Massachusetts became the latest in a series of states to enact legislation cracking down on pharmaceutical industry marketing practices when, on August 10, Gov. Deval Patrick signed into law a healthcare cost containment bill. The ambitious bill, which covers areas such as implementing electronic medical records, boosting the number of primary care physicians, and educating prescribers about generics, includes a hotly contested section on gifts, entertainment, meals, and other payments to healthcare professionals.

Senate Bill, No. 2863, “An Act to Promote Cost Containment, Transparency, and Efficiency in the Delivery of Quality Health Care” (available at www.mass.gov) instructs the state Department of Public Health to create a marketing code of conduct for pharmaceutical and medical device companies that will be “no less restrictive” than the guidelines developed by the Advanced Medical Technology Association and the recently updated Pharmaceutical Research and Manufacturers of America's Code on Interactions with Healthcare Professionals. The code prohibits companies from giving healthcare professionals any gifts that are not related to their own or patient education. The Massachusetts code will go into effect January 1, 2009, and must be updated at least every two years.

The new state law also says that companies will have to disclose any gifts or payments worth $50 or more to healthcare practitioners. The bill applies to not only healthcare professionals, but the organizations they work for, and any employees. Companies will pay a fee for providing this disclosure information, and the data will be made publicly available on a state Web site.

Safe Harbor for CME

An earlier version of the law lumped in CME with other gifts and payments, but the final version specifically allows companies to financially support CME, as long as it meets the Accreditation Council for CME Standards for Commercial Support.

The Massachusetts Medical Society, which argued for a CME exemption, is pleased with the final version. “The more draconian nature of the original language was going to put a real pall on legitimate continuing medical education,” says Bruce Auerbach, MD, president, MMS. As long as the [final] regulations are true to the language and intent of the law we should have no problem with it.”

While the gift ban generated a great deal of publicity in the local press, that aspect was not a big concern for MMS. “[Gift restrictions have] never been a big issue of ours,” says Auerbach. “We're not sure some of the very modest gifts — the pens, pads, mugs, and whatnot — truly influence judicious behavior. That said, we have no issue with anything that would restrict the distribution of those things.”

He's also not concerned that companies will reduce funding for CME or other support of meetings because of the restrictions. “I'm hard-pressed to believe that someone would not continue to support legitimate CME and research because when they set up a booth at an exhibit hall at a meeting, they can't give out pens and notepads. We don't see this as a significant impediment for industry to continue support.”

The pharmaceutical and medical device industries, however, are still quite concerned about the disclosure requirements. PhRMA issued a statement asserting that the public disclosure of payments to healthcare providers would chill scientific research, as physicians working on clinical trials would not want their arrangements with industry publicly disclosed.

An earlier version of the bill included a prison penalty for violators; the final version drops the handcuffs but does say that violators will be punished by fines of up to $5,000 for each transaction. MMS says that's an improvement, but it doesn't go far enough.

“We believe that physicians act in the best interests of their patients,” says Auerbach. “The concept of criminalizing this whole phenomenon was really over the top as far as we were concerned. The fact that there continue to be monetary penalties — while it does not criminalize it the way the threat of jail time would — still puts it into a realm that is of a much more serious nature than we believe it should be.”

Going forward, MMS will continue to monitor the development of the code and implementation of the law. “We will certainly weigh in with comments when any of the proposed regulations go out for public comment to ensure that they're consistent with what we believe to be the proper way for this to be implemented,” says Auerbach.

Get Involved

Currently, 43 states have enacted laws and resolutions related to the pharmaceutical industry; at least nine of those states plus D.C. have adopted legislation specifically related to pharmaceutical marketing practices, according to the National Conference of State Legislatures Web site (www.ncsl.org). And many more bills are pending. Healthcare associations can make a difference in shaping legislation, says Bruce Auerbach, MD, president, Massachusetts Medical Society. Here are his suggestions.

  • Be diligent and stay informed about legislative and regulatory developments in your area.

  • Assign people within your organization, whether they are paid staff or volunteer members, to monitor legislative proposals.

  • Make sure there are spokespersons within your organization who are educated about the issues and ready to respond when the opportunity arises. “You need to come forward with thoughtful, patient-centered, and appropriate commentary,” Auerbach says. “The most important thing you need to have is physicians at the table to proffer their position and perspective.”

Pulse:

  • GlaxoSmithKline announced that beginning in February 2009 it will issue quarterly reports about education and charitable grants it has made to organizations including hospitals, teaching institutions, associations, and CME companies. Currently, two other companies, Pfizer and Eli Lilly, also publicly report grants.

  • Beginning in September, Stanford University School of Medicine prohibited commercial support for specific courses; instead companies can provide grants for use in a broadly defined field or discipline. All grants must go through the Office of CME. Visit med.stanford.edu for more info.

  • Paula S. Jones, DDS, of Naperville, Ill., became the first woman president of the Academy of General Dentistry, during the organization's annual meeting held in Orlando in July.

  • The Healthcare Convention and Exhibitors Association has released an updated version of its “Guidelines for Scientific Exhibits and Poster Displays: Application, Production, and Presentation.” The guide is available at www.hcea.org.

  • The Annual Conference of the National Task Force on CME/Provider Collaboration will be held October 21-23, 2008, at the Baltimore Marriott Waterfront. For information, visit www.ama-assn.org/go/cmetaskforce.

  • The Alliance for CME annual conference will be held January 28-31, 2009, at the San Francisco Marriott. For information, visit www.acme-assn.org.