Pharmaceutical and life sciences companies have long used detailing as a way to effectively communicate the benefits and features of a certain product to physicians. In 2008, the Washington, D.C. city council became the first legislative body in the country to require a license for all active pharmaceutical detailers, even those who promote over-the-counter drugs, or those who worked in the District on a temporary or emergency basis.
The measure, known as SafeRx, requires detailers to adhere to an ethics code, receive continuing education, pay a licensure fee, and promote their products in an honest and nonmisleading way. For sales reps who operate without a license, a fee of up to $10,000 could be assessed against them.
Many opposed the D.C. measure, including physicians, for a variety of reasons, one of which was they felt as though the requirement that physicians tell their patients about risks of off-label use of medicines was unnecessary, intrusive, and time consuming. At least one physician stated that this measure would not be a cost saver (as the D.C. Council intended), as he would likely wind up prescribing a more expensive on-label drug instead of a cheaper off-label alternative, to avoid a forced disclosure.
However, late last year, buried in the Fiscal Year 2016 Budget Support Act of 2015, Washington, D.C. carved out a small exemption to the pharmaceutical detailing law. Previously, it was illegal to engage at all in the practice of pharmaceutical detailing in the District unless you had a license. The District has now changed its law so that if you are engaged in detailing for less than thirty consecutive calendar days per year, you no longer need a detailing license.
DC Pharmaceutical Detailer License Requirements
To obtain a license, detailers have to prove that they graduated from a recognized institution of higher education, pay a fee, and submit a notarized statement that they agree to abide by the ethics code set by the D.C. Board of Pharmacy. Detailers who are able to demonstrate that they have been “performing the functions of a pharmaceutical detailer…on a full-time, or substantially full-time, basis” for at least twelve months prior to March 2008 do not have to submit to the education requirement.
Additionally, for renewal of a D.C. Pharmaceutical Detailer license, a minimum of fifteen credit hours of approved continuing education during the two-year period the license is effective.
Other Requirements Under DC Law
Under D.C. law, a pharmaceutical detailer is to maintain a log of communications with healthcare professionals and their representatives. The log should include information such as who the detailer visited, the date and time of the visit, the products discussed, whether samples where provided, and the type of materials provided to the healthcare professional.
What Does This Change Mean?
While this may be a welcome change, it is unclear what the definition of “consecutive” is. With an unclear definition, different companies may choose to take different interpretations of the law change. For example, certain companies may opt to interpret it in such a way that reps who are dedicated and assigned to D.C. will continue to obtain licensure, while district managers and reps assigned to multiple areas (including the District) will not, since they are not likely to be engaged in detailing for thirty or more consecutive days.
It is too soon to fully understand the ramifications of this change and what other ways companies may opt to interpret it. One thing is sure, one less regulation and a little more latitude for pharmaceutical detailers is a welcome change.
D.C. was the first (and only) legislature to adopt such a strict measure for pharmaceutical detailers, and it will be interesting to see if they start to disintegrate other portions of the licensure requirements as time passes.