Pharma 101 - Pharmaceutical Fraud » Prescription drug

Pharma Group Says “No” To Expensive Gifts to Doctors Which Could Influence Their Drug Choices

Nolan and Auerbach — Fri, 05 Jan 2007 17:51:39 +0000

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), a worldwide trade group said that under their revised ethics code that as of January 1, 2007, they were no longer permitted to provide expensive gifts to doctors. This change to the ethics code was the first in the past 10 years. Members of this trade group are no longer permitted to give physicians money or expensive gifts such as stays in luxury hotels or trips to golf resorts that might influence their prescription drug selections. IFPMA members include Pfizer, GlaxoSmithKline, Sanofi-Aventis, Eli Lilly, AstraZeneca, Merck and Novartis. Here’s to more reform!

For more information click here.

Unapproved devices hit the FDA Radar Screen

Nolan and Auerbach — Fri, 13 Oct 2006 17:14:38 +0000

The FDA recently announced that it had filed for a permanent injunction against Endotec Inc. of Orlando, Florida to stop the illegal distribution of unapproved total joint replacement devices. The lawsuit alleges that the company has carried out the illegal distribution of the devices since March 15, 2002, despite the FDA’s warnings that these actions were illegal. This enforcement activity follows increased FDA awareness and resolve to take action against manufacturers of marketed unapproved new drugs. In 2003, after several decades without any apparent real enforcement, the FDA issued a Draft Compliance Policy Guide concerning marketed (but) unapproved drugs, declaring again that the drugs are illegal and that the FDA would exercise its enforcement discretion. There are hundreds if not several thousand prescription drugs on the market which have never obtained FDA approval in any form, yet year after year are unknowingly prescribed by physicians and taken by patients. Fortunately, the FDA in recent years has stepped up its enforcement efforts, even this month taking action against a manufacturer of unapproved dental drugs.

Omnicare In Trouble

Nolan and Auerbach — Mon, 09 Oct 2006 15:00:57 +0000

Omnicare is the nation’s largest supplier of prescription drugs for nursing homes serving approximately 1.4 patents or more than half the market. However, the company appears to be under investigation for its Medicaid billing practices in three states: Massachusetts, Ohio and Michigan Omnicare’s top executive in Michigan has been indicted on racketeering and Medicaid fraud charges. A spokesperson for the Michigan Attorney General’s Office says the investigation is far from finished. In January 2006, Omnicare disclosed that the U.S. Attorney’s Office in Massachusettts had subpoenaed documents that focused on its relationships with drug manufacturers and distributors. In addition Johnson & Johnson in 2005 disclosed that its company received a subpoena in September 2005 from the U.S. Attorney’s Office in Massachusetts “seeking documents related to sales and marketing of eight drugs to Omnicare, Inc.”

For more information click here.