ePharmaceuticals

Vermont strengthens gift ban

mleppert — Tue, 12 May 2009 17:28:17 +0000

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 [...]

No class action status in CA Vioxx lawsuit

mleppert — Tue, 12 May 2009 17:25:22 +0000

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Angeles Superior Court Judge Victoria G. Chaney denied class action status to plaintiffs seeking to sue Merck for its withdrawn painkiller Vioxx.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 [...]

Device maker enters settlement for failing to disclose payments to physicians

mleppert — Fri, 08 May 2009 17:11:25 +0000

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 [...]

Editor’s Note: Publication of Pharma Compliance Alert to end May 13

admin — Wed, 06 May 2009 05:54:00 +0000

Next week’s issue will be the final issue of Pharma Compliance Alert. We thank you for being a loyal subscriber.

If you are interested in information about customizable, compliance e-learning courses for sales and marketing staff, please contact Maureen Croce at 866-464-2776 or mcroce@hcpro.com.

Ranbaxy recalls Nitrofurantoin

admin — Wed, 06 May 2009 05:51:00 +0000

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 False Claims Act qualifies for additional recoveries

admin — Wed, 06 May 2009 05:49:00 +0000

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.

IOM calls for end to industry support

admin — Wed, 06 May 2009 05:46:00 +0000

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.

PhRMA releases new guidelines for clinical trials

mleppert — Tue, 28 Apr 2009 15:53:50 +0000

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 [...]

Court upholds Vermont ban on data mining

mleppert — Tue, 28 Apr 2009 15:48:49 +0000

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 [...]

Biomet under investigation for possible fraud

mleppert — Mon, 27 Apr 2009 20:02:44 +0000

Government investigators are examining allegations that Biomet improperly sold, promoted, and billed for its bone growth stimulation devices, the company disclosed in an April 14 SEC filing. Federal authorities in West Virginia are investigating sales and marketing practices for Biomet’s subsidiary EBI, which makes electric stimulators for post-surgery patients. The U.S. Attorney in Massachusetts is also [...]