WALTHAM — The Mass. Medical Society (MMS), in testimony presented recently to the Department of Public Health (DPH), issued its support of proposed regulations on pharmaceutical industry conduct, saying the department had developed “comprehensive and thoughtful draft regulations.”
The statewide physicians’ organization stated its long-standing policy that “physicians should avoid undue influence from pharmaceutical companies, insurance companies, and health plans that could influence prescription writing” and that it supports “objective education of physicians by independent authorities about prescription and non-prescription drugs.”
While supporting disclosure and the $50 limit on gifts, the MMS said that it supports the work of the Legislature and the health department in clearly identifying ‘safe harbors’ for legitimate interaction between health care providers and industry.
The society said that specific exemptions to facilitate the education of physicians about products and devices are essential. Included among those are peer-reviewed medical publications and the underwriting of continuing medical-education programs. The society said it also supports the provisions in the regulations to protect research projects from “mandated disclosure of information that would compromise the security of ongoing confidential research.”
The MMS did, however, issue a caution with regard to the gift-ban regulations, stating that reporting requirements, if applied universally and cumulatively to all materials, may create a “paperwork nightmare” that could lead to industry stopping all distribution of samples or educational materials in Massachusetts.
“Such an outcome,” said the society, “would harm the MMS directly as a provider of continuing medical education programs and as the publisher of the New England Journal of Medicine and other peer-reviewed publications. It would also harm our patients who benefit from the use of samples as starter doses to test tolerance and efficacy or to provide otherwise unaffordable treatments.”
Calling the $50 dollar gift limit “reasonable,” MMS sought clarification on whether the amount applied to an individual item or cumulative annual or lifetime limit for a single prescriber, group, or facility. And it called for clarification that would specifically exempt those educational materials and samples and support allowed in the legislation from general reporting requirements.
The society suggested that initial reporting be concentrated in areas of the most interest — meals, gifts and direct payments — and that once the initial system proves its value, further expansions and refinements may be made as needed.