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Access and Authority

Congressional lawmakers have introduced a bill that would enable terminally ill patients to more easily try experimental drugs, Pharmalot's Ed Silverman reports. The bill, Silverman adds, would prevent the federal government, including the Food and Drug Administration and the Drug Enforcement Administration, from impeding access.

Currently, under FDA's expanded access program, severely ill patients can obtain drugs that are in development without being part of a clinical trial, though their request has to be approved by both the FDA and the drug maker, Silverman notes. He adds that patients and their families, as well as advocacy groups and some lawmakers, have criticized this process, calling it "cumbersome and arbitrary." But the requests are typically granted.

The FDA Law Blog's James Shehan argues that the new bill could undermine FDA's expanded access regulatory program. "Although the bill does not mention the companies that make experimental products, the bill could be interpreted as prohibiting FDA from taking enforcement action against anyone who ignored the expanded access regulations, including the companies," he says.

Because of this, NYU School of Medicine's Arthur Caplan tells Silverman that the bill won't become law. "It emasculates the authority of the FDA to control the introduction of new drugs, biologics, vaccines and devices and as such will not gain Congressional approval," he says.