Combination Products Review Program: Progress and Potential

By: Nina L. Hunter, Ph.D., and Robert M. Califf, M.D.

Nina Hunter

Nina L. Hunter, Ph.D., FDA’s Associate Director for Science Policy in the Office of Medical Products and Tobacco

About a year ago, we shared with you our Combination Product Review, Intercenter Consult Process Study Report, which was developed by FDA’s Office of Planning. The report’s findings were derived from focus group studies with reviewers from FDA’s different Centers and included input from industry. Since then, we have built on foundational policies and processes to address many of the issues identified in the report.

The team has made tremendous progress toward the goal of modernizing the combination products review program by improving coordination, ensuring consistency, enhancing clarity, and providing transparency within the Agency as well as with all stakeholders. We are excited to share our progress with you now. The table below summarizes some key achievements from the past year, including publication of draft guidances, a variety of new processes, and a look at future goals.

Robert Califf

Robert Califf, M.D., is Commissioner of the U.S. Food and Drug Administration

As technologies advance across multiple fields, the distinctions that previously allowed combination products to be neatly categorized by FDA’s medical product centers are blurring or even vanishing.

Combination products account for a growing proportion of products submitted for review, and FDA will continue to pursue new approaches to collaboration that ensure safe, effective and innovative medical products are made available to patients as quickly as possible. Continued collaboration with you, our stakeholders, will be critical as together we continue to make progress in this important area.

We are still listening and have much more work to do!

Combination Products Review Table

This table summarizes key Combination Product Review Program achievements from the past year. Click on table for PDF version.

The PDF version of the table is also located here: combination-products-review-program

Nina L. Hunter, Ph.D., is FDA’s Associate Director for Science Policy in the Office of Medical Products and Tobacco

Robert M. Califf, M.D., is Commissioner of U.S. Food and Drug Administration

Trade Alert: FDA Issues New Import Data Requirements

By: Howard Sklamberg, J.D.

One of FDA’s many responsibilities is to review imported products regulated by the agency to determine admissibility. This job has become increasingly challenging with growing volumes of imports of FDA-regulated products each year — from six million import entries in 2002 to 35 million in 2015.

Howard SklambergTo help meet that challenge in a way that benefits both government and the trade community, import entries of products regulated by FDA are submitted through an electronic system called the Automated Commercial Environment (ACE). A final rule published on November 29 in the Federal Register specifies certain data that must be submitted in ACE when an FDA-regulated product is offered for import into the United States. The effective date of the rule is December 29, 2016, 30 days from the date of publication.

The trade community helped us pilot ACE, which is operated by U.S. Customs and Border Protection (CBP), from August 2015 to May 2016. In July 2016, ACE became the sole CBP-authorized system for electronic submissions of entries that contain FDA-regulated products.

The rule also includes technical revisions to certain sections of FDA regulations:

  • The owner or consignee of an FDA-regulated product is now defined as the importer of record. This brings FDA regulations up to date with previous revisions to customs laws. (21 CFR 1.83 and 21 CFR 1005.2)
  • FDA will now directly provide a notice that an FDA-regulated product is to be sampled, rather than having to go through CBP to provide that notice. (21 CFR 1.90)
  • FDA may now provide written notices electronically to the importer of record about FDA actions to refuse FDA-regulated products and/or subject certain drug products to administrative destruction. (21 CFR 1.94)
  • The rule clarifies that FDA can reject an entry for failure to provide through ACE the complete and accurate information required by the rule.

As a result of the more streamlined import process for FDA-regulated products provided by ACE, the rule is expected to lead to an efficient use of FDA and importer resources, and more effective enforcement of laws and regulations enforced by FDA.

FDA will continue to provide assistance to filers working to properly submit the required data. Some of the measures we have instituted:

  • We are offering telephone meetings with importers, customs brokers, and other stakeholders, in real-time, while they are filing entries in ACE. Request a meeting by emailing ACE_Support@fda.hhs.gov.
  • An ACE Support Center is staffed 24/7. Reach FDA staff by email at ACE_Support@fda.hhs.gov or by phone at a domestic toll-free line (877-345-1101) or a local/international line (571-620-7320).
  • Upon request, FDA will assist in a filer’s first ACE submission, or for filers who import various commodities, FDA will assist with every first submission of a particular commodity.
  • Additional assistance for general import operations and policy questions, including FDA product codes and entry requirements, is available via email at FDAImportsInquiry@fda.hhs.gov or by calling 301-796-0356.

