Federal Shelf Life Extension Program Fact Sheet | State …

Posted: February 11, 2019 at 5:41 pm

Fact Sheet Overview

The federal Shelf Life Extension Program (SLEP) extends the expiration dates on qualifying drugs and other materiel in federal stockpiles. SLEP is administered by the U.S. Department of Defense (DoD) in cooperation with the U.S. Food and Drug Administration (FDA).1 The program is an acknowledgement that the actual shelf life of drugs and other medical products may be longer than their stated expiration date, depending on their storage conditions. The purpose of SLEP is to defer replacement costs of stockpiled drugs by extending their useful life.

The program was established in 1986 through an interagency agreement between the DoD and the FDA in response to a Congressional directive to address U.S. Air Force drug stockpiles.2 This initial SLEP program was intended to extend the useful shelf life of medicines with limited commercial use (e.g., chemical agent antidotes) or which the government held in such large quantities that the manufacturer would not accept them for credit when the drugs expired.3 Since then, other federal agencies have entered into a memorandum of agreement with the DoD to participate in SLEP, including other branches of the military, the Strategic National Stockpile (SNS), the Department of Veterans Affairs (VA), the U.S. Postal Service, and the Bureau of Federal Prisions.2

SLEP is currently available only for federally-maintained stockpiles, although there have been ongoing deliberations between the federal government and the states about extending SLEP to state-maintained stockpiles or creating a separate SLEP-like program for state stockpiles. (See State Stockpiles discussion below.)

Note: As of March 2012, Congress is in the process of reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA), which may impact a number of laws and programs described below. Please see ASTHO EUA Current Issues Winter 2012 for more information about reauthorization and its potential impact on EUAs and related issues. (Download a printable PDF.)

SLEP is a fee-for-service program. Participating agencies are required to pay for the FDAs periodic, comprehensive testing and analysis of the drugs and other medical materiel in the SLEP process. Items eligible for SLEP are tested by the FDA. Products that pass testing are granted extended expiration dates but must undergo ongoing testing to monitor their continued shelf life.4 Products that fail testing at any time are destroyed.4 Products that do not receive additional extensions of their expiration dates or are not tested for SLEP are destroyed at their final expiration dates.4 Maintaining controlled storage conditions appropriate for the product(s) is an important factor in the SLEP process.

The program is operated by the DoD Defense Medical Materiel Program Office (DMMPO) (formerly the Defense Medical Standardization Board [DMSB]) and regularly interacts with the FDA and agencies participating in SLEP.2,5 The DMMPO/DoD role in SLEP is to conduct programmatic and administrative functions, including but not limited to: (1) identifying products eligible for testing to FDA; (2) updating the SLEP expiration database; (3) conducting a cost-benefit analysis of extending a drugs expiration date; (4) ordering labels for relabeled drugs; and (5) billing participant agencies.2

The FDA is responsible for testing and evaluating drugs for SLEP. Specifically, the FDA: (1) determines the appropriate tests and methods for the candidate drugs; (2) conducts tests on samples of the candidate drugs; (3) analyzes test results and determines whether and for how long extension is possible; and (4) performs other research to address SLEP issues.2

Not every item stockpiled is a candidate for SLEP. Because of the costs involved in testing, the program is primarily designed for large stockpiles of drugs and medical materiel that are housed in environmentally controlled facilities.2 FDA-approved prescription drugs are most frequently designated for SLEP testing by program participants. Biological products such as vaccines, serums, and nutritional products or items with a history of poor SLEP performance are not eligible for testing.2,4 Items where testing would be time or cost prohibitive are not accepted.4 The focus on testing has been on products that are militarily significant, have limited commercial use, are purchased in large quantities (e.g., antivirals), or are used only if there is an event requiring their administration.2

The procedure to determine whether a drug or other medical materiel is eligible for extension under SLEP involves testing by the FDA. If an extension is granted, the approval document identifies the length of the extension and relabeling requirements. Products under SLEP are regularly retested and must be destroyed if at any time they fail testing.2

