RxP Weekly Reader: Summer’s End Edition #29
Today, two Vermont groups, the Vermont Association on Mental Health and the Vermont Psychiatric Association, jointly called for the trade secret exemption be stripped from the state’s pharmaceutical payment disclosure law, arguing that the clause keeps valuable data and a complete picture of industry relationships out of the public eye. According to the Rutland Herald, Senate President Pro Tem Peter Shumlin (D-Putney) is drafting a bill for the next legislative session that would do just that.
“The bill got watered down by the well-funded pharma lobby on its way to the governor’s desk,” Shumlin told the Herald. “We have an obligation to fix this, because otherwise this disclosure is essentially useless.”
Here are a few bits and pieces about what pharma means for the U.S. presidential election, and what the election may mean for pharma.
The Hill reports that the Biotechnology Industry Organization chairman and former congressman Rep. Jim Greenwood (PA) has said his organization has not traditionally endorsed a presidential candidate, and “will not make an endorsement and, frankly, it is because there are not such great differences between these candidates that it would make sense for us to make such an endorsement.”
Though the pharmaceutical industry, which is often aligned with BIO, tends to support Republican candidates, the report indicates BIO’s own political action committee has not donated money to any candidate in the 2004 or 2008 presidential elections.
In counterpoint, former FDA chief counsel Richard Cooper told attendees at the Food and Drug Law Institute’s 20th annual Advertising & Promotion Conference that an Obama presidency may trigger an up-tic in regulatory activity. Here’s the report in Medical Marketing and Media.
Here, there, and everywhere
Last week, the Associated Press ran an omnibus story on the state of industry influence on American medical education. More a panoramic than news snapshot, the report touches on the revised PhRMA Code, medical journals’ tightening ship when it comes to author disclosures, federal pre-emption, and moves by medical societies to draw lines between their members and their industry underwriters.
What we didn’t know? “The Council of Medical Specialty Societies, which represents 32 specialty groups, this summer started collecting each group’s best practices on disclosure and limitations on speaking and other activities by their officers. Council CEO Dr. Norman Kahn said a new council policy should be ready in November,” according the report.
Waxman chides FDA for “industry priorities”
The Wall Street Journal HealthBlog has a letter from Rep. Henry Waxman (D-CA) addressing the FDA on two issues that concern him: the agency’s loosening of off-label marketing restrictions, and the federal pre-emption case Wyeth v. Levine, in which the Supreme Court will decide whether FDA approval protects companies from being sued by patients who suffer effects of those drugs.
“At a time in which FDA’s own Science Board warns that ‘American lives are at risk’ due to chronic underfunding of the agency,” wrote Waxman, “I am deeply concerned that these industry priorities are being promoted at the expense of the agency’s core public health mission.”
Fly-on-the-wall dept.: MedPAC
A recent American Academy of Family Physicians news bulletin spotlighted some interesting insights from a Medicare Payment Advisory Commission meeting Sept. 4, where commissioners discussed a “national database of financial relationships between physicians and drug and device manufacturers.” For those who like the nitty- gritty, this story’s got it all: reporting limits, clinical trial disclosure delays, drug samples, and more.
Biz journal looks at Bay State gift restrictions
And the Worcester Business Journal ran this look-ahead on what the gift restrictions in the new health care cost and quality bill may mean for businesses, physicians and medical centers in Massachusetts.