ACE replaces the Automated Commercial System, an older electronic submission system. Additionally, ACE provides an efficient single window for importers. Prior to the development of ACE, importers of products regulated by multiple government agencies could in some cases be required to submit information more than once.

ACE has already shown promise in accomplishing the dual goal of protecting public health while also serving the needs of the trade community by facilitating a more efficient review for admissibility of compliant products. FDA processing times for both automated and manual review have already been substantially reduced, by approximately 75% and 93% respectively, compared with the agency’s processing times in the previous system.

The ACE system serves to protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being offered for import that may be associated with a greater public health risk.

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

FDA’s Sunscreen Guidance outlines safety and effectiveness data recommended for additional active ingredients

Editor’s Note: This blog has been updated since its original posting from 9:00AM EST, November 22, 2016.

By: Theresa M. Michele, M.D.

American consumers rely extensively on over-the-counter (OTC) sunscreens to help prevent sunburn. Certain sunscreens are also used, along with other protective measures, to reduce the risks of skin cancer and early skin aging caused by the sun.

Theresa Michele, M.D.The vast majority of sunscreens available in the United States are marketed under a regulatory framework called the OTC Monograph System. FDA reviews the active ingredients in these products to determine whether the ingredients are generally recognized as safe and effective (GRASE) for OTC sunscreen use.

The Sunscreen Innovation Act (SIA) of 2014 established an alternative process for the review of safety and effectiveness of additional active ingredients for use in sunscreens, and set deadlines for reviewing the ingredients and taking certain other actions. But SIA did not eliminate the need for a GRASE determination for new sunscreen active ingredients before reaching the market without an approved marketing application, and it did not relax the scientific standards for these products. Further, FDA’s review deadlines are only triggered after the data have been submitted to the agency.

Since the SIA was passed, FDA has met all of the deadlines for implementing this complex legislation. That includes inviting public comment on our actions, holding requested meetings with industry, issuing draft and final guidances, issuing proposed and final rulemaking required to date, and issuing a report to Congress on our progress.

When the SIA was enacted, eight sunscreen active ingredients were already under evaluation. The FDA has issued proposed sunscreen orders identifying data we believe is necessary for the agency to make a positive GRASE determination on those within the SIA-required time frame, but has yet to receive the additional data we requested.

Today, as required by the SIA, we released a final guidance document that details the Agency’s current thinking on the specific information we believe we need from sunscreen manufacturers or other interested parties before we can determine that a sunscreen active ingredient is GRASE for use in OTC sunscreens. This guidance will also help clarify FDA’s outstanding requests for additional safety and effectiveness data on the eight active ingredients, including the importance of human absorption data.

Sunscreens are intended to be used on a regular basis in liberal amounts and over large portions of the body surface whenever consumers are exposed to the sun. And yet some sunscreen active ingredients may be absorbed through the skin into the body, making it important to complete studies in humans to determine whether, and to what extent, consumers’ use of sunscreen products as directed may result in unintended, chronic, systemic exposure to these ingredients.

The guidance recommends that industry provide data from a Maximal Usage Trial or MUsT, to help determine if the ingredient is absorbed into the blood and at what level. This type of study is designed to capture the effect of maximal use on absorption into the blood. It is the same standard used by FDA for all topically applied drugs, and especially for drugs that are used routinely over the course of one’s life.

Sunscreens are a valuable tool for sun safety and public health, but of course, are not the only tool. Seeking shade at peak sunlight hours and wearing protective clothing, hats, and sunglasses are key to every sun protection plan. The sunscreen page on FDA’s website provides useful information for sun safety.  

FDA is committed to helping to ensure that sunscreens are safe and effective for U.S. consumers, but we need data to move forward.

We hope the final guidance encourages industry to provide the FDA with the data we need, so that together we can help bring a wider assortment of safe and effective sunscreen products to the American public.

Theresa M. Michele, M.D., is the Director of the Division of Nonprescription Drug Products, Office of New Drugs, at FDA’s Center for Drug Evaluation and Research

Visit to West Coast Farmers and Processors Finds Shared Commitment to Food Safety

By: Stephen Ostroff, M.D.

