Public Health Council Fails To Tighten Pharma "Modest Meals" Regulation
Despite widespread opposition among Council members, the Public Health Council voted this morning to enact final regulations on meals provided by the drug and device industry to doctors and other prescribers. The regulations approved today keep intact the expansive, subjective definition of "modest" meals, as whatever a doctor would order on his or her own. The regulations also permit drug sales teams to provide free alcoholic beverages to doctors at drug industry "educational" sessions. Although a number of motions were made to ban alcohol and limit the amount spent on meals, they were not voted on during the somewhat chaotic process of discussing the regulations. (see the Boston Herald coverage)
We were deeply disappointed by the outcome, which ignored extensive evidence that pharma industry marketing practices distort prescribing and raise drug costs for everyone.
By state law, all DPH regulations must be approved by the Public Health Council, comprised of 14 members of the public, in addition to the Commissioner of Public Health. This was the first meeting chaired by Interim Commissioner Dr. Lauren Smith.
The new regulation tightens up some of the reporting requirements dropped from the earlier draft. The Council did approve an amendment authorizing the Commissioner to demand more information about meals provided as part of drug marketing programs, with the intent to revisit the regulation in light of the data received.
Before the meeting started, a representative of Senator Mark Montigny was permitted to speak. He conveyed Senator Montigny's outrage at the proposal. He asked for a count of the number of public comments received in favor of and opposed to the regulation, and was assured that the count would be presented later in the presentation. However, the tally for and against was never presented to the Council.
The discussion focused on two main issues: should the state permit free alcohol to be served at supposedly educational sessions hosted by the drug and device industry, and how should the state define what constitutes a modest meal?
Council member Dr. Muriel Gillick, a Harvard Vanguard physician, spoke eloquently against allowing alcoholic drinks: "Show me the medical school that offers beer before physiology class. Show me the hospital that gives a doctor a shot of vodka before he goes into the operating room to learn a new surgical procedure." She was echoed by Helen Caulton-Harris, Health Director for the City of Springfield:
I bring the perspective of a local public health official working on a community basis with teens and young people around the dangers of alcohol and drugs. To me, it does not send a good message to sanction the provision of alcohol at an educational session. Given what we know scientifically, we should make clear that alcohol does not promote learning.
Also joining the chorus against allowing alcohol were Lucilia Prates Ramos, Dr. Michèle David, José Rafael Rivera and Dr. John Cunningham.
Several motions were made to not permit alcoholic drinks to be provided or paid for, but none of these motions were brought to a vote.
Setting a fixed definition on the cost of modest meals was also discussed extensively. DPH staff argued that it would be difficult to set a fixed dollar amount, since the cost of meals can be mixed in with the cost of a meeting room or AV equipment. Under questioning however, the staff admitted that the drug industry is required now to separate out these costs for reporting purposes.
During the discussion, Harvard health economist Dr. Meredith Rosenthal described the basic meals served at faculty meetings, and eloquently decried the priorities reflected by the regulation, saying "it is poor economic policy to sell out prescriber integrity in the name of economic stimulus." Dr. Gillick asked, "What is the point of the food provided at one of these sessions sponsored by a drug company or medical device firm? Is it to allow physicians to conveniently be able to attend an educational session or is it providing a social occasion desired to promote good relationships between physicians and the sponsor?”
Motions were made to limit spending on meals to $25, or to the federal reimbursement standard. These motions were also never voted on by the Council.
Several times, Lucilia Prates Ramos expressed dismay at the proposed regulations, arguing for limiting the definition of allowable meals and against allowing alcohol. She also raised the issue of the proper location for drug company marketing sessions, moving to not allow meetings at resorts, casino and country clubs.
Dr. Alan Woodward proposed that the regulation be amended to permit the Commissioner to specify additional reporting requirements. He asked specifically that the Department require data on how much is spent on alcohol as opposed to food, a break-out of how much for meals and for meeting places, and the qualifications of speakers presenting at the drug marketing programs. He urged that the regulation be examined in 6 months in light of the data. On the vote to accept the regulation with the change to allow more reporting, 4 members voted no, and another member abstained. Seven members voted yes, along with Commissioner Smith.
We hope the Department takes seriously the heartfelt objections raised by many members today, and commits itself to relook at the regulation next year.