It’s Monday, which means the Arizona Cardinals’ championship dreams go back into hibernation* for at least another year, and it’s six more weeks of winter for the rest of us, at least if you believe the groundhog.
In the pocket: States introduce bills to protect patients, promote transparency
Vermont legislators have proposed a new law that would build on the state’s existing gifts disclosure law. The new version, if enacted, would ban gifts, meals, and certain types of payments from drug and device companies to prescribers, and require all others to be disclosed on a website with the names of the individual physicians. Moreover, the new bill does not include a trade secret clause that some say weakens the existing statute.
Here’s more at the Barre-Montpelier Times-Argus, and an interview with Senate President Pro tem and bill sponsor Peter Shumlin on Vermont Public Radio.
And on the other coast, a bipartisan group of Washington state legislators have introduced a bill that would shore up patient privacy law around notices about prescription drugs, reports the Seattle Post-Intelligencer. Right now, a loophole in federal HIPAA regulations allows patient’s prescription data to be sold to drug companies and PBMs, who then contact patients directly, urging them to refill their prescription with a prescription-switch in mind.
“(The letters and e-mails) are couched as being of service to the patient, but in reality they’re marketing newer, more expensive drugs — without the patient’s doctor having any idea that this marketing pitch is being done,” Rupin Thakkar, a pediatrician in Edmonds and co-chairman of the Washington Coalition for Prescribing Integrity told the Post-Intelligencer.
In other privacy news, Massachusetts State Rep. Stephen Kulik discusses why he introduced a pharmaceutical data-mining ban in the pages of the Worcester Business Journal.
Glory days: Gone at the FDA
The latest GAO report on FDA medical device approval found that the agency has been whisking through of the riskiest class of devices through an abbreviated process, and in a letter we wrote about here, agency scientists indicated device approvals had been mishandled by political appointees. These are just two more signs, the New York Times editorial board says, that indicate the agency is in deep need of repair.
“The Obama administration will have to send a clear signal to the bureaucracy that the days of neglect are over,” writes the Times. “Officials will also have to make clear that the Bush administration’s practice of distorting science and weakening regulation to favor industry also is over.
But a new bill reintroduced last week may provide some answers for the troubled agency. The Food and Drug Administration Globalization Act (FDAGA), introduced by Energy and Commerce heavyweights Reps. John Dingell (D-MI), Bart Stupak (D-MI), and Frank Pallone (D-NJ), would establish a dedicated foreign inspectorate, and would give FDA funds to increase foreign GMP (good manufacturing practices) and pre-approval inspections. Producers of drugs and APIs (active pharmaceutical ingredients) would be inspected every two years and in some cases, four.
FDAGA also recognizes that while oversight is critical, the ultimate responsibility of ensuring quality rests with the manufacturer. The FDA cannot battle tainted drugs with inspections alone; industry must be accountable for their manufacturing supply chains.
The bill requires that manufacturers have a plan in place to formally assess their suppliers before contracting and to conduct ongoing monitoring and evaluation. The Act also requires that manufacturers be able to produce on request an electronic statement documenting every step in the supply chain of a drug, clearly establishing that each element, be it drug, ingredient, or other material, was processed and conveyed under appropriate conditions.
Here’s more at Reuters.
Offensive lines: U.S. attorney talks Lilly off-label marketing
Acting U.S. attorney for Pennsylvania’s Eastern District Laurie Magid paints a damning portrait of Eli Lilly’s marketing strategy to increase geriatric off-label use for dementia, depression and anxiety on the op-ed page of the Philadelphia Inquirer. Magid cites the “5 at 5” slogan reps were given, meaning “5 milligrams of Zyprexa at 5 p.m. would keep elderly patients quiet all night, not bothering the doctors or nursing staff in a long-term-care facility.” Such information was revealed in the course of the $1.4 billion settlement Lilly made around its off-labeling marketing of Zyprexa. Off-label is any use of a prescription drug not approved by the FDA, and it is illegal for companies to market drugs for off-label use.
“Off-label marketing is a sales strategy that ignores the basic purpose of the federal drug-regulatory program, which is to protect the consumer,” she writes. “Off-label-marketing cases are not easy to bring. They can take years and involve the review of millions of documents by an alphabet soup of federal agencies, state regulators, and law-enforcement officers. But we will keep bringing them until this practice stops.”
And in other off-label news, a Medicare rule change would make more off-label cancer drug prescriptions eligible for payments. The rule change expands the list of ‘guides’ used to determine coverage from one to four. Off-label prescribing, already a complex and controversial issue, is further complicated by the fact that three of the four guides that now trigger Medicare coverage are funded by pharmaceutical interests or groups that received industry funding, says the Wall Street Journal.
*In Phoenix right now: Sunny. Highs 69-74 degrees.