This post was written by Lorraine Campos and Joelle Laszlo.
The Department of Veterans Affairs ("VA") has issued a Notice of Proposed Rulemaking on pharmaceutical sales representatives' access to and activities in VA medical facilities. Drug and Drug-Related Supply Promotion by Pharmaceutical Company Sales Representatives at VA Facilities, 75 Fed. Reg. 24,510 (May 5, 2010).
The proposed rule is designed to "reduce or eliminate any potential for disruption in the patient care environment, manage activities and promotions at VA facilities, and provide sales representatives with a consistent standard of permissible business activities at VA facilities." One way the proposed rule endeavors to meet those aims is by requiring that any drug or drug-related promotion at a VA medical facility (broadly defined to include any VA-run source of medical services or benefits) is consistent with the published "criteria-for-use" of the subject drug or drug-related supply, which itself must not have been classified as "non-promotable." The proposed rule also requires: (1) that any corporate-furnished educational program or materials be approved in advance by the target VA facility's Chief of Pharmacy (or equivalent official); (2) that sales representatives make appointments in advance of VA facility visits; and (3) that gifts (of anything but drugs and food) and donations of drugs and drug-related supplies comply with current restrictions, and, with respect to the latter, be approved for acceptance and subject to proper storage, documentation, and dispensing. Potential penalties for non-compliance will include limitations on VA facility access, though the VA notes that since most sales representatives are generally well-behaved, it "do[es] not envision that the proposed paragraph [on penalties for non-compliance] will be invoked with regularity."
The VA asserts that the proposed rule will largely formalize what are currently informal practices and therefore, if anything, the rule will make it easier for pharmaceutical representatives to act, knowing that they will not be subject to some unwritten code. This may be true insofar in many respects. But the proposed rule's pre-approval requirements for “educational programs and materials,” may create confusion. For example, it is unclear whether the VA would (or could) apply the VA’s distinction between promotional programs and “educational” (non-promotional) programs. Moreover, the requirement for prior content approval might create FDA compliance concerns or even raise First Amendment issues.
Comments on the proposed rule must be received by the VA on or before July 6, 2010. Click here to read the full text of the notice.