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

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

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

Helping patients and health care professionals better understand the risks and benefits of medications for pregnant and breastfeeding women

By: RADM (Ret.) Sandra L. Kweder, M.D., F.A.C.P.

Good news for moms and expecting moms across the country. We have a new way of helping health care professionals and patients better understand the effects of medicines used during breastfeeding and pregnancy.

Sandra KwederToday, after years of careful consideration — and listening to public feedback — FDA has published a final rule that sets standards for providing a consistent way for drug manufacturers to provide information about the risks and benefits of prescription drug and biological products used during pregnancy and lactation (the medical term for producing milk). It also includes requirements for ways of communicating relevant information for women and men of reproductive potential.

The new rule eliminates an old and possibly confusing way of communicating risk during pregnancy and breastfeeding, which used letter categories of A, B, C, D, and X, to classify various types of risks. It may look simple, but this system was anything but. As a result, the letter categories that have been a familiar presence in drug labeling since the 1970s were often misinterpreted as a sort of grading system of risks, which gave an overly simplified view of product risks.

Our new method provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus, the breastfeeding child, and women and men of reproductive age.

Here’s a quick overview: Prescribing information for health care professionals provided by manufacturers will now contain required subheadings within the Pregnancy and Lactation subsections: risk summary, clinical considerations, and data. These subsections will provide more detailed information regarding, for example, human and animal data on the use of the drug, specific adverse reactions and information about dose adjustments needed during the pregnancy and post-partum (after giving birth) periods. It will apply not just to new drugs approved from now on, but also to older drugs approved since 2001 that have been marketed for years without their labeling being updated to incorporate important new information related to pregnancy and lactation.

Also today, FDA is issuing what we call a “draft guidance” for industry, to assist drug manufacturers in including information about pregnancy and lactation in their prescribing information according to the requirements of the new rule. We’ll finalize that draft guidance after receiving and incorporating input from the public. To provide comments on this draft guidance, visit this link.

There are more than 6 million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy, so we’re excited about this rule, which will provide an extra layer of safety and informed decision making for patients and health care professionals.

Protecting pregnant women and children of breastfeeding mothers from adverse reactions from medications and informing patients and health care providers about their benefits is an ongoing effort we must constantly update and advance. This new rule is one of many steps along the way — and we believe it will help make a strong and positive difference in safeguarding the American public.

Sandra L. Kweder, M.D., is the Deputy Director of the Office of New Drugs at FDA’s Center for Drug Evaluation and Research

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

FDA Approves a Vaccine to Address a Critical Public Health Need – Trumenba– for Prevention of Serogroup B Meningococcal Disease

By: Karen Midthun, M.D.

Over the last year and a half, there have been numerous reports about outbreaks of bacterial meningitis on several college campuses. Invasive meningococcal disease is a life-threatening illness caused by the bacterium Neisseria meningitidis that infects the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). N. meningitidis is a leading cause of bacterial meningitis, which can have devastating consequences. Between 10 and 15 percent of people who develop meningococcal disease die from the infection, and another 10 to 20 percent suffer permanent complications, such as brain damage or limb loss.

Dr. Karen MidthunThere are five main serogroups of meningococcal bacteria that cause illness: A, B, C, Y and W. FDA has previously approved other vaccines to prevent invasive disease caused by serogroups A, C, Y and W, but they do not protect against meningococcal disease caused by serogroup B, which is the serogroup responsible for the recent outbreaks.  These outbreaks underscore why it’s so important to have vaccines that can prevent meningococcal disease.

FDA recently used several strategies to approve Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by serogroup B. This included use of the accelerated approval regulatory pathway, which allows the agency to approve products that provide meaningful therapeutic benefit to patients over existing treatments for serious or life-threatening diseases, based on evidence that the product has an effect that is reasonably likely to predict clinical benefit. The use of this pathway reduces the time it takes for needed medical products to become available to patients.

Trumenba also received breakthrough therapy designation. This designation facilitated the development, scientific evaluation, and approval of the vaccine. In particular, it provided the manufacturer with more intensive FDA guidance on an efficient vaccine development program, and an organizational commitment involving senior FDA managers. It also provided for a “rolling” submission of the Biologics License Application, which allows for sections of the application to be submitted to FDA for review as they are completed, without waiting to submit the complete application at one time.

FDA also designated this application to receive priority review. I am very proud of the extraordinary effort by FDA review staff to thoroughly evaluate the safety and effectiveness of Trumenba and approve it in record time. Our scientific staff worked tirelessly to complete their evaluation in well under the usual six-months timeframe for priority reviews. My colleagues worked closely with Pfizer, the manufacturer, to address this critical public health need.

We are committed to making important medical products available to people who need them. The approval of Trumenba is just one example of the outstanding work by dedicated FDA staff.

Karen Midthun, M.D., is the Director of FDA’s Center for Biologics Evaluation and Research