The way forward on opioid abuse: A call to action for science-based, comprehensive strategies

By: Margaret A. Hamburg, M.D.

The recent attention paid by state policy makers around the serious public health problem of misuse, abuse, addiction, and overdose of prescription opioid painkillers is commendable. These efforts reflect the strong desire on the part of states where communities have been devastated by opioid addiction and overdose to prevent further tragic loss of life. However, it is important that such efforts comprehensively address the real root causes of the problem, are grounded in science, and will make a real and lasting difference.

Margaret Hamburg, M.D.The most recent state actions in Massachusetts and Vermont would require healthcare providers to take certain steps such as screening for abuse risk and documenting medical need before prescribing the opioid Zohydro ER. They would also require prescribers to participate in and regularly check state databases that track how often the drug is prescribed to a given patient – a measure that can help identify misuse.

Such requirements are consistent with the essential tenets of numerous medical society guidelines on appropriate pain management and – simply put – are precisely what responsible physicians should be doing. As the entities with responsibility for overseeing the practice of medicine, the states have an important role to play in addressing a critical driver of opioid abuse – inappropriate prescribing practices.

However, we can’t just focus on one drug, Zohydro, alone. These requirements would not apply to the prescribing of any of the other opioids on the market that account for some 250 million prescriptions and 18 billion tablets each year. Unfortunately, to date considerable misinformation appears to be diverting attention from more comprehensive policy solutions that apply to all opioids.

Last October, FDA approved Zohydro as a new treatment option for the management of pain severe enough to require daily, around-the-clock, long-term treatment, and for which alternative treatments options have proved inadequate. We have heard from many people who must cope with often severe pain on a daily basis. These are people who need a variety of therapies to have any hope for a quality life. And, importantly, Zohydro does not include the liver toxin acetaminophen, as many hydrocodone products (e.g., Vicodin) do.

Despite claims to the contrary, the fact is that the top dose of Zohydro is no more potent than the highest strengths of other extended-release opioids like Oxycontin and extended-release morphine. And since Zohydro is a Schedule II controlled substance, it is already subject to Drug Enforcement Administration prescribing restrictions. These include requiring patients to have a written prescription from their doctor instead of one provided to the pharmacist over the phone, and the prohibition of refills.

Moreover, the approval of Zohydro is not likely to significantly change overall opioid prescribing and use by patients suffering from pain. Rather, the most likely patients for this medication are those who are currently taking an immediate release hydrocodone product chronically, or people taking another extended-release/long-acting (ER/LA) opioid. And this drug is unlikely to increase the number of people abusing opioids.

Some have asserted that this drug’s approval should have been delayed until it had an abuse-deterrent formulation. Unfortunately, this puts too much faith in the current state of abuse-deterrent technology, which is still in its infancy and has yet to be fully tested in actual market or use conditions. Even the abuse deterrent properties of Oxycontin, the only opioid with an abuse-deterrent claim in its labeling that is consistent with the approach described in FDA’s 2013 draft guidance on this topic, are limited. For example, while the formulation is designed to make abuse by injection more difficult, it doesn’t prevent it and there is nothing barring someone from taking more Oxycontin pills by mouth – the most common form of opioid analgesic abuse.

Addressing the opioid crisis by focusing on a single opioid drug will simply not be effective. Instead, we must focus our collective attention and energy on the key drivers of the problem, which include excessive prescribing, illegal activity by a small number of providers, improper disposal of unused medications, and insufficient prescriber and patient education.

FDA has a critical role to play in combatting misuse and abuse of all opioids. That includes our requiring pointed warnings in the labeling of every ER/LA opioid analgesic drug and revising them to incorporate evolving scientific knowledge of risks and benefits. That also includes FDA requiring all manufacturers of ER/LA opioid analgesics to make available prescriber training and to conduct post-market studies to assess the long-term abuse risks of these products. As an agency, we will be evaluating the success of the risk management steps required of manufacturers of ER/LA opioid analgesics, including Zohydro. And we intend to monitor the utilization of all opioids to identify any emerging abuse issues.