Most people, even if they live in cities or suburbs, understand that there are many types of farms. But to really appreciate how different farms can be, you have to get out there and see it for yourself. By visiting farms in different parts of the country, you see first-hand the food safety challenges that are unique to a region. Farms are different sizes, grow a variety of crops and don’t follow the same growing and harvesting practices. There’s a varied amount of rainfall by region and season, and irrigation methods differ by crop and location. And so, while farmers confront some of the same issues, there can be real differences in the challenges they face.

What produce farmers and other food producers have in common is that they face new federal standards for the production of safe food. Seven foundational rules to implement the FDA Food Safety Modernization Act (FSMA) were finalized by May of this year. These include the produce safety rule, which establishes enforceable safety standards for the production and harvesting of most fruits and vegetables on farms in the United States and foreign farms that produce these commodities for the United States. They also include the preventive controls for human food rule, which establishes safety standards applicable to food facilities, including those that process fruits and vegetables.

I, along with my colleagues at FDA and state counterparts, visited the farmlands of the Pacific Northwest and California earlier this fall to get a sense of how growers, packers, processors and other stakeholders are getting ready to meet the new standards that apply to them. In September, we visited apple orchards and packing houses in Washington and berry growers in Oregon. We toured irrigation systems and met with stakeholders who included growers, water resources groups and tribal representatives.

FSMA West Coast Farm Tour

Parreira Almond Processing Company: Dr. Ostroff, left, and manager Paul Parreira Jr. at the almond hulling and shelling facility in Los Banos, CA.

In October, we visited stone fruit, table grape, citrus, and lettuce and strawberry fields in northern California. We toured an almond hulling and shelling operation in a visit coordinated by the Almond Alliance of California, and held a roundtable discussion about California’s water supply with farmers, representatives of industry associations and others. We visited a major processor of salad items. We finished the trip with an early-morning visit to the Golden Gate Produce Terminal in San Francisco, a trove of organic and conventional produce, as well as specialty and ethnic foods.

Produce farms have not been regulated like this before – it’s new territory for both the farming community and for FDA. We were asked many questions and received a great deal of feedback about the new regulations. But we found a strong commitment to providing consumers with safe fruits and vegetables and to moving forward in a collaborative fashion. For our part, I think it’s incumbent on FDA to protect public health without requiring a lot of unnecessary steps or measures that don’t achieve that goal.

These trips also highlighted the fact that that many food producers and industry associations have already invested a lot of time and effort in food safety measures. In some instances, what they have put in place goes beyond what is required under FSMA. In both trips, we saw farmers, other food producers, and industry associations stepping up to address past safety issues, including by developing their own on-farm standards and implementing audits to verify that those standards are met. Some developed treatment protocols and funded research to fill data gaps. These efforts will make it much easier to meet the new federal standards.

FSMA West Coast Farm Tour

Wenatchee (WA) Reclamation District: Manager Rick Smith, center, shows Dr. Ostroff, right, and colleagues an open irrigation canal system.

The big challenge for the growers in the drought-stricken Western states is water. The drought makes it difficult for growers to predict from month to month and season to season how much water will be available, where it will come from, and what it will cost. Therefore, many had questions regarding the produce safety rule’s water quality standards.

Our state regulatory partners in Washington, Oregon, Idaho and California brought members of the produce community together to meet us and discuss these issues. I am so grateful for their active involvement in making FSMA a success. Karen Ross, secretary of the California Department of Food and Agriculture, Lisa Hanson, interim director of the Oregon Department of Agriculture, Derek Sandison, director of the Washington State Department of Agriculture, and Pamela Juker, representing the director of the Idaho State Department of Agriculture, are strong voices for agriculture and food safety in the West, and we value their partnership and continued input. Both they and their staffs understand the farmers and have long-standing relationships with them. Through recently announced produce safety cooperative agreements with FDA, we will be partnering with each of these states and 38 others to implement the new produce safety rule.

We also had the opportunity to visit farms that have been in families for generations. These farmers take great pride in their work and are determined to keep their food safe but still have questions about how to they can comply with the new requirements. The take-home lesson for us was the need to provide adequate education and training and clear guidance that will help these farmers comply with FSMA. Farmers are looking for this and we’re making sure that we can fill these needs.

There was also a lot of discussion about making sure that the information we provide can be understood by people working on farms who are not native English speakers. There is a great deal of diversity in these regions, including the Hmong-American farmers of California’s Central Valley.

So there’s a lot of work ahead of us, and together we will roll up our sleeves to get it done. We went to see farmers and other food producers, and met a lot of talented people who grow and process the food we eat. We found an incredible diversity in the food that is produced, but a shared commitment to having the safest possible food supply.

