Empowering Consumers through Accurate Genomic Tests

By: Jeffrey Shuren, M.D., J.D.
We’ve come to recognize that almost every disease has a genetic component, and many consumers now are eager to know more about their genetic profiles. They need only send a sample of their DNA collected from their saliva or from a cheek swab to a company, and in exchange they’ll get back information about their genetic risk for development of future disease.

Jeffrey ShurenFDA understands and supports people’s interest in having access to their genetic information and believes such information can help them make more informed choices about their health – so long as that genetic information is accurate – that the results are correct, meaningful and written in a way that consumers can understand. FDA reviews genetic tests for medical conditions, whether they are intended to be ordered by a healthcare practitioner or directly by the consumer, to assure that consumers receive accurate test results.

Telling someone they are at high risk for a life-threatening cancer when they are not—or that they are at low risk for diabetes when they actually are at high risk for this chronic disease does not empower consumers. Consumers are not empowered by tests that tell them they need higher or lower doses of widely-used drugs, when the opposite is true. Moreover, some genetic tests have questionable value. Their impact on patient health is not known, and there are no guidelines for consumers or healthcare practitioners on how to interpret these test results, in part because the risk of getting a disease depends on a number of other factors such as age, sex, ethnicity, or environment and because genetic tests may only assess a limited number of genetic variations that only account for a small part of the risk.

Concerns about the need to demonstrate accuracy were at the heart of our five-year effort to work with the firm 23andMe that resulted last year in the company ceasing marketing its disease risk and drug dosing tests until it could demonstrate their accuracy.

These concerns were hardly theoretical ones. In 2010, at the behest of Congress, investigators from the U.S. Government Accountability Office purchased direct-to-consumer (DTC) genetic tests from four different companies—including 23andMe—and submitted two samples of their DNA to each company to receive risk predictions for 15 common diseases. The results varied across the four companies. One investigator was told that he was at below-average, average, and above-average risk for prostate cancer and hypertension. In some cases, the risk predictions conflicted with an investigator’s actual medical condition.

FDA is not standing in the way of 23andMe selling tests intended to help consumers trace their ancestry, identify relatives and tell them why they like or don’t like the taste of cilantro. Yes, that information can be fun. But Alzheimer’s disease, cancer and heart disease are serious matters. Our concern remains that genetic tests for diseases, just like other tests for medical conditions, such as hemoglobin A1C for diabetes (glucose control) should be accurate. Armed with that accurate information, consumers can take appropriate steps to take charge of their health.

Accurate information empowers. Consumers deserve no less.

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

Filling Information Gaps for Women in Medical Device Clinical Trials

By: David Strauss, M.D., Ph.D.

At FDA’s Center for Devices and Radiological Health (CDRH), results from clinical trials often serve as the foundation for our decisions to approve the most important medical devices—devices, such as implantable heart devices, that carry the greatest risk to patients and have the potential to save or sustain life.

David StraussWhile there is risk inherent with all medical devices and procedures, we look for potential gaps in that foundation—gaps that could be filled with more information or data.

One information gap is that there are not enough women enrolled in some clinical trials.

Why is that a gap?

Underrepresentation of women (or minority or ethnic groups) results in a lack of information for these patients and their physicians regarding risks and benefits of some medical products. Certain differences between women and men—including anatomy and physiology—can lead to medical devices performing better or worse.

FDA is actively trying to learn more about how to optimize the safe and effective use of medical devices in women.

With support from FDA’s Office of Women’s Health, CDRH recently performed an analysis of data from multiple clinical trials conducted in support of cardiac resynchronization therapy (CRT), a pacemaker therapy for patients with heart failure. Only 22% of the patients in the clinical trials were women. We combined individual patient data from multiple clinical trials to increase the number of women in the analysis.

We found that women benefit from CRT significantly more than men do. Patients of both sexes with a left bundle branch block (LBBB), an electrical conduction disorder in the heart, benefited most. However, women did so at a shorter QRS duration (time to complete electrical activation of the heart) than men. In the patients with LBBB and shorter QRS duration, women had a 76 percent reduction in heart failure or death, while there was no significant benefit in men. With LBBB and a longer QRS duration, both women and men benefitted from CRT.

