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Home » Food & Drug Regulation: Library » Newsbriefs

Merged Senate Bill Keeps Sunshine Provision, Implements Few Changes

Date Posted: November 19, 2009

The Senate leadership’s proposed $848 billion health care reform package carries over many of the disclosure requirements found in a key committee’s proposal.

The Patient Protection and Affordable Care Act — which was unveiled Nov. 18 by Senate Majority Leader Harry Reid, D-Nev., after weeks of behind-the-scenes negotiations — is a merger of health reform proposals by the Senate Health, Education, Labor and Pensions (HELP) Committee and the Senate Finance Committee. But in the area of transparency, the merged bill comes down squarely on the side of the Finance Committee version: it incorporates nearly all of that committee’s provisions for disclosure of industry payments to physicians. The competing HELP Committee bill had no such transparency provisions.

Section 6002 of the bill, the “Transparency Reports and Reporting of Physician Ownership or Investment Interests,” contains only one significant change from the Finance Committee’s sunshine provision: it pushes back the starting date for disclosure requirements from March 31, 2012, to March 31, 2013. Apart from this and corresponding date changes — moving the deadline for the Department of Health and Human Services to establish reporting requirements for manufacturers back a year, for example — the requirements are functionally identical.

As before, drug, device and biologics manufacturers would have to reveal all payments or transfers to physicians valued at $10 or more. Payments below that amount still would have to be disclosed, however, if the total combined value of such gifts to a physician in a single year exceeded $100.

Also as in the Finance proposal, the merged bill includes only narrow preemption, permitting states to implement their own requirements as long as they do not directly overlap with the federal ones.

For more information, see the January edition of the FDA Advertising and Promotion Manual newsletter.

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