FDA warns of COVID’s impact on generic drug studies required for approval

The novel coronavirus could disrupt generic drug companies’ plans to conduct studies to collect the data needed to support their applications for approval, the latest way in which the FDA has conceded life sciences companies are being affected by COVID-19.


By Alexander Gaffney, RAC

The disruptions, noted by the FDA this week, could be felt in the generation of what are known as bioequivalence studies. The studies are meant to show that a generic drug has the same effects as the original drug, also known as the “reference listed drug” or RLD.


How Things Work Now

Unlike new drug products, generic drugs do not require extensive clinical evidence of the safety or efficacy of a drug product. Rather, under the terms of the 1984 Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act), a generic drug must only show that it is bioequivalent to the RLD.


Under federal law, companies are required to show that “the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the listed drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions.”


Evidence from those “experimental conditions” that could support a determination of bioequivalence is typically obtained from small studies involving healthy adults.


What’s New

But as COVID-19 has resulted in shutdowns of transportation networks, site closures, stay-at-home orders and interruptions to the supply chain, the FDA said in a notice this week that it is aware that bioequivalence studies may be affected and subject to delays and interruptions.


For example, a planned study site may be closed for non-COVID-19 patients, or study participants may be unable to get to a trial site. For ongoing studies, participants could become sick with COVID-19, making it difficult to assess the effects of the drug product.


The FDA noted that pausing and restarting a trial likely would require protocol revisions and might also affect the data needed to establish the bioequivalence of the product. According to the notice, companies should “prioritize the protection of the study participants as they consider restarting these studies.”


Impact and What’s Next

The interruption of bioequivalence studies could have downstream effects on future FDA approvals of generic drug products—a cornerstone of the Trump administration’s ongoing efforts to control drug pricing. In recent years the FDA has approved record number of generic drug products.


However, according to an AgencyIQ analysis, the agency has also seen falling numbers of submissions (known as Abbreviated New Drug Applications) for approval. That, paired with challenges associated with COVID-19, could result in a reduction in approvals long-term. For example, reductions in the FDA’s ability to travel may also restrict its ability to conduct pre-approval inspections, which may hamstring its ability to approve products.


[To read more about COVID-19’s impact on generic drug approvals, please read out analysis here.]


Key Documents and Dates

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