On October 1, 2008, regulations published by the District of Columbia Board of Pharmacy regarding pharmaceutical sales representatives became effective. These regulations were in response to the passage of the District of Columbia's SafeRx Amendment Act of 2008 (the "Act").

Effective April 1, 2009, a person must be licensed by the District of Columbia Board of Pharmacy (the "Board") to engage in pharmaceutical detailing. The "practice of pharmaceutical detailing" is defined 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 health professional, located in the District of Columbia, for the purpose of selling, providing information about, or in any way promoting a pharmaceutical product."

The regulations define a "pharmaceutical company" as:

"any entity that is engaged in either directly or indirectly, the production, preparation, propagation, compounding, manufacturing, conversion or processing of a drug or biologic product, including any person acting as its agent or representative."

The regulations provide that a pharmaceutical detailer must complete and submit a detailed application to the Board, satisfy pre-education and ongoing education requirements, comply with the code of ethics described in the regulations, fulfill document retention standards and be subject to penalties for failing to comply with the Act and regulations. The pharmaceutical detailer license expires at the end of February in every even-numbered year and the initial license fee is $175, with a renewal license fee of $165.

The code of ethics in the regulations includes ten different standards. Specifically, pharmaceutical detailers are prohibited from:

  • Engaging in any deceptive or misleading marketing of a pharmaceutical product
  • Attending patient examinations without the express, written consent of the patient
  • Making sales calls upon a health professional after the individual has made a written request not to receive any further sales calls

In addition, the pharmaceutical detailer is required to comply with the PhRMA Code on Interactions With Healthcare Professionals. If there is a conflict between the PhRMA Code and the Act and its regulations, the Act and its regulations shall prevail. The pharmaceutical detailer will be required to complete an affidavit to abide by the regulation code of ethics.

A pharmaceutical company with pharmaceutical detailers in the District of Columbia will need to adopt compliance protocols to abide by the Act and its regulations. This will include documentation policies, continuing education benchmarks, license application and renewal processes, and confirming every individual in the pharmaceutical company who is a pharmaceutical detailer.

Companies must determine answers to questions such as:

  • Is a medical science liaison for the company going to need to be licensed as a pharmaceutical detailer?
  • Will the Act apply to pharmaceutical company officials who periodically or episodically provide detailing information to healthcare professionals?
  • Will the Act apply to a pharmaceutical detailer who is based in Virginia or Maryland (both of which have many communities that are in close proximity to the District of Columbia) and may call upon a healthcare professional with an office in the District of Columbia and a contiguous state?

Pharmaceutical companies should review the Act and its regulations and implement the appropriate internal policies to ensure that the important work of its pharmaceutical detailers remain compliant with the necessary requirements.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.