Report: CDRH on Track to Improve Device Submission Review Process

By: Jeffrey Shuren, M.D.

FDA’s Center for Devices and Radiological Health (CDRH) is committed to speeding innovative new medical devices to market and to improving the efficiency of our device submission review process. That’s critical for patients getting access to medical devices that treat often life-threatening conditions. It’s also important for industry’s ability to continue developing new products.

Jeffrey ShurenWhile recent data suggest we’re making solid progress in bringing down total review times for both 510(k) submissions and our higher risk premarket approval applications, it’s always useful to get a reality check.

That’s why, as part of the 2012 Medical Device User Fee Amendments (MDUFA III), FDA agreed with the medical device industry to participate in an independent and comprehensive assessment of our review process.

A third party consulting firm assessed CDRH’s review process, management systems, IT infrastructure, workload management tools, reviewer training programs and staff turnover. Key findings were released in December 2013, along with a list of high-priority recommendations for improvements.

Their Final Report on Findings and Recommendations, released today, affirms that CDRH is on a path to meeting many of the challenges that were flagged in the months leading up to the enactment of MDUFA III, including such topics as sponsor communication, IT infrastructure, reviewer training, reviewer attrition, and submission quality.

Initially, the contractor identified 31 unique issues related to the device submission review process. They concluded that CDRH had taken steps to address 21 of those 31 issues – either through the development and implementation of new MDUFA III provisions, updated systems, and/or processes for review staff – and that we had at least begun to address another nine of the issues. Only one issue – creating the tools and metrics to assess the consistency of decision-making across the program – remained. It was the driver for one of the contractor’s high-priority recommendations.

After the December report came out, we put together our own plan of action to implement the high-priority recommendations. These recommendations call for:

  • Developing criteria and establishing mechanisms to improve consistency in decision-making throughout the review process.
  • Providing mandatory full staff training for the three primary IT systems that support MDUFA III reviews.
  • Identifying metrics and incorporating methods to better assess review process training satisfaction, learning and staff behavior changes.
  • Adopting a holistic, multi-pronged approach to address five quality component areas to standardize process lifecycle management activities and improve consistency of reviews. This approach addresses such topics as corrective and preventive action and continuous process improvement, resource management, document management and system evaluation.

This action plan, also out today, has been divided into two stages. The first stage includes those actions needed to address specific recommendations identified in the December report, most of which will be implemented by 2016. The second stage covers longer-term actions to further enhance the efficiency of our processes beyond what the contractor recommended. We will now begin to execute this action plan. In addition, as we committed to do under MDUFA III, we will now develop an implementation plan for the new recommendations in this final report.

I encourage you to take a close look at the report and our plan of action. I think you’ll agree with me that sustained focus on these various management improvements will translate to more consistent and efficient reviews, advanced innovation and ultimately improved patient health.

Jeffrey Shuren, M.D., is Director of FDA’s Center for Devices and Radiological Health

OpenFDA: Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data

By: Taha A. Kass-Hout, M.D., M.S.

Today, I am pleased to announce the launch of openFDA, a new initiative from our Office of Informatics and Technology Innovation (OITI). OpenFDA is specifically designed to make it easier for web developers, researchers, and the public to access and use the many large, important, health data sets collected by the agency.

Taha Kass-HoutThese publicly available data sets, once successfully integrated and analyzed, can provide knowledge and insights that cannot be gained from any other single source.

Consider the 3 million plus reports of drug adverse reactions or medication errors submitted to FAERS, the FDA Adverse Event Reporting System (previously AERS), since 2004.

Researchers, scientists, software developers, and other technically-focused individuals in both the private and public sectors have always been invited to mine that publicly available data set – and others – to educate consumers, which in turn can further our regulatory or scientific missions, and ultimately, save lives.

But obtaining this information hasn’t always been easy.

