During testimony last week at a Public Health Committee hearing for the Connecticut General Assembly, Connecticut Attorney General Richard Blumenthal urged legislation requiring strict limits and disclosure of gifts from drug makers to doctors that may influence health care decisions. His proposal was made during testimony alongside Connecticut Center for Patient Safety Executive Director Jean Rexford and others familiar with drug company sales policies. The proposed legislation, S270, includes requirements that drug and device makers:
– Adopt a code of conduct, along with training and monitoring to ensure compliance with the Code;
– Annually report all authorized payments or other gifts provided to health care providers that are individually in excess of $50 (disclosure extends for not less than two years following the date of the termination of any speaker or consultant arrangement);
– Prohibit direct payments or other compensation to health care providers, unless in exchange for a bona fide service (e.g. research; participation on advisory boards; collaboration with nonprofit organizations; and presentations at pharmaceutical or medical device manufacturing company-sponsored medical education and training);
– May not provide or pay for meals for health care providers that are (1) part of an entertainment or recreational event; (2) offered without an informational presentation made by a pharmaceutical or medical device marketing agent or without such an agent being present; (3) offered, consumed or provided outside of the health care provider’s office or a hospital setting; or (4) provided to a healthcare provider’s spouse or other guest. Otherwise, meals must be “modest.”
The legislation also puts restrictions on financial supports from companies for the costs of travel, lodging or other personal expenses of nonfaculty health care providers attending any continuing medical education event, third-party scientific or educational conference or professional meetings, either directly to the individuals participating in the event or indirectly to the event’s sponsor. Companies also cannot compensate for:
– The time spent by health care providers participating in any continuing medical education event, third-party scientific or educational conferences or professional meetings;
– Payment for meals directly to a health care provider at any continuing medical education event, third-party scientific or educational conferences or professional meetings, except that a continuing medical education provider or conference or meeting organizer may, at its own discretion, apply any financial support provided by a pharmaceutical or medical device manufacturing company for the event to provide meals for all participants; and
– Sponsorship or payment for continuing medical education or independent medical education, that does not meet the Standards for Commercial Support as established by the Accreditation Council for Continuing Medical Education or equivalent commercial support standards of the relevant continuing education accrediting body, or provides payment directly to a health care provider.
The bill also prohibits companies from providing entertainment or recreational items of any value (e.g. tickets to sporting events or theater), and:
– Payments of any kind, including cash or cash equivalents, equity, in kind or tangible items, including any complimentary items such as pens, coffee mugs or gift cards to health care providers either directly or indirectly, except as compensation for bona fide services; and
– Any grants, scholarships, subsidies, supports, consulting contracts or educational or practice related items in exchange for prescribing, disbursing or using prescription drugs, biologics or medical devices or for a commitment to continue prescribing, disbursing or using prescription drugs, biologics or medical devices;
With regards to CME, a pharmaceutical manufacturing company must separate its CME grant-making functions from its sales and marketing departments, and the company cannot provide any advice or guidance to the continuing medical education provider regarding the content or faculty for a particular continuing medical education program funded by the company.
The bill does not prohibit compensation or reimbursement made to a health care provider serving as a speaker or providing services as a faculty organizer or academic program consultant for a CME however, the bill outlines specific conditions for such compensation.
Discussion
While many manufacturers have already started to disclose payments (e.g. Eli Lily, Merck, GlaxoSmithKline, and Pfizer), and PhRMA has adopted a code of conduct that is covered by most of the recommendations including tickets to sporting events, this has not discouraged critics from introducing bills similar to the Massachusetts law.
This is the second time Mr. Blumenthal has introduced this legislation in the last two years. Violations of this bill result in a civil fine of not more than five thousand dollars per occurrence.
In his statement, Mr. Blumenthal asserted that “health care providers and pharmaceutical companies should interact and exchange ideas and experiences – but in the sunshine of transparency and disclosure.” His ongoing concern is based on the claim that drug companies are focused “relentlessly on practitioners, seeking enhanced sales and profits.” Despite this claim, he acknowledged the fact that “certain pharmaceutical drug companies are taking steps toward self-reform” (as noted above). Mr. Blumenthal however feels such efforts are not enough to “break an industry attraction.”
As a result, he advocated the need for “a state law readily enforceable by state agencies that would protect the physician-patient relationship from drug company influence.” Companies such as Boehringer Ingelheim and Covidien issued statements in opposition to the legislation. A full list of testimony can be found here.
Also submitting a statement in opposition to the bill was PhRMA, who noted that “implementing such a proposal could have a chilling effect on relationships between biopharmaceutical companies and health care providers, relationships that improve pateints’ lives.” PhRMA asserted that restricting “these interactions and requiring disclosure of certain payments to healthcare providers could chill research and development as well as patient access to clinical trials.” The organization pointed out that the legislation will hurt a significant portion of jobs and the economy in Connecticut.
Many in the food industry including several resturants, the Connecticut Resturant Association, and the Connecticut Caterers Association testified against the proposed legistation also largely on the issue loss of jobs for the state and the proposals intention to hurt the local economy.
Ultimately, because the bill could prevent companies from providing grants to physicians, which would also prevent physicians from conducting small initial studies that improve medical practice for patients, the legislation should be opposed. Moreover, as many testified and submitted, since the proposed legislation is burdensome, duplicative, over-reaching and will significantly and negatively impact business, a new approach for disclosure and transparency is needed. In fact, current industry code of ethics and federal legislation already provide a “robust” ethical framework for the drug and device industry, making state laws repetitive.
In the end, legislators need to find a method that does not create less interaction with health care providers, and less opportunity for these providers to obtain valuable education on new treatments because this will hurt patients and the training of physicians. Connecticut and other states considering such laws need to create legislation that maximizes the opportunity for physicians to work with industry so that healthcare providers, and in turn patients, do not lose out on important safety information and medical advancements.