FDA, From a Distance

By: Claudia Heppner, Ph.D.

It is a great honor for me, as a European, to be working for FDA. I am one of the two Locally Employed Staff (Foreign Service nationals) currently working in FDA’s Europe Office in Brussels, Belgium.

Claudia HeppnerI came to this position after serving for 12 years in the European Food Safety Authority (EFSA), which is the European Union (EU) institution that provides independent scientific advice on existing and emerging food safety issues.

Before joining EFSA, I worked with the Secretariat of the EU’s Scientific Committee on Food. I’ve also worked for a multinational company in Belgium and the United Kingdom in the areas of pesticides product discovery and product development, including genetically-engineered plants.

With seven months at FDA under my belt, I enjoy and receive a great deal of satisfaction from my challenging new duties. Together with my colleagues, I am analyzing the range of science and policy issues under discussion in the EU’s decision-making framework. These EU issues span the breadth of FDA-regulated products and may sound familiar to some: updating and streamlining the food safety system; rapid access to innovative medicines; biotech, nanotech, novel foods, mobile and e-health; and, implementation of new legislation on tobacco and electronic cigarettes.

The EU has a complex environment for decision making, involving the “three pillars” (the European Commission, the European Parliament, and the Council of the EU) along with EU organizations that are counterparts to FDA such as the European Medicines Agency, EFSA, and various EU scientific committees.

In addition, each EU Member State (countries that are members of the EU) has its own national law-making bodies and regulatory organizations.

Only the European Commission can propose an EU law. The preparatory steps include: concept papers; a roadmap describing the timeline and significant events; impact assessments examining potential economic, social and environmental consequences; and public consultations.

I quickly learned that the European system is quite different from the legislative process and the notice-and-comment rule making system in the United States. In the Europe Office, we look at each step along the way in the EU decision-making process as a potential opportunity for strategic engagement.

Recently, I wrote a paper that analyzed what the EU is doing to strengthen food regulatory systems in Africa, China, and India. I was struck by the possibilities of what could be achieved through FDA and EU cooperation to help assure the safety of foods shipped to the United States and Europe and to improve public health around the world.

I feel fortunate to be working at FDA and to have the opportunity to broaden my professional horizons. I enjoy the dual focus on science and policy, working on medical product issues as well as foods issues, and observing how a non-EU organization like FDA works.

I look forward to continued learning and to the possibility of contributing to both the U.S. public health and – through FDA’s engagement with the EU – the EU public health.

Claudia Heppner, Ph.D., is a Senior Policy Analyst in FDA’s Europe Office

Find out more about FDA’s Europe Office

Talking Across International Borders About FSMA

By: Michael R. Taylor

Michael R. TaylorAll countries face the challenges presented by a food supply that is increasingly global, and consumers rightfully expect that the food they eat is safe no matter where it comes from. We all have the same goals: safe food, consumer confidence, and efficient and effective oversight to reach those goals.

With that in mind, our partnerships with foreign food producers and our regulatory counterparts in other countries are increasingly important. As we get closer to releasing the final rules that will implement the FDA Food Safety Modernization Act (FSMA), we are reaching across borders to ensure that our international stakeholders have the information and training they need to meet these new standards.

The need for this international outreach is a message that came through loud and clear at a public meeting this April on FSMA implementation. The feedback from agricultural attaches, overseas business owners, and representatives from governments worldwide was that they want to hear more about what to expect, and how to prepare for what’s ahead.

To address these concerns, we invited representatives of foreign embassies and other international stakeholders to attend a roundtable discussion on June 23, 2015. In the attached video, you’ll see both the optimism and concerns that surfaced during the meeting at FDA’s Center for Food Safety and Applied Nutrition in College Park, Md.


On June 23, 2015, FDA held a meeting of representatives of foreign embassies and international stakeholders involved in implementation of the FDA Food Safety Modernization Act (FSMA). This is the fifth video blog in which the people who will be helping to make FSMA a reality share their insights on challenges, opportunities and next steps. (The first video is Voices of FSMA: The Road to Implementation; the second: Voices of FSMA: The Opportunities Ahead; the third: Voices of FSMA: The Challenges We Face; the fourth: Voices of FSMA: Moving Forward.)