Also critical are the development of non-opioid pain medications, treatments for opioid addiction and products that reverse opioid overdose. Just in the past few weeks, for example, FDA approved a major new advance in the treatment of opioid overdose – an auto-injector formulation of naloxone, and we will continue to review new treatments for drug abuse.

Let me say, in no uncertain terms: the prevention of prescription opioid abuse is of the highest priority for the FDA. Nothing can erase the tragedy so many people have had to face as a result of abuse, addiction, or misuse of opioids. But we can make meaningful progress to reduce and prevent our nation’s prescription drug crisis. FDA is committed to reducing abuse of opioids and ensuring appropriate access to pain medicines for patients in need.

But it is critical that we all play a role in developing and implementing smart policies that will result in real change. We urge those states with active prescription drug monitoring programs, as well as insurers and pharmacy benefit managers, to help identify and halt inappropriate prescribing. And we urge all states to consider requiring common sense, responsible pain management prescribing practices for all opioids.

Our nation’s front-line health care professionals, especially physicians and other prescribers, play a key role and have a responsibility to ensure that they are treating patients based on their individual needs. We need to be sure they receive adequate proper training and education and that they practice responsible opioid prescribing in order to improve pain management and minimize prescription drug misuse and abuse.

At the end of the day, the complex public health challenge of opioid abuse requires a comprehensive and science-based approach involving federal and state governments, public health experts, opioid prescribers, addiction experts, patient groups and industry. Then, and only then, will we truly solve this problem and protect the public health.

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

The Commissioner’s Fellowship Program: A Win-Win for FDA and Public Health

By: Dr. Stephen M. Ostroff

As part of my FDA Voice blog series on the important work going on in FDA’s Office of the Chief Scientist (OCS), I’d like to highlight an FDA program that is giving top-tier, early career health care professionals, scientists, and engineers the chance to gain broad exposure to FDA regulatory science and scientific review opportunities. Led by OCS’s Office of Scientific Professional Development, the Commissioner’s Fellowship Program (CFP) is accepting applications from April 16 to May 26, 2014. Those who are accepted into the CFP will be joining FDA’s 7th class of Fellows.

Stephen OstroffDuring the two-year program, Fellows complete rigorous graduate-level coursework and conduct cutting-edge research on targeted scientific, policy, or regulatory issues under the mentorship of an FDA senior-scientist preceptor.

In the CFP, a Fellow is able to gain real experience in an FDA biology, physics, or engineering lab, work with a clinical review team, or work at a regional field laboratory or office. The coursework provides a common core understanding of the science behind regulatory review, encompassing activities across all FDA-regulated product areas.

Specific Fellow projects may focus on FDA review of sponsor applications for new products, monitoring product quality and safety, or other scientific or engineering topics. Fellows work closely with FDA scientists to create better research and evaluation tools and approaches, like assays for chemical or pathogen detection, or methods to assess clinical or health care data. Other science and policy areas of focus may involve foods or medical products in disciplines ranging from laboratory sciences to engineering, law, and ethics.

FDA launched the Fellowship Program in 2008 to achieve three critical goals:

1)      Attract to FDA top-tier scientists who can help tackle targeted regulatory science areas;

2)      Provide regulatory science training to expand the pool of experts;

3)      Recruit top scientific talent — scientists who may not have considered FDA in planning their career.

Since the program started, FDA has graduated 164 Commissioner’s Fellows, 75% of whom continued to work at FDA after completing the program. Our graduates have produced 175 publications based on their Fellowship work, represented FDA with 211 regulatory science presentations, authored or co-authored 917 reviews – ranging from original applications to supplements – and 26 Fellows have been the proud recipients of FDA Honor Awards.

