Turning the Tide on Ebola

By: Calvin W. Edwards, CAPT, U.S. Public Health Service Commissioned Corps

Before accepting their agreements to work in Liberia in a mobile hospital for Ebola patients, I emailed each of the 68 Commissioned Corps officers of the U.S. Public Health Service that they would face danger, needed to accept certain risks, and that they would have to perform under extremely austere conditions.

Capt. Edwards

Calvin W. Edwards, CAPT, U.S. Public Health Service Commissioned Corps

Turns out, if anything, I may have underestimated the hardship.

Initially we lived 12 to a room in two-bedroom cabanas that were intended for four people and had ”septic” issues (sewage backups and overflowing toilets) to boot. We ate MRE’s (Meals Ready to Eat) intended for troops in combat. Six weeks into the two-month deployment, we were moved into tents next to the mobile hospital, about 20 officers per tent.

We worked 12-hour shifts in 90 degree heat and 90 percent humidity, often wearing head-to-toe heavy layers of plastic gear that left us soaked in sweat within minutes. A single slip in protocol could expose us to a deadly virus as we worked with vomiting patients who could defecate up to three gallons of diarrhea a day and could quickly dehydrate.

The Payoff

But when the first patient emerged with a clean bill of health, the hardships were forgotten.

A Liberian physician’s assistant, a man in his 30s, was the first to walk out with a certificate documenting that two tests showed him to be virus-free.

Ebola Survivor

U.S. Public Health Service officers celebrate as a Liberian man adds his handprint to a “survivors wall.” Each patient who overcame Ebola after treatment at the USPHS mobile hospital outside Monrovia was given a set of clothes and essentials and invited to mark their recovery with a handprint.

His family arrived like a chorus, singing, praising God, thanking America, jubilantly crying, and shouting, “He lived!”

This ex-patient became the first person to dip his hand in yellow paint and make an imprint on our “survivors’ wall.” Although total numbers have not yet been released, there were more handprints to come, and more patients survived than died.

Each patient who walked out confirmed that we were correct deciding to cross an ocean to help stop the spread of Ebola. To see a once desperately sick person recover and go home, knowing we had a part in that, was more satisfying than I can describe.

We were the first group of Public Health Service officers to move to the tents that were set up as a hospital in Liberia. Our group, which I commanded, included 24 women and 45 men. I had three weeks’ notice before flying out; some in our group had as little as five days to decide and be deployed.

Since our return, two more groups of Public Health Service officers have been deployed to the hospital built in a remote area about 1.5 hours from downtown Monrovia. The final group is still there.

The Mission

Our mission was to treat health care workers who contracted the Ebola virus. Before our arrival health care workers were leaving in droves, and the volunteer pool was drying up. The creation of our treatment facility helped turn the tide.

Liberia Compound

An aerial photo shows the mobile medical compound where Public Health Service Officers treat health care workers who contract Ebola.

The Liberian Ministry of Health told us that some health care workers were waiting until we had set up the facility before agreeing to come to Liberia. The fact we had a small part in increasing the pool of workers treating desperate patients was awesome. How often in our lives do we get a chance to do something so big?

On the other hand, one of our greatest stresses was how little we could do to help defeat the virus. Often the most we could do was keep people clean and hydrated while hoping their bodies would develop antibodies.

It was especially hard emotionally when we lost a patient at night. Because Ebola patients are most infective right after they succumb to the disease, we could not risk moving them over the dimly-lighted pathway to the morgue.

The Public Health Service officers were the only people working in the hospital. They performed every job, even those most unpleasant, and did it regardless of rank, exalted skills, or letters after their names. Yet all came away happy about the role they played.

For my part, I am both humbled and intensely proud of these men and women — of their skills, dedication, selflessness, ruggedness and resiliency. I wish all Americans could share some measure of my joy.

CAPT Edwards is a Public Health Service officer who serves in FDA’s Office of Regulatory Affairs. The U.S. Public Health Service Commissioned Corps is made up of 6,500 public health professionals who provide leadership and clinical service roles within the federal government agencies to which they are assigned.

In India, With Our Sleeves Rolled Up

By: Howard Sklamberg and Michael Taylor

Howard Sklamberg

Howard Sklamberg

These facts surprise many people, but roughly 80 percent of active pharmaceutical ingredients, 40 percent of finished drugs, 80 percent of seafood, 50 percent of fresh fruit and 20 percent of fresh vegetables come from outside of the U.S.

Each year, the FDA has to assess millions of products grown, harvested, processed, manufactured and shipped from outside of the U.S. And one of the most impressive examples of how this globalization of production, consumption and trade has altered the regulatory landscape is India.

India is quickly becoming a significant player in the global marketplace, representing an important source of FDA‐regulated products. With a diverse population, highly skilled work force, and favorable economic conditions, India has become an increasingly attractive location for companies to operate.

Michael Taylor

Michael Taylor

And with that, Indian regulators have become important strategic partners for FDA. Today, we regularly engage with them on everything from sharing information on clinical trials to collaboratively addressing product safety issues that may harm American consumers.

