by Daniel B. Moskowitz
US Justice Department Probes Vytorin Marketing
The US Department of Justice has launched an investigation into whether Merck and Schering-Plough violated the False Claims Act by using unsupported claims that their cholesterol-lowering medication Vytorin worked much better than generics, which cost one-third the price, in order to market the drug to Medicare and Medicaid beneficiaries. The companies were officially informed of the probe in a September 10 letter, but it was only publicly revealed on November 3 in a Merck filing with the Securities and Exchange Commission. The filing also disclosed that attorneys general in 35 states are investigating Merck's marketing practices for the drug and that the company is facing approximately 140 consumer class actions alleging wrongdoing in the way it promoted Vytorin and its component Zetia.
In Other Legislative and Regulatory News . . .
The Wisconsin Medical Society (WMS) issued a voluntary “complete ban” on its 12,000 members' accepting gifts from pharmaceutical manufacturers. The new ethics policy covers “personal items, office supplies, food, travel and time costs, or payment for participation in online continuing medical education” from any provider of products that the physicians prescribe. The WMS decided that a complete ban rather than a limit on the dollar value of gifts is the best way to avoid conflicts of interest. The new policy also decrees that WMS members “should not serve as members of speakers' bureaus for health product companies.” However, it allows physicians to accept free drug samples for patients but wants the practice to be “limited” and to be replaced by vouchers that physicians can give to patients to reduce the cost of filling a prescription.
On January 1, 2009, Florida plans to begin its Cover Florida program, which will offer no-frills, low-cost health insurance to adults younger than 65 years. The state has selected United Healthcare and Blue Cross and Blue Shield of Florida to sell the policies statewide; Florida Health Care Plans, JMH Health Plan, Total Health Choice, and Medical Health Plans will market the program in a few populous counties. All the policies will cover prescription drugs as well as urgent care, surgery, and preventive care but will exclude reimbursement for treatment of cancer or mental illness. Each of the Cover Florida participating insurers will offer a plan with inpatient and catastrophic coverage and a plan with premiums of about $150 a month without such coverage. Residents who have been without health insurance for a minimum of 6 months are eligible to sign up.
Kentucky is setting up a statewide network of centers to help low-income residents receive free or discounted drugs from pharmaceutical manufacturers. The program, an expansion of a program already in operation in 2 Kentucky towns, Paducah and Elizabethtown, will guide residents through the often complex application procedures for the pharmaceutical companies' assistance programs. The centers will be staffed by volunteers supported by a legislative appropriation of $1 million for training, site set-up, and computers. The program’s goals are to get centers up and running in 90 of the state's 120 counties by March and eventually to open a center in every county.