Rachel E Sachs
Biographic Data
| ID | 8449734 |
|---|---|
| NAME | Rachel E Sachs |
| GIVEN NAMES | Rachel E |
| FAMILY NAME | Sachs |
| SIGNATURE | SACHS R E |
| AFFILIATIONS | Washington University in St. Louis |
| ORCID | 0000-0002-0172-3572 |
| VERIFIED | Yes |
| TOTAL WORKS | 5 |
| TOTAL CITATIONS | 0 |
| WORKS AS AUTHOR | 5 |
| WORKS AS EDITOR | 0 |
| FIRST PUBLICATION YEAR | 2019 |
| LATEST PUBLICATION YEAR | 2023 |
| H-INDEX | 0 |
Extending the US Food and Drug Administration’s Postmarket Authorities
Under current FDA approaches to drug approval, patients, clinicians, and payers may be left with little confidence about a drug's benefit not only when it first enters the market but also for an extended period thereafter. If policy makers continue to favor earlier market access over evidentiary certainty, flexible approvals must be matched by more expansive use of postmarket safeguards, an approach possible within the FDA's existing legal author…
Reforming Reimbursement for the US Food and Drug Administration’s Accelerated Approval Program to Support State Medicaid Programs
Policy makers may wish to consider options for reforming reimbursement for accelerated approval products in addition to reforms to the FDA's operation of the pathway. Policy reform proposals can provide a range of options to evaluate trade-offs of access and pricing
Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval
In this cross-sectional study of 216 drugs granted accelerated approval, state spending on drugs approved through the FDA's growing accelerated approval program represented an outsized amount of spending relative to use. Because drugs with accelerated approval have come to market on the basis of trials using surrogate end points, considerable amounts of this spending may have been attributable to products with unproven clinical benefits
Ensuring Access to Emerging Covid-19 Treatments Through Medicare Reimbursement Policy
Effective pharmaceutical treatments for coronavirus disease 2019 (COVID-19) are urgently needed, and there has been an explosion of research into compounds with potential efficacy against the disease. The highest-profile success to date is Gilead Sciences' antiviral remdesivir, which received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) after preliminary data showed that it may speed patients' time to recove…
Transparency in Health and Health Care in the United States
No prominent works on this page.
Transparency in Health and Health Care in the United States
Ensuring Access to Emerging Covid-19 Treatments Through Medicare Reimbursement Policy
Effective pharmaceutical treatments for coronavirus disease 2019 (COVID-19) are urgently needed, and there has been an explosion of research into compounds with potential efficacy against the disease. The highest-profile success to date is Gilead Sciences' antiviral remdesivir, which received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) after preliminary data showed that it may speed patients' time to recove…
Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval
In this cross-sectional study of 216 drugs granted accelerated approval, state spending on drugs approved through the FDA's growing accelerated approval program represented an outsized amount of spending relative to use. Because drugs with accelerated approval have come to market on the basis of trials using surrogate end points, considerable amounts of this spending may have been attributable to products with unproven clinical benefits
Reforming Reimbursement for the US Food and Drug Administration’s Accelerated Approval Program to Support State Medicaid Programs
Policy makers may wish to consider options for reforming reimbursement for accelerated approval products in addition to reforms to the FDA's operation of the pathway. Policy reform proposals can provide a range of options to evaluate trade-offs of access and pricing
Extending the US Food and Drug Administration’s Postmarket Authorities
Under current FDA approaches to drug approval, patients, clinicians, and payers may be left with little confidence about a drug's benefit not only when it first enters the market but also for an extended period thereafter. If policy makers continue to favor earlier market access over evidentiary certainty, flexible approvals must be matched by more expansive use of postmarket safeguards, an approach possible within the FDA's existing legal author…
Health Systems, Economic Evaluations, Quality of Life (4 works) · Law (4 works) · Medicine (4 works) · Political science (4 works) · Business (3 works) · Drug (3 works) · Food and drug administration (3 works) · Health care (3 works) · Law (3 works) · Pharmacology (3 works)