One sentiment, expressed at the meeting, was: “The United States isn’t the only country concerned about food safety.” From FDA’s perspective, we’re counting on that as we build the partnerships we’ll need to help ensure the safety of foods all over the world. We will join forces with agriculture and public health officials in other countries, international industries and associations, multilateral organizations, and academia to address the unique needs of foreign food producers who must comply with the new FSMA regulations.

We’re operating under the premise that the vast majority of food producers, both foreign and domestic, want to ensure the safety of their foods. We will be relying on our international partners to help us find ways to provide solid verification that the FSMA standards are being met.

The earliest compliance dates will be a year after we publish the first final rules this summer. In the meantime, we are working with our public and private partners to develop training for domestic and international food producers. These partners include the U.S. Department of Agriculture, grower and local food system groups, and the Food Safety Preventive Controls and Produce Safety alliances, whose members include the FDA, local and state regulatory agencies, the food industry, and academia.

We are committed to making FSMA implementation as open and transparent a process as possible. The April public meeting and the June roundtable discussion were just two steps in that process. But they were important steps because both provided open and frank conversations.

We’ve got a long road ahead. We’ve long worked with other countries as trading and regulatory partners. Now, we aspire to be food safety partners, working together and supporting each other when problems arise. These partnerships ultimately will benefit consumers all over the world.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.

FDA Science Forum 2015: Views of FDA

FDA’s 2015 Science Forum attracted more than 800 people from the scientific community. Here’s what some attendees said about the innovative research going on at the agency and why FDA can be a valuable collaborator in research aimed at transforming food safety and medical product development. If you couldn’t attend the FDA science forum, you can still see all the presentations on our web site.

Celebrating the 3rd Anniversary of the FDA Safety and Innovation Act

By: Stephen M. Ostroff, M.D.

Anniversaries are celebrated for many different reasons. Sometimes it is to recognize the enduring strength of an institution. Other times it offers an opportunity to gauge success or progress.

Acting FDA Commissioner, Stephen Ostroff, M.D.One commemoration that falls into the latter category is today’s third anniversary of the signing of the landmark Food and Drug Administration Safety and Innovation Act or, as it is known in the world of Washington acronyms, FDASIA.

FDASIA gave FDA authority to collect user fees from industry over five years, beginning in 2012, to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biological products.

It also promotes innovation to speed patient access to safe and effective products, increases stakeholder involvement in FDA processes, and enhances the safety of the drug supply chain. Just as important, FDASIA improves the agency’s ability to help prevent drug shortages.

FDA has made great strides to implement this important law since President Obama signed it, issuing more than 35 draft and final guidances, more than 10 proposed and final rules, three strategic plans, 14 reports to Congress, 18 public reports, and 13 public meetings designed to solicit input from a vast assortment of stakeholders.

All told, we have completed more than 70% of the law’s deliverables and we continue to maintain our commitment to a transparent and accessible implementation plan that allows the public to follow our progress.

Our work on additional action items continues.

Just two days ago we completed another task – issuing a final rule that requires all manufacturers of certain medically important drug and biologic products to give FDA early notification of potential drug shortages and to report the reasons for that potential shortage.

This step is the latest in a series of changes FDA has made to significantly reduce drug shortages. Those efforts have helped to prevent 282 shortages in 2012, 170 in 2013, and 101 in 2014.

This progress is but one example of how FDA’s work under FDASIA is making an important difference for patients and health care professionals who depend on these products.

One of the most significant provisions of FDASIA was the creation of a new Breakthrough Therapy designation for drugs and biologics intended for serious or life-threatening illnesses where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies.

As of last month, 315 requests for this special designation have been received and 93 drugs and biologics have been granted breakthrough status. Expedited development is underway for the majority of these breakthrough designated products, while 26 breakthrough therapy drug/indication combinations have already been approved and are now on the market for use by patients. This program, which, along with fast track, accelerated approval, and priority review, was the topic of FDA’s final guidance on our expedited review programs, also has helped facilitate earlier and continuing consultation and advice by FDA for industry researchers and product developers.

