Category Archives: Legislation

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E-CIGARETTES GET A “SMOKING” BREAK: D.C. Circuit Clarifies Scope of FDA’s Authority Over E-Cigarettes

By Deborah M. Shelton and Allie Frumin On Tuesday December 7th, the D.C. Circuit Court of Appeals affirmed a lower court’s ruling in Sottera, Inc. v. FDA, No. 10-5032, (D.C. Cir. Dec. 7, 2010) holding that that the Food and Drug Administration (FDA) could not regulate as a medical device the electronic cigarettes (often referred … Continue Reading

IRS Guidance On New Excise Tax On Branded Pharmaceutical Companies: Filing Due January 21, 2011

By Peter S. Reichertz In a prior article dated May 25, 2010, we advised of a new excise tax on branded pharmaceutical manufacturers. We indicated that the Patient Protection and Affordable Care Act ("PPACA") required the Internal Revenue Service ("IRS") to publish guidance "necessary to carry out the purpose" of the section in which the tax … Continue Reading

A MATRIXX Revolution? Is there a need to describe all adverse event reports in SEC filings of life sciences companies?

By Peter S. Reichertz The U.S. Supreme Court has scheduled oral argument for January 10, 2011, in the case of Matrixx Initiatives et al v. Siracusano, Case Number 09-1156, on appeal from the decision of the Ninth Circuit in Siracusano v. Matrixx Initiatives, Inc., 585 F3d 1167 (9th Cir. 2008).  The court granted certiorari on … Continue Reading

FTC Changes Guidance on Environmental Marketing Claims

By Robert L. Magielnicki Many marketers of OTC drugs and devices, cosmetics, foods and dietary supplements make claims with regard to the content of their products and/or the packaging for their products. and their fate in or effect on the environment. These claims are regulated by the Federal Trade Commission (“FTC”) and its “false and misleading” … Continue Reading

Has the Time Come for “Total Recall” of Medical Products?

By Peter Reichertz On July 14, 2010, Congressman Edolphus Towns introduced legislation to provide for the mandatory recall of adulterated or misbranded drugs. The legislation, H.R. 5740, has been referred to the Committee on Energy Commerce. Congressman Towns was the chair of the subcommittee that held hearings about Johnson & Johnson/McNeil and its handling of adulterated children’s drug … Continue Reading

FDA’s Regulation of Laboratory Developed Tests (LDTs) – Changes on Horizon?

By Deborah M. Shelton For years, the Food and Drug Administration has maintained that it has jurisdiction over laboratory-developed tests (“LDTs”) – those in vitro tests developed, validated and used for in-house pathology and diagnostic purposes – as medical devices. Yet the Agency has, with some few exceptions (e.g., IVDMIAs), exercised enforcement discretion, reasoning that … Continue Reading

Banning “Pay-For Delay” Settlements and Resale Price Maintenance are Senate Antitrust Subcommittee’s Top Legislative Priorities

In a recent interview, Senator Herb Kohl (D-Wis.), Chairman of the Senate Judiciary Committee’s subcommittee on antitrust, competition policy and consumer rights, discussed the subcommittee’s legislative priorities for 2010. At the top of the list is passage of the Preserve Affordable Access to Generics Act, which would prevent anticompetitive "pay-for-delay" patent settlements in which a brand-name … Continue Reading

New Taxes for Pharmaceutical and Medical Device Manufacturers/Importers/Distributors

Manufacturers As part of the recently enacted Patient Protection and Affordable Care Act (“PPACA”) – known to most as Healthcare Reform Legislation, new taxes will be imposed on manufacturers of “branded prescription drugs” and most medical devices. These taxes are in addition to the fees already charged by the Food and Drug Administration (“FDA”) for review … Continue Reading

FDA Publishes Proposed Rule on Broadcast Direct-to-Consumer Prescription Drug Advertisement; the 4 New Standards

On March 29, 2010, FDA published a proposed rule setting forth how it would interpret the Congressionally mandated requirement that “major statements” in broadcast Director-to-Consumer (“DTC”) advertisements for prescription drugs be presented in a “clear, conspicuous and neutral manner." See proposed 21 C.F.R. § 202.1(e), 75 Fed. Reg. 15376 (March 20, 2010).    … Continue Reading

FDA Looks to Boost Criminal Prosecutions

In the wake of a scathing March 4th GAO Report, FDA has informed Congress that it will boost criminal prosecutions of pharmaceutical and food industry executives.[1] Although the Agency’s Office of Criminal Investigation (OCI) can prosecute ‘responsible corporate officials,’ according to the GAO Report OCI has failed to exercise this enforcement tool to achieve FDA … Continue Reading
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