The Vermont legislature is getting tougher on the pharmaceutical industry by passing a bill that tightens up the state’s existing gift and payment disclosure law.
The new law closes a trade secret loophole that allowed pharmaceutical companies to submit most data in aggregate form. The bill also expands the disclosure requirement to medical device and biologics manufacturers.
The new bill requires every manufacturer of prescribed products to disclose the value, nature, purpose, and recipient information of any allowable expenditure or gift including:
- Anything of value provided to a healthcare provider for free
- Any payment, food, entertainment, travel, subscription, advance, service, or anything else of value provided to a healthcare provider
The bill specifically exempts reporting of:
- Royalties and licensing fees
- Rebates and discounts for prescribed products
- Payments for clinical trials
- Samples for distribution to patients
- Scholarship or other support for medical students, residents, and fellows to attend a significant educational, scientific, or policy-making conference or seminar
- Provision, distribution, dissemination, or receipt of peer-reviewed academic, scientific, or clinical articles or journals that serve a genuine educational purpose
Vermont Governor Jim Douglas must still sign the bill for it to become law.
Los Angeles Superior Court Judge Victoria G. Chaney denied class action status to plaintiffs seeking to sue Merck for its withdrawn painkiller Vioxx.
Chaney said in her ruling that trying plaintiffs’ claims would require an examination of each proposed class member’s medical needs and history, which Merck successfully argued would be unfair, according to a company statement.
In March, New Jersey Judge Carol Higbee issued a similar ruling denying class action status to a group of plaintiffs who sought reimbursement for out-of-pocket Vioxx costs. In 2007, the New Jersey Supreme Court ruled that certification of a nationwide class of insurers who paid for Vioxx was not appropriate because common questions of fact did not predominate.
Merck stopped selling Vioxx in September 2004 after a clinical trial showed that it increased the risk of strokes and heart attacks in some patients.
In 2007, Merck reached a proposed $4.85 billion settlement to resolve patients’ claims of personal injury due to Vioxx. More than 99% of those eligible signed up for the settlement by the November 9, 2007, deadline, according to Merck. In addition, the company agreed in May 2008 to pay $58 million to settle claims by 29 states and the District of Columbia that it downplayed the risks of Vioxx in advertising.
Medical device maker Synthes, Inc., based in West Chester, PA, entered into a settlement agreement with the New Jersey Attorney General (AG) to resolve allegations the company failed to disclose financial conflicts-of-interest among doctors who conducted clinical testing on its products, according to the AG.
As part of the settlement agreement, Synthes will:
- Prohibit compensation of clinical investigators tied to the outcome of the clinical trial
- Pay clinical investigators fair market value compensation for their clinical trial and consulting work
- Collect information on financial interests from clinical investigators
- Record all financial interests related to clinical investigators in a financial interest information database
- Disclose all financial interests of all clinical investigators on the company’s Web site
- Provide complete disclosure of financial interests to the FDA
- Disclose all financial interests directly to healthcare facilities serving as clinical trial sites
- Train employees on financial interest and disclosure
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Ranbaxy Laboratories issued a voluntary recall for all 100 mg Nitrofurantoin Capsules currently on the market in the United States, the company announced.
Only some lots of Nitrofurantoin do not conform to approved laboratory specifications, but the company decided to recall all of the capsules. Ranbaxy said the capsules are unlikely to produce any serious adverse reactions, but may increase nausea and vomiting.
Michigan’s Medicaid False Claims Act meets the requirements of the Deficit Reduction Act of 2005 (DRA) and the state is entitled to an additional 10% of false claims recoveries, according to the OIG.
Under the DRA, each state with a False Claims Act that is at least as effective in facilitating and rewarding qui tam actions as the Federal False Claims Act in protecting state Medicaid funds is entitled to an extra 10% of fraud recoveries from those actions. For the state to receive the additional money, the OIG must approve the state’s False Claims Act.
The Institute of Medicine (IOM) became the latest organization to call for an end to pharmaceutical industry support for academic medical centers, journals, and professional societies.
The IOM wants entities engaged in health research, education, clinical care, and development to establish guidelines for accepting industry support and to strengthen conflict-of-interest policies, according to an IOM report.
Congress should also require pharmaceutical companies to publicly disclose payments to physicians, researchers, academic health centers, professional societies, patient advocacy groups, and others involved in medicine, IOM said.