In large part, as a result of these expedited programs, we saw the approval of a record number of new drugs in 2014 for the treatment of both rare diseases and more common conditions like various forms of cancer and hepatitis C. We also saw the approval of a record number of biologics, including new vaccines for meningococcus type B.

Innovation is being promoted under FDASIA through greater patient engagement, including a five-year Patient Focused Drug Development program to learn from patients about the impact of their disease on their daily lives. Since its creation, we have held 14 meetings with patients on subjects such as chronic fatigue syndrome, lung cancer, HIV, and narcolepsy.

As this strategy makes clear, knowledge and understanding of a patient’s perspective on disease are critical. But equally significant is the importance of ensuring adequate data quality and transparency in research to develop new treatments. That brings up another area of great progress under FDASIA: addressing the longstanding concern about representation of women and minorities in clinical trials that support marketing applications for medical products.

In 2014, in response to Congress’s request in Section 907 of FDASIA, we produced an Action Plan to help close gaps in data quality, clinical trial participation, and data access. We have issued a guidance document on the “Evaluation of Sex-Specific Data in Medical Device Clinical Studies,” and we’re working to promote clinical trial participation by women and minorities. We also are posting on our website easy-to-understand Drug Trials Snapshots which provide the breakdown of clinical trial participants by age, race, and sex for newly-approved drugs and biologics. Snapshots also summarize whether there were differences in efficacy and safety among different subgroups.

Part of our efforts to implement and achieve the goals of FDASIA is helping us address the enormous global changes affecting FDA’s responsibilities.

With roughly 40 percent of finished drugs coming from outside our borders, and 80 percent of active ingredient manufacturers being located outside of the U.S., protecting the U.S. drug supply chain and making sure that patients have access to the drugs they need is a continuing priority for FDA.

FDASIA includes a set of provisions, contained in Title VII of the statute, which gave FDA new authorities to address the challenges posed by an increasingly global drug supply chain.

Given the enormity of FDA’s responsibilities, including the many new responsibilities authorized by Congress, combined with the budgetary challenges we face in this time of fiscal limitations, user fee funds play a critical role in FDA’s continued progress and excellence, including providing critical support to our staff of experts and helping maintain the high quality of their work.

Looking ahead, we have begun to plan for the next reauthorization of our user fee programs, beginning with a series of stakeholder meetings that began last month.

And, some of the themes advanced in FDASIA – encouraging antibiotic drug development, patient engagement, and the importance of biomarkers – are being considered by Congress as part of the 21st Century Cures initiative now making its way through Congress.

FDASIA provided enormous new responsibilities but also presented many promising opportunities. As we continue our progress in implementing this landmark law, we anticipate that we will continue to meet – and even exceed – the goals of the law as we strive to fulfill our mission to protect and promote the health of the American public.

Stephen M. Ostroff, M.D., is Acting Commissioner of the Food and Drug Administration

FDA China Office’s Lixia Wang Wins Award for HHS Locally-Employed Staff

By: Mary Lou Valdez

The FDA’s mission to ensure that food is safe and medical products are effective for use by U.S. consumers and patients is widely recognized.

Lou Valdez

Mary Lou Valdez, FDA’s Associate Commissioner for International Programs

A lesser-known fact is that the U.S. Department of Health and Human Services (HHS) employs more than 1,700 locally-employed (LE) staff in 60 countries to uphold its mission across five operating divisions, including FDA. Dr. Lixia Wang, a locally-employed staff member working for FDA in China, exemplifies the contributions of our LE staff and is the recipient of the annual HHS LE Staff of the Year Award.

China is a key supplier of goods imported to the U.S. The FDA has made significant regulatory in-roads since establishing its China post in 2008 and in many ways these are due to the contributions made by Dr. Wang and other LE staff in the world’s most populous country.

For example, Dr. Wang was essential in the negotiations of bilateral agreements for the placement of additional staff in China. With Dr. Wang’s contributions, FDA finalized these important agreements, which pave the way for FDA to more than triple its staff size in China. This move will bolster FDA’s work to protect and promote the health of consumers and patients in the U.S. and around the world.

