NOTIFICATION OF DISCONTINUANCE OF A LIFE SAVING PRODUCT.

SEC. 131. NOTIFICATION OF DISCONTINUANCE OF A LIFE SAVING PRODUCT. (a) In General.—Chapter V, as amended by section 130, is further amended by inserting after section 506B the following: “SEC. 506C. DISCONTINUANCE OF A LIFE SAVING PRODUCT. “(a) In General.—A manufacturer that is the sole manufacturer of a drug— “(1) that is— “(A) life-supporting; “(B) life-sustaining; or “(C) intended for use in the prevention of a debilitating disease or condition; “(2) for which an application has been approved under section 505(b) or 505(j); and “(3) that is not a product that was originally derived from human tissue and was replaced by a recombinant product, shall notify the Secretary of a discontinuance of the manufacture of the drug at least 6 months prior to the date of the discontinuance. “(b) Reduction in Notification Period.—The notification period required under subsection (a) for a manufacturer may be reduced if the manufacturer certifies to the Secretary that good cause exists for the reduction, such as a situation in which— “(1) a public health problem may result from continuation of the manufacturing for the 6-month period; “(2) a biomaterials shortage prevents the continuation of the manufacturing for the 6-month period; “(3) a liability problem may exist for the manufacturer if the manufacturing is continued for the 6-month period; “(4) continuation of the manufacturing for the 6-month period may cause substantial economic hardship for the manufacturer; “(5) the manufacturer has filed for bankruptcy under chapter 7 or 11 of title 11, United States Code; or “(6) the manufacturer can continue the distribution of the drug involved for 6 months. “(c) Distribution.—To the maximum extent practicable, the Secretary shall distribute information on the discontinuation of the drugs described in subsection (a) to appropriate physician and patient organizations.”.