Entries by admin_fidj

FDA to Hear Avistan’s Appeal Regarding Proposed Revocation of Drug Approval

On June 28 – 29, 2011, Genentech appeared before the U.S. Food and Drug Administration (FDA) asking the Agency to reconsider its proposal to revoke Avastin’s approval for use in the treatment of breast cancer patients. The FDA approved Avastin three years ago through an accelerated approval process because Avastin is used to treat serious diseases and fills an unmet medical need. This accelerated approval process provides patients access to promising new drugs for treatment of serious or life-threatening conditions while awaiting the results of phase IV confirmatory clinical trials. If subsequent clinical trials fail to confirm the drug’s clinical benefit, the FDA may take action to remove the drug from the market, see 21 C.F.R. § 314, subpart H. This marked the first time the FDA has held a hearing to consider a company’s appeal of such a decision.

Strategies for Resolving Uncertain Tax Positions

As the deadline nears for reporting Uncertain Tax Positions (“UTPs”) to the IRS, practitioners and organizations continue to protest the lack of guidance on various disclosures. Speaking in a webcast on June 28, a PricewaterhouseCoopers representative relayed that the firm is specifically concerned with what it means to record a reserve and how to treat non-GAAP taxpayers. Similarly, the Tax Executives Institute recently called on the IRS to address issues like filing requirements and transfer pricing. Amid all of this uncertainty, we present pre-filing strategies—as suggested by BNA—for resolving future uncertain tax positions.

New Excise Tax for Medical Devices and Prescription Drugs

On March 23, 2011, President Obama signed into law the Patient Protection and Affordable Care Act (PPACA). On March 30, 2011, he signed the Health Care and Education Reconciliation Act of 2010, amending the PPACA (collectively “the Act”).