Dr. Lixia Wang

Dr. Lixia Wang in Beijing

Dr. Wang, who has served as Medical Research Scientist for FDA’s China Office since 2009, was cited for her central role in negotiations concerning the Implementing Arrangements with China’s Food and Drug Administration, and Implementing Arrangement Between the Food and Drug Administration and the General Administration of Quality Supervision, Inspection and Quarantine.

In addition, Dr. Wang has made significant contributions to the HHS mission in China since joining U.S. Embassy Beijing in 2006. From 2006 to 2009, she served as senior local staff in the Office of the HHS Health Attaché, and played a key role in strengthening U.S.-China collaboration on infectious disease.

During that time, she also supported the FDA response to emerging problems associated with melamine in dairy and pet products, and worked to address contaminated blood thinner sourced from China. She played a key role in the 2007 negotiations of binding agreements with the Chinese Government on the safety of FDA-regulated products, and on the opening of FDA’s first-ever overseas office in 2008.

FDA congratulates Dr. Wang, and takes pride in the recognition for excellence and commitment to global public health that she brings to FDA with this award.

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

A Global Fight Against Dangerous Counterfeit and Unapproved Medical Products: From Operation Pangea to FDA’s Global Strategic Framework

By: Howard Sklamberg, J.D., George Karavetsos, J.D., and Cynthia Schnedar, J.D.

Unfolding earlier this month was a global cooperative effort, which included the Food and Drug Administration, to combat the online sale and distribution of potentially counterfeit and illegal medical products. Operation Pangea VIII was a project of massive scope, a lightning move by 115 countries that resulted in more than 2,400 websites being taken offline and the seizure of $81 million worth of potential dangerous illegal medicines and medical devices worldwide.

Howard Sklamberg

Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

It’s a sad and cruel fact that drug and device counterfeiting and adulteration pose serious threats to public health. Unapproved and misbranded prescription drug products and unapproved/uncleared medical devices offered for sale on the Internet are potentially dangerous. The illegal sale of these medicines and devices bypasses both the existing safety controls required by the FDA and the protections provided when these products are used under a licensed practitioner’s supervision.

FDA is dedicated to sustaining and expanding the fight against counterfeits as part of our global strategy that leverages resources and expertise, engages the private and public sectors, and is data-driven and risk-based.

We have developed a Global Strategic Framework for counterfeit and substandard medical products (sometimes known by the acronym SSFFC, for Substandard, Spurious, Falsely-Labeled, Falsified, Counterfeit) to help protect consumers by reducing their exposure to counterfeit and substandard medical products.

The framework is focused on three pillars: Prevention, Detection, and Response.

What’s needed is better prevention of market entry of counterfeit and substandard products. Better detection of these products. And, more efficient response when counterfeit and substandard products are found.

FDA developed this framework in order to lay out a strategic vision of what is needed and how these needs can be met globally. There are areas where our expertise can and does contribute to prevention, detection, and response, but there are other areas where other U.S. federal and local government agencies, foreign counterparts, industry, healthcare professionals, consumer and patients, non-governmental organizations, procurement and donor organizations, standards bodies, and others have a role.

George Karavetsos

George Karavetsos, J.D., FDA’s Director, Office of Criminal Investigations

It is important for all players fighting to combat counterfeit and substandard drugs and devices to understand exactly how to best use our resources, knowledge, and experience, and leverage the work of others. This framework helps shape what roles we can play, minimize duplication of effort, and strengthen our global might in this fight against the criminals.

FDA has many ongoing activities and initiatives that support the framework goals. To better prevent counterfeit and substandard products from entering the market, we are working on improving the transparency, accountability, and integrity of the supply chain. Specifically, we are focusing on good manufacturing, distribution, and pharmacy practices, and we’re working for a convergence of global standards to create a more level playing field for the legitimate supply chain.

We are also implementing the new track and trace law (the Drug Supply Chain Security Act), which outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States, no matter where they originate. This is a collaborative effort whereby FDA is working with drug manufacturers, wholesale drug distributors, repackagers and dispensers (primarily pharmacies) to implement the law and develop the new system over the next eight years. Some of the key goals of this system will be to trace the path of drugs at the package-level through the drug supply chain, help ensure they are legitimate products, and enhance the detection of illegitimate drugs.

