The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation?

In recent years, growing suspicion about the pharmaceutical industry and its motives and methods in product development and promotion has led to unprecedented levels of public mistrust of the industry. This mistrust, fueled by concerns about the insidious impact of commercialization of research, has been further fed by reports of spectacular fines to the world’s biggest pharmas for illegal marketing activities, allegations of industry suppression of negative clinical trial results, and fears of “influence peddling” through physician payments of various sorts.

The Physician Payments Sunshine Act (“The Sunshine Act”) is the US Congress’s response to these concerns. The Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals.

Manufacturers are required to collect and track payment, transfer and ownership information beginning Aug. 1, 2013. Manufacturers will submit the reports to the Centers for Medicare & Medicaid Services (CMS) on an annual basis. In addition, manufacturers and group purchasing organizations (GPOs) must report certain ownership interests held by physicians and their immediate family members. The majority of the information contained in the reports will be available on a public, searchable website.

These new reporting requirements have imposed a considerable burden on all concerned, including IRBs, sponsors, CROs, clinical investigators, and certainly government. Will this added regulatory burden prove effective in promoting more ethical research with improved outcomes for patients and society?

Gary Yingling will discuss the Sunshine Act compliance requirements in the context of the present regulatory environment, enforcement, penalties for failure to comply, and potential unintended consequences, both good and bad.

Speaker

Gary Yingling, BS, MS, JD, Partner, Morgan Lewis, Washington DC

Gary Yingling, BS, MS, JD, Partner, Morgan Lewis, Washington DC
Mr. Yingling’s practice focuses on regulatory and legal issues concerning food, drugs, medical devices and cosmetics. His primary efforts have been working with issues involving the Food and Drug Administration. An area of particular interest has been clinical research/contract research organization/sponsor matters.

Prior to entering private practice, Mr. Yingling was the president of the Food and Drug Law Institute for nine years. Before joining the institute, he was in government for ten years serving in FDA’s office of the general counsel. Before attending law school, he practiced community pharmacy and is a registered pharmacist in Maryland and the District of Columbia. He is also General Counsel for the Consortium of Independent Review Boards, and is deeply involved in consultations on FDA and OHRP legislative and regulatory reform.

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