On March 5, 2012, the Department of Veterans Affairs (VA or the Department) published a final rule regarding drug and drug-related supply promotion by pharmaceutical company representatives at VA medical facilities. The regulation addresses the types of drug and drug-related supplies that may be promoted at VA medical facilities; permissible educational programs presented by pharmaceutical company representatives; the conduct of such representatives while on-site at VA facilities; and the provision of gifts, drugs, or other promotional items to VA employees.

According to the Department, the regulation is intended “to reduce or eliminate any potential for disruption in the patient care environment, manage activities and promotions at VA facilities, and provide pharmaceutical company representatives with a consistent standard of permissible business practice at VA facilities.” VA medical facilities include any property under the control of the VA that is used to provide medical benefits, whether they are outpatient or inpatient facilities. Pharmaceutical company representatives who do not comply with the provisions of the regulation may have their visiting privileges limited, suspended, or revoked following notice of interim action by the VA and an opportunity to respond to charges of non-compliance.

The final rule limits the drugs and drug-related supplies (which includes items such as inhalers, test strips, and insulin syringes) the may be promoted at VA facilities and the manner in which they may be promoted. VA National Formulary (VANF) drugs and drug-related supplies, as well as non-VANF drugs and supplies with VA-developed clinical criteria-for-use, may be promoted under the following conditions:

1. the products must be discussed, displayed, or represented accurately;
   
   
2. the promotion must have significant educational value and not “inappropriately divert VA staff” from their normal duties; and
   
   
3. the product has not been classified by VA as non-promotable.
   
   

Drugs and drug-related supplies that are new molecular entities or non-VANF without criteria-for-use not only must meet the conditions above, but also must be specifically permitted by the Veterans Integrated Service Network (VISN) Pharmacist Executive, Chief of Pharmacy Services, or a designee.

At least 60 days before conducting a pre-scheduled educational program at a VA medical facility, a pharmaceutical company representative must receive approval from the facility’s Chief of Pharmacy Services (or a designee) for both the program and any associated materials. Any materials related to a Risk Evaluation and Mitigation Strategy (REMS) or other duty imposed by the Food and Drug Administration (FDA) on the pharmaceutical company will be deemed suitable for an educational program. Otherwise, the educational program or materials will be deemed suitable only if:

1. industry sponsorship is adequately disclosed;
   
   
2. industry-sponsored data on FDA-approved uses of a particular drug are directly compared to non-industry-sponsored data;
   
   
3. the program does not solicit protected health information or patient participation;
   
   
4. any patient educational materials do not contain the name or logo of the drug manufacturer (with certain exceptions) and are not used to promote a specific medication; and
   
   
5. if the program focuses primarily on a non-VANF drug, the drug must meet the conditions for promotion listed above.
   
   

Gifts to VA employees are prohibited if they exceed the value permissible under federal government ethical rules. Items such as promotional materials, textbooks, continuing education materials, and gratuities may be donated to a medical center library or individual department for use by all employees, however. Gifts supporting VA staff office travel may be accepted following advance legal review. Food may not be provided to VA staff or be brought into VA medical facilities for non-VA staff. Finally, drug and drug-related product samples must be submitted for approval to the Director of the VA facility (or a designee), and samples may not be provided to VA staff for personal use.

Pharmaceutical company representatives must make appointments in advance for all on-site visits. Each VA medical facility may develop a no-contact list, and pharmaceutical representatives are prohibited from attempting to make an appointment with or leave materials for any individual or department on the list. Representatives also are prohibited from paging VA employees, marketing to students, and attending conferences where individual patients are discussed. Further, they generally may not wait for scheduled appointments in patient care areas or leave materials in such areas.

The VA regulation goes into effect on April 4, 2012, and the full text of the final rule is available here. If you have any questions about this VA regulation, please do not hesitate to contact us.