We discuss this in greater detail in today’s Journal of American Medical Association: Internal Medicine. It was FDA’s first individual-patient data analysis involving medical devices from multiple companies.

Later this summer, FDA plans to take two additional steps to address this information gap.

One, CDRH intends to finalize a guidance document that provides a clear framework for how to analyze and communicate data on women in medical device clinical trials.

Two, FDA intends to release an Action Plan—mandated by Congress—that contains recommendations for improving the completeness and quality of analyses of data on women, as well as other populations, in summaries of product safety and effectiveness data and in labeling.

As illustrated in today’s publication in JAMA: Internal Medicine, combining individual-patient data from multiple clinical trials is an additional research tool that can help answer questions about patient groups underrepresented in clinical trials—and help us strengthen the foundation for all of medical devices on the market.

David Strauss, M.D., Ph.D. is a medical officer in FDA’s Center for Devices and Radiological Health.

FDA Encourages Medical Device Data System Innovation

By: Bakul Patel

Thanks to advances in digital health, doctors and their patients are more frequently using computer systems to collect medical data that can provide useful information on a patient’s health.

Bakul PatelSome of these systems, referred to as “medical device data systems,” are off-the-shelf or custom hardware or software products that transfer, store, convert format, and display medical device data without modifying it, and without controlling or altering the functions or parameters of any connected medical devices.

Medical device data systems can collect and store data from a variety of other medical devices, including glucose meters, blood pressure cuffs, and weight scales. This data can be used at home to track certain information or it can be stored for a doctor to review at a later time.

Medical device data systems can be used in hospitals to collect information and data from other medical devices including bedside monitors and infusion pumps. This information can then be stored in a patient’s electronic health record for a more complete review of a patient’s total health.

In 2011, FDA issued a regulation down-classifying medical device data systems. Since that time, FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public.

Today, given the low level of patient risk, we are proposing a compliance policy under which medical device data systems should see their burdens reduced.

Why would we do that?

Since our 2011 action, we’ve been working with two other federal agencies that oversee health IT – The Office of the National Coordinator for Health IT (ONC) and the Department of Health and Human Services, and the Federal Communications Commission (FCC) on a proposed risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids regulatory duplication. In the course of our work on the proposed framework, we sought extensive public feedback. And we listened.

In light of those discussions, we believe that medical device data system products pose little risk. While every medical device and procedure carries a certain level of risk, the health IT report proposes a risk-based framework – where we use our regulatory tools, resources, and expertise where they are most needed – and that’s with devices that carry  greater levels of risk.

This allows developers of medical device data systems to focus on making these products better able to operate amongst various devices and technology systems – resulting in stronger products.

Today’s proposed guidance for manufacturers of medical device data systems is thus consistent with the health IT report we issued earlier this year with ONC and FCC on the proposed framework. That report placed health IT products in three categories according to their risk to patients. FDA’s regulatory oversight of health IT products is focused on the devices that pose higher risk to patients.

Medical device data systems are critical to the success of digital health because they transfer, store, convert, and display a variety of information from medical devices critical to understanding an individual’s health. These systems are the foundation for intercommunication and interoperability among devices and between medical devices and other health IT.

Because they pose such a low risk, FDA does not intend to enforce compliance with the regulatory controls that apply to medical device data systems. FDA believes that this will encourage greater innovation in the development and maturation of these systems.

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

Life-Saving, Smart Regulation on Behalf of Patients with Aortic Stenosis

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

At FDA’s medical devices center, we have a vision—it’s what we strive for each day in our review and assessment of new medical technology. And patients are at the very core of that vision: “Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world.”

Jeffrey Shuren

Our actions are focused on improving the health and enhancing the quality of life of patients. If a device is safe and effective, we want patients to have access to it as quickly as possible—especially if the patients suffering have little to no treatment options.

This week, we’ve taken steps to help those patients suffering from heart valve disease, which impacts more than 5 million Americans, many of whom have few treatment options and are fighting to survive.

Aortic valve stenosis is a serious, progressive, age-related disease that is commonly caused by calcium deposits on the aortic valve that cause it to narrow.. As the heart works harder to pump blood through the smaller opening, it can eventually weaken. Aortic valve stenosis can lead to fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest.

