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Angeles Superior Court Judge Victoria G. Chaney denied class action status to plaintiffs seeking to sue Merck for its withdrawn painkiller Vioxx.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.
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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.
Pharmaceutical companies should provide results summaries for all interventional clinical trials involving patients, according to revised industry guidance.
Companies should publish the summaries whether the FDA approves the medicines or the particular research programs have been discontinued
The newly revised Pharmaceutical Research and Manufacturers of America (PhRMA) Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results also:
- Commits companies to registering clinical trials on public Web sites
- Adopts the authorship standards of the International Committee of Medical Journal Editors
- Enhances disclosure standards for published research
The revised guidelines align with the changes to the PhRMA Code on Interactions with Healthcare Professionals, which became effective in January.
Pharmaceutical companies may soon be unable to collect prescriber data in Vermont.
District Judge J. Garvan Murtha cleared the way for the state to enact a ban on the data-mining of prescription drug information for marketing purpose when he ruled the 2007 law that bans the practice is constitutional.
In 2007, the Vermont legislature passed Act 80, designed to reduce prescription drug costs. The law bans all use of prescriber data for marketing purposes unless a physician opts in and allows the information to be used.
Pharmaceutical manufacturers and the companies that collect prescription drug prescribing data sued Vermont, claiming the law was unconstitutional. After the challenge, the Vermont legislature delayed implementing the law until July 2009.
The pharmaceutical industry and data mining companies also filed suits against similar laws in Maine and New Hampshire. The industry and data mining companies initially prevailed in both suits. However, a federal appeals court ruled Nov. 18 in favor of the New Hampshire law restricting the sale or use of prescribing patterns. An appeal of the ruling against the Maine law is pending in the First US Circuit Court of Appeals.
Pharmaceutical manufacturers paid almost $3 million to 2,280 doctors, hospitals, universities, and others to market their drugs in fiscal year 2008, according to the Vermont Attorney General’s (AG) sixth annual Report on Pharmaceutical Marketing Disclosures.
Almost half of the reported marketing expenditures were for speaking fees and payments, while nearly 25% was for marketing. Almost 60% of the expenditures were direct payments to recipients in the form of cash or check.
Twenty-five physicians and nurses received more than $20,000 in cash or benefits from pharmaceutical companies, according to the report. Pharmaceutical companies spent almost $500,000 on psychiatrists with one psychiatrist receiving more than $112,000 from the industry.
The top five spenders in Vermont on marketing during FY 2008 were:
- Eli Lilly
- Pfizer
- Novartis
- Merck
- Forest Pharmaceuticals
Pharmaceutical companies spent more than $445,000 marketing drugs for diabetes. Spending on drugs for hypertension, depression, and attention-deficit/hyperactivity disorder topped $200,000 for each category.
Pharmaceutical companies designated more than 80% of the expenditures in the report as trade secrets. The AG cannot release that specific information to the public without the manufacturer’s approval. The Vermont legislature is considering a bill that would eliminate the trade secret protection from disclosure. The proposed legislation would also ban more gifts to physicians.
Johns Hopkins Medicine (JHM) and Harvard’s affiliated healthcare institutions are enacting new conflict-of-interest policies that will limit pharmaceutical representatives’ access to healthcare professionals.
The new JHM policy prohibits physicians, scientists, students, and staff members from accepting gifts and meals from medical device companies beginning July 1, according to a JHM release.
The Johns Hopkins Medicine Policy on Interaction with Industry also prohibits consulting arrangements that require no real work. Pharmaceutical manufacturer representatives may only meet with Johns Hopkins staff members in non-patient areas and then only at the invitation of a staff member.
Among other things, the new policy also:
- Requires disclosure of the industry sponsor whenever a company supports non-credit educational courses
- Bans industry funding for Hopkins’ department meetings, retreats, or social events
- Limits when Hopkins employees may speak at, or on behalf of, industry-sponsored programs
- Reiterates an existing ban on ghostwriting
Partners HealthCare, which includes Harvard-affiliated Massachusetts General and Brigham and Women’s hospitals in Boston, is also tightening its policies, Partners announced.
Under the new policy, industry representatives must have written invitations before they can have access to Partners sites and staff.
The updated Partners policy, among other things:
- Prohibits all gifts, including meals and funding for meals, provided directly to staff by industry
- Permits free drug samples to be distributed only through the hospital pharmacy or some other centralized system
- Requires all industry funding for educational programs and fellowships go to a central fund
- Prohibits ghostwriting