Part D/Prescription Drugs

Adding ‘right to try’ to FDA user fee bill would undermine the agency’s work

(By Kelly McBride Folkers for STAT)

As Congress renegotiates the FDA Reauthorization Act, a must-pass piece of legislation that lets the Food and Drug Administration collect fees from pharmaceutical companies that submit their products for FDA review, Sen. Ron Johnson (R-Wis.) has threatened to hold up the bill1 unless the Senate adds a “right-to-try”2 amendment to the House version currently on the Senate calendar. Despite its benevolent intention to help patients without approved treatment options gain access to drugs in development, right-to-try legislation threatens the integrity of clinical trials, which remain the safest way for patients to try experimental drugs. Continue reading article here…

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