As the Internal Revenue Service moves towards full implementation of the Foreign Account Tax Compliance Act (“FATCA”), businesses and financial institutions are seeking greater clarifications, and in some cases exemptions, from the law’s broad new reporting and disclosure requirements. Learn More
On November 16, 2010, the Internal Revenue Service (“IRS”) and the government of Switzerland announced that the IRS has withdrawn its legal proceedings against Swiss bank UBS stemming from the bank’s role in assisting its U.S. clients to shield income from the IRS. Had the summons been fully enforced, it could have led to the revocation of UBS’s operating license in the United States. Learn More
Earlier this week, the U.S. Food and Drug Administration (FDA) cleared a human clinical trial using embryonic stem cells. This clinical trial will examine the effects of the stem cells on a rare disease causing serious vision loss, Stargardt’s Macular Dystrophy. The approval of the trial marked only the second time human trials involving embryonic stem cells have been cleared by the U.S. government. Learn More
On November 23rd, Mitchell Fuerst, Managing Partner of Fuerst Ittleman, PL, presented a webinar on “CFO Best Practices for Tax … Learn More
Medical doctors’ relationships with pharmaceutical industry representatives are insidious. Industry representatives seek to induce physicians to prescribe certain drugs through the use of free samples, sponsored lunch programs, educational symposiums, gifts, reimbursements, payments, and sales calls whereby representatives are armed with detailed prescribing data. Although this interaction remains highly pervasive, a number of attempts have been made to control the situation and offset the rising prescription drugs costs in the United States. Learn More
On November 17, 2010, the FDA issued warning letters to four companies that manufacture caffeinated alcoholic beverages. The FDA declared … Learn More
Last week, Amphastar filed a Notice of Withdrawal, voluntarily dropping its Motion for a Preliminary Injunction in the Company’s suit against the FDA. The Motion, which was filed just eight days earlier, concerned the detention of two shipments from Amphastar’s foreign-manufacturer. The two shipments detained by the FDA contained semi-purified heparin, an intended starting material, for which the Company needs to complete the FDA’s qualification process. Learn More
In another example of the recent enhancement in enforcement of the Foreign Corrupt Practices Act, (FCPA) a global freight forwarder and five oil and gas service companies resolved FCPA investigations conducted by the Department of Justice and the Securities and Exchange Commission by agreeing to pay $156,565,000 in criminal penalties and civil disgorgement, interest and penalties in the sum of $80,000,000. Learn More
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. Learn More
On November 16, 2010, the Office of Foreign Assets Control (“OFAC”), of the U.S. Department of the Treasury announced that … Learn More