When Commissioner Hamburg visited the country last year, she remarked that the “rapid globalization of commerce has posed significant challenges to ensuring consumer safety as the number of suppliers entering the U.S. has increased.” On her visit she signed a milestone Statement of Intent between our two countries  seeking to “collectively work together to improve the lines of communication between our agencies and work diligently to ensure that the products being exported from India are safe and of high quality.”

We are eager to continue the work she started. And improving the lines of communication of which she spoke is the purpose  of our working visit to India. Before the trip we discussed with our teams what we expect from our journey. Our top goal is to listen and learn. We want to understand what challenges the Indian government is facing with regard to drug and food safety. We want to hear from both American companies operating in India, as well as Indian manufacturers. And we want to discuss with our Indian counterparts a number of significant changes in the American regulatory system that affect our relationship.

FDA’s Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations & Policy, and Cynthia Schnedar, Director, Office of Compliance at CDER, meet with Dr. G.N. Singh, Drugs Controller General of India.

FDA’s Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations & Policy, and Cynthia Schnedar, Director, Office of Compliance at CDER, meet with Dr. G.N. Singh, Drugs Controller General of India. Get this and other photos from FDA’s trip to India on Flickr.

It is no secret that relationship has been challenged in the recent past by lapses of quality at a handful of pharmaceutical firms. And while our first regulatory responsibility is to protect the American patient and consumer, we are also very willing to collaborate with Indian regulators and other stakeholders to ensure the achievement of highest standards of safety and quality, something we feel only benefits both nations.

We have harvested some of the fruits of this cooperation already. A significant example of collaboration between the U.S. and India occurred in 2012, when a Salmonella outbreak was traced to a manufacturer in India. An FDA inspection confirmed that the tuna product implicated in the outbreak came from the suspect facility, and the Indian government revoked the manufacturer’s license.

In yet another case, FDA’s India office worked with other United States government agencies to inform industry and Indian regulators about issues associated with an import alert for Basmati rice from India. The FDA office shared laboratory procedures for testing of pesticides.

More recently, in November of 2014, as a continuation of FDA’s efforts to strengthen the quality, safety and integrity of imported drugs, the FDA India Office, in collaboration with our Center for Drug Evaluation and Research’s Office of Compliance and the Office of Regulatory Affairs, held four workshops in India.  The workshops were held in partnership with European Directorate for the Quality of Medicines and Drug Information Association and involved the Indian Drug Manufacturers Association, Parenteral Drug Association and Organization of Pharmaceutical Producers of India. Over 560 participants from the pharmaceutical industry attended the four two-day workshops.

We are confident our trip will yield more examples of such fruitful collaboration, moving the regulatory relationship between two of the world’s largest democracies to the next stage, from the intention to work together, to the ability to work together to solve the complex globalization issues facing both nations.

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

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

European Medicines Agency/FDA Patient Engagement Fellowship: A Time to Learn and Share

By: Nathalie Bere, MSc

I recently returned from a two-week fellowship at the FDA Headquarters in Silver Spring, Md. My mission was to learn about the FDA’s engagement with patients. And, at the same time, to share information on how we involve patients in our work here at the European Medicines Agency (EMA).

Nathalie BereThe EMA is responsible for the scientific evaluation primarily of innovative and high technology medicines developed by pharmaceutical companies for use in the 28 current EU member states as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway. Experts participate in the work of the EMA as members of its scientific committees, working parties, scientific advisory groups, or as members of assessment teams evaluating medicines. They are chosen on the basis of their scientific expertise. The patients and health care professionals’ voices are also fully integrated within the work at the EMA.

At the beginning of December, as I stood outside the buildings at the FDA’s White Oak Campus, I wondered if this somewhat challenging task was going to be feasible within such a short timeframe. I felt that it was very important for me to not only capture the essence of the work at the FDA but to really learn about the different challenges and issues they have faced and how they have been handled. Overall, I wanted to be able to identify areas which could ultimately benefit from an exchange of EMA/FDA experience.

I had no need to worry. I was received openly and positively within the FDA offices by all the staff who took time from their busy schedules to meet me and share their respective work practices. An extensive schedule had been set up to give me the opportunity to learn about the relevant offices and divisions, as well as attend two Advisory Committee Meetings and participate in a Patient Representative Training Webinar. I also had several opportunities to share information with FDA colleagues on how EMA involves patients throughout the development, evaluation, and surveillance of medicines.

It was enlightening to learn that, overall, many of the challenges and benefits of working with patients are remarkably similar for the two agencies.

Engaging with patients is a vital part of any regulator’s work, and this is recognized as a high priority by both the EMA and FDA. Of course, there are differences in the way each agency achieves this, due in part to their different review processes. However, there are definitely areas where I believe each agency can benefit from the other’s experience.

For example, the EMA can benefit from the FDA’s experience in organizing and conducting public events such as advisory committee meetings and patient-focused drug development meetings where FDA experts reach out and gather data from the audience.

