Patrick Administration Passes Tough New Rules Governing Pharmaceutical and Medical Device Industries

New regulations are the most comprehensive in the nation.

BOSTON, March 11, 2009 — The Massachusetts Public Health Council (PHC) today passed broad new rules governing sales and marketing practices of pharmaceutical and medical device companies doing business in Massachusetts.

The sweeping new regulations place Massachusetts at the forefront nationally in monitoring the relationship between industry and health care providers, and will be the strictest in the nation in mandating reporting and public disclosure of certain fees, payments and other compensation provided by companies to physicians. The new rules also contain gift prohibitions and restrictions on meals given by companies to health care providers.

The new rules passed by a vote of 10 to 0. Each of the fifteen PHC members underwent a thorough vetting involving the State Ethics Commission prior to the vote, and three members were not allowed to participate in the discussion or vote on the measure in accordance with conflict of interest laws. Two other members of the Council were traveling and did not attend the meeting.

“I want to thank the Public Health Council and DPH for the thoughtful and fair manner in which they developed these regulations,” said Dr. JudyAnn Bigby, Secretary of Health and Human Services. “These new rules will go a long way toward ensuring transparency about the interactions between industry and providers, a need that other states and industry themselves recognize.”

The regulations will take effect on July 1, 2009 and the first public reporting by companies will be due by July 1, 2010. The information reported by companies to the Massachusetts Department of Public Health (DPH) will be posted on the DPH web site, and will be searchable by company and by health care provider.

“These new rules have been the subject of great interest on the part of the general public, health care advocates and the industry,” said DPH Commissioner John Auerbach. “I believe the enormous amount of feedback, and the thorough consideration by the Public Health Council, has resulted in a strict but balanced regulation. The passage of these rules will make Massachusetts a leader in promoting transparency by requiring disclosure of certain payments by the industry to health care providers in our state. However, these rules also recognize the important role that research and clinical trials play in our state and do nothing that will inhibit that important work,” Commissioner Auerbach added.

With the regulations passed today, Massachusetts will be the:

Only state to require that companies adopt and comply with a state-authored Code of Conduct;

Only state to require disclosure of industry payments to health care practitioners by both pharmaceutical and medical device companies;

The state with the broadest definition of “sales and marketing”;

Only one of two states to make disclosure data part of the public record. DPH will provide a web database that will be searchable by health care provider name and by company.

What Are Some of the Activities that Will be Prohibited or Restricted?
Payment for entertainment or recreation is prohibited, such as tickets to a sporting event, passes to a museum, etc;

Payments in cash or cash equivalents to health care providers, either directly or indirectly, are prohibited, except as compensation for bona fide services;

Financial support by manufacturers to health care practitioners in training;

Complimentary items such as pens, mugs, and calendars are banned;

Meals are restricted and in some instances prohibited. For example, any meals given to health care providers must be modest, and only provided at a training or educational event. They generally cannot be provided or paid for when they occur outside of a health care provider’s office or the hospital setting. Meals to spouses or other guests are prohibited. The rules would allow for industry to sponsor conferences and professional meetings at hotels and convention centers;

The new rules would exempt from disclosure payments made to health care providers for genuine research projects and clinical trials, price concessions such as rebates and discounts, prescription drugs provided solely and exclusively for patient’s use, demonstration and evaluation units and in-kind items provided for charity care. However, all other payments of $50 or more would need to be disclosed publicly;

The rule passed today generated more than one thousand pages of testimony and comment during the public comment period—the most of any proposed regulation in recent memory.

For more information on the regulations passed today visit http://tinyurl.com/azocku.

 

Posted: March 2009


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