Clinical Trials: Enhancing Data Quality, Encouraging Participation and Improving Transparency

By: Margaret A. Hamburg, M.D.

Today FDA is announcing important steps that the agency plans to take to enhance the collection and availability of clinical trial data on demographic subgroups – patient populations divided by sex, race/ethnicity or age.

Margaret Hamburg, M.D.Section 907 of the 2012 FDA Safety and Innovation Act directed us to take a closer look at the extent to which clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups is included in medical product applications, report our findings, and then, within one year, produce an action plan with recommendations for improvements.

Our report, issued on August 20, 2013, found that the agency’s statutes, regulations, and policies generally give product sponsors a solid framework for providing data in their applications on the inclusion and analysis of demographic subgroups. Overall, sponsors are describing the demographic profiles of their clinical trial participants, and the majority of applications submitted to FDA include demographic subset analyses. We also found that FDA shares this information with the public in a variety of ways. Now, one year later, we’re releasing the FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data, which we developed after extensive interaction with stakeholders.

The action plan includes 27 action items that are designed to meet three overarching priorities – improving the completeness and quality of demographic subgroup data collection, reporting and analysis (quality); identifying barriers to subgroup enrollment in clinical trials and employing strategies to encourage greater participation (participation); and, making demographic subgroup data more available and transparent (transparency).

In addition to the action plan, we’re publishing a final guidance entitled, “Evaluation of Sex-Specific Data in Medical Device Clinical Studies.” It was written in response to the fact that certain medical devices may yield different responses in women than men, and yet women are under-represented in some medical device studies. This has led to less information for women regarding the risks and benefits of using these devices.

The guidance includes recommended methods for clinical study design and conduct to increase enrollment of men and women, if needed, and ways to analyze data for sex differences. FDA has held a series of public workshops to raise awareness about common strategies for enhancing recruitment and retention of women in medical device clinical trials. Fully integrating this final guidance into the templates used by FDA’s reviewers of medical devices, and providing a webinar for industry on how to use the guidance, comprise one of the 27 items in our action plan.

I hope you’ll find that the action plan is responsive and pragmatic and, most importantly, when fully implemented, it will improve medical care and public health. Many of the steps it outlines will have a broad impact on the work of FDA’s medical product centers and will require great thought and planning as they are implemented, depending on current evidence and available resources. The action items range from relatively short-term goals that can be achieved in a year, to others that will take 1-3 years, to a small number that will require a longer period, 3-5 years, to achieve.

Although the plan certainly places significant responsibilities on FDA’s medical product centers and other FDA offices, it also engages our partners inside and outside of government to share the responsibility for this important mission. For example, industry is being asked to help develop and share best practices for encouraging broad clinical trial participation, and the National Institutes of Health will be participating in several research projects with FDA.

We know that richer information is collected when different subgroups are enrolled in pivotal studies for medical products. This kind of enrollment in turn gives us greater assurance in the safety and effectiveness of the medical products used by a diverse population.

To set the plan in motion quickly, FDA is setting up a steering committee that will oversee implementation, come up with metrics for measuring progress and be responsible for planning a public meeting to be held within 18 months after release of the plan. FDA has already set up a website where the public will be able to track the agency’s implementation progress. That website will be updated on a regular basis.

Also, we’re reopening our Section 907 public docket to solicit comments for the action plan. I encourage everyone to review the document and consider how you might be able to partner with FDA and others in encouraging necessary and appropriate demographic subgroup diversity and representation.

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

FDA’s JumpStart program: Supporting drug innovation

By: Lilliam Rosario, Ph.D.

When it comes to public health, the U.S. Department of Health and Human Services (HHS) recognizes that innovation drives success.

Lilliam RosarioAs part of the HHS Innovates program, HHS Secretary Sylvia Mathews Burwell and Deputy Secretary Bill Corr acknowledge excellence in the field with the Secretary’s Pick Award, an honor that identifies and celebrates internal innovation by HHS employees.

