FDA, ONC and FCC Encourage Stakeholder Engagement on Proposed Health IT Strategy and Framework

By: Bakul Patel

Last month I blogged about a report outlining our proposed strategy and recommendations on an appropriate risk-based regulatory framework for health information technology (health IT). Issued by the Food and Drug Administration (FDA), the HHS Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), the report was followed by a three-day public workshop with consumer, patient, health care and industry stakeholders.

Bakul PatelOur goals: to promote innovation, protect patients and avoid regulatory duplication. We just posted video of the workshop discussions online so that interested parties can view (or revisit) the events; a written transcript will follow. And public comments on the strategy and recommendations are open until July 7, 2014.

At the workshop, a series of structured panel discussions guided various talks among those present, including health IT experts, representatives from industry (mobile health, medical device and electronic health records), health care providers, research organizations and consumers. Topics ranged from industry best practices to the promotion of an environment of learning and continual improvement, including the proposed risk-based framework and the categories of health IT. In fact, promoting an environment of learning—a core priority area that our report establishes under the health management function—emerged as one of the most discussed priority areas. On the last day, participants discussed how to create and sustain the learning environment, guided by the proposed safety center, led by ONC.

In general, workshop participants agreed with the core of our report, including the need for a risk-based approach that focuses on functionality rather than platform. There also was support for the concept of a multi-stakeholder, public-private Health IT Safety Center—as proposed in the report—although participants wanted additional clarity on its participants, role and governance.

Many viewed the report as “moving the ball forward,” but all recognized that the health IT community still has much work to do. (Some called the event a “starting point.”)

This collaboration with health IT stakeholders is important. The workshop was just one step in the strengthening of our nationwide health IT infrastructure, and we look forward to continued public dialogue and participation. Engagement between health IT stakeholders and the federal government is key to realizing the promise of health IT. We encourage comments on our proposed recommendations for this multifaceted area of health care.

To submit your comments on our proposed strategy, please visit regulations.gov.

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

More information:

Learn more about the Health IT Risk-Based Framework.

Read more about the meeting.

Watch the workshop webcast.

Read the FDASIA Health Report.

FDA’s Final Guidance on Expedited Drug Approvals: Fueling Innovation and Helping Patients

By: Janet Woodcock, M.D.

Janet WoodcockIn recent years, there have been important advances to ensure therapies for serious conditions are approved and available to patients as soon as there is sufficient data to show that the therapies’ benefits outweigh their risks. Despite the progress, there is much more work to be done. Many scientific discoveries still need to be translated into treatments, while patients are urgently waiting for new life-saving therapies.

The Food and Drug Administration (FDA) is committed to doing our part to help bridge this gap. In this context, we have been actively scrutinizing, strengthening and streamlining our regulatory processes at various steps along the path from drug discovery to delivery—including the clinical development phase, the longest and most expensive period of drug development. As part of this effort, we have developed and successfully used a number of flexible and innovative approaches to expedite the development and review of drugs—to the benefit of millions of American patients. The vast majority of the time, the United States is the world’s first country to approve novel medicines. Just last year, three-quarters of the new drugs approved by FDA were approved in the United States before any other country.

Four programs that facilitate and expedite development and review of new drugs that address unmet medical needs in the treatment of serious or life threatening conditions have been especially noteworthy. A look at recent drug approvals suggests that these programs have played an important role in bringing innovative drugs to market. Nearly half of the 27 novel drugs approved by FDA last year took advantage of at least one of these expedited drug development and review approaches. And review times were as short as 4.5 months.

After incorporating input we received from stakeholders to a draft version, we are finalizing our guidance to industry today in order to provide a more detailed explanation of these programs and help drug innovators determine whether their products are likely candidates.

These expedited programs include:

Fast track designation: Providing for more frequent meetings and communications with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, including such things as the design of the proposed clinical trials and use of biomarkers.

Accelerated Approval: Basing approval not on a clinical endpoint but on an agreed upon surrogate marker, that is a measure such as  blood test or urine marker, that is believed to be indicative of a disease state and treatment effect, but not demonstrative of a direct health gain to the patient.

Priority review: Acting on drug applications within 6 months instead of 10 months for standard review, and;

Breakthrough Therapy Designation: Providing all of the benefits of Fast Track designation plus intensive guidance on an efficient drug development program, beginning as early as Phase 1, and the commitment from FDA’s review staff, including senior managers, to work closely together throughout the drug development and review process.

Certainly our new Breakthrough Therapy Designation, created as part of the 2012 FDA Safety and Innovation Act (FDASIA) has been a virtual overnight success. As of May 5, 2014, we have received 186 requests for the designation, and granted 48. Six drugs have been approved, including a late-stage lung cancer drug that was approved—four months ahead of its goal date, using evidence from a trial with 163 patients.

Since its inception in 1992, more than 80 new products have been approved under the Accelerated Approval pathway. It has long been successful in driving innovation in cancer and HIV therapies, but we’re encouraging its broader application in other areas, helped by FDASIA which clarified that FDA has the authority to consider epidemiologic, pharmacologic or other evidence developed using biomarkers or other scientific methods or tools in determining whether an endpoint can support accelerated approval. We’re also exploring whether reviewer training programs and other measures might encourage greater use of this program.

It’s important to note that our own regulatory flexibility is reducing the number of approvals under the accelerated approval program. Most of the recent new drug approvals for rare diseases—approvals of drugs that would qualify for the accelerated approval program based on the serious of the disease and the lack of available therapies and that have shown effects on surrogate or intermediate endpoints—have not been approved under accelerated approval, because they were given regular or “traditional” approval. This meant that they weren’t required to do confirmatory trials required under the accelerated approval program to verify clinical benefit, because we decided that the evidence was already strong enough.