Other promising concepts for the EMA include the FDA’s “patient representative program,” comprising a pool of interested, screened and trained patients who bring the patient voice to the FDA discussions about new and already approved drugs and devices and policy questions. Still more interesting patient-specific communication tools used by FDA are webinars, interactive live-chats and a dedicated newsletter used for training and raising awareness.

In turn, the FDA could benefit from EMA’s experience of engaging with patients earlier during its discussions on specific product assessments. In the EMA’s system patient input can be regularly solicited throughout the medicine’s lifecycle, e.g. in all expert meetings, through written patient consultations, and by patients as voting members within committees.

Other areas that could benefit the FDA include: patient review of all package leaflets and safety communications, and the establishment of a permanent group of patient/consumer organizations that provide a platform for exchange of information on general issues within the EU system.

Now that I  am back at the EMA’s London headquarters after quite a hectic, but enriching experience, I hope  there will be an opportunity at EMA to reciprocate with my new FDA colleagues, who invited me so warmly into their workplace.

This fellowship has provided an opportunity for both the EMA and the FDA to gain an understanding of each other’s respective programs of engaging with patients, and a rich source of valuable information has been shared.

We look forward to further collaboration and regular sharing of information on patient engagement.

I would like to thank Sabine Haubenreisser, EMA Liaison Official to the FDA, based at White Oak; Heidi Marchand, Assistant Commissioner of the Office of Health and Constituent Affairs; and Health Programs Coordinator Andrea Furia-Helms, who facilitated this fellowship.

International Programs and EMA International Affairs:

Nathalie Bere, MSc, works in patient relations in the Stakeholder and Communication Division of the European Medicines Agency in London. 

Through the EMA/FDA confidentiality arrangements our organizations have established procedures to enable our organizations to share information that is not public. These arrangements also facilitate the exchange of staff, including secondments and fellowships, to work together on defined topics and foster increased dialogue and cooperation.

A Year of Significant Progress in Public Health

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.A new year offers both an opportunity to look forward and an opportunity to reflect on the achievements of the previous year. And, in 2014, FDA’s accomplishments were substantial, touching on many of the agency’s broad responsibilities to protect and promote the public health.

Whether our achievements involved medical product safety and innovation, food safety and nutrition, tobacco control, or other areas of our important work, all were accomplished thanks in large part to our ability to respond to evolving needs and opportunities including the embrace of new approvals, technologies and cutting-edge science.

Consider these highlights:

Drug Approvals: This past calendar year, FDA approved 51 novel drugs and biologics (41 by CDER and 10 by CBER), the most in almost 20 years. Among CDER’s 2014 approvals are treatments for cancer, hepatitis C and type-2 diabetes, as well as the most new drugs for “orphan” diseases since Congress enacted the Orphan Drug Act over 30 years ago. Seventeen of these new approvals are “first in class” therapies, which represent new approaches in the treatment of disease. In addition, CBER approved many important biological products in 2014, including a number of groundbreaking vaccines for meningitis B, the flu, and certain types of Human Papillomavirus, the latter of which is expected to prevent approximately 90 percent of the cervical, vulvar, vaginal and anal cancers caused by HPV.

These developments are a testament not just to our expanding understanding of human biology, the biology of disease and the molecular mechanisms that drive the disease process, but also to FDA’s innovative approaches to help expedite development and review of medical products that target unmet medical needs, while adhering to the established standards for safety and efficacy. These include enhanced guidance to shape the research and development agenda, early input on clinical study needs and design, expedited review programs, targeted regulatory advice and other tools and incentives that spur investment and innovation in new medical products to address unmet medical needs.

Opioids: This past year FDA took several actions to address the abuse of opioid drugs. First, we approved abuse deterrent labeling for three opioid products that are designed to deter prescription drug abuse. These drugs used different technologies to combat the abuse problem in different ways, such as by making the product resistant to crushing or dissolving or using “aversive technology” to discourage users from taking more than the approved dosage of the drug. To help encourage the development of more drugs in abuse-deterrent forms, we are also working to provide additional advice to manufacturers. Although abuse-deterrent opioid drugs are not a silver bullet to prevent opioid abuse, we believe that our work in this area will give physicians effective new treatment options with less risk of abuse.

FDA also worked to improve the treatment of patients who overdose on opioids. We approved a new dosage form of naloxone, with an autoinjector to enable a caregiver to administer the drug in the emergency treatment of opioid overdose (as it rapidly reverses the effects of an overdose). While we continue to support development in this area, this approval offers a new valuable tool to help prevent the tragedy of opioid drug overdose.

Antibiotic Resistance: We made important strides in confronting the growing resistance of some bacteria to antimicrobial drugs. Our efforts, which are a critical part of the recently unveiled National Strategy on Combating Antibiotic Resistant Bacteria, offer a multi-pronged approach that recognizes that to effectively address this challenge means simultaneously addressing the many different causes for increasing antibiotic resistance. One important response has been efforts to expand the pipeline of new medical products, including therapeutics to treat and cure infection, diagnostics to aid in the identification of the cause of infection and of resistant infections, and vaccines to help prevent infection with bacteria in the first place.

