WASHINGTON, DC—A proposed regulation published last month in the Federal Register by VA will lay the groundwork for the nationwide standardization of how employees at VA facilities and pharmaceutical industry representatives interact. While each VA hospital currently has systems in place to allow—or sometimes to not allow—industry representatives to come into the facility, those systems vary from VISN to VISN, and sometimes by hospital.

A Nationwide Standard

In 2003, VA issued a directive titled Business Relationships Between VHA Staff and Pharmaceutical Industry Representatives. The directive was created with input from the industry, and outlined what VA considered appropriate activities and interactions between VA medical staff and industry representatives. This allowed for considerable variation in particular VA facilities’ procedures.

That directive officially expired in 2008, though VISNs generally continued to follow the policies. VA is now looking to update the rules to define appropriate interaction, and in the process create a single set of procedures under which industry representatives interact with VA staff.

“We tried to incorporate the directive in the new formulary management handbook,” explained Louis Cobuzzi, associate chief of VA’s Pharmacy Benefit Management Service in an interview with U.S. Medicine. “It’s ongoing. It’s something that we were working on for a number of years. We’d like to establish a national policy, so it makes it easier on [industry’s] end to train their sales representatives.”

This process has included input and discussion with industry officials, who have been clamoring for a single set of nationwide standards for VA, Cobuzzi said. “The communications I’ve received from sales reps note that each VISN varies from one to the other, and it’s hard for them to train their staff. They’re all pushing to get this out. What they want is one consistent approach to follow.”

The regulation published in the Federal Register—open for public comment through July 6—will lay the groundwork for a nationwide standard, with the exact details to be hammered out later. Following the comment period, VA will examine the comments, respond to them, then forward the regulation and the comments on to OMB, which might review it for as long as 90 days.

“At that point in time, we can go ahead and begin to write the policy, which we’ve somewhat drafted already,” Cobuzzi said. “We’re ready to start this as soon as possible once it clears all the hurdles.”

One aspect of that new policy is to discourage VA facilities from banning industry representatives outright. “There are a small number of VA facilities that do not allow pharm reps in the building, period,” explained Mike Valentino, VA’s pharmacy chief. “None of us believe an across-the-board ban is in anybody’s best interests.”

Industry representatives see great potential for benefit in a standardization of practices, but also a potential for increased red tape.

“We think this could be very positive,” explained Marjorie Powell, senior assistant general counsel for Pharmaceutical Research and Manufacturers of America (PhRMA). “At the moment, individual facilities each have their own rules and there’s no consistent way to figure out what they are. However, there could be potential to seriously delay the conveying of information to physicians. The proposed rule makes it clear that a company wanting to provide information for a new medicine has to go through multiple steps [before] they go in and talk to doctors at VA facilities.”

PhRMA is also concerned about provisions requiring all materials presented to physicians be pre-approved by VA. “This essentially duplicates the activities of the FDA,” Powell said.

Concerned the changes could tighten what industry already considers one of the most restrictive health care system formularies, PhRMA will be submitting comments to VA regarding the proposed rules.

Partnership at the Hospital Level

In many VA medical centers, there is a strict system in place outlining how industry representatives approach and interact with VHA staff. However, it is not so strict that it deters industry from visiting. Terrell Washington, PhD, chief pharmacist at the Washington, DC VA Medical Center, explained that his office sees two or three industry representatives every week.

“They make an appointment ahead of time with the person they need to see. Then they log in with the security office and get a vendor badge and then they come straight to [my] office,” Washington explained. “We want to minimize the interruption
of our patient care activities. If you make an appointment, I know you’ll come in and we meet and discuss. Versus if I’m in my clinic and you interrupt me in the clinic, and that could be a problem.”

The need for industry representatives to visit individual medical centers changed significantly several years ago when VA switched to a national formulary. Individual pharmacy chiefs no longer had the final say in what drugs were stocked in their hospital, and physicians were limited—though they can make appeals—to the national list of drugs. “That move to a national formulary changed the game,” Washington said. However, there is still considerable interaction with industry, and it benefits VA staff as much as it does the industry.

“Throughout the years, there has always been a partnership with what might be called a value-added service,” Washington explained. “It’s sometimes very helpful when they do come in. They provide updated information about their medications that have been approved on the formulary—new dosing, changes in their cost structure, new clinical indications that I might be totally unaware of. The key thing is, with the way we have it set up, if everybody works together, then it works great for all of us.”

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