Last Wednesday, the Department of Public Health held its monthly Public Health Council meeting. Commissioner Auerbach emphasized how critical the issues of cost containment and quality are in light of health reform. The top news of the day was the final vote for promulgation of the proposed regulations regarding the state’s code of conduct and disclosure requirements for pharmaceutical and medical device manufacturers. In the end, the Council voted (of those who could vote) unanimously in favor of promulgation of the final version of the regulations with an amendment to review the regulations within one year (where Chapter 305 mandated review every two years).
Commissioner Auerbach emphasized that the Council deliberations must be held to highest ethical standards, with the state Ethics Commission involved in deciding which council members could participate in the vote. After a rigorous review of any potential or perceived conflicts of interest, it was decided that 11 out of the council’s 15 members could participate in the both the discussion of the regulations and the final vote. Three members were recused because of financial conflicts of interest. Several members were more thoroughly vetted because a potential or perceived conflict of interest resulting from past advocacy or litigation-related activities, but the state Ethics Commission decided that they could participate in the discussion and voting. It was also decided that four council members had no conflict at all.
The final version of the regulations was presented by Melissa Lopes, DPH’s Deputy General Counsel who refreshed the Council’s memory of Chapter 305, the law requiring the regulations; the purpose of the regulations; a mock-up of a new publicly accessible website; and a summary of final version of the regulations as well as detailed information on implementation. She described the regulations as “robust approach to conflicts of interest” noting that she believed Massachusetts was going beyond any other state in the nation who has attempted to tackle this issue by including a code of conduct section, a compliance section and a public disclosure requirement.
Lopes also noted that after two public hearings in January and public commentary period, the Department received over 109 pieces of written testimony (which amounted to 1,000 or so pages) of comments from advocates, industry representatives, state legislators, peripheral industries (indicating the impact they believe these regulations would have on there ability to conduct business in the Commonwealth), charitable organizations, payers and purchasers. The comments ranged from concerns about pervasive industry interactions with physicians to concerns about difficulties for national companies to comply with a very specific state law. In her comments, DPH responded to each concern raised.
Some highlights of the final regulations include:
- The regulations now require disclosure of research payments that are for marketing or promotional purposes.
- The regulations will go into effect as planned on July 1, 2009, despite industry pressure to delay their implementation.
- A new provision permits charitable contributions but requires their disclosure, except for in-kind items, like donated drug samples, which need not be disclosed.
- The disclosure requirement was clarified to say that industry had to report on each transaction that was $50 or more. This means that if a pharmaceutical or device manufacturer provides multiple meals, payments etc. that are less than $50 each, no reporting is necessary.
After the presentation, those Council members who could discuss the pending regulations did so in great detail. Some questioned the $50 reporting limit that is mandated by statute and others asked if companies could ask for an exemption from the $2000 filing fee (which they cannot). They also asked important clarifying questions about promotional products, fines/penalties and what types of companies these regulations impact. The most significant discussion surrounded the issues of seeding trials, exemption of charitable donations in emergencies, free samples, and data-mining.
Jessica Hamilton
