July 26, 2006
Vol. 1, No. 19



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IN THIS ISSUE


New York law will help state crack down on Medicaid fraud

Pharma ties to FDA committee members to get greater scrutiny

MN governor proposes to make FDA DTC rules state law

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IN THIS ISSUE


New York law will help state crack down on Medicaid fraud

New York will have increased power to investigate and prosecute Medicaid fraud under new legislation that was sent to the governor on July 14.

The legislation will establish an independent office of the Medicaid inspector general within the state's health department to consolidate fraud detection and prevention.

The law also requires healthcare providers to develop a compliance program that includes:

  • written policies and procedures

  • employee training and education

  • a system to identify and respond to compliance issues

  • a policy of non-intimidation and non-retaliation for participation in the compliance program

    Although New York's Attorney General Elliot Spitzer said the law was "useless" because it doesn't contain a qui tam provision, Bruce Armon, J.D., partner in Saul Ewing's Life Sciences Industry Service Team, says that doesn’t make the law any less important to pharmaceutical companies.

    Armon says putting into place a dedicated office for fraud prevention is important to any pharmaceutical company that's reimbursed through Medicaid. "It gives the state a lot of tools to coordinate its efforts to prevent and investigate fraud and abuse in the Medicaid program," he says.

    Read the bill on the New York state legislature's Web site.

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    Pharma ties to FDA committee members to get greater scrutiny

    The FDA is taking a closer look at its process for letting people with drug industry ties serve on its advisory committees. Although the FDA says its approach for granting waivers to serve to experts with industry ties is rigorous, it has been criticized for being not transparent enough.

    Under its new plan, the FDA says it will draft guidance to identify more clearly how waivers are granted and when they will be disclosed to the public. The FDA also plans to make the entire advisory committee process more transparent. For example, it said it will issue guidance about when certain materials used during committee meetings will be made publicly available and more widely publicize committee schedules.

    The Center for Drug Evaluation and Research is will also assess its use of advisory committees, including the process of choosing members and developing the agenda.

    The FDA's move to add transparency to its advisory committee process comes just weeks after the Journal of the American Medical Association tightened its conflict of interest policy because a group of study authors didn't disclose all financial ties to the drug industry.

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    MN governor proposes to make FDA DTC rules state law

    Minnesota Governor Tim Pawlenty introduced two new pieces of legislation last week in an effort to tighten his state's control over prescription drug advertising. One proposal would adopt the FDA's DTC ad guidelines as state law to allow Minnesota to independently review drug ads and enforce the rules. Pawlenty also proposed legislation to require pharmas to report what they spend on advertising in Minnesota, with the goal of slowing the growth in drug costs and bringing accountability to the pharma industry, according to a report from his office. In addition to proposing state legislation, Pawlenty sent a letter to Congressional leaders calling for a two-year federal moratorium on DTC ads.

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    CONTACT US

    Alexandra Wilson
    Editor
    E-mail address: awilson@hcpro.com