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Massachusetts’ controversial just-codified guidelines governing medical device and pharmaceutical companies’ sales and marketing practices don’t fully please either the industry or its critics.
Health care reform legislation passed last August by the General Court and signed by Gov. Deval Patrick called for the Massachusetts Public Health Council, part of the Massachusetts Department of Public Health, to establish a code governing interactions between health care providers and medical device, pharmaceuticals and biotech companies. The idea was to squeeze marketing and advertising costs from the price of drugs and devices, and make any relationship between a doctor and a vendor clear.
The state isn’t alone in trying to regulate this area. The Washington, D.C.-based trade group Pharmaceutical Research and Manufacturers of America has a voluntary guidebook that contains best practices already.
The Mass. PHC held two hearings in January, took input from critics and proponents and on March 11 passed its final rules. “We believe this is a broad but balanced regulation,” said Tom Lyons, spokesman for the Department of Public Health. The final rules dictate that all companies will adopt and comply with the state’s new guidelines. Among the particular rules is one banning a vendor paying for entertainment or recreation for a provider. It also bans vendors from giving complementary items to doctors, such as mugs or calendars. All payments to providers of $50 or more for any non-research, clinical trial, or other patient-related purposes must also be made public.
Although the PHC made concessions from the original wording, a couple of trade group spokesmen nevertheless had serious reservations. “We’re disappointed,” said Thomas Sommer, president of the Massachusetts Medical Device Industry Council, and a long-standing critic of the regulations. “We’re concerned about the overall message this sends to medical innovators in this state.”
In particular, the rules governing “genuine research” practices don’t reflect just how the medical device industry works and could be an unnecessary hindrance, said Sommer. Nor has the state provided a deadline extension or technical assistance, as his organization requested.
“It’s unfortunate that this statute makes Massachusetts one of the most unfriendly states toward the biotech and pharmaceutical industry in the country,” said Robert Coughlin, president and CEO of the Cambridge-based Massachusetts Biotechnology Council. “It’s not as bad as it could have been, but it’s certainly had a chilling effect on our recruitment efforts for biopharmaceutical companies to not only have clinical trials here but to relocate.”
Not all industry advocates felt so strong. “Overall, the bottom line is that Gov. Patrick and his administration did go the extra mile to clarify the regulations,“ said Patrick Moscaritolo, president and CEO of the Greater Boston Convention & Visitors Bureau. In January, he had warned that a proposed rule that set strict limits on companies from paying doctors to travel or attend events would seriously hamper holding medical conferences and other events in Massachusetts.
A clarification of the rule allows such monies to be paid, provided they go to the organization that is running the event, and not directly to the attending doctors.
If the industry representatives were not entirely happy with the final results, neither were health care reform advocates. “Of course, we wanted full disclosure of all payments made for research purposes,” said Georgia Maheras, coalition manager at the Massachusetts Prescription Reform Coalition, a nonprofit advocacy group based in Boston. However, “in general, the regulations reflect a lot of what we wanted,” she acknowledged.
Rules roundup
Highlights of new medical industry regulations
• Take effect July 1, 2009
• Public reporting rules take effect July 1, 2010
• Companies must abide by a state code of conduct
• All vendor payments of $50, for non-research or patient-related reasons, to doctors must be disclosed publicly
• Prohibits cash payments to doctors, unless for services rendered
• Bans vendors paying for recreation or entertainment of providers
• Restricts and sometimes bans meals
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