The Fellows have brought an infusion of innovative ideas, new talents, and skills to FDA to help build the strong scientific foundation we need in our research and review activities. In turn, the CFP has enabled Fellows to develop their regulatory expertise and work confidently in the FDA environment.

Those Fellows who pursue careers outside FDA bring a deeper understanding of regulatory science and of FDA to their organizations. They enrich the regulatory science enterprise, whether by improving the quality of applications to FDA or by applying the knowledge and tools they’ve acquired through the CFP to develop practical solutions to an important public health challenge.

Stephen M. Ostroff, M.D., is FDA’s Acting Chief Scientist

For more information on eligibility criteria for the FDA Commissioner’s Fellowship Program and to apply for the upcoming class, please visit this Web link:

FDA Commissioner’s Fellowship Program Application Checklist

Getting it Right on Spent Grains

By: Michael R. Taylor

Since the March 31 close of the comment period on FDA’s proposed animal feed rule, we’ve received a lot of questions and comments about so-called spent grains. Spent grains are by-products of alcoholic beverage brewing and distilling that are very commonly used as animal feed.

Michael TaylorTo add to the picture, spent brewer and distiller grains are just a subset of the much broader practice of human food manufacturers sending their peels, trimmings, and other edible by-products to local farmers or feed manufacturers for animal feed uses rather than to landfills. One industry estimate is that 70 percent of human food by-product becomes food for animals.

We’ve heard from trade groups and members of Congress, as well as individual breweries raising concerns that FDA might disrupt or even eliminate this practice by making brewers, distillers, and food manufacturers comply not only with human food safety requirements but also additional, redundant animal feed standards that would impose costs without adding value for food or feed safety.

That, of course, would not make common sense, and we’re not going to do it.

In fact, we agree with those in industry and the sustainability community that the recycling of human food by-products to animal feed contributes substantially to the efficiency and sustainability of our food system and is thus a good thing. We have no intention to discourage or disrupt it.

We also believe the potential for any animal safety hazard to result from this practice is minimal, provided the food manufacturer takes common sense steps to minimize the possibility of glass, motor oil or other similar hazards being inadvertently introduced, such as if scraps for animal feed were held in the same dumpster used for floor sweepings and industrial waste.

We understand how the language we used in our proposed rule could lead to the misperception that we are proposing to require human food manufacturers to establish separate animal feed safety plans and controls to cover their by-products, but it was never our intent to do so. In fact, we invited comment on practical ways to address by-products in keeping with their minimal potential risk.

We will take the necessary steps to clarify our intent in the rules themselves so there can be no confusion. As we previously announced, this summer we plan to issue revised proposals for comment on several key FSMA issues and we will include changes consistent with the points I’ve outlined in this blog.

Our door at FDA has been wide open to stakeholders at every step of the FSMA process. We have learned a lot through active, two-way dialogue with those who have concerns about what we propose or ideas about how we can achieve our food safety goals in the most practical way. We hope and fully expect that dialogue to continue.

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

Proposed Rule Would Expand FDA’s Tobacco Control Authority

By: Margaret A. Hamburg, M.D.

Today we usher in a new chapter in FDA’s role in tobacco control, which began nearly five years ago when the Family Smoking Prevention and Tobacco Control Act enabled us to regulate certain tobacco products, including cigarettes and smokeless tobacco. Now, FDA has proposed a rule that would extend our authority to additional products meeting the legal definition of a tobacco product. This would include electronic cigarettes, some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables not already under the FDA’s authority, as well as future tobacco products.

Margaret Hamburg, M.D.The tobacco product marketplace is evolving at a dizzying pace with many unanswered questions about the health effects of novel products. Especially in the shadow of alarming increases in the number of youths using unregulated products like electronic cigarettes and cigars, it’s more crucial than ever to help prevent early tobacco use that could lead to a lifetime of nicotine addiction. The proposed rule—which would “deem” other tobacco products to be subject to FDA authority—is poised to help make that happen.

