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”) …
By Kurt R. Karst – The Federal Trade Commission (“FTC”) has announced the release of its annual summary of agreements (a.k.a. “drug patent settlement agreements,” “reverse payment agreements” or “pay-for-delay agreements”) filed with the Commission during the last fiscal year (Fiscal Year 2012): “Agreements Filed …
By Kurt R. Karst – In a notice that will be published in the January 17th Federal Register, FDA announces the establishment of Fiscal Year 2013 (“FY2013”) user fee rates established pursuant to the Generic Drug User Fee Amendments of 2012 (“GDUFA”) for both Active Pharmaceutical …
By Alexander J. Varond – FDA announced earlier this week that it will hold a public hearing to obtain input on a potential new pathway to expedite the development of drugs and biological products for serious or life-threatening conditions that would address an unmet medical …
By Kurt R. Karst – In a decision handed down last week by Judge Ellen Segal Huvelle of the U.S. District Court for the District of Columbia, the court may have finally put an end to ViroPharma Inc.’s (“ViroPharma’s”) litigation over FDA’s approval of generic …
By Frank Sasinowski & William Koustas – FDASIA/PDUFA V elevates the role of patients in developing orphan therapies. It mandates that FDA implement ways to bring patients' views into drug development and FDA’s regulatory review. This is appropriate as it is often these patients that …
