…the manufacturers’ ceiling price obligations under the federal common law of contracts and that although the statute mandating the PPA does not create a federal private cause of action, allowing…

…the Senate bill and the Consumers Union, the American Medical Student Association and the Medicare Rights Center have come out in support of the House bill.  One pharmaceutical manufacturer, Eli Lilly,…

…pharmaceutical, medical device, and healthcare law, including civil litigation, and related matters involving the Federal Trade Commission and the Consumer Product Safety Commission.  Mr. Houck’s practice area encompasses controlled substances…

…is not a petition denial, but rather “final agency action.”  What does this mean for challenging such “final agency action,” particularly if there is little to nothing in the administrative…

…Local Union No. 68 v. AstraZeneca Pharmaceuticals LP.  In this case, the Plaintiffs, various union health and benefit funds and an individual consumer, claimed that the Defendants violated “the federal…

…and smokeless tobacco, particularly required Warning statements, would be controlled by FDA.  Although already subject to enforcement by the Federal Trade Commission (“FTC”), certain retail establishments would also be brought…

…much, as it did in a recent case concerning a generic version of ALDARA (imiquimod) Cream, 5% (see our previous post here).  Although most first applicants presumably forfeited 180-day exclusivity…

By James P. Ellison – The relationship between the federal government and qui tam relators is defined in part by statute and case law, but that law does not fully…

…compliance with applicable state, federal, or local laws relating to controlled substances. 21 U.S.C. § 823(g)(1)(B), (D). The Government alleged that Coconut Grove violated numerous federal and state controlled substance…

…of fraud, including fraud related to Federal assistance and relief programs.  Among other things, this legislation included substantial amendments to the Federal False Claims Act (“FCA”), 31 U.S.C. §§  3729-3333….

…in the law as a “civil action to obtain patent certainty”), provided: (1) the NDA holder or patent owner has allowed the 45-day period in which to file a suit…

…self-certified with DEA.  This is a better result than requiring that distributors in all cases have to maintain an document the self certification of its customers.  It also requires the…

By Ricardo Carvajal – FDA has issued a letter to the tobacco industry offering a reminder that, under the standard for cigarettes in FDCA section 907(a)(1)(A), a cigarette or any…

…except in cases of financial need.  The amendment would exempt sponsors of Medicare Part D plans to allow them to waive copayments for first fills of generic drugs as an…

Hyman, Phelps & McNamara, P.C. is very pleased to announce that J.P. Ellison and Kurt R. Karst have been named Directors of the firm. Mr. Ellison works primarily on civil…