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.