I’m proud that this year, the winner of one of three Secretary’s Pick Awards was the Food and Drug Administration’s Office of Computational Science (OCS), part of the Office of Translational Sciences (OTS) in the agency’s Center for Drug Evaluation and Research (CDER). OCS received the award for its work in developing CDER’s JumpStart program, an innovative initiative dedicated to enhancing the efficiency of CDER’s new drug development and review process.

The JumpStart program provides CDER’s new drug review teams with clinical trial data analyses early in the review process when they assess quality, data composition, exploratory analyses, and tools for the analyses. It gives the reviewers a “jump start” on their review providing the information on the quality of the submission as well as analyses to support an effective and efficient evaluation of the medical product submission. You can learn more about JumpStart here. 

Our congratulations to the two other Secretary’s Pick Award recipients, the “Breast Cancer Startup Challenge,” led by the National Cancer Institute, and “Whole Genome Sequencing: Future of Food Safety,” led by the Centers for Disease Control and Prevention. It is a great honor to be recognized side by side with these two innovative programs!

We are proud of the team effort involved in making the JumpStart program a success, and look forward to continued efforts and innovative actions that will help bring safe, effective, and high quality new drug therapies to the American public as efficiently as possible.

For more information on HHS Innovates, visit HHS Innovates Celebrates 7th Round of Innovations!

Lilliam Rosario, Ph.D., is Director, Office of Computational Science, Office of Translational Sciences, at FDA’s Center for Drug Evaluation and Research

Achieving our Mission through Enhanced IT Service Delivery

By: Walter S. Harris, M.B.A, P.M.P.

At its core, FDA is an information- and process-driven organization. Day-in and day-out, FDA’s experts make thousands of weighty and complex decisions by evaluating, and allowing access to, life-sustaining, life-enhancing and life-saving products. This is done using a vast amount of sophisticated and reliable data. And it is done while continuously engaging with consumers, patient representatives, industry, academia and other government agencies.

Walter HarrisSince the establishment of the Office of Information Management and Technology (OIMT) seven months ago, we have fundamentally changed how we support the Agency’s mission — primarily, to increase transparency, and better align functions and resources to achieve more efficient and improved customer support and services. To further these objectives, we have taken the following steps to help transform our service to our internal and external stakeholders.

  • Reorganized the Office of Information Management into a more stable structure that is focused on our customers and the delivery of services. This new IT structure includes robust leadership, increased scientific capability and closer attention to IT’s business and customer needs, including a new IT audit and compliance program.
  • Hired the first Chief Health Informatics Officer (CHIO), Taha Kass-Hout, MD, M.S., to promote and develop innovative enterprise solutions and identify opportunities for transparency and availability of FDA’s public health data to our consumers while ensuring accountability and privacy. With the launch of openFDA, we have demonstrated our ability to respond quickly and accurately to emerging scientific, technological and economic trends.
  • Requested that the CIO Council, FDA’s IT governance board with representation across all of its Centers, focus on opportunities to consolidate IT solutions into capabilities that benefit the agency, eliminating duplication of efforts and creating possibilities for reinvestment.
  • Creating an IT service cost-allocation model that will include a service catalog and identification of cost drivers for IT services.
  • Restructuring our IT portfolio to a service based portfolio model that is in alignment with our cost allocation model.

OIMT, together with IT leaders in the Centers, will transform our IT operation to minimize redundancies, streamline IT, and enhance customer service while lowering IT costs to the agency. We continue to seek opportunities to  identify and tackle issues, improve communications across functional lines, and more fully capitalize on the expertise of our talented staff.

These are exciting endeavors and I am proud of the efforts IT leaders across the FDA have taken to focus on customer service. With a renewed emphasis on service delivery to enable mission outcomes, we are better able to use resources in a manner that will achieve greater efficiency, improve support across the FDA, and provide results that benefit the public health.

Walter S. Harris, M.B.A, P.M.P., is FDA’s Deputy Commissioner for Operations

Dr. Frances Kelsey, Who Protected Americans from Thalidomide, Turns 100

By: John Swann, Ph.D.