An Emergency Use Authorization (EUA) is a type of permission under FD&C Act 564 that allows for the use of an unapproved medical product or an unapproved use of an approved medical product (drugs, biologics [e.g., vaccines], and devices [e.g., diagnostics]) during certain types of emergencies. Products extended under SLEP through the exercise of FDA enforcement discretion receive a new expiration date that is different than the one originally contained on the products labeling and is considered a deviation from the items prior approved use. Similarly, some SNS products may have been stored in conditions that exceeded labeled temperature ranges. Currently, an EUA is required to ensure that SLEP-extended drugs are not in violation of the FD&C Act. (See also ASTHO Current Issues and UpdatesSummer 2011Evolving Policy Issues.) During the H1N1 influenza pandemic in 2009, Tamiflu (in capsules and suspension form) that was held in the SNS, much of which had been tested and extended under SLEP, was distributed to states and localities.2 The FDA issued an EUA that allowed the use of these products beyond the labeled expiration date without requiring that they be relabeled.

States have developed and maintained their own stockpiles of medicines and supplies in addition to those provided by the federal government through the SNS. In preparation for a pandemic, the federal government offered states a 25 percent subsidy to purchase additional antivirals through the SNS program. However, stockpiles held by states, whether purchased with state or federal funds, are not eligible for SLEP.10 In 2006, the National Strategy for Pandemic Influenza: Implementation Plan directed the HHS, the DoD, the VA, and the states to explore expanding SLEP to state stockpiles.11 Similarly, in a report about antiviral strategies for a pandemic, the Institute of Medicine recommended that the SLEP program be extended to other public and private stockpiles.10 That report also suggested using the information gained through SLEP to facilitate the use of properly stored recently expired drugs held outside SLEP.10 These recommendations acknowledged the high cost of replacing expired stockpiles and the potential scarcity of the drugs during a severe pandemic as important reasons for seeking to extend the drugs expiration dates.10

An FDA-led interagency workgroup that included the DoD, the CDC, and the VA determined that including state antiviral stockpiles in SLEP is not currently feasible.2 Reasons cited for the decision included programmatic, resource, quality, and legal considerations:

In addition to evaluating the feasibility of including states in SLEP, the HHS has been analyzing the feasibility of creating a separate SLEP-like program for extending state stockpiles. The Biomedical Advanced Research and Development Authority (BARDA) within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) has been evaluating the infrastructure necessary to support a new program for states and analyzing the comparative cost effectiveness of shelf-life testing to repurchasing for state inventories.12 Cost factors to be considered include laboratory testing, storage site inspection, state personnel, relabeling for extended products, destruction for products not extended, and transportation for products being tested or destroyed.12 The HHS, BARDA, and the states conducted a detailed analysis with state-specific data in 2011, but no results have been released as of March 2012.12

SLEP currently impacts states primarily through SNS deployments containing medicines that have received, or subsequently receive, shelf-life extensions. Shelf-life-extended products that have an expired label date or that have been relabeled may cause concern among healthcare providers and the public about the safety and efficacy of the extended items. Liability fears can arise among healthcare providers and others dispensing the shelf-life-extended items. Furthermore, complications can arise in determining what products are eligible for SLEP when SNS assets have been mixed with non-SNS assets in state, local, or regional stockpiles.

While extending expiration dates potentially saves money for states by reducing the frequency of replacing expired stockpiled medicines, if state stockpiles are eventually included in the federal SLEP or a similar program for states, states will also have to consider the logistical, personnel, and financial implications of participating in such an initiative.

Note: This document was compiled from JuneDecember 2011 and reflects the laws and programs current then. It reflects only portions of the laws relevant to public health emergencies and is not intended to be exhaustive of all relevant legal authority. This resource is for informational purposes only and is not intended as a substitute for professional legal or other advice. The document was funded by CDC Award No. 1U38HM000454 to the Association of State and Territorial Health Officials; Subcontractor PI Elliott, Logan Circle Policy Group LLC.

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Federal Shelf Life Extension Program Fact Sheet | State ...

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