Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

Bill has not made it past committees on four prior occasions, but Rep. Eshoo would like to introduce a new version early next year.

The old saying “if at first you don’t succeed, try, try again” is clearly evident with supporters of the Genomics and Personalized Medicine Act (GPMA). Rep. Anna Eshoo (D-CA) is working to introduce a fifth incarnation of the bill while the current 112th Congress is in session.

Rep. Eshoo is trying to succeed where then Illinois senator Barack Obama and others have failed to get their versions of the GPMA legislation past committees. Rep. Eshoo is promising to reintroduce the bill in Congress by year’s end or in 2012.

The Personalized Medicine Coalition (PMC) has been helping Rep. Eshoo put together the new legislation. Amy Miller, PMC’s public policy director, told GEN that the coalition has identified six priorities for advancing the measure further than past versions:

  • Ensuring adequate representation of the personalized medicine perspective on relevant federal committees
  • Incentivizing personalized medicine by creating a transparent and predictable regulatory environment for products under review by FDA
  • Securing Medicare coverage of personalized medicine diagnostics and related items and services
  • Creating an expedited exceptions process for personalized medicine drugs and biologics under Medicare Part D
  • Establishing R&D tax credits for companies developing personalized medicine drugs and diagnostics
  • Ensuring patient access to personalized medicine through delivery system reforms

“As a coalition, we think it’s our job to tell policymakers what we think will move personalized medicine forward,” Miller noted. “We do understand that there are serious budget constraints right now. And there are some provisions in this bill that shouldn’t cost very much money at all.”

Coordinating Activities

The 2010 GPMA would have authorized spending $150 million for expenses including education and training grants, contracts, or cooperative agreements; a Committee on Public Engagement consisting of private-sector personalized medicine professionals; and a new Office of Personalized Healthcare (OPH) within the Department of Health and Human Services’ (HHS) Office of the Secretary, charged with coordinating the activities of the OPH and other federal agencies with that of private and public entities outside of government.

Last year’s bill also proposed a committee to analyze laboratory review requirements under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, with an eye to eliminating red tape from FDA, the Centers for Medicare and Medicaid Services (CMS), and private laboratory-certifying entities. It also suggested setting up an advisory committee “to expand and accelerate knowledge related to the clinical validity and utility of genomics and personalized medicine.”

Miller said PMC envisions a single committee, a broader advisory panel of at least 21 people within HHS’ Office of the Secretary to support the advancement of personalized medicine within the department and the agencies it oversees, notably FDA and CMS. The Health and Human Services Personalized Medicine Advisory Committee would recommend policies, regulations, and programs to promote public and private funding.

“We don’t really need that many committees. We just need one really good one that works across HHS agencies,” Miller pointed out. As envisioned by PMC, the new bill would retain OPH but bring it within FDA.

OPH had more expansive duties when proposed last year, including developing a long-term strategic plan for personalized medicine, crafting recommendations to delineate the roles and responsibilities of the FDA and CMS, and resolving conflicts between the agencies.

Promoting Reimbursement

An important component of the current legislative concept is forcing Medicare and Medicaid to reimburse healthcare providers for any diagnostics “prescribed, recommended, referenced, or suggested for use in the FDA-approved labeling of a personalized medicine drug/biologic for which Medicare coverage is available.” PMC and GPMA supporters want to end rules requiring CMS to make a national or local coverage determination first.

“We think this is about access to the best medicine, and sometimes CMS is hesitant to cover innovative diagnostics,” Miller said. For example, Miller pointed out, while FDA believed there was enough evidence to recommend diagnostic testing before initial dosing of anticoagulant warfarin, CMS decided against paying for the diagnostic test. “They wanted more evidence than FDA needed for safety and efficacy, and so we’re worried that they set a precedent with that decision,” Miller explained. “If FDA thinks a diagnostic is necessary for the safe and effective use of a drug, then CMS needs to pay for it.”

CMS’ policy has discouraged private insurers from paying for similar diagnostics. Last December, PMC identified lack of coverage as a major impediment to the adoption of diagnostic tests and underdevelopment and underinvestment in the technology.

Instituting Tax Credit

PMC’s suggestions for GPMA also include two tax credits. One is an extension of the Qualifying Therapeutic Discovery Tax Project (QTDP) through 2017. PMC would like to see QTDP expanded to include projects “that aim to further the development of a drug/biologic or diagnostic for personalized medicine.”

The other entails creating an R&D tax credit to cover costs of entities that signed formal agreements to develop, or won approval for, personalized medicine drugs or diagnostics. Companies would also be able to win that credit by persuading the HHS secretary that their products will address an unmet medical need; substantially improve utility of therapeutic or prophylactic compounds for groups with a particular disease or condition or a predisposition to either; or advance the competitiveness of the U.S. in the life, biological, and medical sciences. Additionally, companies can instead persuade the U.S. Secretary of Labor that their products will create jobs in the U.S.

The 2010 GPMA bill was introduced by Eshoo and Rep. Patrick Kennedy (D-RI), who did not seek re-election to Congress. Rep. Kennedy also introduced the 2008 version, and President Obama introduced the first two bills, in 2006 and 2007. Now, as a president facing re-election next year, Obama would likely support a revived GPMA, if only to burnish his biotech credentials.

A Congress eye-deep in budget wars, though, may not be as generous with tax credits as biotech advocates might want. PMC wisely whittled away GPMA’s proposed committees to a single advisory panel. But the coalition and especially Congressional supporters led by Rep. Eshoo will first need to answer what the bill’s likely cost will be in government reimbursements and tax credits. Finally, justification of those expenses will be key for the new GPMA to fare any better than its four predecessors.

Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.

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