Pharmaceutical promotion in veterans hospitals is highly regulated and subject to a number of Federal and Department of Veterans Affairs (VA) regulations. These regulations are designed to ensure that pharmaceutical manufacturers are not able to improperly influence prescribing decisions, especially those that might conflict with VA treatment algorithms and preferred agents.
In addition to the standard Food, Drug, and Cosmetic Act (FDCA) Federal promotion laws, the VA has its own regulations governing drug promotion in the VA. Generally, the VA regulations are more restrictive than the FDCA regulations. For example, the VA prohibits pharmaceutical companies from promoting drugs that are not on the VA National Formulary (VANF) unless the promotion has been specifically approved by the VA Medical Facility Chief, Pharmacy Service.
Key Provisions of VA Pharmaceutical Promotion Regulations
Prior Approval: Pharmaceutical company representatives must obtain prior approval from before promoting any drug or drug-related supply.
Restrictions on Promotional Activities: Promotional activities must be limited to educational presentations and discussions with healthcare providers. Pharmaceutical company representatives are not permitted to directly market to patients.
Compliance Monitoring: The VA conducts regular audits to ensure that pharmaceutical manufacturers are complying with VA regulations.
There are also a number of individual hospital promotion rules, preferences and cultural expectations that pharmaceutical manufacturers should be aware of - often referred to as unofficial “rules of engagement.”
The VA can take enforcement actions against pharmaceutical manufacturers that violate official and unofficial rules and regulations, including denying access to VA facilities and revoking permission to promote drugs in VA facilities. Developing a Federal promotion playbook that incorporates full and complete information can help ensure sales teams understand how promotion practices in Federal market segment differ from the commercial segment.