FDA is committed to protecting public health. Expanding our authority over tobacco products gives FDA additional tools to help reduce the number of illnesses and premature deaths associated with the use of tobacco products. Under FDA’s proposal, these powerful regulatory tools would include age restrictions, rigorous review of new tobacco products and claims, and health warnings.

“Deeming” – and the new health warning requirements included in the proposed rule – would also help to correct a misperception by consumers that tobacco products not regulated by FDA are safe alternatives to currently regulated tobacco products. Equally important, “deeming” would allow FDA to issue future regulations regarding these products, including regulations to reduce their harmfulness, if we determine that would be appropriate to protect public health.

As we work to finalize the proposed rule, we welcome comments and will consider all that are submitted, as well as any data, research and other information submitted to the docket for this proposed rule.

For more information:

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

National Drug Take-Back Day: In the Shadow of Opioid Abuse Crisis, Now More Important Than Ever

By: Douglas C. Throckmorton

There were more than 22,000 deaths in the United States relating to prescription drug overdose in 2010, many of which were due to intentional misuse and abuse. More than half of all abused prescription drugs are obtained from family and friends, which includes many instances in which users simply take these drugs from other people’s medicine cabinets.

Douglas C. Throckmorton, M.D.This Saturday, April 26, 2014, is National Drug Take-Back Day. It’s the eighth nationwide opportunity in four years for the American public to clean out their medicine cabinets of expired, unused, or unwanted prescription drugs, including prescription drugs for pain, like opioids. It’s always a good idea to keep a household free of medications that are no longer needed, and this opportunity to get rid of all of your un-needed drugs, including opioids, is more important than ever.

The facts about opioids are sobering. Here are just a few from the Centers for Disease Control and Prevention (CDC):

  • In 2010, Nearly three out of four prescription drug overdoses involved prescription opioid painkillers;
  • In 2011, the misuse and abuse of prescription opioids was responsible for more than 420,000 emergency department visits, a number that nearly doubled in just five years;
  • In 2012, more than 12 million people reported using prescription opioids for non-medical reasons, that is, using them without a prescription or for the feeling they cause.

So, bring your medications of any kind for disposal on Saturday, April 26, from 10 a.m. to 2 p.m. to a collection site near you. The service is free and anonymous, no questions asked. And it’s easy. Simply go online and key in your ZIP Code, and the site will tell you the nearest drug take-back location. Past drug take-back days have been highly successful. Across the country, more than three million pounds, or 1,733 tons, of prescription medications were collected.

I’d also like to take a moment to remind you that safe disposal of medicine is a year-round activity. For times when there is not an available take-back operation available, FDA’s Disposal of Unused Medicine site offers valuable ‘do-it-yourself’ safety information. As one example, the site includes a list of highly potent medicines that should be disposed of by flushing down the toilet or sink when they’re no longer needed.

FDA, along with many other Federal Agencies, is working on reducing prescription drug misuse and abuse in many ways and we can use your help on this important activity. Please take a careful look around your home, gather unnecessary prescription drugs, and take them to you Drug Take Back collection site. Together we can make difference.

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

Balancing the Prevention of Opioid Abuse and Appropriate Pain Management

By: Margaret A. Hamburg, M.D.

Earlier today I had the opportunity to address the Rx Abuse Summit in Atlanta, Georgia, an important three day conference that brings together local, state and federal agencies, business, academia, clinicians, treatment providers, counselors, educators, state and national leaders, and advocates to share ideas and strategies for reducing the growing number of tragedies resulting from prescription drug abuse.

Margaret Hamburg, M.D.For FDA, stemming the rise in prescription opioid misuse, abuse, addiction, and overdose is an issue of the highest priority. The issue is complicated by the need to balance it with another major public health priority: managing the pain that affects an estimated 100 million Americans.

