The FDA reported to Congress that pharmaceutical companies owning branded drugs may be filing 505(q) petitions for reconsideration (aka “citizen petitions”) to delay approval of generic versions of their drugs. The agency expressed concern that the need for it to respond to bogus petitions delays its ability to perform other necessary regulatory work. The process […]
Category Archives: Federal Legislation
Congress Examining Drug Companies’ Allegedly Improper Use of Citizen Petitions to Delay FDA Approval of Generic Drugs
October 31, 2013 – 3:49 pm
Non-profit Antitrust Organization Requested Increase of Fines for Antitrust Violations
July 31, 2013 – 11:51 am
An independent nonprofit education, research and advocacy organization, the American Antitrust Institute (AAI), sent a letter to the United States Sentencing Commission, asking the Commission to amend a key portion of the formula it uses to calculate fines for antitrust offenses. AAI requested that the Commission increase the standard presumption of illegal overcharge it uses […]
Senators Reintroduce Antitrust Violation Whistleblower Protection Bill
January 28, 2013 – 2:26 pm
Senators Patrick Leahy and Chuck Grassley reintroduced previously stalled Criminal Antitrust Anti-Retaliation Act, which would extend whistleblower protections to employees who give federal prosecutors information in criminal antitrust investigations. The act would amend the Antitrust Criminal Penalties Enforcement and Reform Act (“ACPERA”), which provides leniency to guilty parties who report criminal cartels and cooperate with […]
Antitrust Investigation of Visa Debit Card Fees
May 30, 2012 – 4:20 pm
The United States Department of Justice is investigating whether Visa violated the antitrust laws when it responded to the debit card fee regulations imposed by the Dodd-Frank Wall Street Reform and Consumer Protection Act by increasing fees on merchants. In response to the legislation limiting per transaction debit card fees to about half their former […]
House Passes Bill to Retain Private Damage Protection for Successful Leniency Applicants
May 25, 2010 – 9:10 am
Update May 2010: The House has passed a bill extending the program through 2015, and the Senate is considering a similar bill with bi-partisan support. On June 19, 2009, just two days before the Antitrust Criminal Penalty Enhancement and Reform Act of 2004 (ACPERA) was set to expire, President Obama signed into law a provision extending […]
Congress is Considering Rolling Back Antitrust Exemptions for Insurance Companies
November 30, 2009 – 1:00 pm
Update November 2009: Attorneys General from Vermont, Connecticut, Massachusetts, Oregon, Maine, Arizona, Iowa, Montana, Florida, and Wyoming sent a letter to the Senate Judiciary Committee in support of legislation to strip health insurers of their antitrust exemption. As part of the health care reform debate, a proposal to eliminate the antitrust immunity granted to insurance […]
Broadcom Files New Patent Case Against Qualcomm
October 9, 2008 – 12:55 pm
Broadcom has filed a new patent claim in the Southern District of California arguing that Qualcomm has improperly required customers who purchase chipsets for use in cell phone handsets to pay additional licensing fees when the handsets are sold. In Quanta Computer v. LG Electronics, 128 S. Ct. 2109 (2008), the U.S. Supreme Court recently […]