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 bill unless the Senate adds a “right-to-try” 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.
The money collected through the FDA Reauthorization Act funds approximately 70 percent of the Center for Drug Evaluation and Research, the FDA division that regulates prescription and over-the-counter drugs. This bill must pass in order for the agency to continue approving drugs for safety and efficacy. If the user-fee bill is not reauthorized by Sept. 30, thousands of FDA employees could lose their jobs.
A right-to-try amendment would tack onto this legislation a way for terminally ill patients to use investigational drugs outside of clinical trials and without FDA oversight. But, existing state right-to-try laws do not require that drug companies give patients exercising their “right” experimental drugs, and the policy allows companies to charge patients for them, even if they don’t work or could be fatal. The federal policy would be no different. Ironically, adding a right-to-try amendment to a bill that funds a large part of the FDA’s operations would theoretically allow patients to use drugs that aren’t yet shown to be safe or effective — the very reason the agency exists and requires user fees.