Today marks the 100th birthday of one of America’s most celebrated public servants. Frances Oldham Kelsey, Ph.D., M.D., was born in Cobble Hill, Vancouver Island, British Columbia, and earned her Ph.D. in pharmacology and her M.D. at the University of Chicago. She was on the faculty of the University of South Dakota and practicing medicine when, in 1960, she accepted the offer to become a medical officer at FDA.

John SwannA month after assuming her position she was assigned the review of a new drug application for thalidomide, a sedative that had been used by expectant mothers and many others in dozens of countries since the late 1950s. U.S. law at the time required a firm to provide evidence of a drug’s safety as a requirement for sale. Despite the global popularity of this drug, and despite a constant and increasing pressure from the firm to approve the application, Dr. Kelsey refused to do that without adequate evidence that the drug was safe, a decision that was supported by her colleagues and superiors.

By late 1961 scientists discovered that thalidomide was responsible for crippling birth defects in thousands of babies in many parts of the world. Thanks to Dr. Kelsey’s “exceptional judgment in evaluating a new drug” — as her firm stand was described in the President’s Award for Distinguished Federal Civilian Service she received from President John Kennedy — the U.S. was mostly spared the tragedies. But the close encounter with a public health catastrophe convinced Congress and the White House to resuscitate proposals to revitalize the regulation of pharmaceuticals. The result was the 1962 enactment of the Kefauver-Harris Drug Amendments that mandated “substantial evidence” of a drug’s effectiveness as developed by “experts qualified by scientific training,” in addition to evidence of a drug’s safety, and provided for greater oversight of drug investigations. These and other requirements in the new law established a global standard for the evaluation of drugs.

Frances Kelsey

Dr. Kelsey today, pausing between crossword puzzles.

After 1962, Dr. Kelsey oversaw the evaluation of investigational drugs and, later, of oncologic drugs and radioisotopes. Concerns in the agency with problematical clinical investigations continued in the early 1960s, such that FDA created the Division of Scientific Investigations in 1967 and placed Dr. Kelsey in charge. She remained in this position until 1995. The division engaged in inspections of clinical investigators, animal studies, and institutional review boards involved in drug trials. Thus, Dr. Kelsey helped ensure the reliability of data vital to FDA’s evaluation of therapeutic products over a span of four decades.

Frances Kelsey, the recipient of the highest honor that can be bestowed on a federal civil servant, officially retired from FDA in 2005, but her commitment to the integrity of science in service to the public health continues to inspire those in the FDA and beyond.

To learn more about the life and work of Dr. Kelsey, see her “Autobiographical Reflections.”

More about thalidomide and the 1962 Kefauver-Harris Drug Amendments that came out of this crisis can be seen at http://www.fda.gov/Drugs/NewsEvents/ucm320924.htm.

John Swann, Ph.D., is an Historian at FDA

A Curriculum for Medical Device Progress

By: Francis Kalush, Ph.D.

Horace, the greatest Roman poet of antiquity, spoke of the need to “seek for truth in the groves of Academe” — and in the last four years, my colleagues in FDA’s Center for Devices and Radiological Health (CDRH) and I took his advice. In scores of meetings and two large workshops, we consulted with hundreds of academics about a novel idea: a university-level program to address an important public health need by stimulating the development of new medical devices.

Francis KalushIn 2011, CDRH embarked on an Innovation Initiative to help accelerate and reduce the cost of the development and regulatory evaluation of safe and innovative medical devices. Through that and other programs, we learned that the delivery of new therapies to patients can be accelerated if medical device innovators — including entrepreneurs and university students and faculty — understand FDA’s regulatory processes. We then established the Medical Device Technology Innovation Partnership, and tasked it with developing an educational program that would explain FDA’s standards and procedures for evaluating and approving or clearing medical devices.

