Pass the Patient Focused Impact Assessment Act


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Please Cosponsor S. 1597, the Patient-Focused Impact Assessment Act!

Dear [Decision Maker],

On June 18th U.S. Senators Roger Wicker, R-Miss., and Amy Klobuchar, D-Minn., introduced the "Patient-Focused Impact Assessment (PFIA) Act" (S.1597) which urges greater transparency of product approval at the Food and Drug Administration (FDA). The measure would require the development of a patient engagement assessment tool, the results of which would be included in the publicly disclosed safety and effectiveness data package of any approved drug.

This legislation would allow advocates to see how FDA is incorporating the voice of the patient community during the drug approval process, Its potential impact on victims of rare and fatal diseases, such as Duchenne muscular dystrophy, is instrumental in facilitating the use of necessary and often high-risk medication.

This bipartisan bill calls for FDA to develop a simple and publicly accessible checklist to show how reviewers are or are not using such PFDD tools like benefit/risk surveys, guidance documents and patient-reported outcomes when reviewing applications. The bill also calls for additional FDA clarity on actions patients and industry can take to develop PFDD products to drive further innovation in the field.

To cosponsor the legislation, please contact either SarahLloyd in Senator Wicker's office or Sarah Smith in Senator Klobuchar's office.

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