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Generic drugs : the pay-for-delay problem /
| Clasificación: | Libro Electrónico |
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| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
New York :
Nova Biomedical/Nova Science Publishers,
[2011]
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| Colección: | Public health in the 21st century series.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- GENERIC DRUGS: THE PAY-FOR-DELAY PROBLEM ; GENERIC DRUGS: THE PAY-FOR- DELAY PROBLEM; CONTENTS; PREFACE; PAY-FOR-DELAY: HOW DRUG COMPANY PAY-OFFS COST CONSUMERS BILLIONS; SUMMARY ; RECOMMENDATION; BACKGROUND ; FINDINGS FROM PHARMACEUTICAL AGREEMENT FILINGS FROM FY2004 THROUGH FY2009; STUDY METHODOLOGY ; How Staff Calculated the Additional Delay in Generic Entry Associated with Agreements that Involved Compensation from the Brand to the Generic ; How Staff Calculated the Estimate of 3.5 Billion Annually that Consumers Lose due to Pay-For-Delay Agreements.
- (1) Consumer savings from generic competition (2) Likelihood of Settlements with Payment to Delay, and the Length of Delay; (3) Sales Volume of Drugs for which Settlements are Likely ; (4) Final Estimate Calculation ; Results with Varied Assumptions ; End Notes ; "PAY-FOR-DELAY" SETTLEMENTS IN THE PHARMACEUTICAL INDUSTRY: HOW CONGRESS CAN STOP ANTICOMPETITIVE CONDUCT, PROTECT CONSUMERS' WALLETS, AND HELP PAY FOR HEALTH CARE REFORM (THE 35 BILLION SOLUTION) ; A BRIEF HISTORY ; NEW FTC ANALYSIS OF EMPIRICAL DATA ; Savings to Consumers and the Federal Government ; ENCOURAGING SIGNS.
- LOOKING FORWARDAPPENDIX: CALCULATION OF CONSUMER SAVINGS ; Consumer Savings from Generic Competition ; Likelihood of Settlements with Payment to Delay, and the Length of Delay ; Sales Volume of Drugs for which Settlements are Likely ; Final Estimate Calculation ; Results with Varied Assumptions ; End Notes ; STATEMENT OF THE FEDERAL TRADE COMMISSION, BEFORE THE SUBCOMMITTEE ON COURTS AND COMPETITION POLICY, HEARING ON "ANTICOMPETITIVE PAY-FOR-DELAY SETTLEMENTS IN THE PHARMACEUTICAL INDUSTRY: WHY CONSUMERS AND THE FEDERAL GOVERNMENT ARE PAYING TOO MUCH FOR PRESCRIPTION DRUGS."
- I. THE NEED FOR A LEGISLATIVE SOLUTION A. Permissive Court Decisions have Made Pay-for-Delay Settlements Commonplace in Hatch-Waxman Patent Cases ; B. The Profitability of Delaying Generic Entry Means that these Agreements will become More Prevalent ; C. Pay-For-Delay Settlements Impose Enormous Costs on Consumers and the Health Care System ; D. Permissive Legal Treatment of Pay-for-Delay Settlements Undermines the Hatch-Waxman Act ; E. Legislation is Likely to be Swifter and More Comprehensive than Litigation.
- II. THE ARGUMENTS AGAINST BARRING EXCLUSION PAYMENTS ARE CONTRADICTED BY EXPERIENCE IN THE MARKET III. THE LEGISLATIVE REMEDY; CONCLUSION ; End Notes ; TESTIMONY OF HEATHER BRESCH, CHIEF OPERATING OFFICER, MYLAN, INC., BEFORE THE SUBCOMMITTEE ON COURTS AND COMPETITION POLICY, HEARING ON "PAY TO DELAY: ARE PATENT SETTLEMENTS THAT DELAY GENERIC DRUG MARKET ENTRY ANTICOMPETITIVE" ; A BRIEF HISTORY OF HATCH-WAXMAN ; AUTHORIZED GENERICS ; PATENT SETTLEMENTS.