D.C. Council Passes SafeRx Act; Requires Licensing of Pharma Detailers
January 11, 2008On January 8, 2008, the District of Columbia Council passed the SafeRx Act of 2007 (“Act”), which requires pharmaceutical detailers to be licensed by the Board of Pharmacy. The Act will be presented to Mayor Adrian Fenty for his signature and then to Congress if signed by the mayor. Earlier versions of the legislation are available here. Note that the final version as passed is not yet available. A copy of the press release announcing the Act’s passage is available here.
The Act defines the practice of pharmaceutical detailing as “the practice by a representative of a pharmaceutical manufacturer or labeler of communicating in person with a licensed health professional or an employee or representative of a licensed professional, located in the District of Columbia, for the purposes of selling, providing information about, or in any way promoting a pharmaceutical product.” The qualifications for licensure include a college degree, a notarized statement that the applicant understands and agrees to the requirements of pharmaceutical detailing practice in the District of Columbia, and payment of a licensure fee to be set by the Board of Pharmacy. The educational requirement can be waived for any applicant who has worked full time as a pharmaceutical detailer for at least 12 months preceding the effective date of the Act. The Mayor is required to establish continuing education requirements as a condition of license renewal. Under the Act, the penalty for detailing without a license would be a fine of up to $10,000.
A pharmaceutical detailer is prohibited from engaging in any deception or misleading marketing of a pharmaceutical product. (Previous versions of the legislation deemed off-label information to be deceptive or misleading marketing. We were informed by the D.C. Council’s Office of General Counsel that this language has been deleted from the bill as passed.) Detailers are also prohibited from using a title or designation that might lead a licensed health practitioner or his/her employees to think that the detailer is a licensed health practitioner, unless the detailer is a licensed health practitioner. In addition, detailers would not be able attend patient examinations without patient consent.
The Act also permits the Board of Pharmacy to establish a code of ethics for the practice of pharmaceutical detailing and to collect information from a pharmaceutical detailer regarding the detailer’s communications with licensed health professionals and their employees.
UPDATE:
A copy of the enrolled version of the Act is available here.