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Global Pricing Newsletter: volume two

Sidley Austin LLP
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China, Global, United Kingdom, USA
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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
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USA
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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

EU continues revision and implementation of strict GMP rules

Sidley Austin LLP
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European Union
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February 4 2013

In January 2013, three important developments regarding the EU's good manufacturing practice ("GMP") rules for medicinal products were made public:

European Commission publishes guidelines on use of food-related health claims

Sidley Austin LLP
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European Union
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January 28 2013

On 25 January 2013, the European Commission's new guidelines regarding the use of food-related health claims ("Guidelines") were published in the

China encourages pharmaceutical companies to timely pursue new GMP certification

Sidley Austin LLP
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China
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January 15 2013

In 2010, China's State Food and Drug Administration ("SFDA") issued a new version of its Good Manufacturing Practice (the "GMP") regulations, which

Second Circuit rejects regulation of off-label promotion as misbranding

Sidley Austin LLP
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USA
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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
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USA
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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

EU court rules on classification of certain borderline products as medical devices

Sidley Austin LLP
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European Union
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December 3 2012

In a judgment published on November 22, 2012, the Court of Justice of the European Union (CJEU) confirmed that products intended for the investigation of physiological processes only fall within the scope of the EU Medical Device Directive (9342EEC), as implemented into EU Member State legislation, if the products are intended for a medical purpose

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

Sidley Austin LLP
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USA
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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
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USA
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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.”

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Search results

Global Pricing Newsletter: volume two

Tidal wave of new Proposition 65 notice letters spurs legislative action

EU continues revision and implementation of strict GMP rules

European Commission publishes guidelines on use of food-related health claims

China encourages pharmaceutical companies to timely pursue new GMP certification

Second Circuit rejects regulation of off-label promotion as misbranding

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

EU court rules on classification of certain borderline products as medical devices

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

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

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