Of those 5 million Americans, 1.5 million suffer from aortic valve stenosis and some 500,000 of those have severe aortic stenosis. Patients with severe aortic stenosis will most likely need open-heart surgery to replace their aortic valve. Without such a replacement, progressive heart failure may result and 50 percent of patients may not survive more than an average of two years after the onset of their symptoms.

Until recently, aortic valve replacement required an open-heart surgical procedure, which involves accessing the heart through an incision between the ribs or through the breastbone, while the patient is supported by a heart-lung machine. Unfortunately, many of these patients are elderly and have additional conditions, such as extreme frailty or liver disease. This makes the surgical procedure either too risky to attempt (inoperable) or very risky for death and permanent complications (high-risk for surgery).

In the past few days, FDA has expanded patient access to the benefits of aortic valve replacement by approving the use of two transcatheter heart valve (THV) systems. These catheter-based therapies provide the only effective therapy for inoperable patients and are alternatives to open-heart surgery for patients at high risk for surgery. Both systems allow physicians to perform aortic valve replacement using catheters, so patients benefit from reduced symptoms of heart failure and improve their chances for survival.

Both THVs are typically implanted through an artery in the leg, without opening the chest or heart, or removing the diseased valve. The replacement valve is compressed into a thin, flexible tube called a delivery catheter. The delivery catheter and the replacement valve are inserted into the femoral artery and pushed up to the diseased valve. The replacement valve is then released from the delivery catheter to become immediately functional. If the femoral arteries are not suitable, the replacement valve can be directly inserted into the tip of the heart, other arteries, or the aorta itself, without using the heart-lung machine.

On June 12, 2014, FDA expanded the use of the CoreValve, a self-expanding THV manufactured by Medtronic, to include patients who are at high-risk for open-heart surgery. We had previously approved CoreValve only for inoperable patients. FDA based its approval of CoreValve on clinical data from a 795-patient randomized, clinical study conducted in the United States, comparing the safety and effectiveness of transcatheter aortic valve replacement using CoreValve with that of surgery in patients at high-risk for open-heart surgery. This study showed a lower mortality rate for patients treated with CoreValve.

And today, June 16, FDA approved the Sapien XT, a balloon-expandableTHV, manufactured by Edwards Lifesciences. The Sapien XT is a revised version of their earlier Sapien THV for use in patients with aortic valve stenosis who are either inoperable or at high-risk for open-heart surgery.

The Sapien XT THV uses a smaller profile delivery system than the previously approved Sapien THV. The smaller system helps patients with small or severely diseased vessels. The Sapien XT is also available with an additional, larger-size 29-mm valve, which helps patients with larger-size native aortic valves.

For the Sapien XT approval, FDA based its decision on clinical data from a randomized clinical study and several, single-arm nested registries, conducted in the U.S. The 560-subject randomized clinical trial showed that, for inoperable patients, the Sapien XT device was as safe and effective as the previously approved Sapien device, with better procedure outcomes and reduced vascular complication rates.

The agency also reviewed clinical data from the European SOURCE XT Registry, Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (TVT) Registry, and peer-reviewed articles that showed the benefits of the Sapien XT device for high-risk patients outweighed the risks of the device.

We approved the Sapien XT THV despite observing certain quality system violations during a recent inspection at the Edwards manufacturing facility where the Sapien XT delivery systems and accessories are made. Quality system requirements govern the design, manufacture, and distribution of devices, and we conduct such inspections to assure that devices are safe and effective. When violations occur, according to federal law, we cannot approve a company’s medical device—unless, we allow deviation from quality system requirements through what is known as a “variance.”

This is a rarely used regulatory action that is employed only in special situations of public health need. FDA may grant a variance from any device quality system requirement when the agency determines that it is in the best interest of the public health and that the firm seeking the variance has alternate methods and controls in place sufficient to assure that the device will be safe and effective and otherwise in compliance with the Act.

We granted Edwards Lifesciences a variance from the quality systems requirements for two reasons.

First, we determined that there is an important, immediate need for these technology options and that Sapien XT demonstrates a reasonable assurance of safety and effectiveness for its intended use. This means patients who really need this technology could and should receive it.