This balance goes to the heart of FDA’s mission to protect and promote the public health — and to our role as drug regulators. FDA has a responsibility to demand the best science and data to uphold its high standards to ensure a proper benefit/risk profile for these drugs, and to foster discussion and research that leads to a better understanding of pain and pain drugs.

FDA shares the concerns about safe and appropriate use of all prescription opioid analgesics and the public health consequences associated with misuse and abuse of these drugs. I encourage you to read my remarks from today, in which I detail the many actions FDA has taken to address prescription opioid abuse, targeting key drivers of the problem.

Nothing can erase the tragedy that so many people have had to face as a result of the misuse, abuse and addiction of opioids. But progress to reduce and prevent our nation’s prescription drug crisis is attainable through a comprehensive and collaborative approach. For our part, FDA is committed to reducing abuse of opioids and ensuring appropriate access to pain medicines for patients in need.

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

Collaboration and Medical Countermeasures: Furthering Regulatory Science

By: Dr. Stephen M. Ostroff

“I hope no one ever needs these products,” isn’t something you hear too often, particularly from those developing drugs, biologics, or devices. That point of view—and a universal desire to protect the American public—is what sets biodefense professionals apart.

Stephen OstroffWithin FDA, our Medical Countermeasures initiative (MCMi) does things a little differently as well. Managed by the Office of Counterterrorism and Emerging Threats, in the Office of the Chief Scientist, MCMi thrives on collaborations. We work proactively with industry, academic and federal research centers, FDA product centers and offices, and other government entities in our mission to help protect the U.S. from chemical, biological, radiological, nuclear, and emerging infectious disease threats.

Collaborating is particularly important to advancing regulatory science: developing the tools, standards, and approaches needed to evaluate FDA-regulated products—in this case, medical countermeasures—for safety, efficacy, quality, and performance. When it comes to developing the necessary data for regulatory decisions, medical countermeasures often present unique and complex challenges since the diseases they target rarely occur naturally.

To support regulatory decision-making for medical countermeasures, FDA manages a robust research portfolio under the MCMi Regulatory Science Program. Working with other federal agencies to ensure alignment with U.S. priorities, we fund both intramural and extramural research programs to drive innovation in regulatory science.

Ongoing research projects include:

  • Developing models of radiation damage in lung, gut, and bone marrow organs-on-chips, and using these models to test candidate medical countermeasures to treat such damage;
  • Mapping immune responses to certain biothreat agents and medical countermeasures in humans and animal models to create species-specific immune function maps;
  • Assessing the feasibility of using electronic health record systems to conduct near real-time monitoring of health outcomes, including serious or unexpected adverse events associated with medical countermeasures used during public health emergencies.

For those interested in these and other medical countermeasure-related regulatory science developments, FDA will be hosting our 2014 MCMi Regulatory Science Symposium at FDA headquarters in Silver Spring, Maryland, June 2-3, 2014. The meeting is free and open to the public (pre-registration required).

We welcome poster abstract submissions until April 27, 2014, in topic areas including: animal models, biomarkers and correlates of protection, devices, diagnostics, emergency communication, new technologies, product quality, and surveillance.

I also encourage you to read more about MCMi in action in our Fiscal Year 2013 Program Update.

Stephen M. Ostroff, M.D., is FDA’s Acting Chief Scientist

FDA Works with China to Ensure Medical-Product Safety

By: Christopher Hickey, Ph.D.

Americans benefit greatly from medical products produced by other countries. Approximately 40 percent of finished drugs in the United States come from overseas, as well as more than 50 percent of all medical devices. About 80 percent of the manufacturers of active pharmaceutical ingredients are located outside the United States.

Christopher Hickey

Christopher Hickey, Ph.D., testifies April 3, 2014.

However, this rapid globalization of commerce presents challenges to regulators who oversee the safety and quality of medical products. Many of these challenges manifest themselves in China. As FDA’s country director for the People’s Republic of China, I testified on April 3, 2014 before the U.S.-China Economic and Security Review Commission, an advisory panel created by Congress, on our work to ensure the safety and quality of medical products produced in China and imported into the United States.