In the past, these vast datasets could be difficult for industry to access and to use.  Pharmaceutical companies, for example, send hundreds of Freedom of Information Act (FOIA) requests to FDA every year because that has been one of the ways they could get this data. Other methods called for downloading large amounts of files encoded in a variety of formats or not fully documented, or using a website to point-and-click and browse through a database – all slow and labor-intensive processes.

openFDA logoOpenFDA will make our publicly available data accessible in a structured, computer-readable format. It provides a “search-based” Application Programming Interface – the set of requirements that govern how one software application can talk to another – that makes it possible to find both structured and unstructured content online.

Software developers can now build their own applications (such as a mobile phone app or an interactive website) that can quickly search, query or pull massive amounts of public information instantaneously and directly from FDA datasets in real time on an “as-needed” basis. Additionally, with this approach, applications can be built on one common platform that is free and open to use. Publicly available data provided through openFDA are in the public domain with a CC0 Public Domain Dedication.

Drug adverse events is the first dataset – with reports submitted from 2004 through 2013 available now.

Using this data, a mobile developer could create a search app for a smart phone, for example, which a consumer could then use to determine whether anyone else has experienced the same adverse event they did after taking a certain drug.

As we focus on making existing public data more easily accessible, and providing appropriate documentation and examples to developers, it’s important to note that we will not release any data that could be used to identify individuals or reveal other private information.

OpenFDA uses cutting-edge technologies deployed on FDA’s new Public Cloud Computing infrastructure enabled by OITI, and will serve as a pilot for how FDA can interact internally and with external stakeholders, spur innovation, and develop or use novel applications securely and efficiently. As we move forward with the early stages of openFDA, we will be listening closely to the public, researchers, industry and all other users for their feedback on how to make openFDA even more useful in promoting and protecting the public health.

Taha A. Kass-Hout, M.D., M.S., is FDA’s Chief Health Informatics Officer and Director of FDA’s Office of Informatics and Technology Innovation.

FDA and Health Professionals, Safeguarding the Public’s Health

By: Anna M. Fine, Pharm.D.

At our recent third annual Health Professional Organizations Conference, some of FDA’s most senior leaders exchanged views and discussed issues of mutual interest with senior representatives from key health professional organizations.

Anna FineHeld on FDA’s White Oak campus in Silver Spring, Md., and organized by the FDA’s Office of Health & Constituent Affairs (OHCA), the event was attended by 30 professional organizations representing physicians, nurses, physician assistants, dentists, optometrists, nurse practitioners, pharmacists, and others.

An open and ongoing dialogue between these professionals and FDA is a vital part of addressing many important public health issues. In her opening remarks, FDA Commissioner Margaret Hamburg offered a few examples, such as health professionals’ contributions to the FDA’s MedWatch and Adverse Event Reporting programs and their work in interpreting and addressing medical products’ safety signals. A drug’s safety profile is continually evaluated after FDA approval, and health professionals are encouraged to report suspected adverse events to FDA which allows FDA to conduct comprehensive safety evaluations. Dr. Hamburg also emphasized the importance of health professionals’ engagement in regulatory science research, which provides essential support for the agency’s decisions and ability to bring innovative products to market.

Mitch Zeller, the Director of FDA’s Center for Tobacco Products, speaking at the third annual Health Professional Organizations Conference, on May 14, 2014

Mitch Zeller, Director of FDA’s Center for Tobacco Products, speaking at the agency’s third annual Health Professional Organizations Conference. See more photos of this event on Flickr.

Key FDA leaders who gave presentations throughout the day included Mitch Zeller, the Director of FDA’s Center for Tobacco Products; Dr. Stephen Ostroff, Acting Chief FDA Scientist; and Dr. Peter Lurie, Acting Associate Commissioner of FDA’s Office of Planning and Policy.

In addition, senior scientists from FDA’s centers for drugs, medical devices and food discussed FDA’s priorities and answered questions from the audience. The robust dialogue between the panel members and our stakeholders covered many public health issues including youth and tobacco and FDA’s proposed changes to the food label.