Cynthia Schnedar

Cynthia Schnedar, J.D., Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research

To better detect potentially harmful products before they enter the supply chain on their way to patients, we are focusing on improving information-sharing and communication. Also, as part of our effort for better detection, we are improving our surveillance through more efficient investigations of suspect incidents, and more quickly confirming that products are counterfeit. To this end, we have developed new detection technologies, specifically the handheld device, CD3, which uses wavelength detection to detect counterfeit drugs and packaging at our ports of entry.

Lastly, to better respond to incidents in the most efficient manner, FDA’s Center for Drug Evaluation and Research is developing more effective ways to notify the public of confirmed incidents and quicker removal of counterfeit products from the marketplace.

As for enforcement, we will continue to rely on our skilled professionals in FDA’s Office of Criminal Investigations (OCI) to lead domestic and global investigations to combat counterfeits. For example, OCI’s involvement in the past seven years of Operation Pangea has resulted in the seizure of more than $172 million in unlawful medical products — a real testament to effective international partnership.

We fully recognize that there are sophisticated, global criminal networks engaged in money laundering and the preparation and transportation of illegal products around the world. Importantly, we are meeting this global threat with international collaboration. FDA’s Office of International Programs has engaged with the World Health Organization’s Global Surveillance and Monitoring System, the World Bank, and the U.S. Agency for International Development in securing drug supply chains, reducing the threat of substandard drugs and strengthening regulatory systems.

We also collaborate with many foreign law enforcement organizations. For example, we have an OCI agent permanently assigned to Europol, based in The Hague, Netherlands. We also have a longstanding and solid partnership with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). More recently, OCI signed with the French National Gendarmerie a Letter of Intent to increase law enforcement collaboration.

Moreover, the stakes have grown higher in the U.S. as judges around the country recognize the risks of unapproved drugs in the U.S. marketplace. In January 2015, for example, a Turkish exporter of illegal drugs was sentenced to 30 months in federal prison for his part in the scheme.

As underscored by Operation Pangea last week, our actions to protect the health of Americans from the online sale of potentially dangerous illegal medical products will continue. In the longer term, our focus will be prevention, detection and response. We will need a more coordinated, domestic and global approach that leverages resources, expertise, tools, and trainings, and engages stakeholders, other regulators, and law enforcement.

Through our framework for strategically safeguarding supply chain security and integrity and combatting counterfeit and substandard drugs and devices, we know we are on the right path with the right goal: Protecting public health by helping to ensure that the prescription medications and devices used by health care professionals and patients are safe, effective and of high quality.

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

George Karavetsos, J.D., is FDA’s Director, Office of Criminal Investigations

Cynthia Schnedar, J.D., is FDA’s Director, Office of Compliance, Center for Drug Evaluation and Research

FDA Engages Internationally to Promote Access to Safe, Effective Animal Medicines

By: Bettye Walters, D.V.M.

Regulators around the world are reaching across national borders as they work together to ensure the safety of veterinary medical products.

Bettye WaltersI am a veterinarian on the International Programs Team at the FDA’s Center for Veterinary Medicine (CVM). In this role, I attended the 4th Global Animal Health Conference in Tanzania on June 24 and 25 and participated in the global dialogue about the use and availability of high quality, safe and effective veterinary medical products in developing countries, especially in Africa. FDA embraces the One Health approach, which recognizes the connection between the health of people, animals and the environment.

I was accompanied by my colleague Steven Vaughn, D.V.M., who heads CVM’s Office of New Animal Drug Evaluation. Dr. Vaughn has years of experience exploring the most effective ways to regulate animal medications to ensure that they are high quality and safe.

The conference was attended by leading figures from the world’s governments, academia, industries, and international organizations and its focus was on the concept of “regulatory convergence,” a process that allows countries to bring their regulatory processes into closer alignment. We tackled important ideas related to promoting market control, including the surveillance of veterinary products on the market and improving access to effective animal drugs. We also discussed fostering systems for mutual recognition of regulatory oversight and standards, forming regional organizations, and implementing African regional harmonization initiatives to create a convergence of international guidelines.

