Government (aka “academic”) detailers calling on physicians in Utah will now have to play by the same rules as pharmaceutical representatives. Governor Gary Herbert has just signed into law H.B. 120 (“Information on Pharmaceutical Products”), a bill that “amends the Division of Occupational and Professional Licensing Act related to commercial and academic detailing for prescription drugs.”
This bill “creates standards for providing educational information to health care providers about prescription drugs” and “expands the application of federal regulations that apply to a pharmaceutical manufacturer's drug representatives to other health care providers who make educational statements about a prescription drug.”
Specifically, “An academic detailer and a commercial detailer who educate another health care provider about prescription drugs through written or oral educational material is subject to federal regulations regarding:
(i) false and misleading advertising in 21 C.F.R., Part 201 (2007);
(ii) prescription drug advertising in 21 C.F.R., Part 202 (2007); and
(iii) the federal Office of the Inspector General's Compliance Program Guidance for Pharmaceutical Manufacturers issued in April 2003, as amended.”
Utah, land of the Bonneville Salt Flats, isn’t passing judgment on academic detailing; they’re just leveling the playing field. Unlike the AAMC (which believes that Uncle Sam isn’t subject to conflict of interest when it comes to the sharing of medical information), the Beehive State has their eyes open. Detailing is Detailing is Detailing.
The Information on Pharmaceutical Products Act makes the common sense point that, without public scrutiny there is no guarantee that government-sponsored detailing will present information that is unbiased, peer-reviewed, and aligned with the existing evidence base. Without clear guidelines, there is nothing to prevent government detailers from using their outreach to advocate instead of educate.
Previous government detailing efforts have often focused on demonstrating their own value by highlighting the cost effectiveness of initiatives through savings generated from the increased utilization of generics and other low cost therapies.
Asked another way – how can an “academic detailing” program funded by our nation’s largest payer (Uncle Sam) be considered neutral? Just like detailing programs run by pharmaceutical companies, there is an inherent “interest.” And that’s okay – as long as that “interest” is transparent.
Fairness is the proper yardstick. The general lack of rules or oversight stands in stark contrast to the extreme scrutiny with which industry “detailers” are subject in their interactions with physicians. Starting with the Federal Food, Drug, and Cosmetic Act of 1938, and continuing through the 2010 FDA “Bad Ad Program,” the federal government has imposed a number of regulations on industry’s ability to promote their products and distribute information about their drugs to physicians and consumers. Rightfully so.
And now the government’s detailers must play by the same rules – at least in Utah.
It’s a good first step.
Government-funded detailers should be held to the same standard as industry representatives in every state. This simple, common sense step would ensure providers are receiving accurate, unbiased information on the best treatment options available to improve patient care.
A number of unanswered questions remain. For example, if government detailers stray into off-label conversations, to whom does FDA’s Office of Prescription Drug Promotion send a letter? Whom does the Department of Justice investigate? Who pays the fine?
That’s a good point of departure for a conversation between AHRQ and the FDA – both agencies within the US Department of Health and Human Services.