Drug Shortages

Drug shortages are a persistent and growing threat to ophthalmology practices and the patients who depend on them. The Academy supports a comprehensive policy approach to address the structural causes of ophthalmic drug shortages — and to protect patients and practices when shortages occur.

The Academy supports:

• Pausing step therapy and prior authorization requirements during drug shortages so ophthalmologists have the flexibility to prescribe the best available alternative treatment without administrative delay
• Extending the production window for 503(b) outsourcing facilities to compound drugs that are in shortage or discontinued, to incentivize more facilities to fill supply gaps
• Reforming 340B program policies that restrict multidose use of ophthalmic drops and contribute to unnecessary drug waste — and by extension, to drug shortages
• Investing in domestic pharmaceutical manufacturing to reduce dependence on foreign suppliers and single-source manufacturers
• Improving transparency and mapping of the pharmaceutical supply chain so that vulnerabilities can be identified and addressed before they become crises

Engaging Congress on structural reform

The Academy has submitted formal comments to the House Energy and Commerce Committee, the Senate Finance Committee, and other key congressional bodies on the causes of and solutions to ophthalmic drug shortages. In December 2023, the Academy submitted written testimony to the Senate Finance Committee's hearing on drug shortages, recommending a step therapy pause during shortages, 503(b) flexibility, 340B waste reform, and domestic manufacturing investment.

Supporting the MAPS Act

The Academy has supported the Mapping America's Pharmaceutical Supply (MAPS) Act (S. 1784, H.R. 4191) — bipartisan legislation that would require HHS to update its essential medicines list and create a detailed map of the pharmaceutical supply chain to identify vulnerabilities before they become crises.  

Advancing AMA policy

At the American Medical Association (AMA) House of Delegates November 2023 interim meeting, the Academy presented examples of critical drug shortages in ophthalmology and successfully advocated for AMA policy supporting innovative approaches to diversify generic drug manufacturing and reduce shortages.

Addressing drug waste as a driver of shortages

The Academy has engaged congressional staff on how 340B program requirements — which often prevent multidose use of ophthalmic drops — contribute to waste that exacerbates shortages. The Academy has advocated for modifying tracking requirements or excluding ophthalmic topical drops from 340B restrictions.

Ophthalmology is particularly vulnerable to drug shortages for several reasons. The specialty relies heavily on older generic drugs — products with lower profit margins that are less attractive to manufacturers — and many critical ophthalmic medications are produced by a single supplier or a small number of manufacturers. When one supplier exits the market, the entire specialty feels the impact immediately.  

Drug shortages in ophthalmology are compounded by policies that were not designed with ophthalmology in mind. The 340B drug program's tracking requirements effectively prohibit multidose use of ophthalmic drops at many facilities — leading to significant waste of partially full bottles and putting additional strain on already limited supplies. Medicare Advantage step therapy and prior authorization requirements, which normally require patients to try lower-cost drugs like Avastin before accessing branded alternatives, become an active patient safety threat during shortages — trapping patients in a bureaucratic approval process while the drug they need is unavailable.

The Academy's position is that the pharmaceutical supply chain must be strengthened structurally — through domestic manufacturing investment, supply chain transparency, and appropriate regulatory flexibility for compounding facilities — and that interim protections must be in place to ensure that payer policies do not delay care during supply disruptions.