American Society of Hematology

Drug Shortages Provisions in Public Law No: 112-144, FDA Safety and Innovation Act

Published on: July 10, 2012

On July 9, 2012 President Obama signed into law legislation reauthorizing the Food and Drug Administration's user fee programs for five years and making other changes to FDA programs and policies. The FDA Safety and Innovation Act (Public Law No: 112-144) was developed with bipartisan support over the last six months and was passed by the Congress in late June. The bill allows FDA to collect fees from industry to pay for approval process staff reviewing prescription drugs and medical devices. The new law also creates two new user fee programs to cover generic drugs and biosimilars.

A major piece of the legislation establishes a process by which drug manufacturers are required to provide FDA with early notification when they stop or interrupt the manufacturing of a drug that is life-supporting, life-sustaining or intended for use in the prevention of, or treatment for, a debilitating disease or condition, which could lead to a shortage of that drug in the United States. The intent is to establish a formal process by which FDA can collaborate with manufacturers in order to take actions which could prevent or mitigate drug shortages. Details of the drug shortage provisions of the law follow:

Notification Requirements – The legislation requires manufacturers of a drug to notify the Secretary of Health and Human Services ("the Secretary") of permanent discontinuance or an interruption in the manufacture of a drug, which could lead to a "meaningful disruption" in the supply of that drug in the United States. Meaningful disruption" is defined as, "a change in production that would likely lead to a reduction in the supply of a drug which impacts the ability of manufacturers to meet expected demands for the drug." The legislation provides for an exemption in the notification requirements for routine maintenance or other minor changes, so long as the manufacturer expects to resume production in a short period of time.

Timing of Notification – The legislation requires notification to the Secretary at least six months prior to the date of the discontinuance or interruption in production. If it is not possible to provide six-month advance notification (e.g. unanticipated shortage of raw materials, unanticipated manufacturing or production difficulties, etc.), then notification is required to be submitted as soon as practicable.

Covered Drugs – The notification requirements apply to drugs which are "life-supporting; life-sustaining; or intended for use in the prevention of or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery; and that is not a radio pharmaceutical drug product." The Secretary may by regulation include biological products under this requirement, including products derived from human plasma protein and their recombinant analogs, if the Secretary determines doing so would benefit the public health.

Failure to Meet Notification Requirements – If a company fails to notify the Secretary of discontinuance or disruption, the Secretary shall notify the company of such failure. The company would then have 30 days to submit a written response setting forth the basis for noncompliance. Both the notification from the Secretary and the response from the manufacturer would be available to the public on the FDA website.

Communications of Drug Shortages – The Secretary is required to distribute information on drug discontinuations or shortages to appropriate provider organizations and to the public.

Drug Shortage List – The Secretary would be required to maintain a drug shortage list which includes the name of the drug in shortage; the manufacturer; the reason for the shortage; and the estimation of the time frame of the shortage.

Expedited Inspections and Reviews – The Secretary may expedite establishment inspections and review of NDAs and SNDAs that could help mitigate or prevent a drug shortage.

Issues related to Controlled Substances – The Secretary is required to notify the Attorney General of any notifications from manufacturers of controlled substances. Manufacturers would be permitted to request that the Attorney General adjust the quotas of certain drugs and ingredients subject to the Controlled Substance Act. The Attorney General is required to provide a report to Congress within six months, and every year thereafter, on the number of quota expansion requests received, approved, denied and the reasons for approval or denial.

Confidentiality of Information – The Secretary may not disclose proprietary information when a manufacturer notifies the Secretary of the discontinuance or interruption in production of a drug.

Repackaging guidance – Hospitals may repackage drugs on the FDA shortage list for transfer to another hospital within the same health system.

Reports, Strategic Plan and Study

  • Requires the Secretary to annually report to Congress on the number of manufacturers that reported an interruption or discontinuance in manufacturing and the actions taken by the Secretary to prevent or mitigate a drug shortage and the number of drug shortages occurring during a calendar year
  • Establishes of a Task Force to develop a strategic plan to enhance interagency coordination to avert or mitigate drug shortages; ensure shortages are taken into consideration when the Secretary undertakes regulatory actions; plans for effective communication with stakeholders and the impact of drug shortages on medical research, including clinical trials. The Task Force would also be charged with recommending the establishment of a "qualified manufacturing partner program."
  • Requires the General Accountability Office (GAO) to conduct a study on the causes of drug shortages and to identify ways to prevent or alleviate shortages.
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