Healthy Skepticism Library item: 13735

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Publication type: news

Dombrowski C.
Sunshine Bill Gains Momentum From PhRMA But Time May Be Running Short
FDALegislativeWatch.com 2008 May 28
http://www.fdalegislativewatch.com/2008/05/sunshine-bill-g.html

Full text:

With an endorsement by the Pharmaceutical Research and Manufacturers Association and three drug companies, momentum is building for Senate legislation to set up a federal reporting program for drug and device companies to disclose their gifts to physicians.

The question now is whether it is too late to secure passage in the current Congress or if the momentum is enough to propel the proposal onto a vehicle such as the upcoming Medicare physician payment legislation.

Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, introduced the Physician Payments Sunshine Act, S. 2029, last year to mandate the listing of industry gifts in a national online, publicly-accessible database. They have since made revisions, including a pre-emption of state reporting laws, to attract industry support (1“The Pink Sheet,” May 19, 2008, p. 3).

Joining PhRMA on the bandwagon for the revised sunshine proposal are Merck, AstraZeneca, the device company Medtronic, and AdvaMed, the Advanced Medical Technology Association. Lilly previously voiced support for the new reporting scheme.

Based on the summary of revisions provided by Kohl and Grassley, Consumers Union and other members of a coalition of consumer groups – known as The Prescription Project – are “inclined to be favorable towards this legislation, even though the terms have changed” since its introduction, Steven Findlay, health care analyst with Consumers Union, told “The Pink Sheet.” CU does not endorse legislation until it has reviewed actual language,” he said.

The support of PhRMA and AdvaMed “will add to the momentum behind this much-needed legislation,” he predicted.

Grassley and Kohl have said they want to attach the sunshine bill to Medicare legislation Senate Finance Committee Chairman Max Baucus, D-Mont., is drafting. That package will address physician payment provisions that expire June 30. Baucus has indicated his intent to limit additions to the Medicare bill to non-controversial items. A measure acceptable at least to Democrats will be written over the Memorial Day recess and taken directly to the Senate floor in early June, he said in a May 21 statement.

The revised sunshine bill developed by Kohl and Grassley represents “an acceptable compromise on the issue of transparency,” PhRMA CEO Billy Tauzin told the senators in a May 21 endorsement letter. In particular, he stressed the importance of pre-emption, which results in a uniform, national reporting standard.

Pre-empting enacted or pending state and local marketing reporting or disclosure laws “avoids a confusing myriad of local, state and federal requirements that … are overly burdensome and costly for those required to report.”

Merck CEO Richard Clark also cited the importance of a single national reporting system in gaining his support. He praised changes that allow physicians to verify the accuracy of submitted information and provide for a description of the payments so viewers can understand the context in which the payments were made.

Even as Congress debates the subject of transparency for transactions between drug companies and drug prescribers, more firms have begun their own move toward disclosure.

AstraZeneca will begin reporting its medical education grants, contributions to non-profit organizations, political action committee contributions and phase IV commitments on its Web site over the course of 2008, AstraZeneca U.S. CEO Anthony Zook said in his endorsement letter.

This month, the company began including the results of all its clinical trials for all products, in all phases, including drugs whose further development has been discontinued, he noted.

Last year Lilly initiated a site where it lists grants to organizations and its charitable donations; Pfizer followed suit this month (2“The Pink Sheet,” May 19, 2008, p. 4). Amgen began posting its educational grants and donations May 22 (see 3following story).