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Global Pricing Newsletter: volume two

  • Sidley Austin LLP
  • -
  • China, Global, United Kingdom, USA
  • -
  • February 27 2013

Pharmaceutical and biologic manufacturers operate in an increasingly global economy where legal developments in one market may have cascading impacts

Tidal wave of new Proposition 65 notice letters spurs legislative action

  • Sidley Austin LLP
  • -
  • USA
  • -
  • February 13 2013

On February 4, 2013, Assembly Member Mike Gatto (D-Los Angeles) introduced legislation (AB 227) to amend California Health & Safety Code Section

Second Circuit rejects regulation of off-label promotion as misbranding

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 19 2012

In a widely anticipated ruling the US Court of Appeals for the Second Circuit recently reversed the conviction of pharmaceutical sales representative Alfred Caronia for misbranding under the Federal Food, Drug and Cosmetic Act, based on alleged off-label promotion

Second Circuit declares that the First Amendment shields off-label marketing

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 6 2012

On December 3, 2012, the Court of Appeals for the Second Circuit issued a landmark ruling in United States v. Caronia, No. 09-5006 (2d Cir. December 3, 2012) declaring that truthful, non-misleading off-label promotion is constitutionally-protected commercial speech

Second Circuit rejects FDA regulation of “off-label” promotion as misbranding in Caronia case

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 3 2012

In a widely anticipated ruling, the United States Court of Appeals for the Second Circuit this morning reversed the conviction of pharmaceutical sales representative Alfred Caronia for misbranding under the Federal Food, Drug, and Cosmetic Act (FDCA), based on alleged “off-label” promotion

District court dismisses off-label FCA claims after concluding that industry guidelines do not constitute a legal restriction

  • Sidley Austin LLP
  • -
  • USA
  • -
  • November 20 2012

In August, we wrote about a decision in which a court rejected the government’s theory that submission of claims for services that failed to comply with industry guidelines were “false.”

FDA issues warning letter to Lancôme for anti-aging claims

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 14 2012

On September 7, 2012, the compliance office within the Center for Food Safety and Applied Nutrition (CFSAN) at FDA issued a Warning Letter to Lancôme USA, a subsidiary of L’Oréal, regarding several anti-aging skin care products being marketed as cosmetics

Appeals Court issues important ruling in fraud and abuse case involving individual liability

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 31 2012

A recent D.C. Circuit decision in Friedman v. Sebelius overturned the exclusions of three Purdue pharma executives from participation in federal healthcare programs, holding that the Department of Health and Human Services acted arbitrarily in imposing extraordinarily lengthy exclusions

ALJ opinion signals rejection of FTC’s rigorous substantiation requirements for food and dietary supplement claims

  • Sidley Austin LLP
  • -
  • USA
  • -
  • June 19 2012

Food and dietary supplement manufacturers can take some comfortat least for nowthat the Federal Trade Commission’s (FTC) recent consent decrees that impose on respondents draconian standards for advertising claims will not become the norm for future companies that run afoul of FTC advertising law

Updates on international pricing issues for pharmaceutical and biologic products

  • Sidley Austin LLP
  • -
  • China, European Union, France, Germany, United Kingdom, USA
  • -
  • May 18 2012

Sidley Austin LLP’s Global Life Sciences Team is pleased to provide you with this Global Pricing Newsletter, the first in a periodic series updating clients and friends of the firm on pricing issues around the world that may have an impact on pharmaceutical and biologic manufacturers’ legal and business strategies

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