By Alex J. Varond -
On March 5, 2012, the Department of Veterans Affairs ("VA") issued a final regulation on promotion of drug and drug-related products (i.e., supplies related to the use of a drug, such as insulin needles and inhalers) by pharmaceutical company representatives at VA medical facilities. This rule was issued “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.” We discussed the proposed rule from May 2010 here. Issued nearly two years later, the Final Rule serves as an important guide for marketing drugs and drug-related products at all VA facilities. The VA health system serves more than 5.3 million people at more than 1,300 sites of care, and operates the largest medical education and health profession training program in the United States.
The final rule, which becomes effective on April 4, 2012, includes limitations on the promotion of drugs and drug-related supplies, educational programs and associated materials, providing gifts, food, samples or other promotional items to VA employees or facilities, and the conduct of pharmaceutical company representatives. It also details penalties and procedures in the case of non-compliance.
Promotion of drugs and drug-related supplies
VA National Formulary ("VANF") drug and drug-related products and non-VANF drug and drug-related products with criteria-for-use may be promoted only if: (1) the drug is discussed, displayed, and represented accurately; (2) the promotion has significant educational value; and (3) the drug is not classified as non-promotable. Promotion of non-VANF drugs and drug-related supplies without criteria-for-use, and of new molecular entities, must meet the same criteria but additionally must be specifically permitted by the pharmacy management at the Veterans Integrated Services Network ("VISN") level.
Educational programs and associated materials
VA has defined an educational program as a pre-scheduled event or meeting with a pharmaceutical company representative in which information is provided about a drug or drug-related product. Unless VA agrees otherwise, all educational programs and related materials require 60-day prior approval from the facility’s Chief of Pharmacy Services or another person with delegated authority. Any material relating to a risk evaluation and mitigation strategy ("REMS") or other duty imposed by the FDA will be deemed suitable. All other materials will be approved only if: (1) industry sponsorship is adequately disclosed; (2) industry-sponsored data is adequately compared with non industry-sponsored data; (3) the program does not solicit protected health information or patient participation in pharmaceutical company-sponsored programs; (4) patient education materials do not contain the name or logo of the drug manufacturer (with certain exceptions) and are not used for promotion of a specific medication; and (5) if the education program relates to non-VANF drugs and drug-related supplies without criteria-for-use, the drug must meet the requirements for promotion (see above).
Providing gifts, drugs or other promotional items to VA employees or facilities
Any gift to any VA employee is barred if it exceeds the value permissible under government ethics rules. However, items such as continuing education materials, promotional materials, textbooks, and gratuities may be donated to a medical center library or individual department for use by all employees. Gifts supporting official travel by VA staff can be accepted if cleared through prior legal review.
Sales representatives may not provide food items of any type or value to VA staff (including volunteers and without compensation employees) or bring food items into VA medical facilities for use by non-VA staff (e.g., employees of affiliates). The preamble notes that these limitations on food and gifts to VA employees are consistent with Standards of Ethical Conduct applicable to Executive Branch Employees.
The rule also states that all drug and drug-related product samples must be submitted for approval to the person at the medical facility with the responsibility to review samples, usually the Director. All usage information pertaining to the samples must be sent to the VISN Pharmacist Executive or Formulary Committee, and the samples themselves must be delivered to the Office of the Chief of Pharmacy Services. Samples may not be provided to VA staff for personal use.
Conduct of pharmaceutical company representatives
The rule considerably limits the extent of sales representative contacts with doctors and patients. Pharmaceutical company representatives may initiate on-site, in-person contacts by appointment only, and may not attempt to contact individuals or departments designated by the facility on a no-contact list. Representatives may not page VA employees via a public address (paging) system unless specifically requested by the VA employee, may not market to students, may not attend conferences where information regarding individual patients is discussed, may generally not wait in patient-care areas, and may not leave materials in patient-care areas.
Penalties for non-compliance
Visiting privileges of a pharmaceutical company representative or multiple representatives may be limited, suspended, or revoked for failure to comply with the rule. VA will provide notice of interim action, a chance to respond, and a final written order according to a set timeline. The actions may be applied to visiting privileges for one or more VA medical facilities. The rule also provides an appeals process whereby the pharmaceutical company may request a review by the Under Secretary.
VA has expressed that it intends to maintain the amicable nature of interactions with pharmaceutical companies, and “does not intend to impose sanctions except as necessary to prevent future impropriety.”