Chapter 1 reports on the U.S. drug supply and the complex way it is
interwoven with multiple stakeholders involved in each step of the
process. When investigational drugs show promise for treating
serious or life-threatening diseases, patients are often interested
in obtaining access to them. Congress included a provision in the
FDA Reauthorization Act of 2017 for GAO to review actions taken to
facilitate access to these drugs. Chapter 2 describes (1) actions
FDA and drug manufacturers have taken to broaden eligibility
criteria for clinical trials, (2) actions FDA has taken to
facilitate access to investigational drugs outside of clinical
trials, and (3) information drug manufacturers have communicated to
patients and physicians about access to investigational drugs
outside of clinical trials. Chapter 3 reports on requiring
e-prescriptions for coverage under part D of the Medicare program
for prescription drugs that are controlled substances.
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