Support FAST Legislation

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Please cosponsor HR. 4132, the Faster Access to Specialized Treatments (FAST) Act.

Dear [Decision Maker],

As Congress begins to deliberate the Prescription Drug User Fee Act (PDUFA) reauthorization, we urge you to co-sponsor legislation introduced by Reps. Stearns and Towns, HR. 4132, the Faster Access to Specialized Treatments (FAST) Act.

As someone who is deeply affected by Duchenne Muscular Dystrophy, the proposed legislation has the potential to increase access more quickly to therapies to treat deadly diseases. As you may know, Duchenne Muscular Dystrophy is the most common form of Muscular Dystrophy and the most common lethal genetic disorder of childhood. A muscle-wasting disease that affects primarily males, about 20,000 cases of Duchenne are diagnosed each year worldwide. The average Duchenne patient lives only until his late 20s or early 30s, and no cure exists. But while today there is no cure for Duchenne, there is hope.

Thanks largely to Congress' longstanding commitment to advance Duchenne research and care, the average life expectancy of patients with Duchenne has increased by about 10 years over the past decade, a remarkable improvement. And today, nearly 20 candidate therapies are in the clinical trial process, with several in the pivotal phase 2 and 3 stages. But while promising and hopeful, more must be done to end Duchenne.

The Fast Act puts into law an "accelerated approval" pathway for drugs that are in clinical trials with FDA and that would treat serious and life-threatening illnesses 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.

This is an issue I care about. As your constituent I really hope we will have your support.

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 or cure this disease, along with other serious and life threatening diseases and conditions.

On behalf of all of those directly and indirectly affected by Duchenne, we urge you to co-sponsor this vital and potentially life-saving legislation.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]