The rule for how drug and device makers will have to disclose their financial ties to doctors is 15 months overdue and the longer White House officials sit on it, the more lobbying it gets from different sides trying to shape its final wording.
Republican Sen. Charles Grassley of Iowa this week urged the Obama administration to get it done and published, Bloomberg reports. He pointed out that once final it will still take a year before drug companies are prepared to comply. The rule, which requires companies to publicly disclose any money they have paid to doctors, was supposed to be published in October 2011. He told White House officials that they should release the rule today or at least set a date when they will.
The rule is being considered by the White House Office of Management and Budget, which has not said what is holding it up. In the meantime, it is getting visits from groups with an interest. The American Medical Association (AMA) was recently there, Bloomberg reports, to urge that the rule include a 45-day period before publication on a government database in which doctors could challenge info they think is misleading. A spokesman said the AMA just wants to make sure that its members are treated fairly, but some public advocacy groups like the Union of Concerned Scientists think the AMA is trying to weaken the disclosure rule. Other groups, like the AFL-CIO and AARP, have also lobbied White House officials recently, urging them to get the thing done.
Until the disclosure rule began being kicked around as part of the Affordable Care Act, drugmakers and doctors didn't have to make anything public. Since it became a cause, more than a dozen companies have started making the information available in some form. 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, but allegations later surfaced that four committee members had ties to the pills' manufacturer.
- read the Bloomberg story