Here's a crisis waiting to happen: Within week of a Pfizer clinical trial coming to a screeching but not before killing at least 82 people, does the FDA propose to expand access to experimental drugs. The FDA seems schizophrenic these days because it's also the subject of a Senate Finance Committee investigation because of its less than stellar handling of the approval and possible faulty data of Ketek antibiotic. The new rules are intended to give physicians clear directives on when to grant access to medications, even perhaps at the very earliest stage of development, in cases in which the potential benefit is deemed to outweigh the risks. Use of these unapproved drugs, even those of unknown safety, will be reserved for the gravest medical problems. The proposal is open for comment for 90 days.
The FDA would also allow researchers to charge patients for experimental drugs to recover the costs of development, but not a profit. (Chicago Ketek - Lawyer)
