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Hyman, Phelps & McNamara, P.C. Document Search Results (253) Show: results per page Sort by:  | “No-AG” Agreements are Not “Reverse Payments” Subject to Antitrust Scrutiny Says District Court in LAMICTAL Litigation
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 18, 2012, previously published on December 17, 2012 Excitement over the U.S. Supreme Court’s recent decision to hear Federal Trade Commission v. Watson Pharmaceuticals, Inc. (Docket No. 12-416), a drug patent settlement agreement (a.k.a. “reverse payment” or “pay-for-delay agreement”) case involving ANDROGEL...
| | Support Appears to be Growing to Delay the Medical Device Tax
Carmelina G. Allis; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 17, 2012, previously published on December 13, 2012 Earlier this month, the IRS published final regulations and interim guidance on the excise tax imposed on the sale of certain medical devices intended for human use pursuant to the Health Care and Education Reconciliation Act of 2010 and the Patient Protection and Affordable Care Act. But while...
| | A Deep Dive Into the Second Circuit’s Caronia Decision, Potential Next Steps, and Potential Enforcement Fallout
Hyman Phelps McNamara P.C.;
Legal Alert/Article December 14, 2012, previously published on December 12, 2012 As we promised in an earlier post, we provide here a deeper analysis of the Second Circuit’s holding in United States v. Caronia and the context in which it should be viewed by industry.
| | “Carcinogen-Free” Label Program Proposed in House Bill
Etan J. Yeshua; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 14, 2012, previously published on December 12, 2012 Manufacturers of foods, drugs and cosmetics might possibly be able to label their products as “Carcinogen-Free” with federal approval. In November, Rep. Theodore Deutch (D-FL) and Rep. Sue Myrick (R-NC) introduced the "Carcinogen-Free Label Act of 2012" (H.R. 6601), which...
| | More Legislation Introduced to Strengthen State Cooperation and Federal Oversight of Compounding Pharmacies
Karla L. Palmer; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 13, 2012, previously published on December 10, 2012 On December 5, 2012, Representatives Rosa DeLauro (D-CT) (the ranking member of the House committee responsible for FDA appropriations) and Nita Lowey (D-NY) (also on the House Appropriations Committee and a senior member of the Health and Human Services Subcommittee) introduced a bill to regulate...
| | In Litigation, FDA Explains and Defends FSMA Efforts
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 12, 2012, previously published on December 11, 2012 We previously reported on a lawsuit that seeks to compel OMB and FDA to accelerate the implementation of FSMA. Now the government has filed a motion to dismiss the case and for summary judgment. The motion provides a full accounting of FDA’s efforts to implement FSMA, and is worth reading for...
| | Proposed Legislation Seeks to Amend Controlled Substances Act’s Preemption Provision: A Reminder Of States’ Role in Regulating Drugs of Abuse
John A. Gilbert, Delia A. Stubbs; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 10, 2012, previously published on December 6, 2012 Last week, Representative Diana DeGette (D-CO) introduced legislation proposing to amend section 903 of the Controlled Substances Act (“CSA”) to create an exception for state marihuana laws. Section 903, as currently written, expresses Congress’s intent not to preempt state laws...
| | Red Flags Rule Comes Back
William T. Koustas; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 7, 2012, previously published on December 5, 2012 The Federal Trade Commission (“FTC”) has amended its Red Flags Rule (“the Rule”) to comply with the Red Flag Program Clarification Act of 2010 (“Clarification Act”). As we have previously reported, the Fair and Accurate Credit Transactions Act of 2003...
| | Actelion’s Preemptive Strike over REMS and Biostudy Product Availability Draws Antitrust Counterclaims, Another Drug, and Another Company into the Mix
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 7, 2012, previously published on December 5, 2012 Things are heating up in litigation in the U.S. District Court for the District of New Jersey initiated by Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) in September 2012, which, according to Actelion, “concerns the fundamental right...
| | In Landmark Ruling, Court Reverses Conviction Involving Off-Label Promotion
Hyman Phelps McNamara P.C.;
Legal Alert/Article December 6, 2012, previously published on December 3, 2012 On December 3, 2012, the United States Court of Appeals for the Second Circuit (which is based in New York City) issued a long-awaited ruling in United States v. Caronia, a case involving off-label promotion. In a 2-1 82-page decision that involves a vigorous dissent, the Court vacated the criminal...
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