The FDA’s new rule on “expanded access programs” would allow pharmaceutical companies to give seriously ill patients broader access to investigational drugs outside of clinical trials. A limited number of expanded access programs were created in the past under sketchy FDA rules; the 2 new allied rules—one on the conditions drug companies must meet to create a program, the other on how they can charge for the drugs—ostensibly give pharma a wider berth. Moreover, psychotropic drugs can be provided under the clarified policy.
When the FDA was considering changes to its policy (in part prompted by a lawsuit), it contended with the issue of whether the use of psycho-tropic drugs fits in the definition of “serious medical condition”—with which a patient must be afflicted before a drug company can make an investigational agent available outside a clinical trial. The health insurance industry made an effort to convince the FDA to exclude mental health conditions from serious medical conditions.
In her comments to the FDA after the agency proposed a rule in March 2007, Karen Ignagni, president and CEO of America’s Health Insurance Plans (AHIP), pressed the agency to include a definition in the final rule that said, “A serious disease or condition is one which is persistent, substantially disabling, progressive, and likely to result in death within 6 to 12 months.” She noted that schizophrenia and chronic depression are among the conditions that “cause disabling health effects and suffering for a period of time without death occurring prematurely or in a matter of months.” AHIP was concerned about exposure of its insurance company members to wide claims from policy holders for reimbursement for expensive, investigational drugs obtained through expanded access programs, which might multiply because of the FDA rule liberalization.
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