Regulatory Roundup: New York Governor Wants Stricter Limits On Pharmaceutical Marketing; FDA Revises ICH M3(R2) Guidance.

Regulatory Roundup

FDA issued a revised guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, which is an International Conference on Harmonization (ICH) guidance published originally in 1997. The guidance recommends international standards for nonclinical safety studies in human clinical trials and marketing authorization for pharmaceuticals. The revisions “further harmonize recommendations in a number of areas and include a new section on exploratory clinical studies,” said the document. This revised guidance discusses other nonclinical studies that should be conducted on a case-by-case basis as appropriate, including phototoxicity studies, immunotoxicity studies, juvenile-animal toxicity studies, and abuse potential studies.”

According to an Associated Press article, New York Governor David Paterson would like new, more-strict prohibitions on pharmaceutical companies when it comes to giving gifts and information to doctors. Industry disagrees with the idea, according to the article, arguing that FDA already regulates marketing practices. This isn’t the first time this topic has come up. See PharmTech's related blog posts, “Pharma Marketers May Have to Get More Creative” and “Sunshine on My (Doctor’s) Shoulder.”