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.