Stephen Ostroff, M.D. is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

The Race to bring Penicillin to the Troops in WWII

By: John P. Swann, Ph.D.

John SwannThis Veterans Day we remember that nearly 75 years ago dozens of American academic, commercial, nonprofit, and governmental institutions – including FDA – joined together in a race to provide a promising but complex and unstable medicine to troops fighting in World War II — penicillin. Knowing that infection is the major killer in wars, not battle injuries, their goal was to help turn a British discovery into a crucial wartime medical contribution and what would become an indispensable therapeutic agent long after that conflict ended.

Many people are familiar with the story of Alexander Fleming’s 1928 discovery of a Penicillium mold that had contaminated — and surprisingly destroyed — his cultures of pathogenic organisms.

The strain of Penicillium notatum that Fleming discovered at St. Mary’s Hospital in London

The strain of Penicillium notatum that Fleming discovered at St. Mary’s Hospital in London.

Though Fleming and several others in the next decade studied the mold filtrate, known as penicillin, it was Howard Florey and his colleagues at Oxford who uncovered the drug’s chemotherapeutic potential. Their work began with studies in mice in May 1940 and transitioned to a handful of clinical cases nine months later. However, the drug was difficult to purify. Also, it presented an immense challenge to produce in sufficient quantities for study, and with Britain under siege firms there were too involved in other aspects of the war effort to offer much assistance. So Florey and a colleague came to the U. S. in the summer of 1941 for help.

Northern Regional Research Lab

A meeting of NRRL staff in the 1940s (courtesy of the American Institute of the History of Pharmacy).

Among the first sites they visited was the Department of Agriculture’s Northern Regional Research Laboratory (NRRL) in Illinois, which had extensive experience in fermentation work, and from there they contacted several drug and chemical companies to drum up support.  Americans quickly combined forces to tackle the challenge. The federal Office of Scientific Research and Development (OSRD), the federal entity that organized and facilitated investigations to support the war effort, arranged to act as a clearing-house for the latest research on chemical and other studies of penicillin, exchanging data with dozens of organizations in the U.S. and Britain. NRRL developed several production modifications that increased the yield of penicillin by 100 fold.

Penicillin Moisture Testing

An FDA analyst in the 1950s carries out part of the procedure in testing penicillin for moisture content.

FDA’s first experience with the potential wonder drug was around September 1942, when the NRRL Director approached FDA about testing the antibacterial effectiveness of a small quantity of penicillin. A year later, enough of the drug had been produced to confirm in 200 patients what the early results at Oxford had suggested, and penicillin was ready to enter the war. First, however, OSRD asked that FDA certify every lot produced by the half-dozen or so manufacturers, a task the agency also performed for insulin under statutory authority that began in 1941. Six FDA technicians certified samples for potency, absence of fever-producing contaminants, toxicity, sterility, and optimum moisture, which can affect the drug’s stability. So scarce was penicillin that companies always reconditioned the occasional rejected lot rather than destroying it.

By the end of the war, some of the participating firms had increased purity of the drug from the Oxford group’s one percent to about 85 percent. Penicillin was not only more potent, it was also more abundant, its production having increased by a factor of 500 from 1943 to 1945. In fact, by 1945 the output of penicillin, formerly under severe restriction outside of military and scientific use, was now available for most civilian needs as well. In a few years the cost of producing penicillin had decreased so much that the glass used to store ampules of the drug cost more than the drug itself. FDA’s wartime work was codified in the Penicillin Amendment of 1945, which mandated FDA’s certification of penicillin and, through subsequent laws, most other antibiotics — a responsibility that continued for nearly four decades, when the need for government testing no longer existed based on industry’s record of production.

But it all started with an international effort to provide a lifesaving drug to the armed forces, bringing together all sorts of scientific and medical institutions, including FDA. Like so many others participating in this collaboration on a scale unseen up to that point, FDA played a small but critical role to support our troops at this time of global crisis.

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

Consumer expenditure on FDA regulated products: 20 cents of every dollar

By: Sheri Walker, Ph.D., and Clark Nardinelli

Sheri Walker

Sheri Walker, Ph.D., is an FDA Senior Economist

One of the much-cited statistics about FDA is this: that FDA-regulated products account for about 20 cents of every dollar of annual spending by U.S. consumers. Add up 20 cents of every dollar and it amounts to more than $2.4 trillion in annual consumption that includes medical products, food and tobacco.