Feedback from the audience highlights the need for such a conference.

“It’s great to have this dialogue with FDA officials. It demonstrates that they respect our organizations and want our feedback,” said one stakeholder representative.

“I love coming to these annual meetings, not only to meet FDA personnel but to talk with colleagues in other professions. This is a one-of-a-kind forum,” said another.

As a pharmacist and team leader within OHCA, I can attest to the fact that my FDA colleagues and I benefited as well. We learned a lot about our stakeholders’ concerns and established new connections with health professional organizations—contacts that we plan to follow-up on to explore new opportunities for mutual cooperation and collaboration in the interest of the public health.

Anna M. Fine, Pharm.D., is Director of the Health Professional Liaison Program in FDA’s Office of Health and Constituent Affairs.

Artifacts Tell the Story of Our Culture and FDA’s History

By: John Swann, Ph.D.

Looming sentry-likJohn Swann_0254e over the collection of artifacts that document FDA’s  history, the products  we regulate, and our interactions with the public is a rather large and curious figure. It is a green velvet head with bulbous, languid eyes and two upper teeth in an otherwise large and empty mouth. It doesn’t have ears or hair, but is marked by a few bright green pustules.  This is part of a life-size costume, an element of a public education campaign called Fight Bac! in which FDA was a major participant. It began in the 1990s to alert the public, young and adult alike, to the dangers of food-borne diseases and how to avoid them.

Countless objects in our collection tell the decades-long tale of FDA’s educational activities. For example, the agency still has a cabinet and some of its contents from the “Chamber of Horrors” exhibit that traveled around the country in the early 1930s to alert citizens, legislators, the press and others of the need for a stronger consumer protection law, drawn from egregious examples of how the law then in place fell short.  FDA officials also communicated through a variety of other displays for Congressional testimony and other purposes.

Much of the collection captures the problems that gave rise to the laws and regulations we have today, a regulatory arc often originating with a problem product—sometimes of disastrous proportions. Thus one can find specimens of:

  • Elixir Sulfanilamide, a poisonous preparation of a wonder drug in 1937;
  • thalidomide,  the globally marketed sedative that caused thousands of grave birth defects in the 1950s and 1960s;
  • Bon Vivant vichyssoise, a botulism threat in the early 1970s;
  • the ill-designed Dalkon Shield intrauterine device that caused thousands of pelvic infections; and
  • ephedra-containing dietary supplements from the 1990s that killed several users.

These are among the objects that eerily illustrate why we have the laws and regulations we do.

Decision-making in the agency depends to a considerable extent on investigations and analyses, some of the tools of which are documented here. These artifacts of the growth of regulatory science include:

  • balances and early calculating devices used in the laboratories of the Bureau of Chemistry from the 1900s to 1920s to analyze questionable foods and drugs;
  • triers, tools used for routine sampling of various foods to ensure compliance with the law, from the mid-20th century; and
  • advanced analytical devices from the 2000s to detect sophisticated counterfeiting of medicinal products.

Thatcher_CalculatorTreatments of dubious value for both serious and non-serious diseases make up a significant part of the collection as well. There are hundreds of fraudulent medications, primarily up to about World War II, as well as hundreds of medical devices from the 1950s and 1960s that offered hope with no scientific underpinning.

In addition, how the public came to engage FDA and its work, especially from the 1970s forward, can be seen in a number of objects, including protest buttons and placards from the past two decades.

Artifacts like these tell the story of how our many laws and regulations came to be, how FDA has carried them out, and how the public and FDA have engaged each other in the interest of the public health.

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

For National Women’s Health Week, FDA Resources Help Women Make Informed Health Choices

By: Marsha B. Henderson, M.C.R.P.

“Ask your mother.” In households throughout the country, women often make decisions about foods and medical products for themselves and their loved ones.

8547850411_6e188c4b11_o-1As we celebrate National Women’s Health Week (May 11-17), I want to highlight some of the many ways in which FDA is working to make sure that women have the resources they need to make informed health choices.

