New DTC Principles Emerging").
So What's the Beef With the Strattera TV Ad?
The FDA had asked Lilly on June 14 to pull its Strattera TV ad on the grounds that the flashy graphics made the warnings on side effects too difficult for consumers to comprehend (see warning letter and "Watchdog Group Blasts FDA").
WLF had this to say:
"DDMAC cites no evidence demonstrating that consumers cannot process the information presented in the advertisement. In fact, the TV advertisement conveys its message regarding attention deficit disorder so many times that it is incomprehensible that consumers would miss it. The sole source of authority for DDMAC's allegations against Lilly is the individual judgment of the DDMAC reviewer who signed the letter."I don't recall seeing the ad myself, but the FDA presented promotional material, submitted by Lilly, which included screen shots from the ad. It looks distracting to me. I don't think you have to do a scientific study to tell whether or not an ad is effectively presenting labeling information. To suggest that "evidence" be produced is merely a ploy to delay the process so the ad can run it's course.
The problem is that the review by the FDA happens after the ad is already produced and running. It would be better, as proposed by BMS, that DTC ads be submitted to the FDA for approval BEFORE they run (see "New DTC Principles Emerging").
There is at least one point made by the WLF that I can agree with. It has to do witrh guidance from the FDA regarding TV DTC ads for Rx drugs:
"DDMAC should start providing concrete guidance to industry to help them fulfill this objective and stop playing 'gotcha' with drug companies," said WLF Chief Counsel Richard Samp.Maybe Samp has a point. While the FDA has issued guidance regarding print DTC ads (see "Future of Drug Print Ads"), it hasn't done the same for TV DTC ads. Perhaps that will come sooner than Samp would like.