Our staff of 34 economists comes up with this estimate of FDA’s impact every year. We think it helps the public put in perspective the sheer scope of FDA’s responsibilities, especially when you recognize that FDA is only one of dozens of governmental agencies.

We largely rely on personal consumption expenditure data collected by the Bureau of Economic Analysis (BEA) every year to calculate total consumer spending in each of the major FDA product categories. These product categories include food (except alcohol and meat products regulated by USDA), drugs, medical devices, cosmetics, dietary supplements, and (since 2009) tobacco products.

Clark Nardinelli

Clark Nardinelli is FDA’s Chief Economist

Some BEA expenditure categories include more than one FDA product area. For example, biologics and dietary supplements are included in the expenditure for pharmaceutical and medical products (although, legally, dietary supplements are food). Cosmetic products are captured under the BEA expenditure category for personal care products. Pet food and animal drugs are estimated as a percentage of the pet-related products category. The estimate for medical device products is derived using data from the therapeutic equipment products category from the BEA and data from the Annual Survey of Manufacturers collected by the U.S. Census Bureau.

Food products represent the largest share of spending on FDA products, accounting for approximately 11 cents of every dollar of consumer spending. Without the addition of tobacco products, spending on FDA-regulated products would be slightly less than 20 cents per dollar.

20 cents pie chartWe know that some people say FDA oversees 25 cents of every consumer dollar. Maybe it’s an urban legend – or maybe it harkens back to decades ago. The 20 cents (or 20 percent of spending on consumer goods and services) has held steady over the past 5 years. Americans used to spend a much higher proportion of their income on food – with over 25 cents of every dollar going to food during World War II. But since then the share of food and tobacco in total consumer spending has been falling steadily while the share of consumer spending devoted to medical products has been steadily climbing. Whether those trends will continue, and whether FDA’s 20 cents will hold steady for the next 5 or 50 years, is impossible to predict.

Sheri Walker, Ph.D., is an FDA Senior Economist, and Clark Nardinelli is FDA’s Chief Economist

Key Facts about “Abuse-Deterrent” Opioids

By: Douglas C. Throckmorton, M.D.

Here at FDA, we work diligently to be part of our nation’s solution to the opioid abuse epidemic. While there is no single solution to this complex problem, we continue to encourage efforts to develop new opioid formulations with abuse-deterrent properties that make it harder to abuse these powerful medications.

Douglas C. Throckmorton, M.D.Knowing there are some 100 million Americans with significant pain each year, we need to help ensure that patients in need continue to have appropriate access to pain medications, including opioids. At the same time we must work to ensure that these powerful medications are used as safely as possible.

To date, FDA has approved seven opioid formulations with abuse-deterrent properties consistent with FDA guidance, and there are more in the development pipeline.

What does it mean to be abuse-deterrent? Opioids with abuse-deterrent properties are tablets or capsules that are designed to deter abusers from crushing them into a powder for swallowing, snorting or injecting to create a faster, more intense high.

Each manufacturer has its own proprietary technology for deterring abuse. Some abuse-deterrent formulations consist of tablets with a hardened surface that is difficult to crush and some turn the crushed medicine into a gooey substance that is difficult to inject.  Other current approaches combine the opioid with naloxone or naltrexone, drugs that block the effects of the opioid in the body that are activated when the opioid is crushed.  Additional approaches are currently under development.

The manufacturers of the seven FDA-approved opioids with abuse-deterrent properties to date have all submitted study data demonstrating that the products are expected to deter abuse. This work was guided by the 2015 final guidance for industry, Abuse-Deterrent Opioids — Evaluation and Labeling. As a result of FDA’s review, FDA-approved product “labeling” (prescribing information) for these medications clearly states the product’s abuse-deterrent properties. Other manufacturers have chosen to add what they may intend as abuse-deterrent properties to their product, but FDA has not seen sufficient evidence that these properties are effective and therefore the FDA-approved labeling for these products does not identify them as having abuse-deterrent properties. Prescribers and patients can look to our web site for the list of FDA-approved products with abuse-deterrent properties in their labeling.