China is the source of a large and growing volume of imported foods, medical products and ingredients. In the years spanning fiscal years 2007 and 2013, the total number of shipments of FDA-regulated products from China to the United States almost quadrupled.

The challenges we see in China mirror those we see in other countries with developing regulatory systems. These issues include problems with data integrity, inadequate implementation of quality systems in manufacturing, and inconsistent regulatory oversight, among others.

As China’s role on the global stage expands, FDA has significantly increased drug and medical device inspections there, but we need to continue to strengthen our efforts. FDA is currently working to use Congressionally-appropriated funding to increase from eight to 27 the number of U.S. staff it posts in China. Visa issues that arose with the Chinese government over new FDA staff assigned there were addressed during Vice President Joe Biden’s visit to Beijing in December, and FDA continues its work to post new staff in Beijing in the coming months.

FDA recognizes that strategic engagement in China starts first and foremost with Chinese regulators. China’s Food and Drug Administration, or CFDA, is responsible for the regulation of food, drugs, and devices for domestic distribution in China, and for regulation of certain exported drugs and medical devices.

Senate Committee Hearing, April 3, 2014

Christopher Hickey, Ph.D., testifies before the U.S.-China Economic and Security Review Commission.

FDA has established a strong working relationship with CFDA. Our office has trained hundreds of Chinese inspectors in areas that include inspecting for good manufacturing practices and assessing the quality of data from sites that conduct clinical trials. Experts from FDA’s Center for Devices and Radiological Health now meet regularly with their counterparts from CFDA under the auspices of the International Medical Devices Regulatory Forum. These investments will pay long-term dividends for the American people: a stronger Chinese regulatory system can only strengthen FDA’s efforts to promote and protect U.S. public health.

Finally, in the area of inspections and enforcement, CFDA inspectors now regularly observe FDA inspections in China. And since 2012, FDA’s Office of Criminal Investigations has worked closely with CFDA to fight against Internet-based, illegal distribution into the U.S. of falsified, counterfeit and adulterated drugs.

FDA’s priorities in China match its global priorities: we work to ensure the safety and efficacy of FDA-regulated products. Manufacturers are best situated to make certain that appropriate processes are in place to ensure safety and quality in production. Regulatory bodies should hold companies accountable for lapses in the production process. Inspections and testing are important tools in that process, but they must be used as part of a larger system that emphasizes a preventive, approach to the production of safe, effective, high-quality medical products.

And in our globalized world, it’s increasingly important that regulatory partners work together to ensure the safety of products as they move through increasingly complex supply chains. Patients and consumers – whether in Beijing or Boston – deserve no less.

Christopher Hickey, Ph.D., is FDA’s Country Director for the People’s Republic of China.

For more information, please visit this Web link:

China’s Healthcare Sector, Drug Safety, and the U.S.-China Trade in Medical Products

Marsha Henderson Leads Programs to Improve Health Outcomes for Women

By: Kimberly A Thomas, MPH

Kimberly ThomasI have worked with many clinicians and researchers whose dedicated efforts have helped to improve the health care women receive. FDA’s Marsha Henderson stands out among this distinguished group. For over 30 years, Marsha has led research and educational programs that help improve medical treatments for women and provide women with the resources they need to make informed health decisions.

For these efforts, Marsha was recently awarded the first Dr. Estelle Ramey Award for Women’s Health Leadership from the Society for Women’s Health Research. This award was created to recognize leaders like Dr. Ramey who demonstrate exemplary leadership in women’s health and a commitment to the study of the impact of sex differences on health.

Marsha was honored for her history of serving as a champion for women’s health, and for her leadership of FDA’s Office of Women’s Health. As the assistant commissioner for women’s health, Marsha directs research that helps FDA better understand how sex differences affect the safety and effectiveness of medical treatments.  At FDA, Marsha has also developed outreach programs that make sure that women from diverse communities have access to easy-to-read FDA health and safety information.

