Department of Veterans Affairs and State of Connecticut Focus on Drug Marketing

May 12, 2010

By Susan J. Matthees & Alan M. Kirschenbaum

The state and federal regulatory and legislative focus on drug marketing shows no signs of abating.  Yesterday, we reported on FDA’s “Bad Ad” initiative to get health care practitioners to report to FDA violative drug promotion that occurs in the doctor’s office.  The Department of Veterans Affairs ("VA") is also proposing to turn the screws on drug detailing.  A proposed regulation published on May 5 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.

The proposed rule would impose a number of additional restrictions on sales detailing.  Sales representatives would not be permitted to provide drug samples or free drug-related supplies unless approved by the medical facility.  They would be prohibited from providing food of any type or value to VA staff.  Contacts with practitioners would be by appointment only, and facilities could develop a list of practitioners who do not want to be called on by representatives.  No detailing of professionals-in-training would be permitted unless approved by the clinical staff member.  Sales representatives would be prohibited from waiting or making any presentations in patient-care areas.  In addition, all educational programs and materials would have to be approved by the facility in advance of the program, and no promotional activities would be permitted during an educational program. 

Violations of the rule could result in suspension or revocation of visiting privileges at one or more facilities, or at the VISN or VA-wide level, for a particular sales representative, or even the entire sales force where there is widespread misconduct.

At the state level, Connecticut has joined California, Nevada, and Massachusetts in requiring drug and device manufacturers to adopt a compliance program.  A bill passed by the legislature on May 5 requires pharmaceutical and medical device manufacturers, before January 1, 2011, to adopt and implement a code conforming with the PhRMA code or AdvaMed code on interactions with health care professionals (as applicable), and a comprehensive compliance program in accordance with the HHS OIG’s 2003 Compliance Program Guidance for Pharmaceutical Manufacturers.  The bill authorizes the Department of Consumer Protection to investigate and impose a civil penalty of $5,000 for a failure to adopt and implement a code and compliance program, or a failure to conduct training or regular audit for compliance with the code.  The bill is on its way to Governor Rell’s office for signature.

Categories: Drug Development