Maintaining Transparency between Physicians, Pharmaceutical and Medical Device Companies

Virtually all physicians, 94 percent, have some type of relationship with the pharmaceutical and medical device industries.  Senators Charles Grassley and Herb Kohl introduced the Physician Payments Sunshine Act of 2009 that addresses potential conflict of interests between physicians and prescription product companies.  The legislation, passed as a part of thePatient Protection Affordable Care Act and a Reconciliation package, nowrequires yearly reporting of all physician payments over a cumulative value of $100 dollars.  The bill summarizes its disclosure obligations:  “[The Act] Requires any manufacturer of a covered drug, device, biological, or medical supply that makes a payment or another transfer of value to a physician, a physician medical practice, or a physician group practice to report annually, in electronic form, specified information on such transactions to the Secretary of Health and Human Services.”  Criminal and civil penalties can be imposed for violations of the Act.  Earlier, the Medicare Payment Advisory Commission (MedPAC) recommended in its March 2009 report that Congress should require all manufacturers and distributors of drugs, biological, medical devices and medical supplies to report their financial relationships.  

What remains to be seen is how this law impacts the professional relationship between health care providers and the prescription product industry.  In this 90 minute audio conference, Reed Smith’s James Wood will provide insights on these measures and how they might transform the relationship between the practice of medicine and the creation of prescription products.

Learning Points and Questions To Be Answered:
 

• Why did the Congress believe that the Physician Payments Sunshine Act was necessary
• What are the key elements of the Act, who is affected, and when will the provisions become effective
• What kind of payments must be reported and in what form
• What payments during product development and clinical investigations do not have to be reported
• Why educational relationships between  health care providers, group purchasing organizations and the prescription product makers are an important part of patient care
• Can this new approach aid in the development of better drugs and devices
• Why does transparency extend to any payments of value from manufacturers to all supply chain players including Group Purchasing Organizations (GPOs) and distributors
• Will access to this information affect practice patterns of health care providers
   

Attendees Who Will Benefit From This Audio Conference Include:

• Physicians
• Pharmaceutical, Biotech and Medical Device executives
• Pharmacists
• Health Insurers
• Group Health Plans
• Pharmacy Benefit Managers
• Hospitals
• Medical Schools
• Patient Advocacy or Disease-Specific groups
• Biomedical researchers
• Group Purchasing Organizations (GPOs)

James M. Wood
James M. Wood, Partner with Reed Smith, is an accomplished attorney with more than 30 years of experience representing both drug and medical device manufacturers. He has aided clients with recalls, marketing and promotion, off-label issues, preemption, product liability issues and the reuse of single use medical devices. He served as regional counsel for an international medical device company in a product liability action and was the multidistrict litigation (MDL) liaison counsel in the Gammagard® MDL litigation. James is a highly in-demand speaker for conferences, and is a prolific author of articles for legal publications and industry newsletters. He also co-authored Recalls of Prescription Product: A Proactive Primer, a book that details how to plan and implement the recall process for all regulated products. He earned his J.D. from the University of San Francisco.