We are coming to you today to ask that you devote your attention and energy towards legislation that seeks to expedite the process FDA uses to review drug applications. PPMD has officially endorsed HR. 4132, the Faster Access to Specialized Treatments (FAST) Act, bipartisan legislation that was recently introduced in the House of Representatives.
How you can take action
The FAST Act is consistent with the FDA proposal the PPMD board adopted earlier this year. As such, we are requesting that you – our advocates – contact your members of Congress and urge them to co-sponsor the FAST Act.
We have prepared an email template for you to send to Representatives and a phone script for additional follow-up.
Introduced by Reps. Stearns (R-FL) and Towns (D-NY), FAST puts into law an "accelerated approval" pathway for drugs that are in clinical trials with FDA and that are targeted to serious and life-threatening conditions, like Duchenne, that lack existing treatment options. Among other things, the bill would enable drug sponsors to request that their drug receive Fast Track designation by the FDA, and it would provide greater flexibility in designing clinical trials involving rare disease population. Given the challenges in finding a sizeable population with Duchenne to design an effective trial, this proposal holds promise for the development of drugs to treat the disease.
Portions of the FAST Act are included in the House's draft version of the Prescription Drug User Fee Act (PDUFA). PPMD will advocate that the FAST Act remain in the final user fee package that passes the Congress.
Thank you for all of your hard work and for joining us in this important & simple action.
Let’s keep up the outstanding advocacy!
Ryan Fischer, Director of Outreach & Advocacy
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