Today the Department of Public Health approved temporary regulations that make a mockery of the legislature’s changes to the state’s drug and device marketing restrictions, further eroding doctor-patient protections (see joint press release from HCFA, AARP, MassPIRG and Community Catalyst (pdf)).
The regulations implement a law passed over the summer to relax state restrictions on meals provided by pharmaceutical and medical device companies to doctors. Under the previous law, meals may not be provided unless in a clinical setting. The amendment permits “modest meals and refreshments” to be offered at educational programs outside of a health care setting, such as a restaurant. The regulation approved today ignored the legislative direction to limit permitted meals to those considered modest, and instead, astonishingly, defined “modest” as “similar to what a health care practitioner might purchase when dining at his or her own expense.”
In other words, pick anything off the menu, Doctor. “I’ll have the usual.” Order a drink or two, too. Be our guest.
As a result, drug companies are free to ply doctors with lavish multi-course meals and drinks, paid for by pharmaceutical industry marketing budgets, and ultimately tacked on to the price of prescriptions. Plus the marketing expenses are tax deductible, meaning we all pay higher taxes so drug companies can take doctors out for a great meal.
The temporary regulations approved today expire in December. DPH will conduct a hearing on October 19 to consider permanent regulations.
At today’s Public Health Council meeting to approve the regulations, a number of Council members were openly skeptical. One member asked about alcohol. The DPH staffer explained that there was no barrier to providing any alcoholic beverage at an educational session sponsored by a drug or device marketing department. Another Council member asked how the restrictions would be enforced. Self-reporting was the answer, but with the standard being so vague, how could anyone report a violation in the unlikely event that one wanted to blow the whistle? Another question was raised about how DPH will know whether the “educational” sessions were truly educational, with the member using air quotes to indicate his skepticism. The answer, again, was that it is up to the drug manufacturer to make its own decisions.
In the end, the regulation is a complete capitulation. In fact, the DPH staff indicated that the Mass Life Sciences Center, chartered to be a cheerleader for the industry, was consulted in drafting the regulations. Consumer protection suggestions submitted by HCFA, the Mass Prescription Reform Coalition, and many other groups were not included in these regulations (see our comments (pdf)).
We were distressed when the legislature weakened the gift ban on behalf of the restaurant industry. We are now sickened that Massachusetts regulations have defined “modest” to mean — whatever! Modest means modest. We have 30 days to make our case. We intend to be major presence at the upcoming hearings, and to continue to press our case. The regulations should establish a strict dollar limit, and proscribe industry-provided alcohol at educational programs. To get involved, contact Alyssa Vangeli, 617-275-2922, firstname.lastname@example.org.