The regulations also include general criteria for granting expanded access:

Despite the updated regulations, debate remains over key elements of expanded access:

That measure calls for expanded access to private health insurance for those not covered by Medicare.

The primary intent of expanded access is to provide treatment for a patient's disease or condition, rather than to collect data about the study drug.

"Did Act-Up play a significant role in the whole idea of expanded access to experimental drugs?"

"People on expanded access are sicker than those in clinical trials."

The trials suffer from design and recruitment problems that predate expanded access.

To call for expanded access yet say "it may be time to throw in some new books, too" simply misses the point.

He argued that if the drug had been available in trial groups at the same time as expanded access, "accrual would have been better."

But he said "the feasibility of expanded access may increase as the government securities markets evolve."