Avastin® (bevacizumab) is a medication used off-label by ophthalmologists to treat eye diseases such as macular degeneration and diabetic retinopathy. I estimate hundreds of thousands of doses of Avastin are administered annually in the U.S. alone.
Avastin is repackaged by pharmacists to facilitate the administration of an expensive drug by an ophthalmologist to multiple patients in a cost-efficient manner. The cost of the drug is a major justification for repackaging this agent. The average price often quoted for a dose of ophthalmic Avastin is $50. This compares quite favorably to other medications used for similar conditions; $1,950 for a dose of Lucentis® (ranibizumab) or $1,850 for a dose of Eylea® (aflibercept). Several insurance companies require a patient to have been treated with Avastin before a more expensive therapy will be covered for the patient.
In February, the FDA published Draft Guidance for Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application that stipulates repackaged Avastin be assigned a 4-hour Beyond Use Date (BUD). The 4-hour BUD may be extended to 24 hours if a microbial challenge study is conducted and shows that “microbial growth will not progress to unacceptable levels within the period of the BUD.”
The FDA asserts in the Draft Guidance that repackaging Avastin is manufacturing, not compounding: “For purposes of this guidance, repackaging means taking a licensed biological product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the product.”
The FDA Draft Guidance allows a comment period of 90 days that will conclude in mid-April. The FDA will consider the comments that are submitted and a final Guidance document will be published.
It is my belief that most pharmacists have considered repackaging injectable medications to be a pharmacy compounding function, using USP <797> standards as the guide. This Draft Guidance, as well as the Draft Guidance on Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities, will have a major impact on pharmacy practice due to the strict BUDs that are imposed.
The FDA is justifiably concerned about safety and quality. There are many competing interests to consider related to repackaging drugs and biologicals. If these draft guidance documents become final, I am very concerned the cost of healthcare will skyrocket even faster, patients will be undertreated or untreated, and the drug companies will sell more of their preferred (i.e. expensive) drugs.
Disclaimer: The opinions expressed below belong to Bill Mixon, RPh, MS, FIACP, FACA. He is not speaking for any organization with which he may be affiliated. This is not legal advice.