Senate Adopts Corporate Finance and Executive Compensation Provisions in Financial Reform Bill
On May 27, the Senate released the text of the financial reform bill that was passed the prior week. The bill, known as the “Restoring American Financial Stability Act of 2010″ or the “Act,” would result in sweeping reforms to the financial industry. However, it also contains a number of significant provisions that would affect corporate governance and executive compensation at public companies, as well as Regulation D private placements, whistleblowers and beneficial ownership reporting. This Corporate Finance and Securities Bulletin outlines some of the more important provisions of the Act.
Click here for a complete copy of the Bulletin.
FTC Extends Deadline for Identity Theft Red Flags Rule to December 31, 2010
The Federal Trade Commission announced that it will further delay enforcement of the “Red Flags” Rule through December 31, 2010, while Congress considers legislation that would affect the scope of entities covered by the Rule. The announcement does not affect other federal agencies’ enforcement of the original November 1, 2008 deadline. As a result, the extension does not apply to banks and other financial institutions that are covered by the Red Flags which were separately issued by the Federal Reserve, FDIC, Treasury Department, or National Credit Union Administration. This Antitrust, Franchise & Consumer Client Bulletin discusses the announcement.
Agencies Issue Interim Rules on Dependent Health Care Coverage of Children to Age 26
On May 10, the Internal Revenue Service, the Department of Labor and the Department of Health and Human Services jointly issued interim final regulations addressing the provision of dependent coverage of children to age 26 under the Patient Protection and Affordable Care Act, as amended.
Click here for a copy of the Employee Benefits & Executive Compensation Client Bulletin regarding the new regulations.
Supreme Court Rules Against National Football League in Antitrust Opinion
On May 24, the Supreme Court ruled that the National Football League’s licensing activities are not categorically exempt from antitrust scrutiny under Section 1 of the Sherman Act. The Court’s reasoning in its ruling has important implications for groups or associations of competitors in other industries, too.
Click here to read the May 25, 2010 Client Bulletin published by the Antitrust, Franchise & Consumer Law group with respect to the ruling.
J.D. Salinger Case Extends eBay’s No Presumption of Irreparable Harm Standard for Injunctions in Patent Cases to Copyright Cases
In Salinger and Salinger v. Colting et al., 09-2878-cv (April 30, 2010), the United States Court of Appeals for the Second Circuit vacated the preliminary injunction granted by the district court, holding that plaintiff Salinger must prove irreparable harm and may not simply rely upon a presmption of irreparable harm based on a finding of likelihood of success on the merits of his copyright infringement claim.
Click here to read the Client Bulletin published by the Intellectual Property Client Service Group regarding the decision.
Totes-Isotoner Petitions U.S. Supreme Court to Review Apparel Duties Gender and Age Discrimination Case
On May 6, 2010, Totes-Isotoner Corporation filed a writ of certiorari requesting the United States Supreme Court to review whether different Customs duty rates for men’s and women’s gloves, as well as men’s and children’s gloves, constitute general and age discrimination, thereby violating the Equal Protection Clause of the U.S. Constitution.
Click here to read the Bulletin published by the International Trade Client Service Group regarding this petition.
FDA Transparency Task Force Unveils Draft Proposals on Agency Disclosure Policies; Invites Comments
On May 19, 2010, FDA’s Transparency Task Force released 21 draft proposals for public comment on public disclosure policies aimed at helping consumers, stakeholders, and others understand how the agency operates and makes decisions. Comments are due by July 20, 2010.
Click here for the complete May 25, 2010 Food Regulatory & Policy Bulletin Bulletin to read about the draft proposals and other news.
Supreme Court Asks for Administration’s Input on Generic Labeling Case
Reports are indicating that the Supreme Court has asked the Solicitor General to submit a brief regarding whether the court should hear an appeal by generics companies involving the labeling of their drugs.
Click here for the complete May 25, 2010 Drugs & Devices Regulatory & Policy Bulletin to read about this and other news.
House to Conduct Hearing on J&J Recall, CEO Asked to Testify
The House Committee on Oversight and Government Reform asked Johnson & Johnson CEO William Weldon to testify at its hearing on the recall of certain of its children’s medicines, including Motrin, Tylenol, Zyrtec, and Benadryl.
Click here to read the May 20, 2010 Drugs & Devices Regulatory & Policy Bulletin to read about this and other news.
IOM Report Recommends Framework for Evaluating Science Behind Health Claims, Says Tougher Standards Needed for Foods and Dietary Supplements
On May 12, 2010, the Institution of Medicine released a consensus report, titled Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease recommending that the FDA should apply the same rigor to evaluating the science behind claims of foods’ and nutritional supplements’ health benefits as it devotes to assessing medication and medical technology approvals.
Click here for the complete May 14, 2010 Food Regulatory & Policy Bulletin to read about this and other news.
Lawmakers Announce Review of FDA Inspection, Oversight Procedures
Members of the House of Representatives have indicated that they plan to review the FDA’s inspection procedures as part of a review of McNeil Consumer Healthcare’s voluntary recall of more than 40 children’s over-the-counter medicines.
Click here for the May 13, 2010 Drugs & Devices Regulatory & Policy Bulletin to read about this and other news.
FDA Issues Report on McNeil, House Committee to Investigate
The FDA has published an inspection report detailing some of its findings regarding positive test results for bacterial contamination in children’s product manufactured by McNeil Consumer Healthcare. The company has issued a recall for more than 50 variations of infant’s and children’s products.
Click here for the complete May 7, 2010 Drugs & Devices Regulatory & Policy Bulletin for this and other news.
Food Safety Discussion Gains Momentum
The safety of imported food was the subject of a Congressional hearing and GAO report in early May and the FDA announced that the implementation of PREDICT (the computer program that helps customs officials conduct targeted inspections) has been postponed and the agency continues to weigh and equivalency system.
Click here for the complete May 10, 2010 Food Regulatory & Policy Bulletin discussing this and other news.
FDA Issues Advance Notice of Proposed Rulemaking Implementing Sanitary Food Transportation Act
On April 30, 2010, FDA published an Advance Notice of Proposed Rulemaking (ANPRM) on implementing the Sanitary Food Transaction Act of 2005. The Notice is the first step in writing federal regulations that will govern sanitary practices by shippers, motor vehicle and rail carriers, and others involved in the transportation of food.
Click here for the complete May 4, 2010 Food Regulatory & Policy Bulletin to read about the Notice and other news.
Court Says Patent Settlements May Violate Antitrust Laws
A federal appeals court in New York indicated that patent settlements reached by drug companies may violate antitrust laws when they include payments to rivals to delay the introduction of generic products. The Justice Department has previously asserted that those types of payments may be illegal and the FTC has called on courts to consider the merits of the patents at issue.
Click here for the May 4, 2010 Drugs & Devices Regulatory & Policy Bulletin to read about this and other news.
Qualifying Therapeutic Discovery Project Credit
The new Qualifying Therapeutic Discovery Project tax credit created by the Patient Protection and Affordable Care Act may provide significant financial benefits to small and medium-sized (i.e. up to 250 employees) biotechnology and life sciences companies and their investors.
Click here to read the May 1, 2010 Bulletin published by the Life Sciences and Health Care, Tax Advice & Controversy, and Corporate Finance & Securities Client Service Groups regarding the tax credit.
APHIS Postpones Enforcement of Lacey Act Declaration Metric Requirement
The Animal and Plant Health Inspection Service recently announced a grace period on the enforcement of the metric quantity and units of measure requirement included in the 2008 amendments of the Lacey Act.
Click here for the May 17, 2010 International Regulatory Bulletin regarding the grace period.