H.R.3839 - Drug Shortage Prevention Act of 2012112th Congress (2011-2012)
Summary: H.R.3839 — 112th Congress (2011-2012)
Introduced in House (01/31/2012)
Drug Shortage Prevention Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to: (1) define the term "critical drug" based on the medical necessity and vulnerability to shortage of a drug or biological product; (2) establish, make publicly available, and update semiannually a list identifying each critical drug and its manufacturers; (3) promptly remove from such list any drug or biological product that no longer meets such definition; and (4) establish, make publicly available, and update monthly a list identifying each critical drug that is in a critical drug shortage in the United States, the severity of and reason for the shortage, alternate therapies and regions particularly affected, and an estimated date by which the necessary quantities of the drug will begin reaching providers.
Allows manufacturers to request removal of a drug from such lists on the basis that it doesn't meet the definition of "critical drug" or is not in a critical drug shortage.
Directs the Secretary to: (1) establish a proactive system for giving notice to the public concerning modifications to the critical drug shortage list, (2) establish a system for giving notice of any imminent critical drug shortage to critical drug manufacturers and wholesale distributors and manufacturers of alternative therapies, (3) notify the Attorney General of any critical drug shortage, (4) study the feasibility of creating a national contingency plan addressing critical drug shortages, (5) expedite the review of applications for approval of critical drugs and requests by sponsors of such drugs to approve manufacturing process changes or alternate suppliers of active ingredients, and (6) improve the process for regulating critical drugs.
Express the sense of Congress that the Food and Drug Administration (FDA) should increase the number of personnel responsible for identifying and addressing critical drug shortages.
Amends the Controlled Substances Act to direct the Attorney General to increase a quota as appropriate for a drug listed in a critical drug shortage that is or contains a controlled substance.