If all countries can agree on the testing and safety of animal drugs, each country could have faster access to new medical products and be able to better leverage often-limited resources. While globalization provides many challenges, FDA believes it also offers opportunities for innovation if regulators, industry, and academia are working together for the benefit of all countries.

It’s a small world and solutions to public health problems, for both people and animals, are increasingly found on the world stage. FDA is committed to working with its global partners to promote cooperation in veterinary medicine.

Bettye Walters, D.V.M., is a veterinary medical officer on the International Programs Team at FDA’s Center for Veterinary Medicine.

China’s Pharmaceutical Future – Both Complex and Growing

By: Howard Sklamberg, Richard Moscicki, M.D., and Alonza Cruse

中文(Simplified Chinese)

A visit to any one of the cities we visited on this trip – Shanghai, Nanjing and Beijing – would leave anyone marveling at the scale and trajectory of modern China. But it’s not just the sheer size of the population we were struck by. Rather, it was the seemingly tireless dedication to modernity that provided an almost palpable affirmation of what we already knew: that China — its skylines dotted with construction cranes and landscapes crisscrossed by high speed bullet trains — is inextricably connected with our own country’s economy, and increasingly with our agency’s ever-expanding regulatory mission.

Howard Sklamberg

Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

We traveled to China for a few reasons. First, we wanted to gain more on-the-ground insight into how its drug industry works. We also wanted to offer some helpful perspective to Chinese regulators and drug companies about the Food and Drug Administration Safety and Innovation Act (FDASIA), which passed three years ago and is in the process of being fully implemented. In part, the law gave the FDA new authorities to ensure the safety of the global drug supply chain, in which China plays an enormous part. How enormous? After the United States, China ranks second for the number of FDA-registered drug establishments that the agency regulates, and is the sixth largest provider of drugs and biologics to the U.S.

Our itinerary also included a meeting with the Chinese Food and Drug Administration (CFDA) and a tour of a Chinese pharmaceutical manufacturing plant. And if you asked us what the most important by-product of our trip has been, it was these face-to-face conversations with our Chinese counterparts.

Specifically, we discussed the responsibilities of firms in the global drug supply chain. These days, the drugs we have in our medicine chests may seemingly come from one company, but the ingredients in them may actually come from numerous companies and countries. China is a major provider of many of the active ingredients in finished drug products Americans rely on every day.

Dr. Richard Moscicki

Richard Moscicki, M.D., FDA’s Deputy Director, Center for Drug Evaluation and Research

We had productive discussions with the Chinese about how seriously we are committed to making sure that everyone in the drug supply chain – from the companies that make the active ingredients to those that provide the packaging –shares in this collective commitment to quality. As we did when we spoke with our counterparts in India, we stressed that we apply the same quality and data integrity standards to all countries shipping drug ingredients into the United States.

We delivered the same message to a huge crowd of students at an event hosted by China’s Pharmaceutical University in Nanjing. In our remarks, we set forth our expectations for the delivery of drug quality, saying: “…ideally, our approach will complement the baseline, legal requirement of compliance with the higher bar of firms’ self-interest in being recognized for providing quality products and engaging in a different way with FDA.

While in Nanjing, we had productive discussions with students and stakeholders about FDASIA, quality in contract manufacturing, inspections, regulatory science, and expedited approval pathways that FDA is using to accelerate the process for making novel drugs available to patients.

Additionally, we toured a Chinese pharmaceutical facility and met with CFDA to discuss the revision of China’s Drug Administration Law, our own FDASIA implementation, regulatory science matters, as well as continued collaborative activities. We also had a productive roundtable discussion with leaders from 17 prominent Chinese pharmaceutical companies. We addressed pharmaceutical quality, data integrity, and the approval process for generic and innovator drugs.

Alonza Cruse

Alonza Cruse, FDA’s Acting Director, Pharmaceutical Quality Program, Office of Regulatory Affairs

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. The Office of Regulatory Affairs and our China office have managed a large number of pharmaceutical inspections. The FDA’s office in China has also strengthened relationships with regulators and helped expand the country’s expertise in regulatory operations. And we have worked with industry and academia to explain our regulations and analyze trends and events that might affect the safety of FDA-regulated products exported from China to the U.S.

