FDA Bill Cleared for Enactment!
This evening, the U.S. Senate voted to reauthorize the Prescription Drug User Fee Act (PDUFA), legislation that includes a number of vital reforms and resources that will help to speed access to new treatments for people with ALS! The bill now heads to the President, who is expected to sign it into law.
The ALS Association has strongly supported PDUFA, having worked with Congress, FDA and others for more than a year to speed its enactment. These efforts included developing advertisements featuring a person with ALS, which ran in Capitol Hill publications advocating for PDUFA (click here). The bill is an important victory and includes provisions that will:
*Improve and strengthen FDA's Fast Track and Accelerated Approval processes to speed the approval of drugs to treat ALS and other serious and life threatening diseases;
*Provide the FDA with the flexibility to approve new treatments quicker by utilizing tools such as biomarkers and other surrogate endpoints that can predict whether a treatment is effective much earlier in the drug development process;
*Help to ensure that ALS experts can participate on FDA advisory panels;
*Direct FDA to facilitate the development of breakthrough treatments by working more closely with companies and patients throughout the drug development and approval process;
*Reauthorize the Orphan Drug Grant Program, which provides funding to encourage the development of treatments for rare diseases like ALS;
*Require FDA to work closely with patient organizations, including those representing rare diseases, as it develops guidance and regulations; and
*Provide much needed funding and resources to the FDA which will help the Agency to expedite drug approvals.
Thank you to everyone for helping to make a difference!
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