The Global View of FDA Reform

  • by: |
  • 05/03/2007
Biotech entrepreneuers from India, China, Brazil don't talk about breaking patents, price controls, hating big Pharma...none of the junk that fills the time and effort of the NGOs whose efforts among to -- in the words of one participant "a rounding error" in the war against disease. Rather, it is all about partnerships, raising capital, IP protection and most important...harmonization of regulatory standards with the FDA's Critical Path efforts.

I cannot tell you what excitement the Critical Path effort has stirred among many of the start ups here. The idea of shortening development times, micro-dosings, using biomarkers for toxicity studies, being able to submit a single application to a single standard is the single most important barrier to the development of products for unmet global health needs. Note to the FDA, the Critical Path needs to go global to rev up the global health revolution. Companies overseas DO want to import medicines to the US, but ONLY if they are safe, effective and valuable.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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