1. Patient Choice Act
….for those you love

2. Basic Elements
A drug for deadly diseases that qualifies for fast track, can seek a provisional approval with the establishment of Safety
During provisional term, patients gain access with informed consent.
Full approval continues to be sought, during a provisional term of 5 years (that can be extended by regulators).

3. Benefits
Provides patient rights to early access to investigational therapies under informed consent – giving patients the right to choose their therapies.
Can save thousands of patients’ lives every year who die waiting for FDA approved access to therapies, when all the standard approved therapies run out.
Preserves the existing regulatory system while making it financially viable for the companies.
Promotes innovation and ensures medical advances can reach the marketplace more quickly.
Stops the loss of companies investing in the development of therapies for deadly & rare diseases, and creates jobs, growth and drives American leadership in medical innovation.

4. Calls for Provisional Approval
Manhattan Institute
Milken Institute
Kauffman Foundation
PCAST
NEWDIGS
And many more!
“Such a reform would allow drugs that have been found safe and promising (in Phase I and Phase II clinical trials) to win approval for limited marketing to patients. This would give patients early access to innovative new therapies, while the FDA would retain the ability to collect information confirming the drugs’ safety and effectiveness and to revoke a drug’s marketing authorization later, when appropriate.” Manhattan Institute

5. Legislative Action Many support letters – ALWAYS NEED MORE!!
Set to be introduced in 113th congress
Lead by Cong. Morgan Griffith (R-VA)