D-Day Tomorrow For Pharma Gift Ban Market Regulations
Tomorrow morning (Wednesday 11/21), the Public Health Council will be voting on final regulations implementing the changes to the pharma gift ban and marketing regulations. Over the summer, the legislature changed the law to allow drug and device companies to provide "modest" meals to doctors and other prescribers. The initial rule, which was widely criticized by consumer and medical groups (but supported by restaurants and pharma industry) defines modest as anything a doctor might order on his or her own tab, including alcoholic drinks.
State law empowers the members of the Public Health Council to review and make amendments to proposed regulations - they are the final authority. We hope they use their power if the regulations are not amended.
The cost of meals is also passed on to consumers in the form of higher drug prices. If such wining and dining didn’t work, the drug industry wouldn’t spend $6 billion a year on direct marketing to physicians. In addition, marketing expenses such as meals are tax deductible for the pharmaceutical or device companies, lowering their tax bill, reducing state and federal revenue, and ultimately increasing the tax burden on the remainder of the state residents.
MODEST MEANS MODEST
There's been no public discussion of the issue since the DPH hearing on the regulations. We've called for a strict dollar limit ("modest means modest"), and think that free alcohol is utterly incompatible with educational meetings.
At the hearing, testimony was overwhelming in favor of changing the emergency regulation. For example, the National Physician's Alliance testified that
As physicians, we are deeply disappointed that these regulations undermine the State’s leading commitment to evidence-based prescribing and to the protection of patients from the dangers of undue marketing influence in our profession. The new emergency regulations accommodate industry interests at real expense to patient safety and will result in a high financial cost to the state’s health care budget.
Representing physicians across medical specialties, the National Physicians Alliance (NPA) is united in support of unbiased, evidenced-based education and clinical practice. Marketing interests should not supersede this foundational obligation to patients.
Senator Mark Montigny, a national leader in prescription drug policy, wrote that "allowing medical companies to spend lavishly on meals and entertainment for health care providers means higher costs to the companies which are then passed on to consumers. It is estimated that the medical industries spend over $6 billion a year on marketing to providers. It has also been shown that such marketing predisposes providers to prescribe the products offered by those that feed them. The end result- patients pay more for drugs that they may not need."
Similarly, Reps Jason Lewis and Ruth Balser testified that "The FY13 budget explicitly included language stating that meals and refreshments must be 'modest' in nature. The Legislature chose this language deliberately, and rejected other proposed budget amendments that would have allowed for any and all meals with no restrictions. We feel that the current emergency regulations lack specificity in the definition of 'modest,' and should be rectified through the establishment of clear, concrete and enforceable terms, such as specifying a monetary limit for modest meals."
Specifically, we urge DPH and the Public Health Council to amend the current regulations to:
- Set a concrete and enforceable per-person dollar limit for the meals provided by drug and device manufacturers. Meals should truly be modest and thus should exclude elaborate or gourmet options. To quantify the value of a ‘modest’ meal, we suggest that DPH employ the established and widely used per diem reimbursement rates for state employees as a framework. These amounts are updated each year and are an objective definition of modest.
- Alcoholic beverage should be specifically prohibited at educational presentations where meals or refreshments are provided to health care practitioners, as the provision of alcohol is clearly not conducive to informational communication. We also recommend that DPH require that meals and refreshments be provided within the context of the informational exchange. Thus, food and refreshments should be provided only in conjunction with the informational presentation, as opposed to during a pre-presentation cocktail hour or a post-presentation meal. We also recommend that venues for such educational presentations should not be locations that are otherwise recreational in nature, such as resorts, sporting clubs, casinos or other vacation destinations.
- The emergency regulation wipes out many of the reporting requirements which allow the public to assess spending by drug companies to market their drugs. We urge DPH to amend the regulation to require the current disclosure and reporting requirements. In addition, in order to ensure effective monitoring and enforcement of these requirements, we recommend that DPH require receipts for all expenditures at educational presentations. We further suggest that pharmaceutical and medical device companies be subject to annual audits in order to ensure accurate reporting.
The public will be watching and listening closely tomorrow morning as the Public Health Council takes up these regulations. We hope that the public interest prevails in the discussion.