Pharmaceutical Industry Federal Trade Commission

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AGG Food and Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Alert: FTC Challenges "No-AG" Agreement as Illegal Reverse Payment

On March 30 the US Federal Trade Commission filed suit in federal court alleging that settlements of patent litigation in the pharmaceutical industry in which a pioneer firm agrees not to market an "authorized generic"...more

Quo Vadis FTC: What Does the Commission's Complaint Against Endo Pharmaceuticals and Others Say About the Future of Post-Actavis...

This alert, the title of which is adapted from a March 30, 2016 FTC Staff Attorney blog post, considers the FTC's first lawsuit challenging a so-called "no-AG" agreement. No-AG agreements are components of Hatch-Waxman...more

FTC’s Latest “Pay for Delay” Action Focuses on Noncash “Payments” and New “Product Hopping” Theory of Harm

The Federal Trade Commission (FTC) filed an antitrust complaint this week against Endo Pharmaceuticals and several generic companies, alleging that these companies entered into anticompetitive “reverse payment” settlements of...more

FTC Issues Report on ANDA Settlement Agreements

In January, the Federal Trade Commission issued a report on the terms of settlement agreements between branded and generic drug companies in ANDA litigation under the Hatch-Waxman Act, according to the provisions of the...more

Competition/antitrust law

Focus on the US - Cartel enforcement activity and stiffer criminal penalties against price fixing - The Department of Justice (DOJ) continues to investigate and seek criminal charges against worldwide cartels. This...more

FDA Regulatory and Compliance Monthly Recap — January 2016

OPDP enforcement reaches record low in 2015 as drugmakers face uncertainty in digital marketing - Enforcement by the OPDP has fallen notably since 2010. The decline has been attributed, in part, to the agency's slow...more

More on Patent Settlements Including Litigation at the European Courts

Last week I posted on the European Commission’s (EC) latest report into patent settlement agreements between originator and generic companies in the European Union (EU). The EC says each time it produces these reports that...more

Alert: Top 10 Antitrust Developments and Trends to Watch in 2016

Attention in the US during 2016 will be on the presidential campaign, and the election in November will bring a change in the "antitrust guard" at the top of the DOJ and FTC – even if a Democrat wins – that will drive the...more

FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more

ANDA Update - October 2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Turing Pharmaceuticals Facing NY Antitrust Inquiry in Wake of 5,000 Percent Price Hike

Turing Pharmaceuticals is back in the news over its marketing and distribution of Daraprim, the anti-parasitic drug crucial for treating toxoplasmosis, which can be fatal to patients with compromised immune systems. As you...more

Turing, Daraprim, and Refusals to Deal with Generic Manufacturers

Drug company Turing Pharmaceuticals made headlines recently when it reportedly raised the price of Daraprim, used commonly by AIDS patients to fight life-threatening infections, from $13.50 to $750 per tablet. Amidst...more

US v Bayer: Randomized Clinical Trials not Required for Dietary Supplement Structure Function Claims – Key Takeaways

In a much anticipated opinion for the dietary supplement industry and for products making health benefit statements, the District of New Jersey in US v. Bayer has found in favor of Bayer in holding that the government failed...more

United States v. Bayer: Preventing or Treating Disease Claims

In recent years, the FTC and the Center for Science in the Public Interest (“CSPI”) seem to have seen disease claims everywhere, regardless of whether the FDA has deemed the same claims appropriate, non-disease...more

Discriminating Tastes: Court Puts Long-running Robinson-Patman Act Case To Rest

Described as the Rodney Dangerfield of the antitrust laws, the Robinson-Patman Act—which prohibits anticompetitive price discrimination—gets no respect. The Justice Department and the Federal Trade Commission unapologetically...more

First Amendment Right to Off-Label Promotion – Has Pandora’s Box Been Opened for FDA?

A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products....more

Antitrust Implication of Recent FTC Patent Related Agreement

In recent years, the Federal Trade Commission (FTC) has refocused its efforts on the interplay between the patent system and antitrust law, particularly in the pharmaceutical industry. While most of this focus has manifested...more

Advertising Law - August 2015 #4

In Case You Missed It: Possible Jail Time for TCPA Violations, Microsoft Gets Slammed With Solicitation Scam Class Action, and 'Do Not Disturb' Technology Gets Pushed on FCC - The world of the Telephone Consumer...more

Another FTC Conduct Case to Bolster Generic Drug Competition: Pharmaceuticals Charged with Illegal Non-Compete for Generic ADHD...

The Federal Trade Commission’s (“FTC” or “Commission”) ever-expanding list of enforcement actions to preserve competition for generic pharmaceuticals just grew in a new direction. This week, two generic pharmaceutical...more

FTC Commissioner Wright and D.C. Circuit Judge Ginsburg Criticize Second Circuit’s Actavis Ruling

We have been following developments in People of the State of New York v. Actavis, the New York Attorney General’s “product hopping” suit against Actavis and its subsidiary, Forest Laboratories LLC (together, “Actavis”). Now,...more

FDA Recalls Kim Kardashian’s Post

Last month, Kim Kardashian praised Diclegis, a drug for morning sickness, on her social media accounts. Since Kim doesn’t follow us on social media, we don’t always keep tabs on her. But when her posts raise regulatory...more

Third Circuit Extends Actavis to Reverse Settlement Agreements Involving Non-Cash Consideration - King Drug Company of Florence,...

Addressing for the first time whether reverse settlement agreements involving non-cash consideration merit antitrust scrutiny, the U.S. Court of Appeals for the Third Circuit reversed the district court, applying the...more

Third Circuit Says Actavis Not Limited to Cash

In the first decision by a federal appeals court interpreting the U.S. Supreme Court’s landmark ruling in FTC v. Actavis, the Third Circuit recently held in King Drug Co. of Florence v. SmithKline Beecham Corp. that so-called...more

First Federal Appellate Court Holds a NonCash Reverse Payment Subject to Antitrust Scrutiny: Is the Third Circuit's Decision in...

Recently, the Third Circuit issued the first federal appellate decision interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc.[1], potentially greatly expanding the scope of settling parties in reverse...more

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