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U.S. finally gets payment rule published

Info due in March 2014, will be published in September 2014
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It is 15 months overdue and it will be more than a year before information is public, but at last the government has set out its rule for how it will publish payments from drugmakers to doctors.

Drug and devicemakers have until March 2014 to get their info together, which will include payment information from August through December of this year, Bloomberg reports. Then the U.S. Centers for Medicare and Medicaid Services, which has ownership of the project, will get it into a publicly available database and up online September of next year.

Advocates argued that the public--and patients in particular--need to know when doctors are getting paid by manufacturers and so are potentially influenced to push their products. The new rule will include disclosure of which doctors advising the FDA on drug approvals have some financial tie to the maker. "This increased transparency is intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers," the center said in announcing the rule.

Relationships between doctors and drugmakers have been brought up in a number of cases when FDA advisory panels have ruled for or against drugs in which doctors had some interest. That happened with Bayer's Yaz birth control pills. An advisory panel voted 15-11 to support the contraceptives last year, but allegations later surfaced that four committee members had ties to the pills' manufacturer.

The rule was supposed to be published in October 2011. In recent weeks, there has been intense lobbying both by groups keen to get the data in the public hands, such as the AARP, and those most affected by it, such as the American Medical Association (AMA). The AMA prevailed on a couple of its concerns.

Doctors will get 45 days after information is submitted to vet it for accuracy. So-called indirect payments also will not be included. The center said, for example, if a drugmaker hired a consulting firm, which then paid a doctor to complete the project, the drugmaker would not be required to report that.

"Our feedback during this rulemaking process was aimed at ensuring the new registry will provide a meaningful picture of physician-industry interactions and give physicians an easy way to correct any inaccuracies," AMA President Jeremy Lazarus told Bloomberg in a statement.

- read the Bloomberg story
- the rule is here (pdf)

Related Articles:
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AARP, AFL-CIO and prominent docs to White House: Get us the sunshine rules, stat
Pfizer to report doctor payments
Yaz plaintiffs ask judge to weigh alleged FDA conflicts

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