In 2010, the Department of Veterans Affairs ("VA") proposed a regulation that would impose limits on the promotion of drug and drug-related products to health care professionals working at VA facilities. Under the proposed rule, sales representatives would be permitted to promote their products in VA facilities if the promotion is consistent with any VA clinical criteria for use and has not been placed on the VA’s “non-promotable” list. If a drug is not on the VA National Formulary and has no criteria for use, it may not be promoted absent authorization from the Veterans Integrated Service Network ("VISN") Pharmacy Executive and the Chief of Pharmacy of the VA facility.
Consequently, on March 5, 2012, the VA issued its 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. The final rule amends 38 CFR part 1. 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.”
As noted by the FDA Law Blog, “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. Below is a summary of the final rule provided by the FDA Law Blog.
The “Scope” of the rule governs on-site, in-person promotional activities, including educational activities, by pharmaceutical company representatives at VA medical facilities. It does not apply to the distribution of information and materials through other means. This note clarifies that the rule governs only physical access to VA medical facilities and that information and materials can be distributed through other means than in-person at a VA medical facility.
Pharmaceutical company representatives are free to provide safety and scientific information through means other than on-site, in-person, visits to VA facilities.
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. VA defined nonpromotable drugs as ‘‘drugs designated by VA as non-promotable’’ and inform the public that a list of such drugs will be available upon request or on VA’s Web site at http://www.pbm.va.gov.
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. Drug-related supplies means supplies related to the use of a drug, such as test strips or testing devices, inhalers, spacers, insulin syringes, and tablet splitters.
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.
VA modified the word ‘‘materials’’ where it appears in paragraph (f) with the word ‘‘associated’’ to make clear that the materials discussed in paragraph (f) are those materials intended for use in connection with an educational program. VA noted that this definition applies only to this section and does not apply to the similar terms as used by other U.S. Government agencies, such as the Food and Drug Administration (FDA), in their regulations or guidances.
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).
For those who are by this time utterly confused, this section applies to industry presentations by sales reps and not certified CME activities. If you read the preamble and the regulation it is clear that the VA is defining education as an event with a pharmaceutical representative.
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.
Pharmaceutical company representatives may only distribute materials on-site at the time and location of a scheduled appointment or educational program. In no circumstances may materials be left in patient care areas.VA defined patient-care areas to include, but are not limited to:
- Patient rooms and ward areas where patients may be encountered;
- Clinic examination rooms;
- Nurses stations;
- Intensive care units;
- Operating room suites;
- Urgent care centers;
- Emergency rooms (but not staff offices that may be located in them); or
- Ambulatory treatment centers.
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.
Actions that may be imposed under this section include limitation, suspension, or permanent revocation of visiting privileges at one or more VA medical facilities. In determining the appropriate action, the Director shall consider
- The requirements of the final rule,
- The circumstances of the improper conduct,
- Any prior acts of misconduct by the same pharmaceutical company representative,
- Any response submitted by the pharmaceutical company representative or their supervisor, and
- Any prior written orders issued or other actions taken with respect to similar acts of misconduct.
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.”
The section on education could probably have been clearer about scope and applicability but it is what it is. According to former FDA attorney Arnold Friede, “industry should be happy that the VA now clearly concludes that certain “promotional” programs can simultaneously be “educational” if specific requirements are met.”
Arnold noted that “the requirement that promotional educational programs provided by a pharmaceutical company representative disclose direct comparisons between “industry-sponsored” and “non-sponsored” “sources of data or other analytical information” if and when they “exist for FDA-approved uses of a particular drug”. In other words, on-label promotional programs by industry representatives at VA facilities must now mandatorily include such comparative data. Seems as if this requirement may be difficult to meet given the climate of compliance officers concerns and, at a minimum, will impose significant constraints on industry promotional educational programs at VA facilities to the extent these take place.”
Given the recent emphasis of the Department of Justice (DOJ) for going after drug representatives, the new VA final rule will provide another resource for finding fraud and abuse by drug companies. Violations of the VA final rule will likely get referred to DOJ and the Department of Health and Human Services (HHS) Office of the Inspector General (OIG).
Accordingly, companies who do promotional work with the VA must update their policies to comply with the new rule, which includes retraining sales representatives. Companies could face possible suspension or debarment from doing business with the VA for violating this rule, which could then lead to a larger exclusion from all federal health care programs.