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Can New Personalized Medicine Coalition Influence Pharmacogenomics Regulations?

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More than 20 healthcare and genomics interests last week officially launched the Personalized Medicine Coalition, a non-profit health-policy group aimed at establishing a more powerful voice for pharmacogenomics among regulators, legislators, and the public.

In general terms, the PMC will focus chiefly on helping to guide public policy, such as reimbursement and US Food and Drug Administration procedures, and on “science and finance” in order to “make personalized medicine a reality,” said Edward Abrahams, the group’s executive director and the former director of the Pennsylvania Biotechnology Association.

To be sure, the Washington, DC-based coalition is in its infancy, with a nascent membership list and board of directors, and with no clear publicized goals for the next year or the long term. It has been around for about a year, holding educational forums and organizing itself, but its formal inception occurred Oct. 21 with the launch of its website (www.personalizedmedicinecoalition.org).

Abrahams will officially take the helm as executive director on Nov. 1. “The plan is developing, but we want to make sure that there will be no obstacles in the public policy arena that will impede the progress of personalized medicine,” he told Pharmacogenomics Reporter this week.

Supported “almost entirely” by dues collected from industry members, the PMC also includes the US National Cancer Institute and the US National Human Genome Research Institute as ex-officio members, said Brian Munroe, PMC president and vice president of government relations and public policy at Millennium Pharmaceuticals.

A graduated fee schedule separates members into groups. Small companies, start-ups, large companies, trade associations, academic groups, think tanks, payors, and advocacy organizations pay according to organizational type and size, said Pat Terry, PMC cofounder and secretary, and director of consumer advocacy for Genomic Health. Other support comes from attendance fees associated with meetings and events, he said.

The achievement of 501(c)(3) non-profit status “means that [the PMA] can now go out into the foundation world,” said Abrahams. “One of the goals is to expand the membership and realize some outside funding.”

The total PMC budget is “well over the $250,000 mark,” said Terry.

While the PMC board is “dominated” by industry, it will soon expand to include representatives of research institutions, such as an undisclosed “major research university” recently approved by the board, said Abrahams. He declined to name the university because it had not yet accepted. Representatives of such major industry players as Abbott Laboratories, Affymetrix, AstraZeneca Pharmaceuticals, the Biotechnology Industry Organization, Roche, IBM, Pfizer, and the Pharmaceutical Research and Manufacturers of America also sit on the board [see table at bottom for a complete list of PMC directors].

The group’s membership includes “a diverse coalition of interests, namely physicians, patients, non-profit research institutions — namely universities — pharmaceutical companies, biotechnology companies, venture capitalists, et cetera, that are all in this emerging space,” said Abrahams.

As a 501(c)(3) organization, the coalition is forbidden from engaging in lobbying. Instead, it will serve as a resource for government officials on topics including FDA regulation, Centers for Medicare and Medicaid Services reimbursement, intellectual property, bioethics, and privacy issues, said Brian Munroe.

In hopes of “raising public awareness,” the coalition plans to host monthly meetings, coalition meetings, and ongoing public relations efforts, among other methods, said Abrahams. “We’ll do it through public forums, mainly selected audiences; we’ll commission papers, organize the thought leaders in this area so that the Congress and the agencies, at a minimum, don’t interfere with the progress,” he added.

But as for which incentives or challenges government agencies have in place or might introduce, there is not much discussion. “I certainly don’t want to give the government any ideas,” said Munroe. However, at least one policy does rate public mention so far: “The current policy by CMS to reimburse molecular diagnostic testing at commodity payment levels,” he said. “They’re not providing the necessary incentives to advance personalized medicine.”

The PMC grew out of “ad hoc” meetings with other players during “crisis management” situations, said co-founder said Terry. “You have a scare and people rally together to stake out a position or influence decision making,” he said. These situations included the voluntary data submissions rules proposed in the draft guidance on pharmacogenomics data submissions, released last year; the Medicare Modernization Act; clinical lab freezes; and the co-pay issue with diagnostics. These are among the “variety of uncertain outcomes” that Terry said led him and others to take a “more proactive” approach.

Other organizations, such as Bio and PhRMA, have self interests that sometimes coincide with each other and with the PMC. Sometimes their interests conflict. For this reason and others, these organizations were not the best vehicles to wage these campaigns, said Terry. “If it was under BIO or under PhRMA, you’d have at least the appearance of domination by a particular worldview or a particular group of companies. We really wanted to have some credibility in the public space” through independence, and with it, the ability to stake out positions in civil discourse, he added.

“I think we’re going to have all kinds of conflict” within the coalition, said Terry. Ideally, finding the middle ground is the “niche” that the coalition is going to serve, but no battles have begun yet, partly because of the “enlightened self interest” of pharma and “the like” concerning stratified markets and clinical benefits for those molecularly defined patient strata, he said.

“I think there’s a realization that the blockbuster drug model is not over,” he added.

The most recent meeting of the PMC meeting was a “retrospective review and lessons learned about the Herceptin story,” featuring industry views on the regulatory and reimbursement issues stirred up by the approval of that drug, said Munroe. With the activity surrounding the appointment of Edward Abrahams and the website launch, the next session is not planned yet “as far as I know,” said Munroe.

— CW

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