2019 was a very good year for generic drug approvals
The Food and Drug Administration's Office of Generic Drugs had a good 2019. The agency's director, Sally Choe, noted in recent comments that the office worked diligently to ensure that the generic drug program continued to serve the public health.
Choe pointed out that in 2019 there were a total of 1,014 generic drug final and tentative approvals. Of these approvals, 110 were for complex generic drugs. The approvals contain 108 first generics – medicines that had no generic competition – including drugs to treat or prevent serious conditions such as pulmonary arterial hypertension, breast cancer, seizures, stroke, depression, and various infections.
The Office of Generic Drugs also continued to improve upon efficiencies in generic drug development under the FDA’s Drug Competition Action Plan, or DCAP and FDA’s Generic Drug User Fee Amendments, or GDUFA program. A key part of both DCAP and GDUFA is to make approval of generic drugs easier to obtain by addressing scientific and regulatory challenges that may arise, Choe said.
In 2019, the agency began publishing new information to help give generic drug applicants greater clarity on when they could potentially market products they are developing. The FDA’s transparency in providing data such as the dates of patent expirations and 180-day exclusivity decision status may help applicants make important business and timing decisions, Choe explained.
“We also continue to scientifically identify the evidence generic drug manufacturers need to support their applications before they submit them. This includes identifying the kind of study data needed to show their drug will work the same as a brand name product, which is a key element of our work in providing applicants a clearer and more predictable path to approval. To aid in providing more clarity through science, we awarded 14 new research contracts and 3 grants for innovative research projects on generic drugs. These contracts and grants align with the FDA’s current regulatory science priorities – all designed to help advance generic drug development and their safe and effective use,” said Choe.
In one of these research projects, the awardees will explore the development of model-informed bioequivalence evaluation strategies for long-acting injectable products – to help make sure generic versions of long-acting injectable drugs deliver the same, effective dose as brand name versions. In another project, the awardees will develop and implement a novel data tool based on text analysis and machine learning.
The generic drug program also utilized its laboratories and computer systems to conduct more than 50 GDUFA science and research projects for items such as complex products, the evaluation of inhalers, and assessing the safety and efficacy of generic drugs used to treat patients with low thyroid levels, which requires the delivery of precise doses to avoid adverse side effects.
“Our laboratories also developed new analytical technologies to help ensure generic drugs deliver the same amount of medicine as their brand-name counterparts and that they are of high quality. The GDUFA regulatory science program also worked to help ensure that the development, assessment, and manufacture of high-quality generic drugs is based on modern, scientific standards. We issued 274 draft and final guidances in 2019, including 269 product-specific guidances, to provide more regulatory clarity for generic drug development by giving companies clear scientific advice on how to generate the evidence needed to support approval,” Choe said.
Last year the agency held public meetings and workshops on complex generic drug development, regulatory science initiatives, and regulatory guidances and processes, and also sponsored, co-sponsored, and/or participated in six regulatory science meetings and workshops focusing on generic drug development and GDUFA.
Finally, Choe said that this year public health will remain paramount while "we continue to advance the FDA’s Office of Generic Drugs’ interactions with industry, the research community, lawmakers, patients, health care providers, and other stakeholders throughout the United States and around the world."
A new web page, Upcoming Product Specific Guidances for Complex Generic Drug Product Development, describes plans for issuing new and revised Product Specific Guidances for complex drug products in the next 12 months.
For more information, the 2019 Office of Generic Drugs Annual Report can be found here