The Department of Veterans Affairs (VA) proposed to amend its regulations regarding access to VA facilities to control the promotion of drugs and drug-related supplies at VA facilities and the business relationships between VA staff and sales representatives promoting drugs and drug-related supplies.
As detailed in the Federal Register, the purposes of the proposed rule is 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 practice at VA facilities.
The VA proposed rule would amend 38 CFR part 1 to regulate access to VA medical facilities by sales representatives (including account managers and clinical liaisons) promoting drugs and drug-related supplies. The proposed rule would prescribe Department-wide rules that must be followed by the Veterans Integrated Service Network (VISN), which consists of 21 regions.
The Chief of Pharmacy or other official must approve educational programs and materials presented or furnished by these sales representatives. Materials and programs must focus on clinician education as opposed to marketing of drugs and drug-related supplies. A summary of the program and all materials must be provided well in advance of the proposed date so that a program can be adequately reviewed. Programs and materials must conform to the following guidelines:
- Industry sponsorship (of any kind) must be disclosed in the introductory remarks and in the announcement brochure;
- Marketing activities cannot be conducted during an educational program;
- Promotional materials are not to be placed in any patient care area;
- They must not offer patients a chance to participate in manufacturer sponsored programs and/or require the furnishing of Protected Health Information.
- Patient education materials must not contain the name or logo of the pharmaceutical manufacturer or be used for promotion of specific medications without permission from the VA Pharmacy Benefits Management Service;
- Programs or materials regarding a new drug, drug-related supply, or a new therapeutic indication for a drug, which is already on the VANF but has not yet been reviewed by VA, must be clearly identified as such.
- Programs or materials focusing primarily on non-VANF drugs or drug related supplies are discouraged and must be clearly identified as such.
Sales representative are also prohibited from giving any VA employee any item that exceeds the value permissible for acceptance under government ethical rules, including but not limited to:
- Promotional materials;
- Continuing education materials;
- Textbooks; entertainment; and gratuities
Items may be donated to a medical center library or individual department for use by all employees, in accordance with local policies.
Sales representatives generally may not wait for scheduled appointments or make presentations in patient-care areas (e.g. patient/clinical exam rooms; nurse stations, etc.), but may briefly travel through them.
They must make appointments at the facilities they intend to visit. Local exceptions may apply ‘‘for operational reasons,’ such as a particular facility within a VISN does not have a physician with the required expertise about a particular drug to prescribe.
Promotion in VA medical facilities of VANF and non-VANF drugs or drug related supplies is permitted if:
- The promotion is consistent with criteria-for-use;
- The drug is not classified as non-promotable; and
- The promotion is consistent with the proposed rule and with facility initiatives.
The promotion of non-VANF drugs or drug-related supplies without criteria-for-use, such as for new molecular entities or new indications for existing drugs, must be regulated at the local level in order to allow for different clinical approaches. The promotion of new molecular entities would be permitted, but may be reconsidered if the VANF committee reviews the drug and grants or denies VANF status.
The proposed rule emphasized that the VA allow medical professionals to become educated through the promotion of new molecular entities for the benefit of patients.
A list of individuals or departments that do not wish to be called-on by sales representatives can be created, and sales representatives must not attempt to make appointments with individuals or departments on the list. The list could be obtained at the local office of the Chief of Pharmacy Services.
A sales representative visiting a VA medical facility for a scheduled appointment cannot initiate requests for meetings with other VA staff; however, sales representatives may respond to requests initiated by VA staff during the visit.
The sales representative cannot use the public address (paging) system to locate any VA employee but, the electronic paging system (beepers) is permissible if specifically requested by the VA employee.
- Drug samples and free drug-related supplies must be approved by the Director of a VA facility or other person delegated responsibility;
- Information pertaining to the trial use of these drugs or drug-related supplies must be forwarded to the VISN Pharmacy Executive or VISN Formulary Committee;
- Drug or supply samples may not be provided to VA staff for their personal use; and
- Drugs or drug-related supplies donated for patient use must be delivered to the Office of the Chief of Pharmacy Services for proper storage, documentation and dispensing, and must not be labeled ‘‘sample,’’ ‘‘professional sample,’’ or similar words, unless VA grants an exception in the interests of patient care.
All sales representatives who have business relationships with VA Clinical Services may not provide food items of any type or any 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) above the de minimis value set forth in the standards of ethical conduct for Federal employees.
Sales representatives must ensure that all drugs or supplies are discussed, displayed and represented accurately, in accordance with FDA and VANF guidelines/restrictions.
Sales representatives are prohibited from marketing to medical, pharmacy, nursing and other health profession students (including residents). Exceptions may be permitted when approved by, and conducted in the presence of, their clinical staff member.
A sales representative is not allowed to attend a medical center conference where patient-specific material is discussed or presented.
Gifts of travel in support of VA staff official travel may be accepted by the Department subject to advance legal review.
Any individual, or any company, that fails to comply can lose access to VA facilities, which may include suspension of a sales representative’s access privileges, or denying access to a company’s entire sales force.
The director of the VA Medical Center would make the determination if a violation occurred and if restriction to particular VA facilities is warranted, and would notify the sales representative or company of the violation and any proposed restrictions on access privileges before issuing any final order. The director would be required to provide notice to a company’s sales manager if the proposed action would result in a denial of access privileges for the company’s entire sales force. A company would have the right to a one-time appeal of the matter to the Under Secretary for Health.
As the notice acknowledged, pharmaceutical sales representatives have heavy interaction with local VA staff each year, and this interaction provides valuable information to physicians about how to treat patients and stay up to date with new treatments and advances. Since the VA noted that “in most cases, sales representatives are considerate of VA’s needs and mission, and do not behave inappropriately,” what is the need for this new policy?
It seems a little ironic that for over a year, the Obama Administration was saying the government would not take over health care. Clearly, the VA telling their doctors who they can meet with and where they can get information from is contrary to that notion.
With baby boomers—many of which are Veterans—retiring and numerous soldiers coming back from Iraq and Afghanistan, this policy is unpatriotic. The policy also restricts access to public institutions, which is likely unconstitutional. Our soldiers and Veterans deserve the best care and best access to treatments and medicines for the sacrifices they and their families have made. Since Congress does not cut industry support for these men and women when they are fighting to make us safer, the VA should not cut industry support at home as doctors try to make them healthier.
Comments must be received by VA on or before July 6, 2010.
For more information contact:
Louis E. Cobuzzi, PBM Services (119),
Veterans Health Administration,
Department of Veterans Affairs, 810
Vermont Avenue, NW., Washington, DC
20420; (202) 461–7362.