§1107a Emergency use products

Summary

The President can waive the rule that says service members must be told they can accept or refuse a product that has an emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act. The President must put that decision in writing and say that giving the information would not be in the interests of national security. That waiver power only applies when the requirement to offer the choice comes from an HHS emergency use authorization under section 564. If the President waives that rule and the Secretary of Defense, after consulting with the Secretary of Health and Human Services, finds there is not enough time to give the required information before giving the product, the information must be given to the service member (or the next-of-kin if the member died) as soon as possible but no later than 30 days after administration. That decision cannot be passed to someone else. The fact that the product was given must be entered in the member’s medical record. When HHS authorizes a product under section 564(a)(1) because of a Defense Department determination under section 564(b)(1)(B), subsections (a) through (f) of section 1107 do not apply to that product while the authorization is in effect.