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Regulatory Affairs : May 15, 2009 ( )
GEN's Spotlight on the FDA
Sometimes, during the course of new biotech drug development, the sins of a clinical investigator wind up being visited upon the sponsor. Here are some examples:
The lesson here is simple: sponsors must invest more to educate investigators and improve quality control of clinical studies, whether they take place in the U.S. or not. This is easy to say, but hard to do. In today’s regulatory environment, the failure to make adequate investment in both has negative FDA and civil consequences.
Artfully drafted Clinical Investigator Agreements may not protect a company, especially where the firm has failed in its education and monitoring of the investigator.
And, if you think clinical investigators are the only problem, look at the GAO’s report (GAO-09-448T) on IRB’s vulnerability to unethical manipulations. It is likely that Congress may act on clinical investigator and IRB oversight in the future. Companies would be wise to now anticipate such a move.
Navy Broadsides FDA for Blocking Clinical Trials
Companies frustrated with the FDA can now sympathize with the U.S. Navy, which released an internal report blasting FDA for blocking clinical trials on an investigational blood substitute. The April 4 edition of The Boston Globe published an article detailing the Navy’s allegations, which concluded that the FDA reviews were “faulty,” and showed a consistent pattern of erroneous, misleading, and anecdotal statements, reporting bias, changing requirements, no sense of urgency, and conflicts of interest.
While it is uncommon for another governmental agency to attack FDA with such ferocity, it is more unusual to also include 13 university medical professors as coauthors, as did the Navy’s internal report. The Boston Globe article makes interesting reading, especially in an environment where private industry complaints mirror those voiced by the Navy.
To paraphrase an old saying, where there is Navy smoke, there must be fire among the senior officers to allow this internal publication to surface. Obviously, this presents a challenge to the new FDA management, especially the allegation that soldiers who suffer from severe blood loss on the battlefield were the intended patients for the blood substitute clinical study. Ironically, cancer patients and others have frequently voiced the same complaint about the lack of FDA sensitivity or urgency, with a number of them dying during what appears to be laborious clinical development and review cycles.
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