Entries by admin_fidj

Pharmaceutical Company Lawyer Indicted For Obstructing FDA Investigation Into Promotions of Unapproved Uses of Prescription Drug

An in-house counsel for a large pharmaceutical company was indicted for obstruction of justice and making false statements in relation to an FDA investigation into promotions of “off-label” uses of the company’s prescription drugs. According to the indictment, the in-house counsel sent a series of letters to the FDA in response to FDA inquiries that falsely denied that the company had promoted the drug for “off-label” uses, even though the attorney knew that the company had sponsored numerous such promotions.

IRS Reaffirms Respect for Attorney-Client Privilege in Schedule UTP Disclosures

As we reported several weeks ago, the new Internal Revenue Service (IRS) regulations on uncertain tax positions (UTP) raise significant concerns for taxpayers about attorney-client privilege. The thought is that disclosures required on Schedule UTP may divulge information on the perceived value to a company of pending litigation and other corporate financial events – information that could fall under attorney-client privilege.

Schedule UTP Disclosures Will Put New Companies in the Sights for an IRS Audit

When the Internal Revenue Service proposed the new regulations on uncertain tax positions (UTP) several months ago, many taxpayers felt the hair on the back of their necks go up. In the days before the new Schedule UTP, when IRS auditors came to examine a business, it was a game of cat and mouse – what did the company know that the auditors didn’t, and what were the auditors really looking for? The fear with Schedule UTP was that the required disclosures under the new regs would provide a roadmap for auditors that would put businesses at a disadvantage versus the examiners.

FDA Releases Guidance for Cellular Therapy Sponsors

The U.S. Food and Drug Administration (FDA) have recently published its guidance document, entitled “Guidance for the Industry: Cellular Therapy for Cardiac Disease.” Found here, this document finalizes and incorporates […]