To amend the Federal Food, Drug, and Cosmetic Act to encourage the development of priority antimicrobial products through the award of a transferable exclusivity extension period, and for other purposes.
Re-Valuing Anti-Microbial Products Act of 2018 or the REVAMP Act This bill amends the Federal Food, Drug, and Cosmetic Act to provide for an award of 12 additional months of market exclusivity to a drug manufacturer for a drug designated as a "priority antimicrobial product." (A priority antimicrobial product is intended to treat or prevent a disease attributable to a multi-drug resistant bacterial or fungal pathogen for which there is a critical unmet medical need.)
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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Health
Advisory bodiesCongressional oversightDrug safety, medical device, and laboratory regulationDrug therapyGovernment studies and investigationsHealth promotion and preventive careInfectious and parasitic diseasesIntellectual propertyLicensing and registrationsPrescription drugs
To amend the Federal Food, Drug, and Cosmetic Act to encourage the development of priority antimicrobial products through the award of a transferable exclusivity extension period, and for other purposes.
USA115th CongressHR-6294| House
| Updated: 6/28/2018
Re-Valuing Anti-Microbial Products Act of 2018 or the REVAMP Act This bill amends the Federal Food, Drug, and Cosmetic Act to provide for an award of 12 additional months of market exclusivity to a drug manufacturer for a drug designated as a "priority antimicrobial product." (A priority antimicrobial product is intended to treat or prevent a disease attributable to a multi-drug resistant bacterial or fungal pathogen for which there is a critical unmet medical need.)
Advisory bodiesCongressional oversightDrug safety, medical device, and laboratory regulationDrug therapyGovernment studies and investigationsHealth promotion and preventive careInfectious and parasitic diseasesIntellectual propertyLicensing and registrationsPrescription drugs