And second, Edwards Lifesciences presented us with an appropriate variance plan for addressing its manufacturing problems—including specific controls to permit safe use of the Sapien XT while corrections are underway.

We are committed to flexible, smart regulation, and to working with companies and the clinical community to ensure that innovative new medical devices that demonstrate a reasonable assurance of safety and effectiveness are available for patients in a timely manner.

There is a clear and important public health need for both these devices. With the additional availability of two THV systems, physicians will now be able to treat the widest possible spectrum of patients with severe and symptomatic aortic stenosis. They will be able to choose the procedure or device that best suits each individual patient based on unique patient characteristics, anatomic constraints, implant procedure risks, device characteristics, and overall benefit-risk profiles.

After all, patients are at the core of what we do.

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

Report: CDRH on Track to Improve Device Submission Review Process

By: Jeffrey Shuren, M.D.

FDA’s Center for Devices and Radiological Health (CDRH) is committed to speeding innovative new medical devices to market and to improving the efficiency of our device submission review process. That’s critical for patients getting access to medical devices that treat often life-threatening conditions. It’s also important for industry’s ability to continue developing new products.

Jeffrey ShurenWhile recent data suggest we’re making solid progress in bringing down total review times for both 510(k) submissions and our higher risk premarket approval applications, it’s always useful to get a reality check.

That’s why, as part of the 2012 Medical Device User Fee Amendments (MDUFA III), FDA agreed with the medical device industry to participate in an independent and comprehensive assessment of our review process.

A third party consulting firm assessed CDRH’s review process, management systems, IT infrastructure, workload management tools, reviewer training programs and staff turnover. Key findings were released in December 2013, along with a list of high-priority recommendations for improvements.

Their Final Report on Findings and Recommendations, released today, affirms that CDRH is on a path to meeting many of the challenges that were flagged in the months leading up to the enactment of MDUFA III, including such topics as sponsor communication, IT infrastructure, reviewer training, reviewer attrition, and submission quality.

Initially, the contractor identified 31 unique issues related to the device submission review process. They concluded that CDRH had taken steps to address 21 of those 31 issues – either through the development and implementation of new MDUFA III provisions, updated systems, and/or processes for review staff – and that we had at least begun to address another nine of the issues. Only one issue – creating the tools and metrics to assess the consistency of decision-making across the program – remained. It was the driver for one of the contractor’s high-priority recommendations.

After the December report came out, we put together our own plan of action to implement the high-priority recommendations. These recommendations call for:

  • Developing criteria and establishing mechanisms to improve consistency in decision-making throughout the review process.
  • Providing mandatory full staff training for the three primary IT systems that support MDUFA III reviews.
  • Identifying metrics and incorporating methods to better assess review process training satisfaction, learning and staff behavior changes.
  • Adopting a holistic, multi-pronged approach to address five quality component areas to standardize process lifecycle management activities and improve consistency of reviews. This approach addresses such topics as corrective and preventive action and continuous process improvement, resource management, document management and system evaluation.

This action plan, also out today, has been divided into two stages. The first stage includes those actions needed to address specific recommendations identified in the December report, most of which will be implemented by 2016. The second stage covers longer-term actions to further enhance the efficiency of our processes beyond what the contractor recommended. We will now begin to execute this action plan. In addition, as we committed to do under MDUFA III, we will now develop an implementation plan for the new recommendations in this final report.

I encourage you to take a close look at the report and our plan of action. I think you’ll agree with me that sustained focus on these various management improvements will translate to more consistent and efficient reviews, advanced innovation and ultimately improved patient health.

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

OpenFDA: Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data

By: Taha A. Kass-Hout, M.D., M.S.

Today, I am pleased to announce the launch of openFDA, a new initiative from our Office of Informatics and Technology Innovation (OITI). OpenFDA is specifically designed to make it easier for web developers, researchers, and the public to access and use the many large, important, health data sets collected by the agency.

Taha Kass-HoutThese publicly available data sets, once successfully integrated and analyzed, can provide knowledge and insights that cannot be gained from any other single source.

Consider the 3 million plus reports of drug adverse reactions or medication errors submitted to FAERS, the FDA Adverse Event Reporting System (previously AERS), since 2004.

