S-2055 : Still Just a Bill

Medical Countermeasure Innovation Act of 2015

This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to ensure the issuance of timely and accurate guidelines regarding the use of medical products for countering public health emergencies or material threats.

The Biomedical Advanced Research and Development Authority's contracting authority for procurement of medical countermeasures under Project BioShield is codified. Such procurement no longer requires Presidential approval or an agreement between HHS and the Department of Homeland Security.

The Office of the Assistant Secretary for Preparedness and Response must publish its budget plan for medical countermeasures.

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to explain delays in finalizing guidance regarding development of animal models to support approval of medical countermeasures.

Upon approval, the FDA must award a priority review voucher to the sponsor of a drug or biological product that: (1) is a significant improvement in the prevention, diagnosis, or treatment of a serious condition; and (2) can be used as a medical countermeasure to a material threat. The transferable voucher entitles the holder to have a new medication application acted upon by the FDA within six months.

The sponsor of a medication that is subject to a voucher must pay a user fee based on the FDA's cost for the priority review process.

The FDA must publish a notice each time it issues a voucher or a voucher is used.