By: Sally Choe, Ph.D., Director, Office of Generic Drugs, Center for Drug Evaluation and Research
Safe, effective, high-quality generic drugs play a vital role in the U.S. health care system. FDA-approved generic drugs account for more than 90% of the prescriptions dispensed in the U.S. Affordable access to medicines is a public health priority, and competition from generic drugs can help reduce prices and improve patient and consumer access.
In 2019, the FDA’s Office of Generic Drugs worked diligently to ensure that the generic drug program continued to serve the public health. Our accomplishments for the year include a total of 1,014 generic drug final and tentative approvals. Of these approvals, 110 were for complex generic drugs, which are harder to develop and traditionally have lacked competition in the marketplace. 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 (DCAP) and FDA’s Generic Drug User Fee Amendments (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. For example, in 2019, in alignment with our action plan and with the support of GDUFA funding, 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. 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. 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. Medicines vary widely in their chemistry and the ways they must be manufactured. Our product-specific guidances provide recommendations to help manufacturers develop generic medicines that meet our high standards for comparison to a specific brand-name drug.
Our approvals included careful work to prioritize the review of generic drug applications for which there are no blocking patents or exclusivities or for which there is limited generic competition. This encourages having multiple FDA-approved generic drugs that can be used in place of a brand-name drug with the aim of promoting competition so that there are at least four approved applications for each product (including the brand drug). The FDA’s data show that drug prices significantly decrease once there are at least three generic versions of the same brand name drug on the market.
In 2019 we worked with colleagues across the Center for Drug Evaluation and Research to educate and inform industry and other stakeholders about the agency’s generic drug program and GDUFA. We held public meetings and workshops on complex generic drug development, regulatory science initiatives, and regulatory guidances and processes. We also sponsored, co-sponsored, and/or participated in six regulatory science meetings and workshops focusing on generic drug development and GDUFA which helped us interact with more than 10,000 stakeholders.
With the manufacture of generic drug products and their active ingredients increasing across the globe, we continued to leverage our international efforts, driving global harmonization on scientific and technical standards for generic drugs under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The Office of Generic Drug’s activities with the ICH helped lead to the endorsement of the first ever ICH guidelines focusing on generic drugs.
While our 2019 numbers marked another successful year for the FDA’s generic drug program, we know what truly matters is that our work continued to result in more treatment choices and greater access to affordable medicines for patients and consumers with a wide range of medical conditions. The Office of Generic Drug’s Annual Report provides more details on how the FDA’s generic drug program benefited the public health in 2019.
In 2020 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 U. S. and around the world. Our new web page, Upcoming Product Specific Guidances for Complex Generic Drug Product Development, describes our plans for issuing new and revised Product Specific Guidances for complex drug products in the next 12 months. By sharing tools such as this and further enhancing our efficiency in assessing generic drug applications, we will continue doing all we can to ensure Americans have access to affordable, high-quality generic drugs.
For more information, read the 2019 Office of Generic Drugs Annual Report.