These efforts are already having an impact. In 2014, FDA approved four novel systemic antibiotics. In contrast, only five new antibiotics had been approved in the previous ten year period.

In addition to working on the human medical product side, we also developed and, over the next two years will be implementing, an important complementary strategy to eliminate the use of medically important antibiotics for growth promotion in food-producing animals. This strategy, once fully implemented, also will bring the remaining uses of such drugs to treat, control or prevent disease in these animals under the oversight of veterinarians. All 26 animal health companies who produce those drugs have committed to participate, and 31 products already have been withdrawn from the market.

Pharmacy Compounding: We continued to respond effectively to the 2012 outbreak of fungal meningitis that was linked to contaminated compounded drugs. This included conducting more than 90 inspections of compounding facilities across the nation in the past year. As a result, numerous firms that engaged in poor sterile practices stopped making sterile drugs, and many firms recalled drugs that have been made under substandard conditions. Where appropriate, we have worked with the Department of Justice to pursue enforcement action against some of these facilities.

We also have continued to implement the compounding provisions of the Drug Quality and Security Act (DQSA), and to develop and implement policies to address compounding by state-licensed pharmacies and the new category of registered outsourcing facilities.

Food Safety: Over the past year, the Agency has made great strides in implementing the landmark FDA Food Safety Modernization Act (FSMA). Through our proposed rules for preventive controls requirements for both human and animal food, standards for produce safety, foreign supplier verification programs, third party auditor accreditation, focused mitigation strategies to prevent intentional adulteration of food aimed at causing large-scale public health harm, and requirements for sanitary transportation practices to ensure the safe transport of food, we are working to ensure the safety of American consumers related to the foods they eat.

Nutrition: Good health depends not just on food safety, but also on what we choose to eat. FDA plays an important role in promoting good nutrition and healthy food choices by helping consumers understand the importance and benefits of good nutrition – and of being able to make informed choices about what we eat.

New rules in 2014 to finalize requiring calorie information on restaurant menus and vending machines give our citizens information they need to make healthy food choices and hopefully help reduce the epidemic of obesity in the United States. We also proposed changes to the familiar “Nutrition Facts” label on packaged foods which, when finalized, will give our citizens updated nutrition information, reflecting the most current nutrition science, to help them make healthy choices when purchasing packaged foods.

Tobacco Control: There are few areas that have as profound an impact on public health as tobacco products, which is why, five years ago, Congress gave FDA the responsibility to oversee the manufacture, marketing, distribution, and sale of tobacco products.

Over the past year, we worked with state authorities to conduct more than 124,000 inspections of retailers to enforce the ban on the sale of tobacco products to children. We unveiled the first of its kind national public education campaign—The Real Cost—to reduce youth smoking. And we took the first steps towards extending the agency’s tobacco product authority over additional products such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco, and dissolvables not already subject to such authority through our proposed “Deeming Rule.” In addition, as part of ongoing work on product review decisions, eleven tobacco products that were allowed to enter the market during a provisional period established by the Tobacco Control Act were found “not substantially equivalent” to a predicate tobacco product. As a result of this finding, these products can no longer be sold or distributed in interstate commerce or imported into the United States.

Ebola: The tragic Ebola epidemic in West Africa demonstrates that we do not have the luxury of closing our eyes – or our borders – to the public health problems that exist in the rest of the world. I’m proud that FDA has played an important role in the response to this disease, working closely with colleagues in our government as well as the scientific community, industry and a range of other organizations and nations. We have helped facilitate the development, testing, manufacture, and availability of investigational products for use in diagnosing, treating and preventing Ebola, and worked with sponsors and health care providers to facilitate access to these products as clinical circumstances warrant. In August 2014, FDA designated the drug Z-Mapp as an orphan drug for Ebola, with the hope that this would incentivize further development and study.

And I’m very pleased to report that FDA is represented on the ground in West Africa by dedicated officers of the Commissioned Corps of the Public Health Service who continue to staff and operate the Monrovia Medical Unit in Liberia that was built to treat the health workers who became ill responding to the outbreak. Like everything FDA does, both at home and abroad, our actions on Ebola represent our agency’s continuing commitment to health and safety, and the use of science to advance these important goals.

I am extremely proud of our accomplishments in 2014, and I am confident that FDA will have a successful 2015, as we continue our work to protect and promote the public health.

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

Making the Case for Critical FSMA Funding

By: Michael R. Taylor

Over the past two years, my colleagues and I have written here about what FDA is doing to create the preventive, risk-based food safety system mandated by the FDA Food Safety Modernization Act (FSMA). We’ve taken you along on our visits to farms and food facilities to get input on the FSMA rules we have proposed. We’ve described the changes we’re making within FDA and the framework we’re building to implement those rules after they become final in late 2015 and early 2016.

