The District of Columbia Board of Pharmacy (the Board) recently published regulations available by clicking here making the District the first jurisdiction in the United States to license and regulate pharmaceutical sales representatives who interact in person with healthcare professionals or entities, such as hospitals or long-term care facilities, to sell or provide information about drugs and biologics regulated by the Food and Drug Administration. By April 1, 2009, all persons practicing pharmaceutical detailing in the District must be licensed by the Board. 

The new regulations establish a code of ethics for pharmaceutical detailers, complete with a list of prohibited activities. The rules define the documentation and fees required for issuance of a license, the amount of time the license remains valid, and the penalties that may result should someone practice pharmaceutical detailing without a license. The regulations also include comprehensive documentation and records retention requirements for pharmaceutical detailers that likely will prove quite burdensome.

The most significant substantive requirements of the regulations are:

• Code of Ethics. Pharmaceutical detailers must comply with the Pharmaceutical Research and Manufacturers of America (“PhRMA”) Code on Interactions with Healthcare Professionals. The regulations also stipulate that pharmaceutical detailers must not engage in offering gifts to health professionals, providing misleading information, or harassing or intimidating health professionals. 

• Records Retention. Pharmaceutical detailers must retain records detailing all of their communications with licensed health professionals, entities or their employees in the District for a period of five years from the date of the communication. The records must be provided to the Board of Pharmacy upon request.  Moreover, on leaving employment with the pharmaceutical company, detailers have ten days to provide the Board with written notice of who at the company to contact for access to these contact reports.

• Education Requirements and Waiver. To obtain a license, an individual must have graduated from a Board-approved institution of higher education. Applicants who can demonstrate they practiced pharmaceutical detailing full-time or substantially full-time for at least the twelve-month period immediately prior to March 26, 2008, may obtain a waiver, but applicants seeking such a waiver will be required to provide detailed documentation to substantiate their experience.

• Mandatory Continuing Education. Pharmaceutical detailers will have to complete fifteen hours of continuing education every two years to renew their licenses.  Fortunately, the regulations allow manufacturers to certify in-house training programs with the Board – some of which are already a normal part of sale representative training. Beginning in 2010, the Board will conduct random audits of continuing education credits reported by pharmaceutical detailers on their licensure renewal forms.

The new regulations key procedural requirements are:

• Application for Licensure. An applicant for a license must submit (1) a completed application form that includes the applicant’s Social Security number, two recent passport-type photographs and a photocopy of a US government-issued photo identification; (2) an official certificate of graduation from a Board-approved school of higher education; (3) all required fees; and (4) a notarized statement that he or she agrees to abide by the Safe Rx Act’s requirements, including the Board’s Code of Ethics. Click here to access an application packet. Licenses must be renewed by the last day of February of each even-numbered year.

• Fees.  The fees for licensure and renewal are as follows: (1) Initial license fee $175.00; (2) Biennial renewal fee $165.00; (3) Late fee $85.00; (4) Duplicate certificate $34.00; and (5) License verification $34.00.

• Fines and Other Penalties.  An individual practicing pharmaceutical detailing without a valid license may be fined up to $10,000. In additional, prosecutors may seek injunctive relief or criminal sanctions, including imprisonment for a period not to exceed one year.

Several states across the country have considered or are contemplating similar legislation regulating pharmaceutical sales representatives. Legislatures in other jurisdictions likely will look to the District’s experience with its experiment in licensing and regulating pharmaceutical sale representatives as they consider new ways to address continuing concerns about the high cost of prescription drugs. 

To discuss how the new District regulations may impact your business, please contact:

Larri Short
short.larri@arentfox.com
202-775-5786

Lisa C. Edwards
edwards.lisa@arentfox.com
202.857.6339