ASCRS supports efforts to ensure the safety and sterility of compounded drugs. H.R. 3204, the Drug Quality and Security Act (P.L. 113-54), enacted in November 2013, seeks to improve safety of compounded drugs. The Drug Quality and Security Act represents a compromise between the Senate Health, Education, Labor, and Pensions (HELP) and House Energy and Commerce Committees. The law created a new category of pharmacies—outsourcing facilities—that would voluntarily submit to stricter Food and Drug Administration (FDA) oversight.
H.R. 3204 incorporated some of the provisions advocated by ASCRS and the medical community, such as eliminating a requirement for national patient-specific prescriptions for all compounded drugs, including those made from bulk substances, and the opportunity to review FDA’s recommendations before certain drugs are placed on a “do not compound” list. The bill’s sponsors intended for traditional compounding for patient-specific prescriptions and limited office use to continue to operate under current state law. As a result of the efforts of ASCRS and the ophthalmic community, key senators—including Sens. Rand Paul (R-KY) and Tom Coburn (R-OK) and the sponsors of the bill, Sens. Lamar Alexander (R-TN) and Tom Harkin (D-IA)—submitted congressional statements for the record stating that the bill’s intent was not to regulate office use or limit repackaging.
However, ASCRS had concerns with how the FDA would interpret this new law. Most importantly for ophthalmology, the bill did not include repackaging or office use in the compounding definition and left it to the FDA to determine how repackaged drugs, such as Avastin, are regulated.
The FDA has now released draft guidance for 503A traditional pharmacies and 503B outsourcing facilities, which states that FDA will allow both traditional pharmacies and outsourcing facilities to repackage biologics, including Avastin, for ophthalmic use.
However, ASCRS and other ophthalmology stakeholder groups have concerns with the Beyond Use Dates (BUD) that the draft guidance lays out. The draft guidance provided for a BUD of four hours or equal to the time within which the opened product is to be used as specified on the approved labeling, whichever is shorter, for traditional compounders. The BUD can be extended to 24 hours if microbial challenge studies are performed. The same BUDs apply to outsourcing facilities but can be extended to five days if the outsourcing facility conducts adequate compatibility studies on the container closure system (the syringe) to ensure product integrity.
In ASCRS’ discussions with providers and compounding stakeholders, the conclusion has been that the BUD timeframe is extremely short. Specifically, there are concerns that the five-day expiration date will severely limit the use of Avastin. ASCRS is now working in a coalition with other ophthalmology groups to notify the FDA of the issues surrounding these short BUD timeframes and asking these to be extended in the final guidance document.
ASCRS and others in the ophthalmic community have provided testimony to the FDA recommending the BUDs be extended and to ensure FDA guidance does not impact the availability of compounded drugs for office use.
21st Century Cures- Accelerating Access to Drugs and Devices
ASCRS has long supported efforts to improve access to new drugs and devices, maintaining that the current Food and Drug Administration (FDA) approval process is outdated and overly onerous. Over the last several years, ASCRS has been actively involved in accelerating access to new drugs and devices and increasing focus on improving regulatory predictability necessary for innovation.
ASCRS continues to urge Congress to be vigilant about any measures that would inappropriately increase the regulatory burden for medical device innovation, hurt America’s competitive advantage, and delay or deny appropriate care for patients. Therefore, we continue to encourage the passage of much-needed reforms that will address the delays in the approval of new devices and drugs. Visit ASCRS' Legislative page for the most recent developments on this issue.