Michael Taylor

Michael Taylor

Now we’re at a critical juncture as Congress considers the funding that will help transform all the plans and preparations we’ve shared with you into protections that will greatly reduce the number of illnesses caused by contaminated foods and greatly increase consumer confidence in the safety of our food supply. President Obama’s FY 2016 budget request, released to Congress yesterday, would provide an additional $109 million for FSMA implementation. In the current fiscal year, FDA received an additional $27.5 million.

Why do we need this money? Because a lot of work must be done right now to ensure that the FSMA rules are implemented smoothly and effectively in late 2016 and 2017. Let me give you a few examples of areas in need of additional funding that, through FSMA, will transform the food safety system into one that prevents hazards instead of just responding to them.

Under FSMA, our approach to food safety inspections and compliance will be fundamentally different. FDA will deploy inspectors who are specialized in specific food commodities, rather than covering a broad range of FDA-regulated products. Backed by technical experts, they will assess the soundness and performance of a facility’s overall food safety system. Achieving this will require a major reorientation and retraining of more than 2,000 FDA inspectors, compliance officers and other staff involved in food safety activities.

While FSMA has given us new enforcement tools to use against those who flout safety requirements, the vast majority of food producers want to comply and keep their products safe. FDA will be issuing guidance documents that will be essential to helping industry meet FSMA requirements. Funds are needed now for FDA to recruit additional experts who can ensure that guidance development is based on the best science and knowledge of industry practices. These experts will also collaborate with industry, academia, and state extension services to ensure that their concerns are heard, that their advice is sought and used, and that the guidance documents reflect the most cost-effective solutions.

I cannot say enough about the importance of education and technical assistance to help farmers, processors and importers—especially small businesses—implement the new standards. Approximately 300,000 entities could be subject to the final FSMA rules. FDA wants to make a substantial investment in providing such assistance and making training materials widely available. In addition to direct technical assistance, FDA would use a large portion of these resources to provide financial support to state agencies and public-private-academic collaborative entities, such as the Produce Safety Alliance and the Preventive Controls Alliance. FDA has also joined with the U.S. Department of Agriculture’s National Institute of Food and Agriculture (NIFA) in providing grants that will fund food safety training for small, sustainable and organic farm owners and food processors.

We cannot make FSMA a reality without our state partnerships. There are more than 3,000 state, local and tribal government agencies involved in food safety. To align state programs with FDA’s new facility inspection and compliance approach, the agency will provide states with funds for inspector training, information sharing capacity with FDA and other states, state laboratory coordination, and inspector certification programs. These preparations have already begun but they must be accelerated in 2016 if the states are to be prepared to conduct sound, consistent inspections when industry must comply with the new prevention standards starting in late 2016. In addition, to successfully implement the produce safety rule, FDA must build state partnerships and capacity in 2016 to provide education and technical assistance to growers.

About 50 percent of fresh fruits, 20 percent of fresh vegetables, and 80 percent of seafood consumed by Americans comes from other countries, so it is clearly essential to modernize how we ensure the safety of imported foods. The Foreign Supplier Verification Program (FSVP) mandated by FSMA, will require importers to implement supplier verification plans to help ensure food produced overseas meets U.S food safety standards. This shift presents an enormous challenge for both FDA and food importers, given that last year there were approximately 88,000 consignees receiving food shipments and, in 2013, 12 million entries for FDA to oversee. FSVP will require a substantial regulatory development process, increased staffing and the training of more than 400 investigative and compliance personnel within FDA to enforce the regulation. It will also require extensive training and technical assistance for importers.

Those are just the highlights; there’s much more to be done. The bottom line is that without investment now, and sustained funding afterwards, there is the risk that the implementation of FSMA will be uneven or even delayed. This would be bad for everyone, including those who must meet the new standards and those who must enforce them. Most importantly, it would be bad for consumers, who want to be sure that the foods they are eating and serving their families are safe.

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

Australia, Brazil, Canada, Japan, and the US: Safeguarding Medical Devices

By: Kim Trautman, M.S.

The FDA and its regulatory counterparts abroad have the weighty responsibility of ensuring the safety of the thousands of regulated medical devices imported in their countries each year. To make this task more manageable, FDA and regulatory agencies in Australia, Brazil, Canada, and Japan embarked in 2014 on a pilot called the Medical Device Single Audit Program (MDSAP). Its goal is to develop a process that allows a single audit, or inspection to ensure the medical device regulatory requirements for all five countries are satisfied, in an efficient yet thorough manner.

Kim TrautmanOn January 1, 2015 the MDSAP pilot reached a major milestone – manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. were invited to participate in the program. This summer, when Japan enters the MDSAP as a full member, the same invitation will be issued also to medical device manufacturers interested in marketing in Japan.

Under this pilot, audits will be conducted by recognized third-party organizations, and medical device regulators in the participating countries will be able to use these inspection reports when making their regulatory decisions. Not only does this program reduce the participating regulators’ need to individually perform routine inspections; it allows them all to have the same reliable information about inspectional findings.