This learning tool grew from collaborations with Stanford University, University of Virginia, Howard University, The Johns Hopkins University, University of Maryland at College Park and at Baltimore, and University of Pennsylvania.

The program, called the National Medical Device Curriculum, will provide students at academic institutions and science and technology innovators with the core information about the regulatory pathway to market. This includes an understanding of the expertise needed to design, test and clinically evaluate devices; identify the root causes of adverse events and device malfunctions; develop designs for devices with repetitive functions; and, navigate FDA’s regulatory process.

The mode of the curriculum is a series of fictional case studies based on real-world medical device scenarios. The four learning tools developed so far cover the following subjects: the regulatory pathways for medical devices; safety assurance and risk management planning; and the regulatory pathways for novel devices and for devices that are substantially equivalent to already marketed predicate devices.

Each of these fictionalized case studies includes a student module and an instructor’s guide with ideas for exercises and discussion in class. The curriculum was tested at several universities and received high praise. For example:

  • William E. Bentley, from the University of Maryland James Clark School of Engineering found that the case studies “are of tremendous pedagogical value, and we are definitely incorporating them into our curriculum.”
  • ŸArthur L. Rosenthal, Ph.D., a professor at Boston University’s College of Engineering, used the case studies to teach advanced biomedical product design and development and reported that “the students found the material engaging as well as providing essential context for their projects.”
  • ŸYouseph Yasdi, Ph.D., MBA, executive director at The Johns Hopkins Center for Bioengineering Innovation and Design, found that the cases are “a good fit” for his program to train engineers to better understand regulatory issues.

More case studies are being planned to help train the next generation of entrepreneurs and keep the U.S. a leader in medical device innovation. Regulatory training is particularly important in the development of medical devices, as the industry is heavily populated by small companies that may not have the expertise to navigate FDA’s requirements.

The National Medical Device Curriculum is a step forward in our Agency’s efforts to encourage and facilitate the development of new medical products — drugs, biological products and medical devices — that has been made possible by the great scientific breakthroughs in the last two decades, such as the mapping of the human genome and the invention of nanotechnology. Those of us who worked on this novel curriculum hope it will encourage and advance the development of new devices for patients and help protect and promote the public health.

Francis Kalush, Ph.D., is a senior science advisor at FDA’s Center for Devices and Radiological Health

FDA Salutes World Sickle Cell Awareness Day

By: Jonca Bull, M.D.

Today is a World Sickle Cell Awareness Day, an annual reminder that Sickle Cell Disease (SCD) is a major area of unmet medical need that causes serious and devastating consequences to many thousands of children and adults. It is an occasion that has been commemorated each year since 2008, when the General Assembly of the United Nations adopted a resolution recognizing SCD as a global public health concern. I am happy to have this opportunity to help raise awareness about the impact of this disease on patients and their families, and to emphasize the need for additional therapies to prevent or treat SCD and its complications.

Jonca BullSCD is a genetic disorder that most commonly affects people of African descent; however, it also affects Hispanics, Asians, and people of Mediterranean and Middle Eastern descent. Millions of people are living with this disease all over the world. Here in the U.S., there are about 100,000 people with SCD and it is estimated that the disease occurs in one of every 500 Black or African American and one out of every 36,000 Hispanic-American births. Additionally, one in 12 African Americans carry sickle cell trait, the gene for the disease. People with SCD have “sickled” or abnormally shaped red blood cells that get stuck in small blood vessels blocking the flow of blood and oxygen to major organs in the body. These blockages can cause severe pain, organ damage or even stroke in some cases. SCD is a chronic and debilitating disease affecting people for their entire lives.

The Food and Drug Administration is committed to continuing the dialogue around Sickle Cell Disease to facilitate the development of safe and effective treatments to prevent the disease or reduce its complications. On February 7, 2014, our agency held a Patient-Focused Drug Development meeting to ask patients with SCD and their families, caretakers, and advocates about the various aspects of their disease and how it affects their lives on a daily basis. We heard from approximately 300 people on their treatment regimens, symptoms and complications from treatments, and what they would like to see in terms of future treatments. FDA learned a great deal from this meeting, and we hope this is the first of many successful collaborations leading to the development and approval of effective therapies for SCD.