Researchers, scientists, software developers, and other technically-focused individuals in both the private and public sectors have always been invited to mine that publicly available data set – and others – to educate consumers, which in turn can further our regulatory or scientific missions, and ultimately, save lives.

But obtaining this information hasn’t always been easy.

In the past, these vast datasets could be difficult for industry to access and to use.  Pharmaceutical companies, for example, send hundreds of Freedom of Information Act (FOIA) requests to FDA every year because that has been one of the ways they could get this data. Other methods called for downloading large amounts of files encoded in a variety of formats or not fully documented, or using a website to point-and-click and browse through a database – all slow and labor-intensive processes.

openFDA logoOpenFDA will make our publicly available data accessible in a structured, computer-readable format. It provides a “search-based” Application Programming Interface – the set of requirements that govern how one software application can talk to another – that makes it possible to find both structured and unstructured content online.

Software developers can now build their own applications (such as a mobile phone app or an interactive website) that can quickly search, query or pull massive amounts of public information instantaneously and directly from FDA datasets in real time on an “as-needed” basis. Additionally, with this approach, applications can be built on one common platform that is free and open to use. Publicly available data provided through openFDA are in the public domain with a CC0 Public Domain Dedication.

Drug adverse events is the first dataset – with reports submitted from 2004 through 2013 available now.

Using this data, a mobile developer could create a search app for a smart phone, for example, which a consumer could then use to determine whether anyone else has experienced the same adverse event they did after taking a certain drug.

As we focus on making existing public data more easily accessible, and providing appropriate documentation and examples to developers, it’s important to note that we will not release any data that could be used to identify individuals or reveal other private information.

OpenFDA uses cutting-edge technologies deployed on FDA’s new Public Cloud Computing infrastructure enabled by OITI, and will serve as a pilot for how FDA can interact internally and with external stakeholders, spur innovation, and develop or use novel applications securely and efficiently. As we move forward with the early stages of openFDA, we will be listening closely to the public, researchers, industry and all other users for their feedback on how to make openFDA even more useful in promoting and protecting the public health.

Taha A. Kass-Hout, M.D., M.S., is FDA’s Chief Health Informatics Officer and Director of FDA’s Office of Informatics and Technology Innovation.

FDA and Health Professionals, Safeguarding the Public’s Health

By: Anna M. Fine, Pharm.D.

At our recent third annual Health Professional Organizations Conference, some of FDA’s most senior leaders exchanged views and discussed issues of mutual interest with senior representatives from key health professional organizations.

Anna FineHeld on FDA’s White Oak campus in Silver Spring, Md., and organized by the FDA’s Office of Health & Constituent Affairs (OHCA), the event was attended by 30 professional organizations representing physicians, nurses, physician assistants, dentists, optometrists, nurse practitioners, pharmacists, and others.

An open and ongoing dialogue between these professionals and FDA is a vital part of addressing many important public health issues. In her opening remarks, FDA Commissioner Margaret Hamburg offered a few examples, such as health professionals’ contributions to the FDA’s MedWatch and Adverse Event Reporting programs and their work in interpreting and addressing medical products’ safety signals. A drug’s safety profile is continually evaluated after FDA approval, and health professionals are encouraged to report suspected adverse events to FDA which allows FDA to conduct comprehensive safety evaluations. Dr. Hamburg also emphasized the importance of health professionals’ engagement in regulatory science research, which provides essential support for the agency’s decisions and ability to bring innovative products to market.

Mitch Zeller, the Director of FDA’s Center for Tobacco Products, speaking at the third annual Health Professional Organizations Conference, on May 14, 2014

Mitch Zeller, Director of FDA’s Center for Tobacco Products, speaking at the agency’s third annual Health Professional Organizations Conference. See more photos of this event on Flickr.

Key FDA leaders who gave presentations throughout the day included Mitch Zeller, the Director of FDA’s Center for Tobacco Products; Dr. Stephen Ostroff, Acting Chief FDA Scientist; and Dr. Peter Lurie, Acting Associate Commissioner of FDA’s Office of Planning and Policy.