Manufacturers, too, can benefit from the MDSAP pilot by cutting down on the number of regulatory audits they have to host, thereby minimizing manufacturing plant and personnel disruptions. This form of international and standardized oversight lessens the burden on manufacturers by bringing more consistency and transparency to the regulatory process.

The MDSAP pilot does not increase regulatory requirements for medical device manufacturers – the audits cover only existing requirements of the regulatory authorities participating. In many cases, these requirements are already harmonized or very similar to one another, such as the international standard for medical devices quality management systems (ISO 13485:2003), the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the U.S. Quality System Regulation (21 CFR Part 820), and other specific pre- and post-market regulatory requirements of the authorities participating in the MDSAP pilot.

The FDA will accept MDSAP audits as a substitute for routine FDA inspections, typically done every two years for all classes of medical devices and including in vitro diagnostic devices. Pre-approval inspections for devices requiring premarket approval applications (PMAs) and “for cause” compliance inspections will not be part of the MDSAP pilot.

Manufacturers that choose to participate in the pilot program will help to shape the policies and procedures of the fully operational MDSAP, which is scheduled to begin in 2017. We expect that the MDSAP pilot will enhance confidence in third party audit programs, increasing the footprint of this global endeavor.

The FDA is pleased to be part of this MDSAP pilot. International cooperation promotes global alignment of regulatory approaches and technical requirements, expanding the safety net that protects patients world-wide.

New information about how countries will participate in the MDSAP pilot is available on the FDA’s MDSAP pilot web page.  Manufacturers can find additional information on the MDSAP web pageThis MDSAP page provides information on the auditing organizations involved in the pilot for interested manufacturers to contact directly.

Kim Trautman is Associate Director of International Affairs at the FDA’s Center for Devices and Radiological Health

Food Safety Together

By: Mary Lou Valdez and Julie Moss Ph.D., R.D.

In early December, we represented the FDA in Cape Town, South Africa, at the third annual conference of the Global Food Safety Partnership (GFSP). FDA has been a strong supporter of the GFSP since 2012, when it was launched by the World Bank and Commissioner Margaret A. Hamburg, M.D., gave the keynote address at the first conference. FDA provides the Partnership with financial support and technical expertise.

Julie Moss (left) and Mary Lou Valdez (right)

Julie Moss (left) and Mary Lou Valdez (right)

The World Bank is uniquely positioned to facilitate the GFSP and create a “big tent” where all parties in the global supply chain can work together to help ensure that all food products are safe for consumers. While government agencies like FDA develop standards and regulations, and provide regulatory oversight, it is the food industry, not the government, which produces safe food for consumers. To be successful in improving global food safety, we need to create partnerships across nations and sectors. The unique role of GFSP is to enable and catalyze a clear strategic direction to strengthen food safety systems and supply chains globally in ways that can only be achieved or enhanced collectively.  The GFSP brings together government, industry, academic, consumer and international organizations, providing a unique and valuable opportunity for all of these parties to cooperate in new and creative ways to improve food safety. This requires coordination to focus our efforts and avoid duplicating each other’s work.

Attendees at the 2014 Food Safety Global Conference.

Attendees at the 2014 Food Safety Global Conference.

During the conference, we acknowledged progress on many ongoing food safety activities (e.g., needs assessment progress in Zambia and Good Aquaculture Practices training in Malaysia, among others) and we moved forward in building a framework for a long-term strategy to collectively support and sustain investment in food safety systems. Yet, there is still much work ahead for 2015, which will be a critical year for the GFSP, as we will further refine our strategy and look forward to making great strides in key GFSP initiatives, including work to strengthen food safety systems in China and Zambia. Success in protecting the safety of the world’s food requires a new paradigm with new partnerships across nations and sectors. Moving forward, we intend to work to expand and promote this valuable partnership in the coming year to continue to strengthen the global food safety net for all consumers.

At FDA, we recognize that today’s food supply chain is global, complex, and interconnected. Because the U.S. imports half of its fresh fruits and 80 percent of its seafood, our efforts to protect the U.S. food supply must be global, and we must build strong partnerships to create a world-wide product safety net to protect public health. GFSP is an example of our ongoing efforts to build partnerships as we aim to prevent unsafe products from entering the market, no matter where the products come from or where they are consumed.

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

Julie Moss, Ph.D., R.D., is Deputy Director, International Affairs Staff in FDA’s Center for Food Safety and Applied Nutrition

Together: A Food Safe America

By: Michael R. Taylor

I recently had the pleasure of speaking at the Consumer Food Safety Education Conference convened by the Partnership for Food Safety Education (PFSE). The conference brought together food safety educators from across the country – people in state and local health departments, universities, extension services, and food businesses who are working every day on the front line, with consumers, to reduce food safety risks by improving consumer food handling practices.

Michael Taylor

Michael Taylor

The theme of the conference was “Together: A Food Safe America” – a theme that captures so well the sense of community, high purpose and energy that were present so abundantly at the conference. I shared the podium with two good friends and colleagues representing key FDA partners on food safety – USDA’s Acting Under Secretary for Food Safety Brian Ronholm, and Joe Corby, the Executive Director of the Association of Food and Drug Officials, which represents state and local food safety officials.