Only limited treatment options exist for this disease, and more development is needed. In 1998, the FDA approved hydroxyurea to reduce the frequency of pain crises and the need for blood transfusions in adult patients with Sickle Cell Anemia. While the use of hydroxyurea has proven to be helpful in reducing complications in some patients, it is not universally effective and the mechanism of action is not completely understood. Other treatments, such as chronic transfusion therapy, although effective for some, can present problems for patients, which limits their use. Stem cell transplantation has been noted as a potential cure for SCD, but due to the lack of matched donors and associated risks during and after the procedure, this is also a limited option. As part of the FDA’s effort to facilitate the development of new SCD treatments, our Office of Minority Health has funded research to identify new methods to improve the safety and availability of blood for transfusion, and FDA’s drug experts are working with members of the pharmaceutical industry and outside researchers.

As we take the time today to reflect on the impact of Sickle Cell Disease, our agency encourages the search for new and better SCD therapies through medical innovation by using information gained from patients and their caregivers in the recent Patient-Focused Drug Development Meeting on Sickle Cell Disease. We will continue to join our efforts with those of patients, researchers, industry, and sister agencies such as the Centers for Disease Control and Prevention and the National Institutes of Health, to lessen the burden of Sickle Cell Disease across the globe.

Jonca Bull, M.D., is Director of FDA’s Office of Minority Health

FDA and Texas Join Forces in Immediate Response to Oil Spill

By: Dennis Baker

There’s never a good outcome after ships collide. But after a March 22, 2014 accident in which a barge and a ship collided in the Houston Ship Channel, a collaborative, flexible response led by FDA and its state partners prevented a catastrophe. Spilled into the waterway were 167,800 gallons of bunker fuel, a waste product from traditional fuel oil processing that is a cross between a solid and a liquid. What followed the collision was an immediate and coordinated federal-state response, underscoring the collaborative flexibility of FDA.

Dennis BakerFDA’s Dallas District Office, Office of Emergency Operations, and the Texas Department of State Health Services (DSHS) began working together within 24 hours of the spill. Trained personnel from FDA’s Office of Regulatory Affairs’ Southwest Region and Dallas District were communicating daily with state public health officials and investigating the risks to public health. A Southwest Region shellfish specialist, Chris Brooks, was part of a team monitoring reports from DSHS’ Seafood Safety Group regarding the condition of Galveston Bay, into which the channel flows to the south.

As a result of such close and early collaboration following the spill, the DSHS and the Dallas District Office jointly activated the Texas Rapid Response Team (RRT) on March 27 for information and coordination purposes, and Incident Commanders were appointed. Then, a very quick response unfolded.

  • More than 70 seafood firms were identified by DSHS—with the list growing to 103 firms—and visits were scheduled to ensure their products were not contaminated.
  • A state-wide consumer alert was broadcast to inform the public about the spill and dockside deliveries of seafood were monitored throughout the area.
  • A massive oil recovery operation swung into place as the oil slick moved southward toward Matagorda Bay. Much of the bunker fuel spilled was ultimately captured by spill containment equipment.
  • The state issued a public consumption advisory recommending that people not eat fish, crabs or shrimp from the Galveston and Matagorda bays.
  • The DSHS contacted licensed seafood firms from Beaumont to Corpus Christi, an expanse of some 300 miles, and advised them to review their HACCP (Hazard Analysis and Critical Control Points) plan provisions for chemical contaminants. The firms were also encouraged to strengthen their dockside receipt procedures that include visual and organoleptic (taste, color, odor and feel) exams prior to accepting seafood.

This is but a snapshot of the mechanics of a successful federal-state collaborative effort, an immediate response to protect public health.

Learn more about FDA’s Office of Regulatory Affairs.