FDA’s Office of Women’s Health (OWH) offers educational resources to help women at every stage of their adult lives—covering topics that range from college health to healthy aging. We develop and disseminate easy-to-read health materials and educational videos for women. We also connect women to these resources and other safety information on the FDA’s For Women website.

Throughout this week, OWH will be conducting special health promotions to connect women to resources on how to stay healthy. Starting today, women can order a free kit of OWH health materials on topics including mammograms, sleep problems, pregnancy, and contact-lens care. OWH is also collaborating with FDA’s Office of Communications to share tips for new mothers and other resources.

Lastly, we’re using social media to challenge women to take better care of their health. Encourage the women in your networks to follow us on Pinterest for a special challenge and health tips each day of the week. Use #1wk4health to participate.  In addition, follow @fdawomen and join us on May 13 at 1 pm for a Twitter chat we are co-hosting with the National Institute of Health’s National Heart, Lung, and Blood Institute and Office of Research on Women’s Health; the Department of Health and Human Services’ Office of Minority Health; and Everyday Health.

Once the week is over, I hope you will continue to look to FDA for women’s health resources. Encourage the women in your community to read our health materials, watch a video or participate in one of our social media activities.

Marsha B. Henderson, M.C.R.P., is FDA’s Assistant Commissioner for Women’s Health

Building Expertise and Crossing Boundaries to Improve Oversight

By: Howard Sklamberg, J.D.

To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world.

Howard SklambergAs FDA’s Deputy Commissioner for Global Regulatory Operations and Policy (GO), I oversee FDA’s efforts to further advance its thinking and strategies from a primarily domestic to a globally focused regulator.

GO coordinates the efforts of FDA’s Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP), and works with all of FDA’s product centers on scientific, manufacturing or other regulatory challenges. The highly skilled and dedicated workforce in ORA and OIP is responsible for conducting domestic and foreign inspections, deepening collaborations with local, state and foreign regulatory partners, helping these regulatory partners to strengthen their regulatory systems, and fostering the use of science-based standards and regulatory coherence around the globe to promote the public health of our citizens.

We have to be able to share information with our regulatory partners. We need their help to implement new regulations that have worldwide impact on the oversight of food under the Food Safety Modernization Act and medical products under the Food and Drug Administration Safety and Innovation Act. Working together with these partners, we can ensure an effective public health safety net for our citizens and communities.

An important new priority for FDA is to make fundamental changes in the way we operate in today’s world by aligning our efforts across the agency to keep pace with the acceleration of scientific innovation and the global expansion of the markets. So much of FDA’s work cuts across multiple product areas. How do we make that work as a large and complex agency?

Commissioner Hamburg and senior leaders across the Agency are committed to strengthening our ability to do just that and are collaborating to achieve greater operational and program alignment across the Centers and ORA.

A key part of this process is to enhance specialization across FDA. For ORA, enhanced specialization means that investigators, compliance officers, import reviewers, laboratory personnel, managers and others will have increased technical expertise in a specific commodity area and will work closely with subject matter experts in FDA’s centers. Over time, ORA’s geographic-based model will evolve to a commodity-specific, program-based model that will provide ORA staff the opportunity to gain increased expertise in specific product areas, such as pharmaceuticals, food, animal feed, medical devices, biologics, and tobacco. They will work as part of a team with the staff from other centers, collaborating, for example, with the Center for Drug Evaluation and Research on pharmaceutical oversight or with the Center for Food Safety and Applied Nutrition on food safety issues.

It is especially important that experts in the centers and ORA be engaged in helping to develop compliance policies and priorities. Working with the centers on these broader concerns puts ORA investigators and compliance officers in a better position to implement the preventive approaches contained in new statutes and work together more seamlessly with the centers.

These and other changes that are part of the agency’s focus on program alignment will deepen our knowledge and make us more effective and efficient, with more clarity and coherence in our communications and actions.

