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Patient Choice Act

Patient Choice Act. ….for those you love. Basic Elements. FDA provisional approval of fast track drug after establishment of Safety Full approval continues to be sought Distribution under informed consent Enables provisional approval of drugs on the market in approved countries for > 4 yrs.

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Patient Choice Act

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  1. Patient Choice Act ….for those you love

  2. Basic Elements • FDA provisional approval of fast track drug after establishment of Safety • Full approval continues to be sought • Distribution under informed consent • Enables provisional approval of drugs on the market in approved countries for > 4 yrs

  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 Status • Introduced in 113thcongress on May 22nd • Many support letters – ALWAYS NEED MORE!! • Lead by Cong. Morgan Griffith (R-VA), Cong. Peters (D-VA), Cong. McCaul (R-TX)

  6. Activities • Presented legislation at DIA on a panel with National Health Council, Vertex Pharmaceuticals, and Abigail Alliance • Working with Patient and Rare Disease Communities • CHI Dinner with Freshmen Congressmen from CA • Film Festival • Kauffman Foundation, Here.Us.Now • Global Genes and Rare Project, RARE • Fight to Live, Fight To Live

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