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.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-11-18 11:13:162014-11-10 18:23:01Pharmaceutical Company Lawyer Indicted For Obstructing FDA Investigation Into Promotions of Unapproved Uses of Prescription Drug
On November 16, 2010, the Office of Foreign Assets Control (“OFAC”), of the U.S. Department of the Treasury announced that it reached a settlement with Pinnacle Aircraft Parts, Inc. (“Pinnacle”) […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-11-17 15:47:032014-11-10 18:23:01Pinnacle Aircraft Parts, Inc. Reaches Settlement With OFAC For Violation Of Reporting, Procedures, And Penalties Regulations
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.
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.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-11-15 10:04:272025-12-09 13:39:35Schedule UTP Disclosures Will Put New Companies in the Sights for an IRS Audit
On October 29, 2010, the Office of the Chief Counsel of the Internal Revenue Service (IRS) issued Chief Counsel Advice (CCA) 2010-43-028, which discusses the effect of the First Sale […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-11-15 08:11:522014-11-10 18:23:01Internal Revenue Service Office of the Chief Counsel Carves Out Narrow Exception for Properly Applied First Sale Rule in Customs Law
On October 26, 2010, the Taxpayer Advocate Service (“TAS”) announced that it will recommend in its annual report to Congress that the IRS change its mission statement to reflect its […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-11-15 08:06:042014-11-10 18:23:01Taxpayer Advocate Service Recommends IRS Change Mission Statement to Reflect New Expanded Role
Facing criminal and civil charges relating to the manufacturing and distribution of certain adulterated drugs made at its Cidra Manufacturing Plant in Puerto Rico, GlaxoSmithKline (GSK) has pleaded guilty and […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-11-15 08:04:522014-11-10 18:23:02Whistleblower Lawsuit Results in $750 million Settlement for GlaxoSmithKline
With only a few months left until the 2011 tax filing season, Congress seeks to come to decisions regarding Federal Income Tax, specifically addressing issues such as the Alternative Minimum […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-11-11 16:38:072014-11-10 18:23:02Lame Duck Congress Addresses Expiring Bush-era Tax Cuts, the Alternative Minimum Tax, and Tax Reform for the Upcoming Tax Year
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 […]
Fuerst Ittlemans Managing Partner, Mitchell S. Fuerst, Esq., is a featured speaker and participant at a series of upcoming meetings and conferences focused on stem cell medicine and age management […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2010-11-09 17:35:242025-12-09 13:39:35Mitchell Fuerst Featured Speaker at Upcoming Stem Cell and Age Management Medicine Conference and Meeting
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.
Pinnacle Aircraft Parts, Inc. Reaches Settlement With OFAC For Violation Of Reporting, Procedures, And Penalties Regulations
On November 16, 2010, the Office of Foreign Assets Control (“OFAC”), of the U.S. Department of the Treasury announced that it reached a settlement with Pinnacle Aircraft Parts, Inc. (“Pinnacle”) […]
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.
Internal Revenue Service Office of the Chief Counsel Carves Out Narrow Exception for Properly Applied First Sale Rule in Customs Law
On October 29, 2010, the Office of the Chief Counsel of the Internal Revenue Service (IRS) issued Chief Counsel Advice (CCA) 2010-43-028, which discusses the effect of the First Sale […]
Taxpayer Advocate Service Recommends IRS Change Mission Statement to Reflect New Expanded Role
On October 26, 2010, the Taxpayer Advocate Service (“TAS”) announced that it will recommend in its annual report to Congress that the IRS change its mission statement to reflect its […]
Whistleblower Lawsuit Results in $750 million Settlement for GlaxoSmithKline
Facing criminal and civil charges relating to the manufacturing and distribution of certain adulterated drugs made at its Cidra Manufacturing Plant in Puerto Rico, GlaxoSmithKline (GSK) has pleaded guilty and […]
Lame Duck Congress Addresses Expiring Bush-era Tax Cuts, the Alternative Minimum Tax, and Tax Reform for the Upcoming Tax Year
With only a few months left until the 2011 tax filing season, Congress seeks to come to decisions regarding Federal Income Tax, specifically addressing issues such as the Alternative Minimum […]
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 […]
Mitchell Fuerst Featured Speaker at Upcoming Stem Cell and Age Management Medicine Conference and Meeting
Fuerst Ittlemans Managing Partner, Mitchell S. Fuerst, Esq., is a featured speaker and participant at a series of upcoming meetings and conferences focused on stem cell medicine and age management […]