This process is still in its early stages. There is a lot of planning still to be done, and we will work to ensure a transparent and inclusive process. Nevertheless, change is coming and I am excited and proud to be part of a transformation that can only strengthen our efforts to safeguard the foods and medical products that are so important in the lives of people all over the world.

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Strong Review Performance Brings Innovative Medical Products to Patients

By: Margaret A. Hamburg, M.D.

There are many ways FDA supports biomedical innovation as part of our mission to protect and promote public health. We are committed to finding ways to ensure that safe and effective products can get to the people who need them as swiftly as possible. With that in mind, we were pleased with new data in two reports, one looking at FDA’s review performance for prescription drugs, the other for medical devices.

Margaret Hamburg, M.D.A study by the London-based Centre for Innovation in Regulatory Science (CIRS) looked at trends in the number of drug approvals and approval times by FDA and our regulatory counterparts in Europe and Japan for new active substances (NASs). These are similar to what FDA refers to as New Molecular Entities (NMEs). As the study authors said, approvals are often a measure of the pharmaceutical industry’s output and are, along with approval times, used as markers of the regulatory environment.

The study found very little difference between the agencies in approvals of new drugs in 2013: FDA approved 29, Japan approved 28, and Europe approved 30. According to the report, Europe experienced a significant increase in approvals compared to 2012, in part because it was “catching up” on a number of compounds that had been approved by FDA in previous years.

But where the agencies really differed was in drug approval times. FDA’s median approval time in 2013 was 304 days. In Japan it was 342 days, and in Europe it was 478 days. You can read more about our 2013 NME approvals in FDA’s Novel New Drugs Summary, which we blogged about in January 2014.

And it turns out that FDA was consistently faster than its regulatory counterparts over the time frame 2004-2013. In this period, the overall median approval time for new drugs in the United States was 304 days, compared to 459 days in Europe, and 487 days in Japan. Moreover, of the 21 new drugs approved by all three agencies during the latter part of that period – from 2009-2013 – 76% of those drugs were approved first by FDA.

Regulatory systems vary, and making these direct comparisons can be a challenge. Indeed, the CIRS report doesn’t discuss why FDA’s review times are faster than those of our regulatory counterparts. However, our review times certainly benefit from our innovative and flexible approach to drug development and approvals that includes such mechanisms as priority review, fast track designation, and accelerated approval. In the 2004-2013 timeframe, for example, the study pointed out that 44% of the NMEs received priority review from FDA, meaning that FDA’s goal is to take action on the submission within six months rather than 10 months under standard review.

And FDA’s accelerated approval pathway has helped bring innovative drugs to market for patients suffering from serious or life-threatening illness but who have limited treatment options. Such drugs include Sirturo (bedaquiline), to help patients with multi-drug resistant tuberculosis, and Ferriprox (deferiprone), to help patients with thalassemia (a genetic disorder causing anemia) to avoid iron overload from blood transfusions.

Our most recent approach to expedited drug review and approvals, the breakthrough therapy designation, went into effect in July 2012 with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) – so it isn’t well captured during the timeframe for this particular study. But the breakthrough designation is already helping to ensure that products that treat unmet needs get to patients as quickly as possible. Since July 2012, FDA has received 178 breakthrough designation submissions, granted 44 designations and already approved six of the designated drugs. Just last week we approved a late-stage lung cancer drug under the breakthrough designation – four months ahead of its goal date, using evidence from a trial with 163 patients.

I’m also happy to report new data for medical devices showing that FDA is on track towards meeting the review performance goals that were agreed to with industry and approved by Congress – under the Medical Device User Fee Amendments (MDUFA) of 2012, also part of FDASIA.

FDA committed to posting a quarterly performance report under the medical device user fee program. The latest report, issued in the last few days, covers performance reported through March 31, 2014. Review times, as measured in average total days for 510(k) submissions, have continued to decline since last year. With nearly all of the fiscal year (FY) 2012 submissions now closed, average review times have dropped from a high of 154 total days for submissions received in FY 2010 to 144 total days for FY 2012.   

