Guidance on Biologics: Restrictions on Beyond-Use Dates
As part of its enforcement authority for compounding of prescription medications under the 2013 Drug Quality & Security Act, the FDA clarified in 2015 that Avastin is not considered a compounded drug but a repackaged biologic, subject to repackaging guidelines. In issuing this clarification in its ‘Draft Guidance on Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application,’ a new concern emerged. The FDA proposed excessively short beyond-use dates (BUDs) for traditional compounders and outsourcing facilities that essentially put bevacizumab out of reach entirely for retina specialists and their patients who rely on it for sight-saving treatment.
ASRS Launches Take Action to Preserve Avastin
In response ASRS launched ‘Take Action to Preserve Avastin,’ a grassroots campaign that generated 300 unique member letters urging the FDA to maintain availability of repackaged bevacizumab by setting aside arbitrary proposed BUDs and focusing on the science as extensive clinical research has shown that repackaged bevacizumab remains stable, sterile, and efficacious with BUDs longer than those proposed by the FDA when standardized aseptic procedures are followed.
In June 2015 ASRS, AAO and others urged members to support both congressional and senatorial sign-on letters to help increase the BUDS. In June 2016, ASRS and others testified to the FDA urging it to focus on science in setting BUDs.
As a result of these efforts, in 2017, the FDA issued a “Revised Draft Guidance” providing a pathway to longer BUDs but leaving ambiguity in the process. In March 2017 comments, the ASRS applauded the Agency for creating a pathway for outsourcing facilities to extend BUDs of finished biologics through stability testing, and asked for clarification on what would constitute passage of the product-related impurities provision in their proposed guidance. In June 2017, the ASRS again urged the FDA for clarification at its listening session on regulations affecting physician offices. ASRS spoke with several outsourcing facilities that repackage bevacizumab and all agree that further guidance is needed before they can comply with the new requirements that would extend the BUD.
In the final guidance published in January 2018, the FDA, at the urging of the ASRS, added references to Appendix A to clarify the tests required to extend the BUD.
- ASRS Comment Letter: Regulations Governing Drug Compounding -- June 2017
- ASRS Letter re: Revised Draft Guidance on Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application -- March 2017
- ASRS Comments on Prescription and Hospitals and Health System Compounding Requirements Under FDA Draft Guidance --July 2016
- ASRS submits its official comment letter to FDA - May 2015
Click blue links for information
- FDA Invites ASRS to Weigh In on Regulations Governing Compounding Jun. 7, 2017
- ASRS Provides Further Comments to FDA in Ongoing Quest to Preserve Avastin Mar. 15, 2017
- FDA Releases Revised Draft Guidance on Repackaging Biologics Providing Pathway to Extend BUDs Jan. 12, 2017
- FDA Issues Long-Awaited Final Guidance on Compounding (503A) Pharmacies Dec. 29, 2016
- Avastin Coding Changes in Effect for 19 States, 3 Territories - January 6, 2016
- ASRS joins AAO and ASCRS in grassroots campaign in support of senatorial sign-on letter urging the FDA to abandon its one-size-fits-all approach to repackaged biological products - including Avastin. - June 25, 2015
- ASRS joins AAO and ASCRS in a grassroots campaign in support of congressional sign-on letter urging FDA to allow appropriate BUDs for compounding or repackaging drugs with history of safe and efficacious use over longer time periods. - June 9, 2015
- ASRS submits its official comment letter to FDA - May 19, 2015
- ASRS President Tarek Hassan, MD, weighs in on the FDA's proposed BUDs in Retina Times. - May 7, 2015
- ASRS leaders make the case for longer BUDs during official FDA listening session. FDA concedes Avastin is unique in the field of biologics. - April 16, 2015
- FDA releases ‘Draft Guidance on Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application' - February 13, 2015
- ASRS launches Take Action to Preserve Access to Avastin campaign, generating 300 unique member comment letters to the FDA encouraging longer BUDs. - March 16, 2014
- ASRS launches Take Action to Preserve Access to Avastin campaign, generating 300 unique member comment letters to the FDA encouraging longer BUDs. - February 18, 2014
- Despite Guidance Setback, ASRS Continues to Push for Access to Avastin - July 9, 2014
- FDA Guidance on Compounded Drugs Limits Distribution for Office Use to Approved Outsourcing Facilities - July 2, 2014
- ASRS Call to Action: Ask Congress to Support Letter to FDA on Pharmacy Compounding - June 19, 2014