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Stephen Ostroff

FDA Compliance

FDA 2015: A Look Back (and Ahead), Part 1

A summary of medical product innovation

Published: Wednesday, January 13, 2016 - 16:06

Since March 2015 it’s been my pleasure to serve as the Food and Drug Administration’s (FDA) Acting Commissioner. The FDA has broad responsibilities, and I’d like to share some important accomplishments during 2015.

Tasked with overseeing products that account for about 20 cents of the consumer dollar, we work on a wide range of topics in any given year. Scientific advances and unprecedented innovation in the sectors we regulate make it an exciting time to work at and lead the FDA. To protect and promote the public health, our regulatory decision making must be nimble and current, and adapted to the forward march of science.

One measure of our success is revealed in the September 2015 study, “Mission Possible: How FDA Can Move at the Speed of Science,” by FDA’s independent science board. The study documents the agency’s progress and transformation throughout the last eight years, dating from a time when the FDA had been increasingly unable to meet its scientific responsibilities due to chronic underfunding, a loss of scientific expertise, and the need to implement new legislative mandates without the resources to do so. In stark contrast, today the FDA’s regulatory science enterprise is much stronger, which better allows us to effectively fulfill our commitment to protect the public health. The report also provides recommendations for future investments in regulatory science to ensure the FDA keeps pace with emerging trends in science and technology.

Medical product approvals

We strive to modernize and streamline the regulatory process along the entire development, review, and product oversight continuum. More than 40 novel drugs approved in 2015 include four new treatments for patients with multiple myeloma, two new drugs for patients with heart failure, and other drugs for rare or “orphan” diseases. Several approved vaccines include one for serogroup B meningococcal disease, the first seasonal influenza vaccine to contain an adjuvant (intended for people 65 years and older), and a new indication for an anthrax vaccine to prevent disease following exposure to anthrax. This is the first vaccine to receive an approved indication based on the Animal Rule, which provides for testing certain products on animals alone. The innovative devices approved include a device that extends the survival time of patients with brain cancer, and a transcatheter pulmonary valve that can be placed in certain patients with congenital heart disease, without requiring open heart surgery.

The United States leads the world in approving novel drugs first, and we’ve seen important progress in our device review program. Our average time to reach decisions on premarket approvals (PMAs) has dropped 36 percent since 2009. Not since 2001 has the FDA approved as many medical devices under the original premarket approval pathway and the panel track supplement pathway (for significant changes to a PMA device) as we did in 2015: There are 58 as of December 14, 2015.

When we talk to drug and device makers during the early stages of development, and apply better regulatory science to our ultimate review of their applications, products that are likely to fail are weeded out, allowing manufacturers to focus on those more likely to attain approval. At the end of the day, innovative therapies are only helpful to patients if they work and are demonstrated to be safe. So it is imperative that we ensure the right balances among patient access, sound science, and safe and effective products.

Amplifying the patient voice

Enhancing the patient’s voice in the medical product approval and evaluation process is an important emerging area of product development, which we have embraced in a number of ways.

Those living with a disease are in a unique position to provide essential insights about life with their condition, its severity, and the adequacy of treatment options. We also recognize that patients and caregivers have their own perspectives on benefits and risks of medical products, and we believe this input should be considered during regulatory decision making.

The Patient-Focused Drug Development Initiative is a five-year effort that includes holding at least 20 public meetings in different disease areas. Seventeen of those meetings have occurred, and seven more are being scheduled. After receiving patient input during each meeting and in the agency docket, FDA develops a voice-of-the-patient report that is then posted on our website. In a complementary effort, our medical device program launched the Patient Preference Initiative. It includes studies to evaluate patient preferences in medical devices, and publishing of a draft guidance that describes how patient tolerance for risk and their perspectives on benefit, in addition to clinical data and other information, may be considered in the FDA’s benefit-risk assessments for certain medical devices. This year FDA approved a weight-loss device treatment, and our decision was informed in part by data from a patient preference study funded and co-designed by the agency.

In September 2015, the FDA announced its first-ever Patient Engagement Advisory Committee, which will provide advice on complex issues related to the regulation of medical devices and their use by patients. This advisory committee will help ensure that the needs, experiences, and perspectives of patients are considered in our work and incorporated in our decision making.


Five years ago Congress authorized an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. The intent was to create greater competition in the medical marketplace that would not only increase treatment options for patients, but also lead to less expensive alternatives to comparable products. The FDA has been developing its biosimilar program since then, an effort that led to the approval of the first biosimilar in March 2015. And there are more applications in the pipeline. To prepare, the FDA has produced a variety of guidances in this area, including the recent draft guidance on how these biosimilars should be named.

Advancing the development of sequencing tests and strengthening clinical trials

Today the FDA is better prepared and more engaged than ever in facilitating the development of new technologies in sequencing and precision medicine (as well as new uses for older technologies). These efforts help to achieve more precise diagnosis or treatment, through the development and review of state-of-the-art diagnostics that use genetic information to make therapies more targeted.

We continue to move forward on the White House’s Precision Medicine Initiative to advance biomedical understanding by leveraging genomic advances, health information technologies, and new methods of analyzing large volumes of data. In December 2015 we launched the FDA’s precisionFDA web platform, a cloud-based portal that will allow scientists from industry, academia, government, and other partners to come together to foster innovation and develop the science behind next-generation sequencing and help us design treatments tailored to a person’s individual genetic blueprint.

We also are working to refine clinical trial design and statistical methods of analysis to create more efficient studies with smaller patient populations, more focused therapies, and better outcomes. For instance, we continue to support collaborative efforts in clinical trials, such as the I-SPY trials (for breast cancer) and the Lung-MAP protocol (for lung cancer).

It’s impossible to capture in one article the many ways that the FDA’s focus on regulatory science is helping drive innovation and speed the discovery, development, and delivery of medical products to prevent and cure disease and improve health. This article has covered medical product innovation; in parts two and three of this series, we’ll look at medical product safety; and food, tobacco, and antimicrobial resistance, respectively. We are immeasurably proud of these accomplishments, which provide a strong foundation for continuing success.


About The Author

Stephen Ostroff’s picture

Stephen Ostroff

Stephen Ostroff, M.D., is the Food and Drug Administration’s acting commissioner of food and drugs. Before being named acting commissioner, Ostroff served as the FDA’s chief scientist since January 2014. In this capacity, he was responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. Ostroff graduated from the University of Pennsylvania School of Medicine.