Dennis Baker is FDA’s Regional Food and Drug Director, Office of Regulatory Affairs

Marsha Henderson Leads Programs to Improve Health Outcomes for Women

By: Kimberly A Thomas, MPH

Kimberly ThomasI have worked with many clinicians and researchers whose dedicated efforts have helped to improve the health care women receive. FDA’s Marsha Henderson stands out among this distinguished group. For over 30 years, Marsha has led research and educational programs that help improve medical treatments for women and provide women with the resources they need to make informed health decisions.

For these efforts, Marsha was recently awarded the first Dr. Estelle Ramey Award for Women’s Health Leadership from the Society for Women’s Health Research. This award was created to recognize leaders like Dr. Ramey who demonstrate exemplary leadership in women’s health and a commitment to the study of the impact of sex differences on health.

Marsha was honored for her history of serving as a champion for women’s health, and for her leadership of FDA’s Office of Women’s Health. As the assistant commissioner for women’s health, Marsha directs research that helps FDA better understand how sex differences affect the safety and effectiveness of medical treatments.  At FDA, Marsha has also developed outreach programs that make sure that women from diverse communities have access to easy-to-read FDA health and safety information.

Marsha Henderson with award

Marsha B. Henderson, FDA Assistant Commissioner for Women’s Health, with FDA Commissioner Margaret A. Hamburg, MD (left) and Phyllis Greenberger, President & CEO of the Society for Women’s Health Research (right).

When I first came to the FDA in 2004, Marsha immediately showed me how the work we do at FDA can have a positive impact on women’s lives. Her leadership motivated me to find new ways to promote scientific discussion and expand educational outreach.

When Marsha accepted her award she not only acknowledged the tremendous personal honor, but she also recognized all of the scientists, health educators, and general staff at FDA whose daily work helps to improve the outcome of medical treatments for women. Her comments demonstrated why she is so deserving of this leadership award. I congratulate her on this honor and thank her for distinguished career serving as a voice for all women.

Kimberly A Thomas, MPH, serves as a senior advisor for communication and outreach in FDA’s Office of Women’s Health.

Women Scientists at FDA: A Legacy to be Proud Of

By: Suzanne Junod, Ph.D.

This is National Women’s History Month, a good time to reflect on FDA’s history of advancing women as scientists and health professionals. This tradition began with FDA’s predecessor in the late 19th and early 20th centuries, the Bureau of Chemistry in the Department of Agriculture. Several early female FDA scientists came out of the University of Pennsylvania, one of the first universities in the country to offer women chemistry degrees in the late 19th century.

Suzanne JunodHarvey Wiley, known as the Father of the 1906 Pure Food and Drugs Act and its “crusading chemist,” hired FDA’s first female laboratory chief. When his superiors found out that the “M. E. Pennington” he had selected to head a research laboratory was actually Mary Engles Pennington, he successfully argued that since she had received the top score on the Civil Service exam, he had no grounds on which to refuse her the position.  His argument carried the day.

Frances Kelsey, who had earned both an M.D. and a Ph.D. in pharmacology, was hired by FDA in 1960 as a medical officer. She came into the agency with top scientific credentials and a strong research background. In part, it was her experience with animal research that led her to question the effects of the drug thalidomide on fetal animals when that drug was submitted for FDA review. She had still not received a satisfactory answer to that question when the dangers of thalidomide became known and it was discovered to be a potent teratogen, an agent that can lead to birth defects. Thalidomide was never approved for marketing in the U.S.

FDA’s first women field inspectors, in contrast, were hired only after President Lyndon Johnson declared that the federal government would lead the way in implementing the 1964 Civil Rights Act. Imogene Gollinger, the first woman hired, had a degree from New York University and experience as a science teacher. She recognized that she was given the “opportunity of a lifetime” and happily reported to FDA wearing white gloves and a hat, which were immediately exchanged for standard-issue coveralls.

