Healthy Skepticism Library item: 15251

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Grogan K.
US state puts stricter disclosure rules in place for pharma
Pharma Times 2009 Mar 13
http://www.pharmatimes.com/worldnews/article.aspx?id=15487

Full text:

The State of Massachusetts has passed what it calls “tough new rules” governing sales and marketing practices of pharmaceutical and medical device companies doing business there.

The state’s Public Health Council says that the sweeping new regulations “place Massachusetts at the forefront nationally in monitoring the relationship between industry and health care providers”. It says that they are also the strictest in the USA in mandating reporting and public disclosure of certain fees, payments and other compensation provided by companies to physicians”.

The new rules passed by a vote of 10 to 0 and will take effect on July 1, 2009 – the first public reporting by companies will be due a year from then. Massachusetts is the only state to require disclosure by device makers, as well as drugmakers, and just one of two states to make such disclosures public.

Payment for “entertainment or recreation” is prohibited, under the new regulations, as is cash given to health care providers, “except as compensation for bona fide services”. Financial support by manufacturers to health care practitioners in training is banned, as are items such as pens, mugs, and calendars.

Meals must be “modest, and only provided at a training or educational event”, noted the state Department of Public Health, which noted that the new rules do not cover “genuine research projects and clinical trials”, as well as other “price concessions such as rebates and discounts”. However, “all other payments of $50 or more would need to be disclosed publicly”.

The move by Massachusetts has caused a furore over the past year among some drugmakers who have said that it would deter healthcare professionals in the state’s many academic health centres from working with pharmaceutical research companies. Robert Coughlin, president of the Massachusetts Biotechnology Council told the Boston Globe that it is now seen as “the most unfriendly state in the nation toward industry, “adding that “in these tough economic times, you don’t want to send a chilling message to an industry that’s a growth industry.”

DPH Commissioner John Auerbach acknowledged that “these new rules have been the subject of great interest on the part of the general public, health care advocates and the industry.” However he added that “the enormous amount of feedback, and the thorough consideration by the Public Health Council, has resulted in a strict but balanced regulation”.

It will make Massachusetts “a leader in promoting transparency”, he added, but the rules “also recognise the important role that research and clinical trials play in our state and do nothing that will inhibit that important work”.