FDA releases draft Sunshine Law guidelines

April 9, 2013 By Sony Salzman

The FDA published a draft of its financial disclosure guidelines, due to take effect by August , that parallel the healthcare reform law’s Sunshine Act.

The 35-page document details all physician-relationship rules companies will have to follow when applying for marketing applications with the FDA.

The document seeks to answer lingering questions about how reporting should be carried out, how bias is determined and which physician/manufacturer relationships must be reported. The guidance has been updated from a May 2011 version, based on recommendations from 13 individuals and interested parties, according to the federal watchdog agency.

The guidelines define the specific compensation, payments, parties involved and all other information that will need to be reported under the FDA’s internal rules, apart from any requirements mandated by the Physicians Payment Sunshine Act provision of the Affordable Care Act, which requires public disclosure of payments and gifts to physicians.

According to a survey published last month, more than half of physicians are concerned about public exposure of the doctor/industry relationship, especially considering that Obamacare’s transparency rules were published some 15 months behind schedule.

Companies undergoing a clinical study must report any physician compensation that might change based on the outcome of the study, or any payments made to investigators with proprietary or stock interested in the company, according to the draft guidance. Companies will also need to report any study sponsor with more than $50,000 worth of equity in the company, and all payments to investigators that exceed $25,000.

If the federal watchdog agency suspects that physician relationships have skewed the outcome of the study, it can audit the data, request further data on the study or require a separate study on the data in question. The FDA can also refuse to consider the study data in the application all together, according to the draft guidance.

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