Given the volume of U.S. trade with China, we are working to expand our presence there to significantly increase the number of inspections we conduct. Staffing increases will allow FDA to enhance its training efforts and technical collaboration with Chinese regulators, industry and others. In fact, in November 2014, we signed a Memorandum of Understanding with the Chinese government that expands our cooperation and will facilitate those staffing increases.

FDA’s priorities in China match its global priorities: we work to ensure the safety and efficacy of FDA-regulated products. China’s size and relentlessly expanding economy have an increasingly significant impact on the products that Americans consume, particularly pharmaceuticals.

We trust our trip to China added to the growing collaboration between FDA and our counterpart agencies there, ensuring the safety of the pharmaceutical products exchanged between our two nations.

Howard Sklamberg is FDA’s Deputy Commissioner, Global Regulatory Operations and Policy
Richard Moscicki, M.D., is FDA’s Deputy Director, Center for Drug Evaluation and Research
Alonza Cruse is FDA’s Acting Director, Pharmaceutical Quality Program, Office of Regulatory Affairs

FDA Continues its Collaboration with Canada in Phase 2 of the U.S.-Canada Regulatory Cooperation Council

By: Lou Valdez, M.S.M.

For more than 30 years, FDA has enjoyed a robust partnership with our Canadian regulatory colleagues. In FDA, we are excited to build upon this relationship in Phase 2 of the U.S.–Canada Regulatory Cooperation Council (RCC).

Lou ValdezThe RCC was established in 2011 by U.S. President Barack Obama and Canadian Prime Minister Stephen Harper to develop smarter and more efficient and effective approaches to regulatory cooperation between the two countries. The RCC aims to bring the U.S. and Canadian regulators and stakeholders closer in terms of sharing information, combining expertise, eliminating duplicative work and creating an enabling environment to foster and facilitate ideas.

In Phase 1 of the RCC, our governments identified important regulatory issues to work together to improve. For example, as a result of the cooperation between FDA and Health Canada, we reduced the regulatory burden for industry through the development of the Common Electronic Submission Gateway (CESG). Led by our FDA Medical Product Centers, the CESG allows industry to simultaneously submit electronic applications to both FDA and Health Canada for pharmaceutical and biological products.

In Phase 2, over the next three years, FDA has committed to work with the Canadian Food Inspection Agency (CFIA) and Health Canada in the areas of:

  • Food Safety
  • Medical Devices
  • Over-the-Counter Drug Products
  • Pharmaceutical and Biological Products, and
  • Veterinary Drugs.

Together with CFIA and Health Canada, we developed five individual work plans describing specific activities within the above areas and two Regulatory Partnership Statements outlining the institutional frameworks for this cooperation.

Throughout the implementation of these work plans, American and Canadian stakeholders will have opportunities to engage with the regulatory agencies to provide updates on significant industry and consumer trends and associated implications for regulatory systems.

FDA is committed to continuing our valued partnership with Canada and using the RCC as an important tool upon which to build. Learn more about FDA’s work under the RCC at http://www.trade.gov/rcc/.

Lou Valdez, M.S.M., is FDA’s Associate Commissioner for International Programs

FSMA: The Future Is Now – Stakeholder Perspectives

On April 23-24, 2015, FDA hosted the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The national public meeting in Washington, D.C., continued on the second day with a panel discussion on stakeholder perspectives.

Participants: Sandra Eskin, J.D., Director, Food Safety, The Pew Charitable Trust; Leon Bruner, D.V.M., Ph.D., Executive Vice President for Scientific and Regulatory Affairs and Chief Science Officer, Grocery Manufacturers Association; Marsha Echols, J.D., Legal Advisor, Specialty Food Association; Richard Sellers, Senior Vice President of Legislative and Regulatory Affairs, American Feed Industry Association; David Gombas, Ph.D., Senior Vice President of Food Safety and Technology, United Fresh Produce Association; Sophia Kruszewski, J.D., Policy Specialist, National Sustainable Agriculture Coalition; Stephanie Barnes, J.D., Regulatory Counsel, Food Marketing Institute. Moderator: Roberta Wagner, Director for Regulatory Affairs, Center for Food Safety and Applied Nutrition, FDA.