We regulators have a responsibility, through our oversight of the food industry, to do everything we reasonably can to make sure that the foods consumers bring into their homes are as safe as they can be. We are doing this by building into our food safety standards and compliance programs modern concepts and techniques for preventing the contamination that can make people sick.

Under the FDA Food Safety Modernization Act (FSMA), we at FDA have a new mandate to build a farm-to-table system of prevention, encompassing work that must be done to make food safe at four major stages of the commercial food system. These pillars of prevention include:

  • Production of produce on the farm,
  • Practices in food processing and storage facilities,
  • Transportation of food, and
  • Practices in grocery stores and restaurants.

But there’s a fifth pillar of prevention, and that’s the consumer. We all know that, even with the best of efforts by commercial food producers and handlers, consumers still must play a crucial role in preventing the introduction and spread of contamination – by keeping their hands and food surfaces clean, by keeping raw meat and produce separate, and by being sure to cook food to proper temperatures and chill food through prompt refrigeration.

It seems like common sense – and the basic ideas are – but food safety educators know that it’s far from simple to provide consumers the information, tools, and motivation they need to turn common sense into sustained behavior change. But they are out there, every day, doing the hard work.

We in government and the food industry need to better support our food safety educators.  FDA, USDA, and the Centers for Disease Control and Prevention (CDC) do some good work on food safety education. For example, at FDA, our current programs include targeting groups and individuals who are especially vulnerable to foodborne illness and partnering with the National Science Teachers Association to incorporate food safety into the science curriculum at the middle and high school levels. But there is more we can do to support food safety educators at the front line, in their daily work with consumers in clinics, in schools and in communities – where most of the food safety education, and all of the behavior change, takes place.

At FDA, we will be building food safety education into our risk-based priority setting paradigm, which means documenting better the contribution that education makes to reducing risk, evaluating what works to sustainably improve consumer practices, and targeting resources where they will make a real difference. Federal food safety agencies – and their finite resources – are overwhelmingly focused on the congressional mandate to prevent hazards arising from the commercial supply chain, which makes sense: that’s what we regulate. But, backed up by the right analysis, we can effectively target and increase our investment in consumer education in ways that will make a real difference for public health.

But the federal government can only do so much. And that’s where PFSE comes in. The Partnership brings together government, industry and consumer leaders to pool their expertise, share their perspectives, and collaborate on the hard work of food safety education. I applaud and thank the consumer groups, food companies, and trade and professional associations that are contributing their time, creative energy and resources to the work of the Partnership. And I salute the PFSE’s Executive Director Shelley Feist for her leadership and her sustained commitment to food safety and consumer education.

Working hard, and working together, we can have a Food Safe America.

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

Progress on FSMA: Getting Down to Implementation

By: Michael R. Taylor

This is the second of two FDA Voice blogs about state listening sessions on updates to four of the rules proposed to implement the FDA Food Safety Modernization Act (FSMA).

It appears to me that people all over the country are rolling up their sleeves and preparing to make FSMA a reality.

Michael Taylor

Michael Taylor

My team and I have just returned from visits to Georgia, North Carolina and Florida, states that are top producers of the fruits and vegetables that the world enjoys. We were there for listening sessions on the updates, or supplements, that FDA published in September to four proposed FSMA rules overseeing human and animal foods, both domestic and imported. Earlier in the month we visited California and Vermont for similar meetings.

When we visited states last year to discuss the FSMA rules that FDA originally proposed, beginning in January 2013, there were strong feelings that some aspects of our original proposals, such as the water quality standard, would be overly costly and not adequately adaptable to the range of production practices and conditions across the country. Farmers, manufacturers and importers want their foods to be safe, but they want rules that are as targeted as possible to risk and are practical to implement. We listened to their concerns, and we reviewed a wide range of written comments. They all formed the basis for the supplemental proposals that we issued in September, which have been well received.

During these most recent state visits, all of which were hosted by the heads of state agriculture departments, we heard continued support for FSMA and the need to implement it well, with mostly clarifying questions about the content of the rules. In fact, most of the discussion revolved around what has to be done once the rules take effect. We’re getting down to the nitty gritty of implementation.

Our day in Georgia began with breakfast with Commissioner of Agriculture Gary Black and Natalie Adan, director of the agriculture department’s Food Safety Division. The conversation centered on the importance of our partnerships with the states. FDA will be relying heavily on its state counterparts to provide training, technical assistance and compliance oversight.

There was also an appreciation, and a strong sense of priority, expressed by Commissioner Black and all of the state agriculture leaders, that the proposed FSMA rules will hold imported foods to the same standards as those produced in this country. That levels the playing field in the eyes of U.S. food producers, and it is also essential for food safety.

In all three Southern States, as well as in Vermont and California, there was some confusion about some of the specific terms of the proposed rules, especially the water quality and testing requirements. We are committed to providing clear guidance so that expectations are understood, as well as education, technical assistance and practical tools to facilitate compliance.

