Plans to craft a voluntary marketing code for the device industry will be discussed by AdvaMed board members the week of Dec. 16.

Although AdvaMed (as the Health Industry Manufacturers Association) adopted a voluntary code in the early 1990s, the new initiative, likely to be completed by early 2003, comes at a time of increased scrutiny of the pharmaceutical industry's promotional practices.

The comment period for the HHS Office of the Inspector General's draft pharmaceutical compliance guidance expired Dec. 2. AdvaMed did not formally submit comments on the guide, which OIG has said will be applicable only to drug manufacturers for the time being (¹ 'The Gray Sheet' Dec. 2, 2002, In Brief).

Nevertheless, drug and device lawyers have tried to anticipate broader policy implications of the guide. At a recent Food & Drug Law Institute event, for example, Sidney Austin Brown & Wood Partner Paul Kalb, MD, and Assistant U.S. Attorney of the Eastern District of Pennsylvania James Sheehan concurred that the guide is relevant to devices (² Also see "Device Firms May Be Held To OIG Pharmaceutical Compliance Standards" - Medtech Insight, 11 November, 2002., p. 13).

In Dec. 2 comments, the Pharmaceutical Research & Manufacturers of America maintains that its own marketing code should be embraced by OIG in further updates to the draft. PhRMA's voluntary code took effect July 1 and OIG has recognized it as the minimum standard for industry to follow.

Several features of the PhRMA code, such as its emphasis on the ethics of gift-giving, promotional venues and interactions between health care professionals and sales reps, are likely to have counterparts in the AdvaMed document.

Qualitative differences between the two industries will dictate some degree of variance. The AdvaMed code is likely to discuss the role of company technicians during the training of physicians using a new device, for example.

Elsewhere within the health care industry, marketing codes have also been recently adopted by group purchasing organizations - collectively and individually - largely in response to Senate Judiciary/Antitrust Subcommittee scrutiny.

Device firms may be spared the intense focus on business practices that the pharmaceutical and GPO sectors have drawn from lawmakers and the public. The Medical Device User Fee & Modernization Act raised the industry's overall profile in Washington, however, and with this visibility may come more appeals for oversight.

In terms of perception alone, the industry has weathered attempts by BlueCross BlueShield and Project HOPE to publicize the link between rising health care costs and medical technology innovation (³ Also see "Medical Technology Cost Awareness “Campaign” Led By Blues, Lewin Report" - Medtech Insight, 28 October, 2002., p. 17).

As a whole, the device industry enjoyed several distinct policy triumphs in 2002, which in many cases corresponded with the wills of high-ranking officials in the Bush administration.

FDA Commissioner Mark McClellan, in his former capacity as White House health economics advisor, was credited with helping to expedite Medicare's payment policy for drug-eluting stents, although the technology has not yet been approved.

McClellan also may be poised to interact more successfully than his predecessors with CMS in ensuring timely coverage decisions in the wake of FDA approvals. Collaborative reviews and a "harmonized" FDA/CMS approach are advised by the HHS Secretary's Advisory Committee on Regulatory Reform.

HHS Secretary Tommy Thompson's "one-department" policy - including close coordination by Bush appointees Claude Allen, deputy secretary of health, and Alex Azar, HHS general counsel, and FDA Chief Counsel Daniel Troy - offers a streamlined approach that is welcome to many manufacturers, as is the 2003 Republican Congress.

Guidant President and CEO Ron Dollens, with his recent role on the HHS regulatory reform panel, and his imminent chairmanship of the Healthcare Leadership Council - he will assume that post Jan. 15 - provides an example of how chief execs demonstrating regulatory savvy can take a pro-active role in stewarding health policy. "Health policy is Guidant's number-one strategic issue.... I also think that it is by definition our industry's number-one," Dollens stressed at a trade meeting in October. HLC will unveil its 2003 legislative agenda mid-January in Washington, D.C. Ongoing initiatives of the alliance, comprising CEOs across various health sectors, include medical liability and the uninsured.

Device Marketing Code Follows Pharma Effort; Dollens Is HLC Chair Jan. 15

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