OGD’s 2020 approvals, regulatory work kept pace despite COVID-19

The US Food and Drug Administration (FDA) approved or tentatively approved 948 generic drug applications in 2020, with a significant portion aimed at potential treatments and supportive therapies for patients with COVID-19, according to the annual report from FDA’s Office of Generic Drugs (OGD).
 
In response to the pandemic, OGD devised a system for identifying generic drugs with the potential to treat COVID-19 and accelerating those assessments, according to OGD’s Director Sally Choe, PhD. “This system for identifying generic drugs to address the COVID-19 public health emergency involved establishing infrastructure and resolving assessment issues to support prompt actions involving critically-needed generic drugs,” she wrote.
 
Those accelerated generic products included antibiotics, sedatives for ventilated patients, anticoagulants, and pulmonary medications, according to FDA.
 
Outside of responding to the COVID-19 public health emergency, OGD boasted approval of 72 “first generics,” as well as 30 generics under the Competitive Generic Therapy pathway.
 
Some of the notable first generic approvals included efavirenz, lamivudine, and tenofovir disoproxil fumarate tablets for the treatment of HIV-1 infection; dimethyl fumarate delayed release capsules for the treatment of multiple sclerosis; and dabigatran etexilate capsules for the prevention of stroke and systemic embolism.
 
Also, in 2020, FDA moved forward with implementation of its Drug Competition Action Plan. In January, the agency published a new web page, which is updated biweekly, that lists all approved Abbreviated New Drug Applications (ANDAs) for products that have received Competitive Generic Therapy designation, meaning that they have inadequate generic competition.
 
In March, the agency finalized its Competitive Generic Therapy guidance, offering details on incentives for development, review, and market entry for drugs with inadequate generic competition. Specifically, the guidance describes the process to request designation as a Competitive Generic Therapy and the criteria for designating drugs in this category. (RELATED: FDA Finalizes Guidance on Competitive Generic Therapies, Regulatory Focus 13 March 2020)

OGD also reported a record level of communication with generic drug sponsors through controlled correspondence, allowing generic manufacturers to request information on a specific element of generic drug product development. In 2020, OGD responded to 3,711 controlled correspondence inquires from industry. (RELATED: Generics: FDA finalizes guidance on controlled correspondence, Regulatory Focus 17 December 2020)
 
The Pre-ANDA program, created under the Generic Drug User Fee Amendments of 2017, is another route by which developers can communicate with FDA, both via written communication and meetings, to “help clarify regulatory expectations early I the development process and during application assessment,” noted Choe. Developers of complex generic products can benefit from early engagement with FDA through this program. The goal is to avoid the situation where generic competition is lacking “even after patents and exclusivities no longer block generic drug approval,” she said, adding that OGD fielded 121 product development and pre-submission pre-ANDA meeting requests in 2020.
 
Safety actions were also a part of OGD’s 2020 activities. OGD’s Clinical Safety Surveillance Staff, which analyzes postmarket generic drug adverse events reports and trend to identify safety issues, supported the voluntary market withdrawal of bacitracin injection products due to risks of pneumonia or empyema in infants, as well as an albuterol sulfate inhaler voluntary recall. OGD also assisted the Nitrosamine Impurities Task Force in addressing safety issues related to the presence of nitrosamine impurities in some generic products, including angiotensin II receptor blockers, ranitidine, metformin, and rifampin products.
 
OGD Annual Report