Yesterday, August 3rd, Congress took a first step toward reducing prescription drug prices and ensuring Americans have access to affordable medicines. By a vote of 94-1, the Senate passed S.934, the FDA Reauthorization Act of 2017. Passing this bill will improve approval of generic drugs, and it is a sign that Congress is interested in taking action to lower drug prices.
The act reauthorizes the Food and Drug Administration to collect and spend fees so it can approve prescription drugs and medical devices, and regulate them after they enter the market. It also includes the Franken-Collins Amendment, which is intended to promote approval of generic drugs. The House of Representatives has already approved the bill, which was delayed by Senate Republican attempts to repeal the Affordable Care Act. Since this act has overwhelming bipartisan support, President Trump is expected to sign it.
The FDA’s user-fees agreements are renegotiated every five years and fund almost half of FDA operations. If they are not reauthorized by the end of September, the FDA would have to fire over 5,000 employees and postpone the review of many medicines. This bill allows the FDA to access $9 billion in fees over the next five years and to hire more employees to speed up its work.
It also includes the Franken-Collins Amendment to promote approval of generic drugs. This amendment sets a timeframe of no more than eight months for the FDA to prioritize the review of new drugs introduced into uncompetitive markets. It also improves the visibility of the backlog of priority review applications, provides more resources and communication to improve the quality of applications when they are submitted, and enhances the FDA’s ability to discern potential drug shortages by boosting its capacity to track drug trends.
Generic drugs help reduce costs and make sure Americans can get the medicines they need to stay healthy. The Senate’s approval of this bill to promote generic drug access and boost the FDA’s resources is most welcome, and the overwhelming support indicates that Congress is concerned about drug prices and determined to take action. For the sake of consumers, President Trump should swiftly sign this bill into law, and Congress should pass other, broader proposals to stop price gouging and encourage affordable drugs.