It’s important to recognize that FDA refers to these drugs as “abuse-deterrent” not abuse-proof. There will always be some potential for abuse of these products. For instance, a patient can orally ingest a quantity beyond what is prescribed. It’s also true that people intent on abusing an opioid may find ways to overcome the abuse-deterrent properties of the drug that were not identified during premarketing research. With this in mind, FDA requires that any drug approved as having abuse-deterrent properties be further evaluated by its manufacturer after it is marketed. The manufacturer is required to conduct studies to evaluate the impact of the product on abuse in the community. If necessary, we may approve updated product labeling that describes the drug’s abuse deterrent features after approval.

Still, abuse deterrent technology certainly helps. That’s why FDA is looking at ways to encourage the development of abuse-deterrent generic versions of an opioid since none currently exist. We released draft guidance for industry in March and we’re looking forward to an interesting public discussion of the topic next Monday and Tuesday.

The FDA opioid action plan we issued in February involves a multi-faceted approach to reducing opioid misuse and abuse. And we continue to look for ways to make a difference. We recently announced we would help fund the development of assessment tools to evaluate packaging, storage, delivery, and disposal solutions, as well as product formulations, designed to prevent or deter misuse and abuse of opioid analgesics.

Support for abuse deterrent formulations is one important part of a strategy to help prescribers and patients make the best possible choices about how to use these powerful drugs. Our goal is to find the balance between appropriate access to opioids for patients in pain and the need to reduce abuse and misuse of these medications.

Douglas C. Throckmorton, M.D., is Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research

National Cyber Security Awareness Month: Understanding the Interdependencies of Medical Devices and Cybersecurity

By: Suzanne B. Schwartz, M.D., M.B.A.

October is National Cybersecurity Awareness Month. Proclaimed by President Obama each year, Cybersecurity Awareness Month encourages the public and industry to understand the importance of cybersecurity and to be vigilant when it comes to the technology we rely on every day, including helping patients remain confident in the safety of their medical devices.

Suzanne SchwartzMany medical devices are “life critical systems”—meaning they play a crucial role in monitoring and protecting human life. As more and more of these systems use technology to interconnect, we must be dedicated to securing them from hackers and cyber-attacks.

Here at FDA, we work with hospitals, health care professionals, and patients to provide medical device manufacturers with guidance for monitoring, identifying, and addressing cybersecurity vulnerabilities in their devices before and after they have entered the market. To further counter threats, FDA has been making a deliberate effort to work with outside groups—including those we have previously not engaged with—such as security researchers.

This outreach has allowed our guidance to evolve. While manufacturers can incorporate controls in the design of a product to help prevent these risks, it is essential that manufacturers also be proactive and on guard for potential vulnerabilities and emerging threats throughout the lifecycle of devices, and be prepared to devise solutions—points made in FDA’s draft guidance on postmarket medical device cybersecurity, issued in January 2016.

A life cycle approach requires creating, evolving, and maintaining a comprehensive cybersecurity risk management program starting from early product development and extending throughout the product’s lifespan. A key component of such a program is what should be done after a product’s potential risks and vulnerabilities have been identified. A life cycle approach should include manufacturers collaborating with entities that discover threats or vulnerabilities to a medical device’s cybersecurity in order to understand and assess the identified risks. It should also include manufacturers developing appropriate solutions prior to the vulnerabilities being publicly disclosed, which is an added protection for patients.

But, our work alone won’t achieve safety if all stakeholders do not recognize and remain vigilant against potential threats. Medical device manufacturers, government agencies, health care delivery organizations, health care professionals, and patients all share this responsibility.

In recognition of this shared responsibility, FDA has entered into a partnership with the National Health Information Sharing and Analysis Center (NH-ISAC), and the Medical Device Innovation, Safety, and Security Consortium (MDISS) to foster rapid sharing of medical device vulnerabilities, threats, and mitigations within the hospital and health care ecosystem. Doing so will help to proactively address cybersecurity threats and vulnerabilities that may impact patient safety.

Digital connections provide great power to innovate—and security must keep pace with that innovation. Safeguarding our sector’s—Healthcare and Public Health (HPH)—critical infrastructure therefore includes first identifying, and then addressing previously unforeseen medical device cybersecurity vulnerabilities. As National Cybersecurity Awareness Month rolls on, we encourage everyone to be aware, vigilant, and committed to upholding and strengthening cybersecurity. Through a joint approach encompassing the public and several government agencies, we are beginning to see the necessary change in culture within the medical device ecosystem, accompanied by progress in the management of medical device cybersecurity. FDA’s January 2016 workshop “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” highlighted some of the progress that has been made. Moreover, recent examples of coordinated vulnerability disclosure between medical device manufacturers and security researchers demonstrate the promise of partnership in addressing medical device cybersecurity. But there is still work to be done, and we must remain committed to working collaboratively to address our goal of protecting the public health.