FDA’s review times for higher risk devices that must go through the premarket approval (PMA) process are showing similar improvements. The same report we recently issued, for example, demonstrates the average time to decision for a PMA has been dropping, from a high of 464 days in FY 2009.

While we continue our efforts to reduce the time for the premarket review of medical devices, we’re also focused on reducing the time associated with product development. A few weeks ago we proposed a new program aimed at providing earlier access to certain medical devices that are intended to treat or diagnose patients with unmet needs for life threatening or irreversibly debilitating diseases or conditions.

The Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (“Expedited Access PMA” or “EAP”) program features earlier and more interactive engagement with FDA staff. This includes the involvement of senior management and a collaboratively developed plan for collecting the scientific and clinical data to support approval. These features, taken together, should provide patients with earlier access to safe and effective medical devices.

In addition to the Expedited Access PMA Program, the FDA published a separate draft guidance that outlines the agency’s current policy on when data otherwise collected prior to approval can be collected after product approval. To ensure that a device is safe and effective and to provide timely patient access to important devices, it’s critical to get the right balance between pre-market and post-market data collection.

While FDA is always striving to improve in the area of medical product review performance, I’m pleased to be able to report on the progress we’re making. The FDA of the 21st Century, through the creation of new pathways, designations and programs for drug products and medical devices, is actively encouraging innovation and speeding the availability of promising medical products to patients who need them.

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

Johns Hopkins and UCSF-Stanford join FDA’s Centers of Excellence in Regulatory Science and Innovation

By: Stephen M. Ostroff, M.D.

If you’ve been following my blog series about the Office of the Chief Scientist (OCS), you know about a critical component of nearly all FDA efforts to promote innovative approaches to developing and evaluating our regulated products – collaboration! This week FDA made two new additions to its network of academic partnerships known as Centers of Excellence in Regulatory Science and Innovation (CERSIs).

Stephen OstroffThe first partner brings together a team of leading scientists at the University of California at San Francisco (UCSF) in a joint effort with Stanford University. The second, Johns Hopkins University, builds on a long history of collaboration with FDA. Both partners received FDA funding through a competitive application process to establish CERSIs that will promote cross-disciplinary regulatory science training, scientific exchanges, and leading-edge research focused on FDA science priority areas.

This latest expansion of our CERSI network is an exciting development. The specialized, cutting-edge science required for FDA’s increasingly complex mission makes it imperative that we leverage available knowledge and infrastructure from collaborative partners in academia. These partnerships enrich the breadth and depth of FDA expertise, enabling us to base our regulatory decisions on the most current scientific evidence. They also enable FDA to bring its expansive experience to academia, ensuring that the new scientific approaches being developed at these institutions can be applied in a way that increases their usefulness for evaluating FDA-regulated products. And most important of all, patients and consumers will ultimately benefit from the investment.

Like those FDA previously established at the University of Maryland and Georgetown University, CERSIs are part of FDA’s effort to promote a vibrant, collaborative, regulatory science culture that enables us to tackle the scientific challenges presented by breakthroughs in medical product development and to improve food safety and quality.

As with the others, the joint UCSF-Stanford and the Johns Hopkins CERSIs will be managed by OCS’s Office of Regulatory Science and Innovation, together with teams of scientists from across FDA. Each new CERSI brings specific goals and unique strengths to enhancing FDA’s regulatory research and review.

The UCSF-Stanford CERSI will bring West Coast representation to the CERSI network and enable FDA to access UCSF’s powerhouse in quantitative sciences and pharmacology. Pre-eminent teams of scientists from both institutions and FDA scientists will be working together to develop and offer courses and workshops in drug development and regulatory science through UCSF’s American Course in Drug Development and Regulatory Sciences (ACDRS).

