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2009-01-18 HEALTH CARE & PRESCRIPTION DRUGS TESTIMONY

105 CMR 970.000: Pharmaceutical and Medical Device Manufacturer Conduct


Department of Public Health

105 CMR 970.000: Pharmaceutical and Medical Device Manufacturer Conduct, which seeks to implement the ban on the provision of gifts from pharmaceutical and medical device companies to health care practitioners and requires disclosure of the payments made to health care practitioners.

MASSPIRG is a statewide wide, member supported,  non-profit public interest organization with a long history in health care reform and in particular working to lower the cost or prescription drugs. One example is a report we released in 2006,  Paying the Price, The High Cost of Prescription Drugs for Uninsured Americans, http://masspirg.org/MA.asp?id2=25401 which shows the rising cost of prescription drugs in Massachusetts and across the country. Our findings included a number of policy reforms including a ban on drug company gifts to medical providers, to stem the rising tide of prescription drug prices.

MASSPIRG worked last year to help pass the Health Care Cost Containment Law which included the Prescription Drug Marketing reforms.

Unfortunately, the regulations, 105 CMR 970.000: Pharmaceutical and Medical Device Manufacturer Conduct, as drafted, do not adequately protect Massachusetts consumers.  Consumers must be assured that their doctors and other prescribers are making decisions in the best interest of patients based on evidence-based information. The proposed regulations do not provide sufficient relief from the distortions caused by industry marketing practices that continue to drive up health care costs in Massachusetts and across the country.  The goal of the Massachusetts’ legislature was to ensure consumers have full knowledge of their physician’s relationship with pharmaceutical companies and reduce the overall cost to the health care system.

Implementation of this law will not hurt the biotechnology industry in Massachusetts. Since Minnesota’s gift ban and disclosure legislation passed in the early 1990s, pharmaceutical industry jobs there grew by over 36%, compared with 19.7% nationwide.   Sales representatives can continue to visit doctor’s offices and provide factual information about their products to educate providers. These representatives can continue to provide drug samples to providers so long as they are intended for patients. Companies can hire physicians to conduct or consult on industry-sponsored research, as long as the compensation they provide is reasonable for the services being provided.   

 The Gift Ban

MASSPIRG appreciates the limitation on gifts as provided in this regulation, however, more action is needed to curb the influence of this marketing technique.  Even small gifts set up an expectation of reciprocity.  It is human nature to want to do something in return for even a token gift.   Additionally, the proposed regulation only bans gifts for “sales and marketing.” Gifts given for educational and practice-related purposes, such as expensive textbooks and computers, are not banned.  We believe there should be a ban on all gifts including textbooks and computers and all meals.

Prescription drug costs contribute significantly to the steadily increasing high cost of health care.  Gifts and payments made to physicians inflate health care costs by leading to unnecessary prescribing of the highest cost and least proven drugs.  Approximately 94% of physicians receive gifts and payments from pharmaceutical companies.  The Department of Public Health needs to do more to protect Massachusetts consumers.  

Disclosure

The Department of Public Health does not require full disclosure of all payments to all physicians in these draft regulations.  Companies are not required to include any payments made for research purposes.  Consumers have the right to know how much their providers are getting paid for any purpose.

Research payments are often exorbitant and extremely influential.  As recent news articles have indicated, research physicians can be paid millions of dollars as part of their consulting arrangements with companies.  Recent investigations of university researchers who failed to disclose large sums of money from the industry illustrate the pitfalls and inconsistencies of self-reporting.   Massachusetts residents and the state cannot rely on companies to voluntarily disclose their payments.  Only state-enforced disclosure of all payments will ensure that the public and the state have a full and accurate understanding of all financial relationships between companies and providers.

 The information disclosed is not private.  Companies are only required to disclose the value, nature and recipients of the payments.  Companies already disclose information about clinical trials to the Federal Drug Administration (FDA) and National Institutes for Health (NIH).  The FDA publishes this information in a public database.  In 2008, the pharmaceutical industry endorsed a federal bill that would have required public disclosure of all payments made to all physicians.

Thank you for your consideration and attention.  Please contact me at 617-292-4800 if you have additional questions.

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