Yesterday, DPH issued temporary regulations that, unless changed, will gut the state’s drug and device marketing regulations, which were proudly heralded in 2008 as a step toward curbing drug industry marketing abuses and addressing spiraling health care costs. In a shocking capitulation to industry, the DPH regulations go even further than the amendments passed this summer by the legislature, which had weakened the ban on industry providing lavish meals to physicians. DPH would allow drug, device and biotech companies to pay for physician meals outside clinical settings, with no restrictions on the cost of the meals.
A DPH staffer acknowledged that the administration’s Mass Life Sciences Center was consulted about the language--- companies meeting down the street at the BioPharm America 2012 Conference must be thrilled. Pharma’s lobbyist, Marjorie Powell, was quoted in the Globe on Thursday,, saying “the Massachusetts law was placing unnecessary restrictions on the industry as it tries to work with health care providers” and she reported meeting with DPH employees who were drafting the regulations. Yet DPH refused to meet with consumer advocates in the Massachusetts Prescription Reform Coalition, nor incorporate any of our written recommendations.
This summer, the Massachusetts legislature repealed the component of the gifts and disclosure law that prohibits pharmaceutical and device companies from giving gifts to Massachusetts doctors, nurses, and other health care providers. The amendment made it legal for the industry to provide "modest meals and refreshments” off-site, at restaurants and other facilities “conducive to informational communication.” DPH was then required to define these terms but it failed to do a credible job, allowing “modest” to simply mean “similar to what a health care practitioner might purchase when dining at his or her own expense.” If that isn’t bad enough, public health experts at the DPH also decided not to address the issue of industry paying for wine or alcohol. Can this possibly be reasonable, given the law’s requirement that payment for meals and refreshments be allowed only in a venue “conducive to informational communication?”
HCFA reports that at yesterday’s Public Health Council meeting to review and approve the regulations “a number of Council members were openly skeptical. One member asked about alcohol. The DPH staffer explained that they saw rationale in the law for barring alcohol. Another Council member asked how the restrictions would be enforced. Self-reporting was the answer. How would DPH know whether the ‘educational’ sessions were truly educational? The DPH replied that it would be up to the drug manufacturer to make its own decisions.”
The gifts ban and disclosure law was an early reform aimed not only at protecting patients but also reducing health care costs—an important goal for sustaining our near-universal coverage in Massachusetts. Numerous peer-reviewed studies show that marketing tactics such as providing meals and gifts influence prescribers to select the latest, most expensive drugs when generics or other lower-cost, equally effective alternatives are available.
Although the gift ban is backed up by sound policy rationales and studies, the politics have been challenging. The pharmaceutical industry teamed up with the restaurant industry and lobbied hard to withdraw the gift ban in 2009, 2010 and 201l. But now they have nearly succeeded in undermining the law, gaining far more concessions from the Patrick administration in these regulations than the legislature allowed.
The DPH regulations would end all disclosure requirements, which under the law apply not just to physicians but to all providers. The DPH regulations dismantle this system as well as the $2,000/company annual fee that supports it. The pretext is the upcoming implementation of the Physician Payments Sunshine Act in Obamacare, which requires industry to report all payments to physicians and teaching hospitals. But the MA law includes disclosure of payments to all providers, including nurse practitioners and physicians’ assistants, key primary care providers in MA who are increasingly the target of industry marketing. Such disclosures are not preempted by the federal law.
Fortunately, Massachusetts medical schools and medical centers have enacted their own policies to shield physicians, researchers, physicians-in-training and other staff from the influence of inappropriate marketing. They have instituted bans on gifts, meals, inappropriate consulting and other marketing, basing their policies on a strong commitment to medical professionalism and good patient care. These institutions acknowledge that relationships with pharmaceutical, device and biotech companies are essential for research and innovation---we all agree with the Mass Life Sciences Center on that. However, these institutions are also committed to erecting firewalls that protect patient care and medical education from industry influence. But they cannot regulate physicians that are not in their systems---the Massachusetts law bridged that gap by creating a blanket policy for all providers.
We call on patients, consumer advocates, legislators, physicians and other providers to join us in reversing the DPH emergency regulations and maintaining the letter and spirit of this important law.
--Marcia Hams, Director of Prescription Access and Quality
-- Anna Dunbar-Hester, Policy Analyst
This blog was made possible by a grant from the Attorney General Consumer and Prescriber Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin.