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

FDA’s Janet Woodcock, M.D., recognized by the Institute for Safe Medication Practices: Receives Lifetime Achievement Award for her career in public service

By: Margaret A. Hamburg, M.D.

FDA’s mission is to protect and promote the health of the American public. The FDA employees who dedicate their careers to this worthy goal do so not for personal reward or public recognition but because of an extraordinary commitment to improving public healthcare. Which is why it is even more special when these employees receive public acclaim.

Margaret Hamburg, M.D.

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

One such individual is Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER). Janet recently was awarded the Institute for Safe Medication Practices (ISMP) Lifetime Achievement Award, recognizing “an individual who has had a significant career history of making ongoing contributions to patient safety and has had a major impact on safe medication practices.” This award is well deserved.

During her nearly 30 year career with FDA she has served in several different capacities in addition to her current position, including Director of the Office of Therapeutics Research and Review in the Center for Biologics Evaluation and Research (CBER) and as FDA’s deputy commissioner and chief medical officer. Throughout her career, Dr. Woodcock has helped the Agency elevate and transform its approach to medical product safety, personally leading the way on many key safety initiatives from their beginning to implementation.

During her distinguished career Dr. Woodcock:

  • Conceived and oversaw creation of the Adverse Event Reporting System (AERS) system, to manage the increasing number of spontaneous reports of adverse drug reactions submitted to FDA;
  • Co-led the FDA Task Force on Risk Management, one of the Agency’s first efforts to clearly delineate pre- and postmarket safety surveillance and management of medical product risks;
  • Chaired the Council on Pharmaceutical Quality, launched in 2007, presaging many of the Agency’s subsequent safety initiatives;
  • Led the launch of Safety First, a program created to help ensure alignment between premarket drug safety review and postmarket surveillance;
  • Led the creation of the Sentinel Initiative, a data-driven national system that allows active—close to “real time”—safety surveillance using electronic data from healthcare information holders;
Janet Woodcock

Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research

Through all of these accomplishments, and many others, Janet Woodcock has helped ensure that FDA can fulfill its mission effectively. She has championed the use of innovative new tools and approaches, and she has forged and enriched many partnerships with industry, academia, healthcare providers, patients and colleagues in government, including across the FDA.

Her work has helped lead FDA into a new century, an extraordinary time of transformation and opportunity in medical science. With these changes, FDA’s responsibilities have also grown enormously. We must continue to ensure that our capabilities for drug product evaluation, oversight, and regulation keep pace with these developments. Thanks to Janet’s vision and hard work, along with many of her colleagues at FDA, I am confident that FDA is up to the task.

I want to thank Dr. Woodcock for her years of dedicated service to the American public, and congratulate her on this most recent recognition of her many contributions.

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

2014 Drug Approvals: Speeding Novel Drugs to the Patients Who Need Them

By: Margaret A. Hamburg, M.D.

Preliminary data announced earlier today shows that 2014 is shaping up to be another strong year for novel drug approvals, which is certainly good news for many patients and their families.

Margaret Hamburg, M.D.With a few weeks left in December, our Center for Drug Evaluation and Research (CDER) has so far approved 35 novel new drugs in 2014 compared to 27 in 2013. These numbers include both new molecular entities (NMEs), submitted to CDER in New Drug Applications (NDAs) and new therapeutic biologics submitted to CDER in Biologics License Applications (BLAs).

But the numbers don’t tell the full story. What really matters is that many of these new products offer significant clinical value to the care of thousands of patients with serious and life-threatening diseases. That’s certainly the case for patients with rare diseases that affect 200,000 or fewer Americans. So far this year we’ve reached a milestone with a record 15 approvals for rare diseases. The previous high was 13 drugs in 2012. These results are all the more significant because patients with rare diseases often have few or no drugs available to treat their conditions.

And here’s another point of interest – to date, 15 of the approvals have been first in their class drugs, another indicator of their potentially strong clinical impact.

To ensure that 2014’s novel drugs get to patients as quickly as possible, CDER effectively employed a variety of regulatory tools including FDA’s expedited development and review programs – fast track, priority review, accelerated approval and our new breakthrough therapy designation. Early and repeated communications with sponsors have also been helpful in speeding these products to market.

Consider for example, Blincyto, approved just last week to treat Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia. CDER employed all of its expedited review programs to help get this drug to market as early as possible, five months ahead of its review goal date. The sponsor also benefited from incentives for drugs that treat rare diseases.

Another example is Harvoni, the first combination pill approved to treat chronic hepatitis C virus genotype 1 infection and the first approved regimen that does not require administration with interferon or ribavirin. With this and other recent approvals, we are helping to change the treatment paradigm for patients living with hepatitis C. Harvoni received breakthrough therapy designation and was assigned priority review.

One of the more challenging areas of drug development has been the rather barren field of antibacterial drugs. Among our 2014 approvals to date are three new antibacterial drugs – Dalvance, Sivextro and Orbactiv—to treat skin infections, specifically acute bacterial skin and skin structure infections (ABSSSI). These drug approvals represent a welcome but modest increase in activity in this product area. Prior to 2014, only five new systemic antibacterial drugs were approved during the period from 2004 – 2013.

I want to congratulate the management and review staff at CDER for these very impressive preliminary numbers. Thanks in large part to CDER’s hard work and dedication, 34 of the 35 drugs approved so far in 2014 were approved before or on their Prescription Drug User Fee Act (PDUFA) review goal date and 23 of the 35 drugs were available to patients in the United States before they were available to patients in Europe.

In this holiday season of joy and reflection, we have much to be grateful for in the work that CDER does every day on behalf of patients.

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

Implementing the Unique Device Identifier System into health care systems is critical for reaching its potential to benefit public health

By: Jeffrey Shuren, M.D., J.D.

As the FDA works with manufacturers to launch a new system of identifying medical devices using standard bar codes and numbers, we look forward to the day when the system, called the Unique Device Identifier (UDI) system, will be fully set up— with identifiers on device labels and a corresponding database of identifying information about most of the devices in the U.S. marketplace.

But why does that matter?

Jeffrey ShurenMuch like vehicle identification numbers (VINs) for automobiles, UDIs are intended to streamline the monitoring of devices, improve safety tracking and recall efficiency, and even make it easier to evaluate device performance over time. So while there’s little doubt that UDI can improve patient safety, modernize how we evaluate devices once they are in use, and facilitate future device innovation, these benefits will only become a reality when the UDI system is adopted and integrated into the health care system—when hospitals, doctors’ offices, patient registries, heath care insurance companies, and others incorporate UDI as part of their standard electronic health information systems.

Without the practical implementation on the clinical side, UDI will be codes and a database with limited utility to improve patient care or reach its other critical goals.

The FDA is thinking about this now—not later. While going full steam ahead to fulfill our responsibility for implementing UDI regulations for medical device manufacturers, we are doing everything we can to promote the widespread adoption of UDI in the U.S. health care system.

We commissioned the Brookings Institution to create a “roadmap” for provider systems, patients, payers, supply chain personnel, and many others, to adopt and utilize UDIs. This report, released on Friday, December 5, provides 17 recommendations for adopting UDIs across three major intersections of the health care system—providers (e.g., electronic health records, hospital inventory management, billing records); administrative transactions (e.g., claims data and payment information); and patient-directed tools (e.g., mobile apps and public awareness campaigns).

We’re working hard to create and populate an efficient and useful UDI system for medical devices. But even the perfect system will fail to improve patient care if it’s not properly integrated into electronic health information systems. That process has to start now.

Today, we are co-sponsoring with Pew Charitable Trusts and the Department of Health and Human Services Office of the National Coordinator (ONC) a meeting where some 400 experts are convening to discuss changes that are needed to store and share UDI information throughout the health care system, with the ultimate goal of improving patient care.

The goal is to have the UDI system not only up and running—but actually used as the key to unlock important data that can help patients.

But how does such a system really help patients and the providers who care for them? Consider a possible scenario where the connections made via UDI could make an important difference in patient care.

A patient undergoing knee surgery—we’ll call him John—has the UDI of his knee implant scanned and electronically recorded into his clinical record.

When John is discharged, he can also register the UDI into his personal health record (PHR), available from his provider, through a variety of mobile apps that can enable two-way communication with his provider.

Having the UDI recorded will help John to know if safety alerts apply to his specific implant. It will also help him accurately report any potential adverse event to the provider, the FDA, or the manufacturer, with the confidence that the UDI ensures that all parties know what the type of device may be causing John—and possibly other patients—problems. Importantly, if John hears about knee implants being recalled, he will be able to quickly pinpoint, by using his UDI, if his particular type of implant is involved in that recall. If it’s not, John may avoid needless anxiety; if it is, he can take any necessary action, such as following up with his orthopedic surgeon.

The UDI from John’s surgery is also available to be transmitted to a total joint replacement registry, without any of his personal information. Data from the registry may then be used to support the development of innovative implants and reduce the data requirements for — or replace altogether — postmarket studies conducted by the device manufacturer to demonstrate long-term performance.

The possibilities of UDI are exciting—better and more precise information can lead to better care and better awareness of how medical devices work in the general population. The FDA is working to set up the system, but implementation and integration are critical. The question is—if we build it, will people adopt it?

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

From Wariness to Welcome: Engaging New England on Food Safety

By: Michael R. Taylor

This is the first 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).

What a difference a year makes.

In August last year, my team and I visited New England to talk about the rules proposed in 2013 to implement FSMA. We were met with skepticism and some genuine fear that our produce safety proposals did not take full account of local growing practices and would both disrupt traditional practices and deter innovation. These weren’t easy conversations, but they proved instrumental in FDA’s decision to propose—on Sept. 29, 2014—updates, or supplements, to four of the proposed FSMA rules overseeing human and animal foods, both domestic and imported. These proposals include significant changes in the produce safety proposal and related elements of the preventive controls rules for food facilities.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.We weren’t quite sure what to expect when we flew to Vermont on Sunday, November 16, for a listening session the next day on the proposed supplemental rules. But the tenor of this visit was dramatically different, and very positive, beginning with the detour we took from our FSMA mission on Sunday to visit leading players in Vermont’s local food movement and artisanal cheese-making community.

Accompanied by Vermont Agriculture Secretary Chuck Ross, we first toured the Vermont Food Venture Center (VFVC) in Hardwick, a regional food hub that leases space to small food businesses, providing kitchen equipment, food storage and business consultations. The goal of this modern, well-equipped facility, as executive director Sarah Waring explained, is to strengthen Vermont’s local food network and agricultural economy.

We then toured Jasper Hill Farm in Greensboro, a renowned maker of artisanal cheeses.  We were welcomed by brothers Mateo and Andy Kehler, who have taken an innovative approach to making cheese, using both traditional methods and the latest technology. Their goal is to establish a network of local farms that supply the milk, with Jasper Hill aging and distributing the cheeses in an effort to support small dairy operations.

Our goal was to continue the dialogue we started this year with the cheese-making community to better understand, as food safety regulators, what goes into making artisanal cheeses. We learned a lot, tasted some great cheese, and left impressed by the community-oriented commitment at both VFVC and Jasper Hill Farm, and by their use of top-tier tools to strengthen Vermont’s local food system.

When we arrived back in Montpelier Sunday night, the setting was like something out of a postcard. This picturesque town, the nation’s smallest state capital, was dusted in the season’s first snow, which only accentuated its natural beauty and charm. We were happy to be there.

Monday morning we drove to the Vermont Law School in South Royalton for the FSMA listening session. This school, set in the rolling landscape of rural Vermont, is renowned for its commitment to sustainable environmental practices.

We saw familiar faces. Some had come to the meeting directly from their farm—through the snow. There were people from all over the Northeast—people who had participated in our series of listening sessions throughout New England in 2013. But this time, the response and dialogue were different. We heard acknowledgement and appreciation that we had addressed many of their concerns in our revised proposals by making the proposed rules more feasible, while still meeting our public health goals.

Much of the discussion focused on implementation of the rules, and, interestingly, some of the concerns echoed those we had heard in a November 6 listening session in Sacramento, CA, a place not only on the opposite side of the country but so different in its production systems. Many are finding the complexity of the proposed rules daunting, such as the technical underpinnings of the E.coli benchmark for water quality and the various boundary lines and exemptions that determine who is covered. We’ve always said that we wouldn’t take a “one size fits all” approach, which has contributed to making the rules more complicated. This only underscores our responsibility to explain the rules clearly and to provide education, technical assistance and guidance.

Secretary Chuck Ross said early and often that we need to educate before and as we regulate. And he’s right. I am struck anew by the importance of our partnerships with state leaders. Vermont’s Ross and California Secretary of Food and Agriculture Karen Ross have been invaluable in helping us develop these rules, as they will continue to be as we move towards implementation.

We were grateful for the participation in the listening session by food safety advocates Lauren Bush and Gabrielle Meunier, who each spoke of the devastating effects of foodborne illnesses. Lauren almost died after eating a salad contaminated by E.coli in 2006 and Gabrielle’s young son fought, and recovered from, a Salmonella infection in 2008 after eating tainted peanut butter crackers. Their stories underscore the underlying reason for the effort that so many are making to implement FSMA—to keep people safe.

Some participants expressed the view that even though we decided to defer, pending further study, our decision on an appropriate interval between the application of raw manure and harvest, some kind of interval is needed to protect crops from pathogens. Some suggested that the 90 to 120-day intervals set forth by the U.S. Department of Agriculture’s National Organic Program be adopted as an interim measure.

Others inquired how the FSMA rules would affect them based on very individual scenarios. We asked them, and we’re asking everyone, to comment on the supplemental rules and include those scenarios for us to consider in drafting the final rules. We don’t want to create unintended harmful consequences.

The deadline for commenting on the four 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.

Our Vermont trip was followed by state listening sessions in Georgia, North Carolina and Florida. I will be filing another FDA Voice blog on what we learned in those Southern states.

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

Reflecting on our steps to give Americans more informed food choices

By: Michael R. Taylor

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.Yesterday we released final rules to make it easier for Americans to make informed choices about the foods they buy at major chain restaurants and similar retail food establishments and from vending machines. Every day, for years to come, millions of consumers will see and benefit from ready access to calorie information they would otherwise lack.

In evaluating public health issues, FDA must often make difficult decisions and strike delicate balances. For an issue like menu labeling that touches so many people and must address the complexities of our modern food system, it is natural that there would be a wide range of views. So we appreciate the very positive reactions to our rules from the restaurant industry, the vending industry, consumer groups and public health experts, including the following:

We also know that, while our FDA team worked long and hard on these final rules, crafting them after carefully reviewing more than 1,000 comments on our original proposals, our work is not done. We will continue to work with all affected industries to answer questions about the rules and facilitate compliance in a practical way that can benefit the health of Americans for many years to come.

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

Providing Consumers More Information with Menu and Vending Labeling

By: Margaret A. Hamburg, M.D.

Increasingly, Americans are paying more attention to the foods we eat – the kinds, the quantities, the sources, and the individual ingredients that go into our meals. We know that when we have more information about the nutritional content of our food, we have the opportunity to make more informed choices.

Margaret Hamburg, M.D.Increased awareness about the choices we make certainly does not mean that we always eat what is healthy. But whether we choose to eat french fries or a tuna sandwich, those selections should reflect informed decision-making. That can only happen if the right information is available to make those choices. That’s why the two new rules FDA issued today on menu and vending machine labeling are so valuable for consumers.

Some states, localities and big restaurant chains are already doing their own forms of menu labeling. The new rules will require calorie information to be listed in a consistent, direct and accessible manner on menus in chain restaurants and similar retail food establishments, and on vending machines. Under the menu labeling rule, certain additional nutrition information will need to be available in writing when customers ask for it.

This is especially important, because about one third of the calories Americans eat and drink come from foods and beverages consumed away from home. In addition, research shows that when we eat out we often consume less nutritious foods and underestimate the number of calories we are taking in.

People can clearly benefit by knowing more, and the new FDA rules will help to do just that. They are not requirements about what people should eat or what restaurants should serve, but rather they will place more information in the customer’s hands so that they can make more informed choices for themselves and their families.

After considering more than 1,100 comments on the proposed versions of these rules, the rules create a consistent approach that will establish a level playing field for larger chain restaurants, while not being overly burdensome on small businesses or individual food establishments. The menu labeling rule applies to restaurants and similar retail food establishments only if they are part of a chain of 20 or more locations and satisfy other criteria.

Few decisions are as critical to our health and our daily lives as those involving the foods we eat. With these new rules on menu and vending machine labeling, Americans can be more certain that those choices are informed ones.

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

China Journal: strengthening relationships to protect public health

By: Margaret A. Hamburg, M.D.

I am just about to wrap up a jam-packed five-day visit to China, a fascinating country with a dramatically growing economy and with an increasingly significant impact on the products that Americans consume. Indeed, a key reason for my trip is the important and growing collaboration between FDA and our counterpart agencies in China to ensure the safety of the large volume of foods and medical products exchanged between our two nations.

Margaret Hamburg, M.D.Of the 200 countries that export their products to the United States, China ranks first in exports (in dollar value) to our nation. It is the sixth largest provider of food and the sixth largest provider of drugs and biologics. Only the United States has more FDA-registered drug establishments than China. And these numbers are growing. Between 2007 and 2013, China’s annual exports of FDA-regulated products to the U.S. nearly quadrupled, reaching 5.2 million “lines” (portions of a shipment) of imported goods in 2013.

Ensuring the safety and quality of these and other U.S.-destined FDA-regulated goods is a major challenge. To meet it, FDA has transformed itself— from a domestic agency that focused primarily on products manufactured in the U.S. to a truly global agency grappling with the many challenges of globalization.

Among the many efforts in this area, an important component is the FDA’s establishment of permanent outposts staffed by FDA experts in all major exporting regions, including in China. We have 13 FDA staff members currently stationed in the country, primarily in Beijing. Their job is to help ensure that the food and medical products being exported from China meet our standards. FDA’s China Office does this by providing significant support for the Agency’s inspections in China, by strengthening our relationships with Chinese regulators, by working with industry and other stakeholders, by providing important information and technical assistance to all interested parties, and by analyzing trends and events that might affect the safety of FDA-regulated products exported from China to the United States.

Given the volume of U.S. trade with China, we are working to more than triple the number of American staff we place in China. Placing more FDA experts in China will allow FDA to increase significantly the number of inspections it performs in this dynamic, strategic country, as well as to be more effective partners with our colleagues here in China. Such dramatic staffing increases will also allow FDA to enhance its training efforts and technical collaboration with Chinese regulators, industry and others.

This week, we took an important step forward in strengthening our relationship with China when we signed an Implementing Arrangement with the China Food and Drug Administration (CFDA). We expect to sign a similar Implementing Arrangement with the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) in the coming weeks. These documents, which build on 2007 agreements with the same two agencies, help to frame the work our inspectors will do in China and create mechanisms for collaboration on inspections.

FDA is also engaging with other stakeholders to create sustainable models for training future champions of regulatory science and quality. Here in China, we helped to create a world-class graduate degree program in international pharmaceutical engineering management (IPEM) at Peking University (PKU), an institution renowned for educating Chinese leaders and thinkers.

This partnership with PKU began in 2005 with just two courses on current good manufacturing practices. These proved hugely successful, and drew attention from Chinese drug companies and regulatory agencies, as well as industry and regulators in neighboring countries. The following year, PKU established a master’s degree program in IPEM, with support from FDA and multinational pharmaceutical companies. The program was formally launched in March 2007, with courses in regulatory science, pharmaceutical science, engineering, and more.

One of the highlights of my trip this week was speaking to more than 200 PKU students, future leaders who will help to accelerate the modernization of this nation’s pharmaceutical industry. I discussed not only FDA’s growing regulatory cooperation with China but the importance of strengthening regulatory science in China to ensure that the highest standards are used to support the development, review, and approval of new medical products, as well as the manufacturing and safety monitoring of medical products. All of this can make an enormous difference in the lives of patients in China, the U.S. and beyond.

Also this week, I met with top Chinese regulatory officials, toured CFDA’s mobile laboratories that test for counterfeit drugs and contaminants in food, and attended the 9th International Summit of Heads of Medicines Regulatory Authorities in Beijing.

Throughout the week, we addressed tough problems that require global solutions. Our discussions ranged from how best to advance biomedical product innovation, expand access to important pharmaceuticals through generic and biosimilar regulatory pathways, and how coordinated action, along with using new, state-of-the art technologies and analytical methods, will more effectively protect the public from substandard or counterfeit products. We are also making tangible progress in strengthening FDA’s partnership with our Chinese counterparts to better oversee the increasingly complex international supply chain and to prevent problems before they occur.

As I prepare for the journey home, I am encouraged by what we accomplished. And all of this bodes well for our ability to promote and protect protect public health in the future.

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

View Photos from China:

Commissioner Margaret A. Hamburg, M.D., tours an FDA China Office mobile lab that tests for counterfeit OTC drugs and contaminants in food

Commissioner Margaret A. Hamburg, M.D., meets with Chinese pharmaceutical executives

Commissioner Margaret A. Hamburg, M.D., with students of Peking University

 

Additional progress on reducing the abuse of opioid pain relievers

By: Janet Woodcock, M.D.

FDA’s approval today of the extended-release opioid pain medicine Hysingla ER (hydrocodone bitartrate) marks additional progress in the fight against the ongoing misuse and abuse of prescription opioids. Hysingla ER’s approval provides prescribers with another option for managing pain severe enough to require daily, around-the-clock, long term opioid treatment in patients for whom alternative treatment options are inadequate, while potentially reducing hydrocodone abuse.

Janet WoodcockIn pre-approval testing, Hysingla ER exhibited properties that we expect will reduce the likelihood users could abuse the drug by chewing the tablet and ingesting it orally, or crushing it into powder for snorting or injecting. This is important because immediate-release combination products containing hydrocodone are among the most frequently abused opioid products. Hysingla ER is the fourth prescription opioid approved with product labeling that is consistent with the FDA’s 2013 guidance on abuse-deterrent opioids. The drug’s abuse-deterrent properties are expected to reduce – but not totally prevent – abuse by these routes.

While Hysingla ER has the same active ingredient (hydrocodone) as Zohydro ER, the only other approved extended-release hydrocodone product, there are important differences between the two. Hysingla ER has approved abuse-deterrent labeling, while Zohydro ER does not. Also, Zohydro ER is taken every 12 hours, and so comes in lower dosage strengths than Hysingla ER, which is taken every 24 hours. FDA has not yet determined whether Hysingla ER will prove to be safer than Zohydro ER.

It’s important to address some potential misperceptions about these extended-release hydrocodone products.

First, it would be misleading to suggest these products are stronger than other opioids on the market. Both Zohydro ER and Hysingla ER contain larger amounts of hydrocodone compared to immediate-release hydrocodone combination products because they need to be taken much less frequently. The range of tablet strengths for Hysingla ER is comparable to the strengths of existing approved extended-release opioids. The highest tablet strength of Hysingla ER, 120 mg, is comparable in potency to the currently marketed highest tablet and capsule strengths of extended-release morphine and hydromorphone products which, like Hysingla ER, are taken once daily.

Second, we do not expect these drugs to increase the number of patients treated with opioids. FDA is monitoring the use of all opioid products carefully and has been monitoring Zohydro ER prescribing since it was approved. In July 2014, Zohydro ER’s sixth month of marketing, there were 3,588 outpatient retail prescriptions dispensed. This represents 0.23% of the 1.6 million extended release, long acting (ER/LA) opioid analgesic prescriptions and only 0.02% of the nearly 18 million prescriptions dispensed for all opioid analgesics during the same month.

As with all extended release opioid medicines, FDA will carefully monitor and assess the use of Hysingla ER over time, and we are requiring the manufacturer to conduct studies to measure the effects of the abuse-deterrent features on abuse in the community.

Third, FDA has heard concerns about whether there is a need for additional prescription opioids. Given what we know about the needs of doctors and patients for additional choices of medicines, we believe having an additional choice of pain medicine like Hysingla ER, the first once daily hydrocodone product, is beneficial overall when treating patients in pain.

This latest approval also marks an important reminder of the limitations of today’s abuse-deterrent formulations. The reality is that opioids with abuse-deterrent properties can still be abused. Currently available abuse-deterrent technologies are important and offer a step in the right direction, but the science in this area is still evolving.

Prescription opioids with abuse-deterrent properties will not completely fix the prescription opioid abuse problem, but they can be part of a comprehensive approach to combat the epidemic. And the development of abuse-deterrent opioids is only one of many elements of FDA’s overall approach, which includes provider and patient education, close monitoring of approved opioids, and review and approval of drugs to treat addiction and prevent overdose. We will continue to work hard to address the serious problem of opioid abuse while providing needed pain medicines for patients.

Janet Woodcock, M.D., is Director of FDA’s Center for Drug Evaluation and Research