The concerns about women being able to keep up with the men proved to be misplaced. Gollinger was teased for buying a shopping cart to carry her heavy bag of inspector’s equipment, but she soon noticed men using them as well. While women willingly did the heavy and dirty field work, such as climbing into boxcars to obtain grain samples, they were increasingly drawn to investigative work involving piecing together data rather than simply gathering samples for analysis. For the female inspectors, compliance activities soon began to gain parity with traditional field sampling in FDA’s field operation.

Today, women make up approximately 59 percent of FDA’s work force, all of whom are involved in protecting and promoting public health. This is a legacy to be proud of as we celebrate women’s history.

Suzanne Junod, Ph.D., is an Historian at FDA.

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What’s new in the FDA’s 2015 budget?

By: William Tootle

A few days ago, President Obama released his Fiscal Year 2015 Budget Message to Congress, which included a high-level summary of his proposed funding for the FDA. Today the White House is out with the full budget, complete with all of the nitty gritty details.

William TootleAlthough these budgetary times are difficult, the FDA received some good financial news. The president is requesting a $4.7 billion budget for FDA, an 8.1 percent increase over the 2014 budget that Congress passed earlier this year.

For ease in discussing a budget of such scope, we typically group budgetary line items into a few large categories. This year our categories are medical product safety (which also includes our premarket review activities) and food safety (which also includes cosmetics).

Most of the $61 million increase for medical product safety comes from increases that were written into the statute when Congress authorized each of the five-year user fee programs.

One new line item in the budget is $25 million to strengthen oversight of the pharmacy compounding industry. In 2012 there was a fungal meningitis outbreak that killed 64 people and infected over 750 others in 20 states. This outbreak was shown to be the result of compounded drugs – the combination of two or more drugs to create a custom medication – that were created in unsafe conditions. To better protect the American people, FDA stepped up activities within available resources and Congress passed the Drug Quality and Security Act, giving us new responsibilities and authorities, but without commensurate resources. The President’s proposed 2015 budget doesn’t provide FDA with a $25 million increase to cover the agency’s pharmacy compounding activities. The money is coming from trims “on the margin” to other portions of our medical product programs.

The food safety portion of the budget includes $263 million in increased funding — including $253 million to implement the landmark Food Safety Modernization Act or FSMA. That 2011 law provided FDA with the authorities and mandates to build a modern domestic and imported food safety system designed to prevent rather than react to food-borne illness. Every year, contaminated food sickens about 48 million Americans and kills about 3,000.

FDA estimated in 2012 that it would need $400 million to $450 million to implement FSMA. Since then, the agency has received $78 million and issued proposed rules for all seven of the foundational provisions of FSMA.

Most of the $253 million proposed for FY 2015 would come from new user fees for imported foods, imposed on the industry. It’s worth noting that with current resources, we will still be able to issue the rules, but we won’t be able to effectively implement them and improve food safety without new resources to retrain inspectors, provide guidance and technical assistance to industry, partner with state agencies and build the modern import safety system Congress mandated.

The budget contains one final broad category of note, promoting the development of products that can be used to prevent or protect the public from bioterrorism. These medical countermeasures promote readiness against deliberate and naturally occurring public health threats. The FY 2015 budget includes $25 million for this initiative, the same as in FY 2014.

The FDA delivers significant results that help Americans every day in many different ways. FDA’s drug approval system continues to lead the world in both quality and speed. The agency approved 27 drugs that are entirely new to medicine in 2013, including advances in the treatment of rare forms of cancer and a virtual cure for Hepatitis C. The FDA approved a new flu vaccine, and a bird flu vaccine to be reserved in case of an outbreak. In addition to new drug approvals, the FDA has reduced the time it takes to review new medical devices. And the agency is promoting greater safety of cosmetic products. Finally, the FDA has made progress in carrying out new tobacco control legislation.

Americans rely on the FDA to keep their food and medical products safe and effective. The Fiscal Year 2015 budget contains the blueprint for how the FDA plans to accomplish this mission. We invite you to follow this link to peruse the details of the FDA budget of greatest interest to you.

William Tootle is Director of FDA’s Office of Budget