Current Challenges in Managing Relationships Between Industry and Physicians
Panelists Sidney Welch and Marc Wilenzick discussed the current challenges in complying with various state and federal requirements regarding biopharmaceutical company interactions with prescribing physicians including the new Massachusetts law, and legislation passed recently by the Vermont legislature (awaiting the Governor's signature), as well as voluntary guidelines, such as the PhRMA Code.Legal Track session--4 pm on Tuesday may 19 Moderator: Steve Stranne, Partner, Bryan Cave Panelists: Sidney WeWelch, Partner, Arnall Golden Gregory Marc Wilenzick, Counsel, Pfizer Panelists Sidney Welch and Marc Wilenzick discussed the current challenges in complying with various state and federal requirements regarding biopharmaceutical company interactions with prescribing physicians including the new Massachusetts law, and legislation passed recently by the Vermont legislature (awaiting the Governor's signature), as well as voluntary guidelines, such as the PhRMA Code. Welch stated the changing environment has been recognized at the provider level--for example, academic medical centers have been encouraged to train and retrain young physicians and medical students away from an expectation of entitlement to one that is more consistent with bans on giftgiving and meals for physicians. Some companies, such as Pfizer, have also adopted their own policies that are more stringent that these laws and guidelines. Mark Wilenzick described Pfizer's transparency efforts which include registration of all phase 1 clinical trials and observational trials [beyond the clinical trial registry requirements of the Food and Drug Administration Amendments Act of 2007(FDAAA)]; posting of all political contributions; and posting of the status of Food and Drug Administration (FDA) post-marketing commitments. Wilenzick stated that industry has been criticized unfairly for failure to meet post-marketing commitments when, in fact, FDA's postings were not up-to-date. He also stated that on July 1st, Pfizer will begin to post publicly payments to prescribing physicians regardless of whether a federal sunshine law is enacted. Additionally, Pfizer plans to conduct a study to assess consumer comprehension of clinical trial results information when it is "translated" into non-technical language. This could help to inform the current efforts by the National Institutes of Health (NIH), in implementation of FDAAA to propose regulations that would govern whether non-technical summaries of clinical trial information can appropriately e posted for use by patients and consumers. Welch, Wilenzick and Stranne discussed the quandary of ensuring that doctors are informed of the most current information regarding new therapies and uses. Industry has long supported Continuing Medical Education (CME) and if that activity is questioned, it is not clear how that information exchange would be replaced or from where its funding would come. Some have suggested that physicians could do the research themselves and find up-to-date research and developments online--but that seems to be an inefficient method. Another quandary is that company payments to physicians for work they conduct for the company are being questioned; however, physician expertise is needed by companies and, as Wilenzick noted, "they won't work for free." The panelists discussed what constitutes fair market value for payments to physicians for research or consulting services, and indicated that if a federal sunshine law, such as that introduced this year by Senator Grassley, is enacted, it could create competition among physicians and an atmosphere where higher fees are expected, because other physicians are compensated at a higher rate. In contrast, it could also discourage the participation of some physicians who may not want their name and payments from companies posted publicly.