Office of Generic Drugs 2020 Annual Report (PDF 1.65MB)

Director’s Message

Welcome to the sixth Annual Report of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA). Access to more affordable medicines remains a significant public health priority for FDA, and competition from generic drugs can help lower drug prices and improve access for American patients and consumers. Amid rapidly advancing science and unprecedented global challenges, the FDA’s generic drug program has continued its steadfast efforts to help increase the availability of more affordable, high-quality drugs in the United States. Right now, 9 out of 10 prescriptions in the United States are filled by generic drugs. Generic drugs have saved the health care system $2.2 trillion dollars in the past decade. 1 That is good news for the public health of Americans.

OGD’s work in 2020 continued at a steady pace even as the COVID-19 global pandemic presented additional complexities, resulting in new realities and unique challenges. Our work this year, both routine and unexpected, may never have been as important.

Generic Drugs in the Time of a Pandemic

In 2020, we were encouraged to see how past efforts to improve the FDA generic drug program’s efficiency, quality, and predictability were even more critical as OGD focused on supporting the approval of safe and effective generic medicines for use in fighting COVID-19.

During the COVID-19 public health emergency, FDA and OGD quickly pivoted to prioritizing the assessment of generic drug submissions for products that could help address COVID-19 as the top priority. More than 660 supplements and 50 original applications were approved for drug products used to treat patients with COVID-19. In addition to our emergency response to the pandemic, OGD and the entire generic drug program maintained FDA’s rigorous standards for evaluating non-COVID-19 products based on quality data and sound science.

We identified and pursued tools and strategies to aid in the fight against COVID-19. OGD created a system for identifying generic drugs that are critical to the treatment of patients with COVID-19 and subsequently took regulatory and scientific action to accelerate review of those products. This system included establishing the infrastructure to rapidly complete tasks and resolve review issues in support of taking timely actions on critical generic drugs used in the pandemic.

OGD also worked diligently to support manufacturers of approved generic drugs who needed to make changes to manufacturing processes or facilities to address disruptions caused by the pandemic. The drug products they produce included antibiotics, sedatives used in ventilated patients, anticoagulants, and pulmonary medications, among others.

We also developed regulatory and scientific approaches to help efficiently restart generic drug development programs interrupted by the pandemic. For instance, we directly assisted applicants with resuming bioequivalence studies, including answering their questions about protocol revisions and information collection.

OGD Continued To Ensure Access to More Affordable Medicine

As OGD and the rest of FDA worked on the response to COVID-19, OGD also made significant progress this year with its everyday mission of improving access to generic drugs, which results in more competition in the market and more affordable medicines for the American public.

In the prescription drug market, OGD helped increase competition by approving or tentatively approving 948 Abbreviated New Drug Applications (ANDAs), including 72 first generics. These were relatively consistent numbers compared to recent years and speak to the continued strength of the overall generic drug program. We also approved 35 generics with the Competitive Generic Therapy (CGT) designation, including a quarterly record of 17 CGT approvals in the first quarter of fiscal year (FY) 2020.

OGD’s strategic, proactive approaches to supporting generic drug development and assessment have a real impact on American patients. For example, for the first time, patients with multiple sclerosis now have a generic Tecfidera (dimethyl fumarate), patients with toxoplasmosis now have a generic Daraprim (pyrimethamine), and patients experiencing severe hypoglycemia now have a generic glucagon.

Providing manufacturers with information to develop and submit higher quality applications also helps increase competition. An important tool used to communicate with prospective generic drug applicants is called controlled correspondence. A controlled correspondence inquiry is submitted to the Agency by (or on behalf of) a generic drug manufacturer or related industry, requesting information on a specific element of generic drug product development. The opportunity for industry to submit controlled correspondence supports the creation and submission of higher quality generic drug applications. In 2020, FDA responded to 3,711 controlled correspondence inquiries submitted by industry — a record!

The pre-ANDA program, which was established under the Generic Drug User Fee Amendments of 2017 (GDUFA II), is another tool we continued to support throughout 2020 to provide product development assistance to generic drug developers. Through written communications and meetings, OGD is able to help clarify regulatory expectations early in the development process and during application assessment. This program has a special focus on complex generic drug products, such as some inhaled or injectable products, which can be more challenging for generic drug developers to copy, often leading to a lack of generic competition even after patents and exclusivities no longer block generic drug approval. In 2020 we received 121 product development and pre-submission pre-ANDA meeting requests.