Marsha Henderson with award

Marsha B. Henderson, FDA Assistant Commissioner for Women’s Health, with FDA Commissioner Margaret A. Hamburg, MD (left) and Phyllis Greenberger, President & CEO of the Society for Women’s Health Research (right).

When I first came to the FDA in 2004, Marsha immediately showed me how the work we do at FDA can have a positive impact on women’s lives. Her leadership motivated me to find new ways to promote scientific discussion and expand educational outreach.

When Marsha accepted her award she not only acknowledged the tremendous personal honor, but she also recognized all of the scientists, health educators, and general staff at FDA whose daily work helps to improve the outcome of medical treatments for women. Her comments demonstrated why she is so deserving of this leadership award. I congratulate her on this honor and thank her for distinguished career serving as a voice for all women.

Kimberly A Thomas, MPH, serves as a senior advisor for communication and outreach in FDA’s Office of Women’s Health.

FDA Seeks Comment on Proposed Health IT Strategy That Aims to Promote Innovation

By: Bakul Patel

Health information technology (IT) offers many benefits to the American people and health care providers. Health IT products, technologies and services can prevent medical errors, improve efficiency and health care quality, reduce costs and increase consumer engagement. They also can help with identification of, and quick response to, public health threats, and further health research. But while health IT benefits are far-reaching, technology can bring risks to patients if not designed, developed, implemented, or maintained properly.

Bakul PatelI’m glad to share that FDA, along with the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communications Commission (FCC), has recently released a report outlining our proposed framework for health IT. This report fulfills the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) requirement that we develop a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health IT that promotes innovation, protects patient safety and avoids regulatory duplication.

We’ve developed a proposed framework that fulfills this requirement and would allow Americans to reap the benefits of health IT. This is a growing field with many benefits. For example, electronic health records allow providers to access accurate patient data. And computer-aided detection software can analyze an electrocardiogram (EKG) signal and help determine if a person is having a heart attack, helping providers give timely treatment.

In health IT, the best approach is a risk-based approach. We believe risk assessment should primarily focus on the function of the health IT product, not its platform. So we’ve identified three categories of health IT. The first is administrative and relates to functions such as billing and scheduling. This area has minimal risks for patient safety and does not require additional oversight.

The second relates to health management functions, including provider order entry, electronic communication and patient identification. In this category, we’ve identified four priority areas that can be scaled and applied throughout the health IT product lifecycle:

•              Promote the use of quality management principles;

•              Identify, develop, and adopt standards and best practices;

•              Leverage conformity assessment tools; and

•              Create an environment of learning and continual improvement.

Since safety risks for products in the health management category are sufficiently low, even if a technology in this category meets the definition of a medical device, FDA does not intend to focus oversight on it. Rather, FDA intends to focus our attention on the third category, which relates to medical device functions, such as computer-aided detection software and radiation treatment software. Such products are already FDA’s focus because they generally pose greater risk to patients than the products in the other two categories.

We’re not recommending that new areas of FDA oversight are needed.

Along with ONC and FCC, we will continue to develop this framework through public engagement, especially in fostering the further development of a quality-focused culture for health IT. We do not believe that regulation should be, or needs to be, the first approach used to reach this outcome. The agencies are holding a three day public workshop on May 13, 14, and 15 at the National Institute of Standards and Technology to discuss the framework and its components. We encourage consumers, providers, and health care organizations to register for the workshop and to submit comments. Health IT has brought, and continues to bring, many benefits and we are looking forward to engaging with you on this important topic.

Bakul Patel is senior policy advisor in FDA’s Center for Devices and Radiological Health.

For more information please visit these Web links:

FDASIA Health IT Report

Public Workshop – Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology, May 13-15, 2014

Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology Report; Notice to Public of Availability of the Report and Web Site Location; Request for Comments