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Amid ramped up production of vaccines, CARES Act gives FDA power to head off potential drug shortfalls. Prevent Blindness is urging the FDA to use its authority to ensure TED treatment drug supply isn’t interrupted.
As coronavirus disease 2019 (COVID-19) cases continue to spike in many parts of the United States, health officials continue to deal with myriad shortages, including much-needed medications.
Treatment delays, even temporary, can be detrimental to a patient’s health. The U.S. Food and Drug Administration (FDA) can take action to help prevent drug shortages and protect treatment access without compromising the COVID-19 pandemic response.
Over the last several months, Prevent Blindness, has stepped up to ensure that patients do not face shortages of medications that help protect their vision. The organization is concerned about shortages of teprotumumab (Tepezza, Horizon Therapeutics).
Jeff Todd, president and CEO of Prevent Blindness, pointed out that the Food and Drug Administration in 2020 approved teprotumumab for the treatment of thyroid eye disease (TED).
He has lead the organization’s efforts to guard against potential lapses in therapy for patients living with TED. Teprotumumab currently is the only FDA-approved treatment of the underlying causes of TED.
Sara Brown, director of government affairs at Prevent Blindness, noted that the organization is concerned that the manufacturing of teprotumumab has been limited due to the manufacture of the COVID-19 vaccine.
“We believe the production of the COVID-19 vaccine is of the utmost importance,” she said. “As we understand it, there are some mechanisms that the FDA could take to ensure the manufacture of teprotumumab without disruption of production of the vaccine.”
Brown noted that there are patients across the country who are in the midst of treatment with the drug, and without that continued treatment their vision could be adversely impacted.
Teprotumumab received FDA approval in 2020 and that could play a factor in how much is available. As the only drug of its kind in the market, the stock is not plentiful.
“We have concerns considering that the FDA in the past has used its authority to prevent drug shortages,” Brown said. “We would hope that they use this precedence”
When the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law on March 25, 2020, lawmakers included a provision amending the drug shortage reporting requirements and creating new requirements related to medical device shortages.
Congress anticipated potential shortfalls with other medications and built language into the CARES Act to guard against these issues. It granted the FDA the ability to thwart shortages.
“Congress directed the FDA to be able to expedite and prioritize applications or inspections that could mitigate or prevent a drug shortage,” Todd said. “The FDA can prioritize to review relevant data and can institute strategies to release individual batches of drugs.”
Over the last 10 months, there has been an increased demand for products used to diagnose and treat COVID-19 patients. This has placed stress on the manufacturing and delivery of vital products, having more information about drug, drug ingredient, and device shortages has been seen as more critical.
The CARES Act expands the scope of drug products subject to notification. Previously, drug manufacturers were required to notify the Food and Drug Administration (FDA) of shortages or expected shortages of drugs that are “life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition.”
The FDA notes that it has been closely monitoring the medical supply chain “with the expectation that it may be impacted by the COVID-19 outbreak, potentially leading to supply disruptions or shortages of drug and biologic products in the US,” and adds that notifying the FDA according to this guidance will help the agency to prevent or mitigate shortages.
The FDA added that it maintains public lists of drugs and biologics that are subject to shortages. The list includes the name of the product, the reason for the shortage, and the estimated shortage duration, based on information submitted by the manufacturer. This posted information may also include information that the manufacturer makes available to stakeholders and patients about the shortage.
“It is critical that the treatment is not delayed and is provided without interruption during the active phase,” Todd said. “As an organization dedicated to protecting patients from avoidable vision loss, ensuring patients have access to therapies that can address the devastating and sight-threatening consequences of TED is a significant priority.”
While the group has not heard any anecdotal information from ophthalmologists regarding shortages of teprotumumab, it noted that ophthalmologists are aware of the potential for shortfalls in the supply.
“We have heard from patients who have expressed a concern about the shortage, and are already facing treatment disruption,” Todd said.
Unlike other ophthalmic medications, teprotumumab is in a unique position as a newly approved drug and as a first-of-its-kind treatment option for TED.
“One of the challenges is that some of the other drugs have been out longer and have larger supplies produced,” Todd said. “Teprotumumab, because it is new, does not have the backup supply.”
Going forward, Brown said the organization will take its case to Congress, if necessary.
“We will continue to encourage the FDA to use the authority it has received from Congress to head off any potential shortages,” she concluded.