FDA Report Shows Prioritization of Generics

As the coronavirus disease 2019 (COVID-19) pandemic revealed manufacturing challenges, a new FDA report shows that the agency prioritized generic drugs in 2020 and approved more than 650 between March 2020 and January 2021.¹

Generic drugs are a major priority for the FDA, according to the report.

There are more than 10,000 FDA-approved generic drugs, and 9 of 10 prescriptions in the United States are filled by generics.¹

Furthermore, according to the report, generic drugs have saved the health care system close to $2.2 trillion in the past decade alone.¹

The COVID-19 pandemic revealed many challenges in the sourcing and manufacturing of generic drugs, as supply chains were disrupted. Shortages not only limited access to generic drugs, but also affected supplies of personal protective equipment and potential treatments for COVID-19.²

For example, according to Dan Kistner, PharmD, group senior vice president of pharmacy solutions at Vizient Inc, the volume of products coming out of China is unknown, though experts know that 13% of active pharmaceutical ingredients are manufactured there.

The lack of knowledge around plants’ exact locations made it impossible to predict which drugs would be in shortage as the pandemic began, though experts thought that generics were less at risk than brand-name drugs.²

In an interview at the beginning of the pandemic, Kistner said branded drugs have stronger contingency plans because they have sole manufacturers.

Although generic drugs have a backup supply with other manufacturers, Kistner said those safeguards can fail during a global pandemic.²

Despite these concerns, the FDA continued to approve new generics and adapt to the new challenges, according to the report.¹

“Amid the challenges of a worldwide pandemic and rapidly advancing science, the FDA’s generic drug program continued steadfast efforts to help increase the availability of safe, effective, high-quality, more affordable drugs in the US,” according to the report. “Altogether in 2020, the FDA’s generic drug program moved steadily forward, even as the COVID-19 pandemic presented additional complexities, resulting in new realities and unique challenges.”¹

As the pandemic began, the FDA pivoted to start prioritizing generic drug submissions involving potential treatments and supportive therapies for COVID-19. Officials also created a system for identifying these potential treatments and took regulatory and scientific action to accelerate their research and approvals.

These actions involved establishing infrastructure and resolving assessment issues to support prompt actions involving critically needed generic drugs, according
to the FDA’s report.¹

The FDA also worked to support manufacturers by developing new approaches to restart development programs that were interrupted by the pandemic.

For example, officials directly assisted applicants with bioequivalence studies affected by the pandemic, including answering questions about information collection and protocol revisions, according to the report.¹

In addition to steps related to the COVID-19 pandemic response, experts were encouraged to see continued progress on other efforts to improve generic drug programs.¹

“Carrying on our regular, [non-COVID–related] work, we were encouraged to see how our past efforts to improve the generic drug program’s efficiency, quality, and predictability added to our resilience with supporting rapid approval of safe, effective generic medicines for use in fighting the| sudden occurrence of the pandemic,” according to
the report.¹

In total, the FDA approved or tentatively approved 948 generic drug applications, including 72 first generics. There were also 30 generics approved under the Competitive Generic Therapy (CGT) pathway, including a quarterly record of 17 CGT approvals in the first quarter of fiscal 2020.¹

October 2020 saw the most activity, with 78 approvals and 15 tentative approvals. February 2020 saw the fewest, with 51 approvals and 10 tentative approvals. Important approvals included the generic of Daraprim tablets for patients with toxoplasmosis, the generic glucagon for injection for patients with severe hypoglycemia, and the generic of Tecfidera for patients with multiple sclerosis.¹

REFERENCE

1. Choe S. FDA’s generic drug program in 2020 helped ensure availability of high-quality, affordable drugs amid COVID-19. FDA. February 11, 202 Accessed February 16, 2021. https://www.fda.gov/news-events/fda-voices/fdas-generic-drug-program-2020-helped-ensure-availability-high-quality-affordable-drugs-amid-covid
2. Antrim A. Drug manufacturers must increase transparency during pandemic. Pharmacy Times. May 25, 2020. Accessed February 16, 2021. https://www.pharmacytimes.com/publications/issue/2020/May2020/drug-manufacturers-must-increase-transparency-during-pandemic