Learn More

For more information about National Cybersecurity Awareness Month including tips on cyber safety, visit the Stop.Think.Connect.™ campaign website. You can also find more information about medical device cybersecurity on FDA’s Center for Devices and Radiological Health web page.

Suzanne B. Schwartz, M.D., M.B.A., is Associate Director for Science and Strategic Partnerships at FDA’s Center for Devices and Radiological Health

SCORE at Six Months: Meeting the Challenge of Complex Recalls

By: Stephen Ostroff, M.D., and Howard Sklamberg, J.D.

When a potentially contaminated food is on the market, time is of the essence to keep people from becoming ill. Yet there are times when it is difficult to determine what actions should be taken. This can happen when we do not have enough information to reach a clear decision.

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

To better address these situations, in April FDA established a team of senior leaders that is brought in to make decisions in the most challenging cases. The team is called SCORE, which originally stood for Strategic Coordinated Outbreak Response and Evaluation, but it soon became clear that the scope of its work is broader than outbreaks. The team looks at cases in which recalls and other actions may be needed, even when there are no reports that people have fallen ill. So SCORE now stands for Strategic Coordinated Oversight of Recall Execution.

And we’re happy to report that SCORE is already making a difference, helping to overcome obstacles and streamlining processes to get potentially harmful foods off the market as soon as possible to reduce further consumer exposure.

In the last six months, SCORE has reviewed and directed operations in cases that include flour contaminated with peanut protein, (a major food allergen), facilities contaminated with Listeria monocytogenes, pistachios in which Salmonella was detected, and baby food that was not manufactured in compliance with infant formula regulations. All of these cases resulted in recalls and announcements issued by the firms and FDA.

Howard Sklamberg

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

SCORE was launched, in part, in response to concerns raised by the Department of Health and Human Services’ Office of the Inspector General about FDA’s ability to ensure that companies initiate voluntary recalls in a prompt and effective manner. While FDA staff were already helping to facilitate thousands of prompt and successful voluntary recalls, we recognized the need for an enhanced response in certain, more complex cases.

In the cases brought to the team, we believe that SCORE has helped determine the right course of action and shorten recall timeframes, getting the products off the market faster. SCORE has helped improve tactical planning, leading to additional inspections and sampling assignments, and to getting the word out to more consumers about potentially dangerous products. In one case, FDA suspended a food facility’s registration after a reinspection and additional sampling requested by SCORE showed continued contamination. Suspension of registration effectively shuts a facility down until FDA determines that there is no longer a reasonable probability that foods produced there will cause serious illnesses or death.

We set individual deadlines and got prompt results in these, and other, instances. FDA staff are seeing these actions as a model for their efforts going forward.

FDA has been evolving over the past few years into an agency that speaks with one voice in its oversight of food safety. SCORE’s membership includes leaders from within the directorates of Foods and Veterinary Medicine and Global Regulatory Operations and Policy, in addition to the Office of the Chief Counsel. The spectrum of expertise covers inspections and investigations, compliance and enforcement, policy, legal, communications, outbreak response and, most important, science.

This team is in its infancy but the results it has achieved thus far signal an integrated approach to food recalls that will help ensure a swift response no matter what obstacles arise. The arrival of the compliance dates for the FDA Food Safety Modernization Act rules overseeing the safety of domestic and imported foods are putting additional food safety controls in place to help reduce food contamination. And the work of SCORE and its colleagues will continue.

SCORE’s goals for the next year include identifying and closing gaps that slow the process of determining whether a food is a threat to public health or interfere with identifying the right actions to take in response to potential contamination. Our ultimate goal is to continue to improve our ability to protect consumers from contaminated food.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine, and Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy.

FDA’s Opioids Action Plan: A Midyear Checkup

By: Robert M. Califf, M.D.

As FDA works to address the opioid epidemic of abuse, misuse and addiction, it’s valuable to see firsthand some of the ways the crisis is affecting our communities.

This summer, I toured areas hard-hit by the opioid crisis in Tennessee, West Virginia, and Kentucky, visiting  with survivors of opioid addiction and overdose as well as community activists, government officials, and health care providers, all of whom are working diligently and creatively to address and overcome this crisis.