This CERSI will also offer scientific exchanges and training that target three of FDA’s regulatory science priority areas: transforming toxicology to improve product safety, improving clinical studies and evaluation, and harnessing diverse data through information sciences to improve health outcomes. In addition to FDA funding, the UCSF-Stanford CERSI is leveraging funds from the two academic institutions, through courses like the ACDRS, and from a recent Burroughs Wellcome Foundation Award in Innovation in Regulatory Sciences.

The Johns Hopkins CERSI will focus on three core FDA strategic priorities: clinical evaluations, social and behavioral science, and food safety. The university’s internationally recognized faculty in these areas and its geographic proximity to FDA will facilitate intellectual exchange among university faculty, FDA staff, and scientists. FDA staff can take advantage of workshops, symposia, courses, certificate programs, and a Master’s degree in Regulatory Science as well as others areas close to FDA’s strategic goals. Johns Hopkins is also known as a leader in innovative approaches to educational and life-long learning, including Internet-based courses that will be available to FDA scientists and staff worldwide.

Collaborating with our academic partners is crucial to our ability to expand the scientific foundation and infrastructure FDA needs to deliver on the promises of using 21st century science and technology to fulfill our regulatory mission.

Stephen M. Ostroff, M.D., is FDA’s Acting Chief Scientist

The Commissioner’s Fellowship Program: A Win-Win for FDA and Public Health

By: Dr. Stephen M. Ostroff

As part of my FDA Voice blog series on the important work going on in FDA’s Office of the Chief Scientist (OCS), I’d like to highlight an FDA program that is giving top-tier, early career health care professionals, scientists, and engineers the chance to gain broad exposure to FDA regulatory science and scientific review opportunities. Led by OCS’s Office of Scientific Professional Development, the Commissioner’s Fellowship Program (CFP) is accepting applications from April 16 to May 26, 2014. Those who are accepted into the CFP will be joining FDA’s 7th class of Fellows.

Stephen OstroffDuring the two-year program, Fellows complete rigorous graduate-level coursework and conduct cutting-edge research on targeted scientific, policy, or regulatory issues under the mentorship of an FDA senior-scientist preceptor.

In the CFP, a Fellow is able to gain real experience in an FDA biology, physics, or engineering lab, work with a clinical review team, or work at a regional field laboratory or office. The coursework provides a common core understanding of the science behind regulatory review, encompassing activities across all FDA-regulated product areas.

Specific Fellow projects may focus on FDA review of sponsor applications for new products, monitoring product quality and safety, or other scientific or engineering topics. Fellows work closely with FDA scientists to create better research and evaluation tools and approaches, like assays for chemical or pathogen detection, or methods to assess clinical or health care data. Other science and policy areas of focus may involve foods or medical products in disciplines ranging from laboratory sciences to engineering, law, and ethics.

FDA launched the Fellowship Program in 2008 to achieve three critical goals:

1)      Attract to FDA top-tier scientists who can help tackle targeted regulatory science areas;

2)      Provide regulatory science training to expand the pool of experts;

3)      Recruit top scientific talent — scientists who may not have considered FDA in planning their career.

Since the program started, FDA has graduated 164 Commissioner’s Fellows, 75% of whom continued to work at FDA after completing the program. Our graduates have produced 175 publications based on their Fellowship work, represented FDA with 211 regulatory science presentations, authored or co-authored 917 reviews – ranging from original applications to supplements – and 26 Fellows have been the proud recipients of FDA Honor Awards.

The Fellows have brought an infusion of innovative ideas, new talents, and skills to FDA to help build the strong scientific foundation we need in our research and review activities. In turn, the CFP has enabled Fellows to develop their regulatory expertise and work confidently in the FDA environment.

Those Fellows who pursue careers outside FDA bring a deeper understanding of regulatory science and of FDA to their organizations. They enrich the regulatory science enterprise, whether by improving the quality of applications to FDA or by applying the knowledge and tools they’ve acquired through the CFP to develop practical solutions to an important public health challenge.

