Category: Gift ban
Gift ban for the Mass Device Kit
Gov. David Paterson looks to add New York to the list of states prohibiting gifts to physicians from medical device and pharmaceutical sales reps.
If Gov. David Paterson gets his 2010-2011 executive budget past the state legislature in Albany, N.Y., you'll be able to add New York to the list of states with strict limits on the interaction between physicians and medical device sales representatives.
Doctors at Mass. General Hospital and Brigham & Women's Hospital who sit on the boards of medical device, pharmaceutical and biotech firms must limit their pay to no more than $5,000 a day.
Doctors who work for Partners HealthCare and sit on the boards of medical device, pharmaceutical or biotech firms are under increased scrutiny , after the owner of Mass. General Hospital and Brigham & Women's Hospital enacted new rules governing potential conflicts of interest.
The Harvard Medical School-affiliated hospitals are home to a number of senior officials who enjoy high-profile — and often lucrative — seats on the advisory boards of major companies in the medical sphere. According to the new rules, however, their pay for those seats must be limited to $5,000 a day for actual board work — or "a level befitting an academic role" — and the docs can no longer receive company stock as compensation.
New Jersey attorney general Anne Milgram wants the Garden State to clamp down on industry payments to physicians, mirroring laws already on the books in Massachusetts and Vermont.
New Jersey attorney general Anne Milgram wants the Garden State to adopt rules akin to regulations in Massachusetts and Vermont, so-called "gift bans" governing the relationship between industry and physicians.
Like its more northern neighbors in the Bay and Green Mountain states, the proposed rules aim to address "the pervasive and largely unregulated conflicts of interest that arise from the financial relationships between physicians and pharmaceutical and medical device companies."
Orthopedists left out more than 20 percent of the payments they landed from medical device makers in their research presentations, according to a study in the New England Journal of Medicine, bolstering arguments for so-called "sunshine laws" mandating disclosure of industry payments to physicians.
More than 20 percent of payments made to surgeons by the five leading orthopedic device makers were not disclosed by the docs during presentations of their research, according to a study in the New England Journal of Medicine.
The study examined reports of payments made to physicians by five manufacturers of total hip and knee prostheses in 2007 — DePuy, Smith & Nephew, Zimmer Holdings Inc., Biomet Inc. and Stryker Corp. — and reviewed the disclosure statements for any doctors who gave a presentation or served as a committee member or board member at the 2008 annual meeting of the American Academy of Orthopaedic Surgeons.
A Minnesota judge denied a request to reconsider the dismissal of a class action suit against the Boston Scientific subsidiary. Also in the Land of 10,000 Lakes, a supposed sunshine law isn't shedding much light on industry payments to physicians; and Maine's senators are under fire from all sides in the debate over healthcare reform.
Guidant suit dismissed
A federal judge in Minnesota denied a request to reconsider his 2007 dismissal of a class action suit against Guidant Corp. (now a Boston Scientific Corp. subsidiary) over an implanted defibrillator recall.
The suit, by a group of third-party insurance payors, sought redress for payments they were forced to make when patients' defibrillators had to be replaced after their 2005 recall.
Ruling that the motion to reconsider was nothing more than "an attempt to relitigate old issues," federal Judge Donovan Frank of the U.S. District Court for Minnesota declined to reconsider his 2007 decision to dismiss the lawsuit:
The leaders of five orthopedic device makers now in the clear over kickback allegations say their interactions with doctors are both transparent and necessary.
A few months after settling federal allegations that they ran kickback schemes, five orthopedic device makers say their new procedures ensure that their interactions with surgeons are transparent, above-board and, above all, absolutely necessary to the development of new devices and technologies.
The Boston University law professor and pharmaceutical industry monitor on the origins of the Massachusetts gift ban and how medical device makers came to fall under its rules.
Kevin Outterson, an associate law professor at Boston University, is an expert on patent law and intellectual property as it applies to the pharmaceutical industry. He works to balance the incentives behind innovation with making sure low-income people have access to life-saving therapies.
MassDevice spoke with Outterson about the background behind states' efforts to rein in industry, specifically "Big Pharma," and how medical device makers came to be folded into the strict Massachusetts regulations governing industry payments to physicians.
MassDevice: Can you give us a quick history of the roots of the gift ban in efforts to regulate the pharmaceutical industry?
