Potential policy reforms to strengthen the accelerated approval pathway Journal Article
| Authors: | Kaltenboeck, A.; Mehlman, A.; Pearson, S. D. |
| Article Title: | Potential policy reforms to strengthen the accelerated approval pathway |
| Abstract: | The accelerated approval pathway for new drugs in the United States is often praised but faces growing criticism of whether it is finding the appropriate balance between uncertainty, access and cost. To support efforts to strengthen the pathway, this paper provides an analysis of key concerns and the advantages and disadvantages of ten potential policy reforms-those achievable through the US FDA action alone, and those that would require a combination of government, payer and life science industry actions. Accelerated approval sits at the heart of many of the controversies regarding drug approvals and pricing, and this analysis provides perspectives on how best to strengthen the pathway within the broader landscape of an innovative US healthcare system. © 2021 Future Medicine Ltd. |
| Keywords: | placebo; drug safety; risk benefit analysis; drug approval; united states; outcome assessment; methodology; evidence based medicine; food and drug administration; risk assessment; health care policy; drug cost; health insurance; medicaid; medicare; prescription; government; drug surveillance program; health care system; interpersonal communication; drug labeling; cost; health care access; randomized controlled trial (topic); shared decision making; access; uncertainty; biomedicine; fda; drug information; innovation; new drug; human; article; surrogate endpoints; accelerated approval pathway; policy reforms |
| Journal Title: | Journal of Comparative Effectiveness Research |
| Volume: | 10 |
| Issue: | 16 |
| ISSN: | 2042-6305 |
| Publisher: | Future Medicine |
| Date Published: | 2021-11-01 |
| Start Page: | 1177 |
| End Page: | 1186 |
| Language: | English |
| DOI: | 10.2217/cer-2021-0184 |
| PROVIDER: | scopus |
| PUBMED: | 34427103 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 December 2021 -- Source: Scopus |