Robert Califf

Robert Califf, M.D., is Commissioner of the U.S. Food and Drug Administration

My visit to the nationally-recognized neonatal intensive care unit at East Tennessee Children’s Hospital was deeply moving and set the stage for the rest of my tour and underscored the urgency of fighting this epidemic. More than a third of the babies admitted to the NICU have neonatal opioid withdrawal syndrome (NOWS), a condition which can be life-threatening if not recognized and treated

Watching a nurse treat a fretful baby suffering from NOWS underscored the complexity of the opioid problem.  Many women taking opioids haven’t planned their pregnancy, don’t immediately know they are pregnant and may not be aware of the risk that opioids pose to their unborn child. This includes those women who are taking medication as part of medication-assisted treatment (MAT) which also includes counseling and behavioral therapies. For women on MAT, the risk of NOWS must be balanced against the additional dangers of untreated opioid addiction during pregnancy.

How best to prevent NOWS and treat opioids use disorder was a continued theme of my trip, and among the issues we grappled with during a roundtable at the University of Tennessee’s Medical Center hosted by Surgeon General Vivek Murthy, who is traveling the country to discuss solutions to opioid abuse as part of his TurnTheTideRx campaign. I’m pleased that expanding access to and the use of evidence-based MAT is a key focus area for the Administration, is a part of the HHS-wide opioid initiative, and is an approach supported by a recent FDA advisory committee.

In Charleston, WV, I met with several patients who are reclaiming their lives with the use of MAT including “Dave.” Like so many others, Dave became addicted to opioid pain medication after being treated for an injury. As a result of his addiction, his marriage failed and he lost contact with his children. But with treatment, he has reunited with his family and next spring will graduate from college and hopes to taper off of his treatment.

Throughout my tour, I heard that opioid education – including training during medical school and residency and greater public awareness far and wide – is a key component in fighting the opioid epidemic. At a roundtable in Charleston, Gov. Earl Ray Tomblin and U.S. Sen. Joe Manchin singled out their state’s model mandatory education program for prescribers and they told me the state is leading an effort to implement the CDC’s Guideline for Prescribing Opioids for Chronic Pain as a best practice for their state-run Medicaid program.

At a firehouse in the town of Williamson, WV, I met with those on the frontlines of the opioid epidemic – the firefighters and first responders who carry life-saving naloxone to help reverse an overdose. They told me more education about naloxone was needed and told me that they appreciate our efforts to help make naloxone more available to the general public.

My last stop this summer was to Kentucky where I toured the emergency room at the Pikeville Medical Center and participated in a roundtable with physicians, pharmacists, and state policy and community leaders brought together with the help of the regional organization Operation UNITE. UNITE coordinates treatment for those with substance use disorder as well as support for their families and friends, and educates the public about the dangers of drug use. These measures, combined with a recent state law requiring prescribers to register with a prescription drug monitoring program are working, we were told.

Throughout my travels, I listened and learned more about how FDA can help end this crisis. I also had the chance to share what FDA has been doing this year to implement a multipart plan to address the opioid epidemic.

Our milestones so far include:

  • Developing warning and safety information for immediate release opioids and requiring that prescription opioid analgesics and opioid-containing cough product labels include strengthened warnings about the risk of using benzodiazepines at the same time.
  • Working to better understand the long-term safety of using extended release/long acting opioids. Sponsors must now conduct a number of studies to generate postmarket data on these products.
  • Issuing draft guidance for industry to support the development of generic versions of approved opioids with abuse-deterrent formulations.
  • Seeking advice from the National Academy of Science Engineering and Medicine on how to balance both the needs of patients with pain and the need to address opioid misuse and abuse.
  • Supporting increased access to naloxone; for instance, by awarding a contract to conduct consumer behavior studies based on model product labeling for a potential OTC version of the antidote and by launching a competition to create a mobile app that could help find the closest available naloxone treatment in an emergency.
  • Approving the first implantable treatment for the maintenance treatment of opioid dependence.

The community-based successes I observed on my three-state tour reinforced my view that we are making important progress in addressing this crisis.  But continued hard work, creative ideas, and collaboration — across government, with the medical profession, health care providers, industry, and, most importantly, patients and their families, is still required.

We at FDA will continue to work with all of these groups, using all the resources at our disposal, to improve the judicious and responsible use of opioids and to help bring an end to this epidemic.

Robert M. Califf, M.D., is Commissioner of the U.S. Food and Drug Administration