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Patient Choice Act

Patient Choice Act. ….for those you love. Basic Elements. A drug for deadly diseases that qualifies for fast track, can seek a provisional approval with the establishment of Safety Durin g provisional term, patients gain access with informed consent.

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Patient Choice Act

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  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 innovationand ensures medical advances can reach the marketplace more quickly. • Stops the loss of companiesinvesting 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)

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