In North Carolina, we received a warm welcome from Agriculture Commissioner Steve Troxler who, as an elected official, has made food safety a campaign issue and a priority for his leadership and his department. In the listening session, Debbie Hamrick of the North Carolina Farm Bureau was very interested in how we will train our workforce to go out onto the farms, and how farmers will know how to meet the requirements. She offered to rent a bus and fill it with FDA officials and farmers to tour the area. Our reply: You’re on. She wants to work with us and we want to work with her.

We were also asked how we’re going to pay for all this and that brought up the critical issue of funding, which is a concern. It is urgent that FDA receive adequate funding for the training, technical assistance, state partnerships and import oversight that is essential for sound implementation of the FSMA rules beginning in late 2016 and 2017.

Florida was the final leg of this journey, which was fitting given Florida’s history of commitment to agriculture and food. Adam Putnam, the commissioner of agriculture, is a former U.S. congressman who had a leadership role in getting FSMA enacted. And Florida has been a pioneer in food safety, enacting seven years ago mandatory on-farm safety standards for the growing of tomatoes.

The listening session took place at the Gulf Coast Research and Education Center at the University of Florida’s Institute of Food and Agricultural Sciences. Driving there, we left the interstate highway to find ourselves suddenly in the midst of tomato fields, citrus groves and grazing cattle. We may think of Disney and spring training when we think of Florida, but agriculture is woven into the fabric of the state.

It was great to see Martha Rhodes Roberts, a long-time food safety leader in Florida, who moderated our listening session. As in Georgia and North Carolina, the Florida audience was a diverse mix of growers and people involved in various aspects of the food industry. The people we met in all three states appreciated both the changes we proposed in the supplemental rules and the continuing dialogue we are having on their implementation. They are ready now to get the job done.

I’d like to close with a reminder that the deadline for commenting on the four proposed supplemental rules for Produce Safety, Preventive Controls for Human Food, Preventive Controls for Animal Food and Foreign Supplier Verification Programs is Dec. 15. Visit our FSMA page on fda.gov for more information.

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

For an AIDS-Free Generation: Access to Drugs and Diagnostics Is Essential

By: FDA Commissioner Margaret A. Hamburg, M.D. and HHS Assistant Secretary Jimmy Kolker

Margaret Hamburg, M.D.On World AIDS Day this year, tens of millions of people with HIV are now living healthy, productive lives because of access to safe and lower priced medicines. We rejoice in this achievement, because all people, no matter how rich or poor, deserve to have the medicines they need to live their lives in the best health possible.

We can truly see in our future an AIDS-Free generation because of the wide availability of prevention and treatment tools. But the availability of these drugs and diagnostic tools, especially in Africa, was never a given. Ten years ago, in 2004, the U.S. Food and Drug Administration (FDA) committed to support the President’s Emergency Plan for AIDS Relief (PEPFAR) by introducing an expedited review process to make generic and low-cost treatment more readily available for the most affected countries. PEPFAR requires antiretroviral drugs to be safe, effective, and of high quality and supports their distribution to people needing treatment around the globe. But meeting these requirements can be costly and time-consuming. Those suffering from AIDS cannot wait. The FDA, an agency that is part of the Department of Health and Human Services (HHS), applied the tentative approval process in order to increase dramatically the number of products approved for purchase and distribution by PEPFAR.

Thanks to the commitment of FDA scientists, as of today FDA has issued expedited approval decisions for 179 products, including 39 formulations specifically designed for children that allow flexible dosing across multiple weight bands and many innovative formulations, such as fixed-dose combinations and co-packaged products that improve adherence to treatment and reduce the risk of developing resistance. The 179 tentative approvals allowed PEPFAR to purchase products at a lower cost, leading to cost savings of hundreds of millions of dollars. These savings contributed to additional patients being able to receive treatment.

Jimmy KolkerAccording to UNAIDS, by June 2014, 13.6 million people around the world had access to antiretroviral therapy. This is an important success, but many more people still need access.

Unfortunately, too many countries lack the regulatory capacity to conduct product registrations in a timely manner. This makes it difficult for these countries to provide high-quality rapid HIV tests and treatment.

The FDA and the HHS have been working with the Department of State Office of the Global AIDS Coordinator (S/GAC); the World Health Organization; the Global Fund to Fight AIDS, Tuberculosis, and Malaria; and other organizations to help countries build both their health care systems and regulatory capacities.

Importantly, FDA has partnered with host country health ministries to help strengthen regulatory capacities in support of their public health programs. PEPFAR recently contributed $1.5 million in support of this FDA partnership to further regulatory system strengthening in the East African community.

With these improvements, countries battling HIV and AIDS can build the systems necessary to ensure that patients get the high-quality treatment they need, which one day will lead to the realization of an AIDS-free generation.

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

Jimmy Kolker is Assistant Secretary for Global Affairs in the U.S. Department of Health and Human Services