Conditional and Lenient Drug Approvals

SSRN Electronic Journal · 2025-01-01

Optimal Push, Pull, and Failure Funding for Global Health

SSRN Electronic Journal · 2025-01-01

European priority review vouchers for neglected disease product development

BMJ Global Health · 2024 · 6 citations

• Political Science
• Medicine
• Environmental health

INTRODUCTION: Neglected diseases are a significant global health challenge. Encouraging the development of therapeutics and vaccines for these diseases would address an important unmet medical need. We propose a priority review voucher programme for the European Union (EU). The developer of a drug or vaccine for a neglected disease would receive a voucher for accelerated assessment of a different product at the European Medicines Agency (EMA). METHODS: This study uses retrospective observational data to estimate the potential commercial value of the proposed voucher programme using a five-step approach: (1) estimating the time saved in the EMA accelerated regulatory review; (2) gauging time reductions in accelerated pricing and reimbursement decisions by EU member states; (3) selecting 10 high-revenue products launched between 2015 and 2020 representing typical voucher users; (4) analysing IQVIA MIDAS sales data for the selected products and (5) calculating the net present value (NPV) of the voucher based on the 10 products. RESULTS: The accelerated EMA review would reduce regulatory time by an average of 182 days. Additionally, products could save more than a year in many member states through an expedited 120-day pricing and reimbursement review. The estimated NPV of regulatory acceleration by two quarters would be €100 million. In addition, if France, Italy and Spain reviewed pricing and reimbursement in only 120 days, then the value would double. CONCLUSION: An EU voucher estimated at more than €100 million, coupled with a US$100 million counterpart, offers a meaningful incentive for novel product development. However, the voucher programme should be part of a comprehensive strategy for tackling neglected diseases, rather than a standalone solution.

Consequences of a shortage and rationing: Evidence from a pediatric vaccine

Journal of Health Economics · 2023-09-29 · 3 citations

FDA Global Drug Inspections: Surveillance Of Manufacturing Establishments Remains Well Below Pre-COVID-19 Levels

Health Affairs · 2023 · 5 citations

• Political Science
• Business
• Environmental health

During the initial phase of the COVID-19 pandemic, the Food and Drug Administration (FDA) halted inspections of most overseas drug manufacturing establishments. Looking at data from the period 2012-22, we observed steep declines in both foreign and domestic inspections in 2020. By 2022, numbers of inspections remained well below prepandemic levels, with a 79 percent decrease in foreign inspections and a 35 percent decline in domestic inspections compared with 2019. There was no corresponding reduction in drug manufacturing or imports. Also, the resources allocated per inspection surged, although the FDA's overall budget and staffing remained steady. Finally, citations rose dramatically, despite all establishments being given advance notice of inspections. The findings of our study underscore the pressing need to explore alternative methods for ensuring drug safety.

Consequences of a Shortage and Rationing: Evidence from a Pediatric Vaccine

National Bureau of Economic Research · 2023-07-01

Shortages and rationing are common in health care, yet we know little about the consequences.We examine an 18-month shortage of the pediatric Haemophilus Influenzae Type B (Hib) vaccine.Using insurance claims data and variation in shortage exposure across birth cohorts, we find that the shortage reduced uptake of high-value primary doses by 4 percentage points and low-value booster doses by 26 percentage points.This suggests providers largely complied with rationing recommendations.In the long-run, catch-up vaccination occurred but was incomplete: shortage-exposed cohorts were 4 percentage points less likely to have received their booster dose years later.We also find that the shortage and rationing caused provider switches, extra provider visits, and negative spillovers to other care.

European Priority Review Vouchers for Neglected Disease Product Development

SSRN Electronic Journal · 2023-01-01

US Tropical Disease Priority Review Vouchers: Lessons In Promoting Drug Development And Access

Health Affairs · 2021 · 9 citations

• Business
• Environmental health
• Medicine

The COVID-19 global pandemic has devastated lives and economies. It has served as a reminder of how critical it is to invest in preventing and treating infectious diseases. Until the COVID-19 pandemic, the largest US government-sponsored reward for infectious disease drug and vaccine development was the Tropical Disease Priority Review Voucher program. Under this program, the Food and Drug Administration awards a priority review voucher to the sponsor of a new drug or vaccine for tropical infectious diseases. The voucher then can be exchanged for the faster review of one drug. We provide case studies for tropical disease voucher recipients between 2007 and 2018, examine the effects of the voucher program on product innovation and access, and recommend that policy makers protect the voucher program while creating complementary incentives.

The Method of Democracy

2020-12-24

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Harvard Dataverse · 2019-01-01

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