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FDA Regulations for HCV Drug Development - are they too Strict?
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Jules Levin, NATAP
One of the controversies discussed quite a bit at EASL was FDA regulations slowing conducting of studies of the combination of two oral HCV drugs. A number of companies are conducting initial studies of the combination of 2 oral drugs overseas. This issue received a lot of attention in the hallways in between sessions and coffee breaks at the conference by both academic researchers and companies. The Roche INFORM Study was conducted in New Zealand. Simultaneously they were conducting safety studies in the USA. This is because the FDA requires certain safety data of the combination before studying it in patients. This controversial issue forces drug companies to consider the studies overseas so as not to accelerate development. Regardless what you think about the FDA development rules, this one and others, the companies are able to avoid the rule. The FDA appears hamstrung by the climate in Washington DC regarding numerous FDA stories like food safety, plus the FDA is under scrutiny from Congress regarding drug safety due to among other cases the glitazones where safety concerns emerged after approval. I think perhaps also in the mix is the lack of activism. HIV was considered a deathly disease where accelerated drug development was crucial so the regulations were liberal allowing accelerated development. HCV appears not to be as compelling and as serious in terms of a deathly disease BUT tell that to the numerous cirrhotic patients and patients with advanced liver disease who need therapy including the need for a 2 oral drug regimen for prior nonresponders including African-Americans and HCV/HIV Coinfected. So I think the FDA may be too cavalier here or missing these points that for a number of seriously advanced patients accelerated drug development is crucial. In coinfection HCV is the leading cause of death. Among monoinfected and coinfected often patients have not even tested and remain unidentified as HCV+.
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