In addition, senior scientists from FDA’s centers for drugs, medical devices and food discussed FDA’s priorities and answered questions from the audience. The robust dialogue between the panel members and our stakeholders covered many public health issues including youth and tobacco and FDA’s proposed changes to the food label.

Feedback from the audience highlights the need for such a conference.

“It’s great to have this dialogue with FDA officials. It demonstrates that they respect our organizations and want our feedback,” said one stakeholder representative.

“I love coming to these annual meetings, not only to meet FDA personnel but to talk with colleagues in other professions. This is a one-of-a-kind forum,” said another.

As a pharmacist and team leader within OHCA, I can attest to the fact that my FDA colleagues and I benefited as well. We learned a lot about our stakeholders’ concerns and established new connections with health professional organizations—contacts that we plan to follow-up on to explore new opportunities for mutual cooperation and collaboration in the interest of the public health.

Anna M. Fine, Pharm.D., is Director of the Health Professional Liaison Program in FDA’s Office of Health and Constituent Affairs.

Artifacts Tell the Story of Our Culture and FDA’s History

By: John Swann, Ph.D.

Looming sentry-likJohn Swann_0254e over the collection of artifacts that document FDA’s  history, the products  we regulate, and our interactions with the public is a rather large and curious figure. It is a green velvet head with bulbous, languid eyes and two upper teeth in an otherwise large and empty mouth. It doesn’t have ears or hair, but is marked by a few bright green pustules.  This is part of a life-size costume, an element of a public education campaign called Fight Bac! in which FDA was a major participant. It began in the 1990s to alert the public, young and adult alike, to the dangers of food-borne diseases and how to avoid them.

Countless objects in our collection tell the decades-long tale of FDA’s educational activities. For example, the agency still has a cabinet and some of its contents from the “Chamber of Horrors” exhibit that traveled around the country in the early 1930s to alert citizens, legislators, the press and others of the need for a stronger consumer protection law, drawn from egregious examples of how the law then in place fell short.  FDA officials also communicated through a variety of other displays for Congressional testimony and other purposes.

Much of the collection captures the problems that gave rise to the laws and regulations we have today, a regulatory arc often originating with a problem product—sometimes of disastrous proportions. Thus one can find specimens of:

  • Elixir Sulfanilamide, a poisonous preparation of a wonder drug in 1937;
  • thalidomide,  the globally marketed sedative that caused thousands of grave birth defects in the 1950s and 1960s;
  • Bon Vivant vichyssoise, a botulism threat in the early 1970s;
  • the ill-designed Dalkon Shield intrauterine device that caused thousands of pelvic infections; and
  • ephedra-containing dietary supplements from the 1990s that killed several users.

These are among the objects that eerily illustrate why we have the laws and regulations we do.

Decision-making in the agency depends to a considerable extent on investigations and analyses, some of the tools of which are documented here. These artifacts of the growth of regulatory science include:

  • balances and early calculating devices used in the laboratories of the Bureau of Chemistry from the 1900s to 1920s to analyze questionable foods and drugs;
  • triers, tools used for routine sampling of various foods to ensure compliance with the law, from the mid-20th century; and
  • advanced analytical devices from the 2000s to detect sophisticated counterfeiting of medicinal products.

Thatcher_CalculatorTreatments of dubious value for both serious and non-serious diseases make up a significant part of the collection as well. There are hundreds of fraudulent medications, primarily up to about World War II, as well as hundreds of medical devices from the 1950s and 1960s that offered hope with no scientific underpinning.

In addition, how the public came to engage FDA and its work, especially from the 1970s forward, can be seen in a number of objects, including protest buttons and placards from the past two decades.

Artifacts like these tell the story of how our many laws and regulations came to be, how FDA has carried them out, and how the public and FDA have engaged each other in the interest of the public health.

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

For National Women’s Health Week, FDA Resources Help Women Make Informed Health Choices

By: Marsha B. Henderson, M.C.R.P.

“Ask your mother.” In households throughout the country, women often make decisions about foods and medical products for themselves and their loved ones.

8547850411_6e188c4b11_o-1As we celebrate National Women’s Health Week (May 11-17), I want to highlight some of the many ways in which FDA is working to make sure that women have the resources they need to make informed health choices.

