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US: OGD sees higher approvals in 2022

2023/03/07  FDA

Welcome to the eighth Annual Report from the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).

In 2022, generic drugs remained a significant public health priority for the FDA. Competition from generic drug makers helped make drugs more widely available and generally less expensive, allowing millions of patients to access the medicines they need more easily. The approval of generics often means that there are multiple manufacturers for a drug product, which also stabilizes the supply of medicines and reduces the risk of drug shortages. It is estimated that 91% of all prescriptions in the United States are filled as generic drugs, with more than 32,000 generic drugs approved by the FDA to date.

Ultimately, generic drug competition generates billions of dollars in savings each year for consumers and our health care system over higher-priced brand-name drugs. For example, a recent FDA study showed the savings accrued during the first year after approval for new generic drugs approved in 2018, 2019, and 2020 to be approximately $53.3 billion. This means tens-of-billions of dollars were saved each of those years, economy-wide, from new generic approvals.1 Generic drug competition offers tremendous public health benefits for the United States by helping to lower drug prices and improve access to needed medicines for American patients.

Topics of this report include:

  • The Renewal of the Generic Drug User Fee Amendments
  • Scientific Research: Helping to Increase Access to Complex Generic Drugs
  • Abbreviated New Drug Application (ANDA), First Generics, Drug Competition Actions
  • International Collaboration
  • Expanding Access to COVID-19 Drug Treatments

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