Beyond approvals and helping improve the quality of applications, OGD also continued its implementation of the FDA’s Drug Competition Action Plan (DCAP) by taking steps to: improve the efficiency of the generic drug development, review, and approval process; maximize scientific and regulatory clarity with respect to complex generic drugs; and close loopholes that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition Congress intended. This included publication of guidances for industry, Manual of Policy and Procedures, and other policy documents and actions.

Improving affordability of and patient access to generic drugs has long been, and continues to be, a top priority for the Agency for the foreseeable future. Under DCAP, we have been looking across all our regulatory work to consider how we can continue to take steps to facilitate generic drug competition and access, including beyond what might be considered more traditional regulatory tools.

For example, FDA opened public dockets and issued a guidance to seek user feedback on how to enhance the Orange Book to make this key resource as useful as possible for stakeholders, including any improvements that could be made to advance the Agency’s goal of improving access to high-quality, more affordable treatment options for Americans. Our related efforts are listed on the DCAP web page, which is updated regularly.

Additionally, October 31, 2020 marked the 40th anniversary of the first official Orange Book. The Orange Book is consistently among the top search terms used on the FDA website and remains one of the Agency’s most popular web resources. Along with other information, the Orange Book contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education on drug product selection and to foster containment of health care costs.

We also continued to leverage science and research through general recommendations and in product-specific guidances specifically to help applicants develop generic drugs that can meet our high approval standards. Recommendations in product-specific guidances help make industry’s research and development decisions more efficient and cost effective by identifying the most appropriate methodology and evidence needed to support a finding of therapeutic equivalence of a generic drug to a specific brand-name drug during OGD’s assessment process, particularly for hard-to-copy complex generic drug products.

This year, OGD was excited to announce the award of a 5-year grant from the GDUFA Science and Research Program that went to the University of Maryland and the University of Michigan to establish The Center for Research on Complex Generics. The $5 million grant aims to enhance research collaborations with the generic drug industry to further OGD’s mission of increasing access to safe, effective, high quality, and potentially lower-cost generic drug products. This goal will be pursued through collaborative research, training, workshops, laboratory projects to meet development needs, a Complex Generics Scholars program, and exchange of resources between FDA, the generic drug industry, and stakeholders.

OGD’s work also extends beyond our borders in an effort to ensure Americans continue to have access to lower-cost, safe, effective, and high-quality medicines. This year, we maximized our involvement in the International Pharmaceutical Regulators Programme (IPRP) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) by sharing information with more than 30 regulatory agencies and leading harmonization initiatives to promote scientific and regulatory exchange and identify topics for potential international harmonization efforts for generic drugs. OGD is leading and collaborating with ICH experts to develop a new ICH guideline (M13) to harmonize bioequivalence standards for immediate release solid oral dosage forms (M13). We also continued to leverage and strengthen bilateral partnerships with Health Canada and the European Medicines Agency to advance collaborative efforts intended to address complex scientific and regulatory issues for generic drugs.

Even with the unprecedented demands of the COVID-19 pandemic, OGD continued to exceed the majority of our performance goals for application assessments and other commitments. The generic drug program is stronger than ever, and we continue to take timely actions on COVID-19 and non-COVID-19 related ANDAs. That is good news for Americans.

Sally Choe, Ph.D.
Director, Office of Generic Drugs

Generic Drug Approvals

The impact of generic medicines on the consumer pocketbook is enormous — saving consumers more than a trillion dollars over the last decade. 2 In 2020, the generic drug program approved or tentatively approved 948 generic drug applications, known as Abbreviated New Drug Applications (ANDAs). Among the total approvals were 50 original applications and 668 supplement submissions for drug products used as potential treatments and supportive therapies for patients with COVID-19.

2020 Generic Drugs Approved and Tentatively* Approved

*A tentative approval does not allow the applicant to market the generic drug product and postpones the final approval until all patent/exclusivity issues have been resolved.

First Generics

First generic drugs provide access to needed therapies that treat a wide range of medical conditions and where little or no competition has previously existed. First generics are particularly important to public health, and OGD prioritizes the review of first generic drug submissions. In 2020, we approved 72 first generic drugs.

Significant First Generic Drug Approvals in 2020