By Ricardo Carvajal – FDA announced that it will host a series of public meetings on the recently issued proposed rules on preventive controls for human food and standards for produce safety. Fact sheets on the proposed rules are available here and here. The first meeting …
By JP Ellison – Earlier this month, the U.S. Sentencing Commission (the “Commission”) issued a Notice of Proposed Amendments to the U.S. Sentencing Guidelines, which are used by federal courts to determine sentences for criminal violations. The Notice contains several proposals that may be of interest …
By Delia A. Stubbs – Last Friday, January 25, 2012, after two days of discussion and deliberation, an FDA Advisory Committee voted 19 to 10 in favor of rescheduling combination hydrocodone from its current placement in Schedule III to Schedule II. The decision was informed by …
Hyman, Phelps & McNamara, P.C. ("HP&M") will hold a complimentary webinar on Thursday, January 31, 2013, from 12:00 – 2:00 PM (Eastern) on the Second Circuit's recent and long-awaited decision in United States v. Caronia. This webinar is not just another summary of the Second Circuit's decision. …
By Jennifer D. Newberger – On January 24, 2013, FDA finalized the Humanitarian Use Device (HUD) Designations guidance, issued in draft on December 13, 2011. The guidance addresses HUD requests, a first step in obtaining approval of a Humanitarian Device Exemption (HDE). A HUD is a …
By Ricardo Carvajal – Pharmacists Planning Service, Inc. ("PPSI"), a California-based “nonprofit public health, consumer, pharmacy education organization,” submitted a citizen petition asking FDA to make St. John’s Wort ("SJW") available only behind the counter. Specifically, the petition asks FDA “to remove sales of [SJW] …
By Karla L. Palmer – On January 22, 2013, the United States Court of Appeals for the District of Columbia Circuit dismissed a petition for review filed by several interest groups and individuals who petitioned DEA to initiate the federal rescheduling of marijuana. The case stems …
Hyman, Phelps & McNamara, P.C. is participating in the Food and Drug Law Institute's Food Week 2013 being held February 5 – 8 in Washington, D.C. This program provides an opportunity for food law, regulation and policy stakeholders to gather practical guidance on cutting-edge issues …
By Carmelina G. Allis – The FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. 78 Fed. Reg. 4307 (Jan. 22, 2013). This rule finalizes a proposed rule issued on September 23, 2009. The new rule, …
Hyman, Phelps & McNamara, P.C. will hold a complimentary webinar on Thursday, January 31, 2013, from 12:00 – 2:00 PM (Eastern) on the Second Circuit's recent and long-awaited decision in United States v. Caronia. This webinar is not just another summary of the Second Circuit's decision. Nor …
By Kurt R. Karst – Last week, Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) filed what might be the company’s last motion in its preemptive lawsuit filed last September in the U.S. District Court for the District of New Jersey seeking declaratory …
By Jeffrey N. Wasserstein – On January 17, 2013, the Office for Civil Rights of the U.S. Department of Health and Human Services announced the issuance of its much anticipated (and long-awaited) final rule (in prepublication form) relating to the modification to the HIPAA Privacy, Security …
By Kurt R. Karst – Late last year, FDA submitted to Congress the Agency’s latest report on FDC Act § 505(q) citizen petitions. The report, titled “Fourth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions For Stay of Agency …
On December 3, 2012, the United States Court of Appeals for the Second Circuit overturned the criminal conviction of Alfred Caronia. The court ruled that the government could not prosecute pharmaceutical representatives such as Mr. Caronia for speech promoting the lawful, off-label use of an …
By Kurt R. Karst – Although FDA has yet to accept an application for a biosimilar version of a biological product licensed under the Public Health Service Act (“PHS Act”) pursuant to the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) …
