Federal Trade Commission Pharmaceutical Industry

The United States Federal Trade Commission is an independent federal agency established in 1914 by the Federal Trade Commission Act. The agency is charged with protecting consumers from misleading, fraudulent or... more +
The United States Federal Trade Commission is an independent federal agency established in 1914 by the Federal Trade Commission Act. The agency is charged with protecting consumers from misleading, fraudulent or deceptive marketing claims, as well as regulating unfair business practices that undermine the competitive marketplace.    less -
News & Analysis as of

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

King Drug Co. of Florence, Inc. v. SmithKline Beecham Corp. (3rd Cir. 2015)

Ever since the Supreme Court's decision in FTC v. Actavis in 2013, courts (predominantly district courts) have grappled with the scope of the decision. It was evident that the presence of a large cash payment from the...more

Expanded HSR Antitrust Reporting for Pharma Licensing Deals Is Here to Stay

On June 9, 2015, the U.S. Court of Appeals for the D.C. Circuit, in its ruling in Pharm. Research & Mfrs. of Am. v. FTC, upheld the FTC's expansion of HSR reporting requirements for pharmaceutical companies, and solidified...more

Health Update - June 2015

Examining Fee Splitting Statutes in the Context of Value-Based Healthcare - Editor’s note: One of the goals of the Affordable Care Act (ACA) is to align incentives among provider communities and their patients and...more

Expanded FTC Premerger Notification Rules Specific to the Pharmaceutical Industry are Upheld by the D.C. Circuit

The D.C. Circuit recently affirmed a lower court’s decision upholding regulations adopted by the Federal Trade Commission (FTC) requiring a Hart Scott Rodino (HSR) Act premerger notification filing for transfers of patent...more

Cephalon and Teva's $1.2 Billion Consent Order with the FTC: Is it Really a Harbinger of Things to Come?

On June 17, 2015, the U.S. District Court for the Eastern District of Pennsylvania approved a consent order (the “Consent Order”) between the Federal Trade Commission and defendants Cephalon, Inc. and its parent, Teva...more

Focus on Tax Controversy and Litigation - Supreme Court Decides Maryland v. Wynne and Rules that Maryland Tax Scheme Is...

In This Issue: - Maryland’s Tax Scheme Ruled Unconstitutional - “FTC Generator” Case Update - FSA Rules that Equitable Disgorgement May be Deductible Expense - District Court Upholds Attorney Client...more

Intellectual Property and Technology News (North America), Issue 26, Q2 2015

The Internet of Things: EU vs US guidance - Reports from the European Commission and the FTC on privacy and security best practices for IoT - key issues and highlights... Are IPRs impacting the pharmaceutical...more

California Supreme Court Decision in Cipro Highlights the Lack of Predictability in Antitrust Jurisprudence and Counseling

On May 7, 2015, the Supreme Court of California issued an opinion in In re Cipro Cases I & II, a case centered on pay-to-delay settlements between drug makers and generic manufacturers. The Court found the existence of an...more

Your Drug Patent Rights Transfer May Be Reportable, Court of Appeals Confirms

On Nov. 6, 2013, the Federal Trade Commission (FTC or Commission) modified its Hart-Scott-Rodino Act (HSR) rules to clarify that transfers of patent rights within the pharmaceutical industry constitute potentially reportable...more

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