Stephen M. Ostroff, M.D., is FDA’s Acting Chief Scientist

For more information on eligibility criteria for the FDA Commissioner’s Fellowship Program and to apply for the upcoming class, please visit this Web link:

FDA Commissioner’s Fellowship Program Application Checklist

FDA Works with China to Ensure Medical-Product Safety

By: Christopher Hickey, Ph.D.

Americans benefit greatly from medical products produced by other countries. Approximately 40 percent of finished drugs in the United States come from overseas, as well as more than 50 percent of all medical devices. About 80 percent of the manufacturers of active pharmaceutical ingredients are located outside the United States.

Christopher Hickey

Christopher Hickey, Ph.D., testifies April 3, 2014.

However, this rapid globalization of commerce presents challenges to regulators who oversee the safety and quality of medical products. Many of these challenges manifest themselves in China. As FDA’s country director for the People’s Republic of China, I testified on April 3, 2014 before the U.S.-China Economic and Security Review Commission, an advisory panel created by Congress, on our work to ensure the safety and quality of medical products produced in China and imported into the United States.

China is the source of a large and growing volume of imported foods, medical products and ingredients. In the years spanning fiscal years 2007 and 2013, the total number of shipments of FDA-regulated products from China to the United States almost quadrupled.

The challenges we see in China mirror those we see in other countries with developing regulatory systems. These issues include problems with data integrity, inadequate implementation of quality systems in manufacturing, and inconsistent regulatory oversight, among others.

As China’s role on the global stage expands, FDA has significantly increased drug and medical device inspections there, but we need to continue to strengthen our efforts. FDA is currently working to use Congressionally-appropriated funding to increase from eight to 27 the number of U.S. staff it posts in China. Visa issues that arose with the Chinese government over new FDA staff assigned there were addressed during Vice President Joe Biden’s visit to Beijing in December, and FDA continues its work to post new staff in Beijing in the coming months.

FDA recognizes that strategic engagement in China starts first and foremost with Chinese regulators. China’s Food and Drug Administration, or CFDA, is responsible for the regulation of food, drugs, and devices for domestic distribution in China, and for regulation of certain exported drugs and medical devices.

Senate Committee Hearing, April 3, 2014

Christopher Hickey, Ph.D., testifies before the U.S.-China Economic and Security Review Commission.

FDA has established a strong working relationship with CFDA. Our office has trained hundreds of Chinese inspectors in areas that include inspecting for good manufacturing practices and assessing the quality of data from sites that conduct clinical trials. Experts from FDA’s Center for Devices and Radiological Health now meet regularly with their counterparts from CFDA under the auspices of the International Medical Devices Regulatory Forum. These investments will pay long-term dividends for the American people: a stronger Chinese regulatory system can only strengthen FDA’s efforts to promote and protect U.S. public health.

Finally, in the area of inspections and enforcement, CFDA inspectors now regularly observe FDA inspections in China. And since 2012, FDA’s Office of Criminal Investigations has worked closely with CFDA to fight against Internet-based, illegal distribution into the U.S. of falsified, counterfeit and adulterated drugs.

FDA’s priorities in China match its global priorities: we work to ensure the safety and efficacy of FDA-regulated products. Manufacturers are best situated to make certain that appropriate processes are in place to ensure safety and quality in production. Regulatory bodies should hold companies accountable for lapses in the production process. Inspections and testing are important tools in that process, but they must be used as part of a larger system that emphasizes a preventive, approach to the production of safe, effective, high-quality medical products.

And in our globalized world, it’s increasingly important that regulatory partners work together to ensure the safety of products as they move through increasingly complex supply chains. Patients and consumers – whether in Beijing or Boston – deserve no less.

Christopher Hickey, Ph.D., is FDA’s Country Director for the People’s Republic of China.

For more information, please visit this Web link:

China’s Healthcare Sector, Drug Safety, and the U.S.-China Trade in Medical Products