FDA’s Office of Women’s Health (OWH) offers educational resources to help women at every stage of their adult lives—covering topics that range from college health to healthy aging. We develop and disseminate easy-to-read health materials and educational videos for women. We also connect women to these resources and other safety information on the FDA’s For Women website.

Throughout this week, OWH will be conducting special health promotions to connect women to resources on how to stay healthy. Starting today, women can order a free kit of OWH health materials on topics including mammograms, sleep problems, pregnancy, and contact-lens care. OWH is also collaborating with FDA’s Office of Communications to share tips for new mothers and other resources.

Lastly, we’re using social media to challenge women to take better care of their health. Encourage the women in your networks to follow us on Pinterest for a special challenge and health tips each day of the week. Use #1wk4health to participate.  In addition, follow @fdawomen and join us on May 13 at 1 pm for a Twitter chat we are co-hosting with the National Institute of Health’s National Heart, Lung, and Blood Institute and Office of Research on Women’s Health; the Department of Health and Human Services’ Office of Minority Health; and Everyday Health.

Once the week is over, I hope you will continue to look to FDA for women’s health resources. Encourage the women in your community to read our health materials, watch a video or participate in one of our social media activities.

Marsha B. Henderson, M.C.R.P., is FDA’s Assistant Commissioner for Women’s Health

Building Expertise and Crossing Boundaries to Improve Oversight

By: Howard Sklamberg, J.D.

To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world.

Howard SklambergAs FDA’s Deputy Commissioner for Global Regulatory Operations and Policy (GO), I oversee FDA’s efforts to further advance its thinking and strategies from a primarily domestic to a globally focused regulator.

GO coordinates the efforts of FDA’s Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP), and works with all of FDA’s product centers on scientific, manufacturing or other regulatory challenges. The highly skilled and dedicated workforce in ORA and OIP is responsible for conducting domestic and foreign inspections, deepening collaborations with local, state and foreign regulatory partners, helping these regulatory partners to strengthen their regulatory systems, and fostering the use of science-based standards and regulatory coherence around the globe to promote the public health of our citizens.

We have to be able to share information with our regulatory partners. We need their help to implement new regulations that have worldwide impact on the oversight of food under the Food Safety Modernization Act and medical products under the Food and Drug Administration Safety and Innovation Act. Working together with these partners, we can ensure an effective public health safety net for our citizens and communities.

An important new priority for FDA is to make fundamental changes in the way we operate in today’s world by aligning our efforts across the agency to keep pace with the acceleration of scientific innovation and the global expansion of the markets. So much of FDA’s work cuts across multiple product areas. How do we make that work as a large and complex agency?

Commissioner Hamburg and senior leaders across the Agency are committed to strengthening our ability to do just that and are collaborating to achieve greater operational and program alignment across the Centers and ORA.

A key part of this process is to enhance specialization across FDA. For ORA, enhanced specialization means that investigators, compliance officers, import reviewers, laboratory personnel, managers and others will have increased technical expertise in a specific commodity area and will work closely with subject matter experts in FDA’s centers. Over time, ORA’s geographic-based model will evolve to a commodity-specific, program-based model that will provide ORA staff the opportunity to gain increased expertise in specific product areas, such as pharmaceuticals, food, animal feed, medical devices, biologics, and tobacco. They will work as part of a team with the staff from other centers, collaborating, for example, with the Center for Drug Evaluation and Research on pharmaceutical oversight or with the Center for Food Safety and Applied Nutrition on food safety issues.

It is especially important that experts in the centers and ORA be engaged in helping to develop compliance policies and priorities. Working with the centers on these broader concerns puts ORA investigators and compliance officers in a better position to implement the preventive approaches contained in new statutes and work together more seamlessly with the centers.

These and other changes that are part of the agency’s focus on program alignment will deepen our knowledge and make us more effective and efficient, with more clarity and coherence in our communications and actions.

This process is still in its early stages. There is a lot of planning still to be done, and we will work to ensure a transparent and inclusive process. Nevertheless, change is coming and I am excited and proud to be part of a transformation that can only strengthen our efforts to safeguard the foods and medical products that are so important in the lives of people all over the world.

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