We urge drug developers and others interested in this movement to take a close look at today’s final guidance. For those drugs that qualify, participating in one of these expedited programs can reduce the time and possibly the cost of developing new therapies that can save lives. That’s a win for drug innovation and for patients.

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

FDA and Pan American Partners Work to Strengthen Regulatory Systems

By: Charles Preston, M.D., MPH

Regulatory systems are essential for good health care because they ensure safe, high quality and effective medicines. However, these systems must be strengthened in many parts of the world — a subject that is a core effort of the Pan American Network for Drug Regulatory Harmonization (PANDRH).

Charles PrestonI had the privilege of representing the FDA at a recent steering committee meeting, and I am happy to report that this network, which includes countries from all over the Western Hemisphere, is ready to adapt to new challenges like globalization, and improve its effectiveness.

In the past, the network has concentrated on upgrading regulatory standards by developing guidances and strengthening regulator capacity through training. There have been many successes, including multiple guidances issued and numerous trainings conducted.  However, there is a recognition that these efforts need new focus.

Thus, PANDRH has a strategic plan for modernizing its activities.

Rather than only developing region-specific guidances, it proposes improving standards by leveraging the work of global bodies, such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, and the Pharmaceutical Inspection Cooperation Scheme.

To strengthen capacity for oversight, PANDRH members will work to develop and implement a globally agreed upon set of regulator competencies, and use this to drive curricula and training objectives in the region. By doing this, the regulatory workforce can be professionalized, which will strengthen it for the future.

Another new emphasis will be to use evidence to help set priorities. The secretariat and PANDRH member states will now analyze data from evaluations of regulatory systems in the region to decide on future activities and benchmark success.

The importance of these changes is obvious: in today’s world of global manufacturing, trade and consumption, national regulators must be truly professional and able to implement global standards.

These are exciting developments that portend an auspicious new direction for PANDRH. FDA will continue its active engagement in the network’s efforts. They are essential to achieving a world in which everyone has access to safe, high quality and effective medical products that can protect or restore human health.

Charles Preston, M.D., MPH, is a medical officer in FDA’s Office of International Programs

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.

FDA’s “Voice of the Patient:” Listening to Those Most Affected by Their Disease and Treatments

By: Theresa M. Mullin, Ph.D.

Last year, FDA began the Patient-Focused Drug Development (PFDD) program to more systematically obtain the patient perspective on certain diseases and their treatments.  The effort is part of an FDA commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).

Theresa MullinAfter conducting a public process to nominate disease areas for fiscal years 2013-2015, FDA held the first PFDD meeting on April 25, 2013. This meeting focused on chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME), sometimes called CFS-ME, a debilitating disease for which there are currently no FDA-approved treatments.

Here, we heard directly from patients, patient advocates, and caretakers about the symptoms that matter most to them, the impact the disease has on patients’ daily lives, and the patient experience with currently available treatments. FDA staff, including members of FDA’s Division of Pulmonary, Allergy, and Rheumatology Products, listened carefully to the personal accounts of this devastating condition.

After the meeting, we released a report titled The Voice of the Patient: Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, a detailed summary of the meeting. In this report we documented, in the patients’ own words, what mattered most to them in terms of impacts of the disease and treatment approaches. This summary included the patient testimony at the meeting, perspectives shared in 230 docket comments, as well as unique views provided by those who joined the meeting webcast.

These reports serve an important function in communicating, to both FDA review staff and the regulated industry, what improvements patients would most like to see in their daily life. FDA believes that the long-term impact of this program will be a better, more informed understanding of how we might find ways to develop new treatments for these diseases.

Soon after the CFS and ME meeting, in June 2013, we conducted similar meetings on HIV and lung cancer, and these summary reports are now available on our website. The reports for our recent meetings on narcolepsy and sickle cell disease will be posted soon.  Our most recent meeting was held on fibromyalgia on March 26, 2014. On May 13, we held the meeting on pulmonary arterial hypertension, and coming up next is the meeting on inborn errors of metabolism, on June 10.

By the end of FY 2015, we plan to have conducted at least 16 PFDD meetings to hear from patients suffering from a wide range of conditions. These are currently identified on our web page. For the remaining two years in PDUFA V, we will conduct another public process to identify the diseases that will be addressed during that time.

We are gratified by the enthusiastic response within the patient community to PFDD, and we look forward to continued success with these meetings — and the long-term benefit they can offer for drug development in important therapeutic areas.

Theresa M. Mullin, Ph.D., is Director of FDA’s Office of Strategic Programs in the Center for Drug Evaluation and Research

Progress on the 2012 Drug Innovation Report by PCAST (President’s Council of Advisors on Science and Technology)

By: Janet Woodcock, M.D.

More than 18 months ago, a group of Presidential advisors from industry, academia and the Federal government concluded that while the basic biomedical sciences have seen stunning progress in past decades, challenges remain in translating those scientific advances into practical solutions. To accelerate the development of new therapies, the President’s Council of Advisors on Science and Technology (PCAST) made a number of recommendations that called for action by all of the players in the innovation ecosystem including industry, academia, health care professionals and such federal agencies as the National Institutes of Health, the Centers for Medicare and Medicaid Services and the FDA.

Janet WoodcockPCAST’s detailed list of recommendations for FDA generally fell into four categories: advancing regulatory science through public private partnerships; encouraging the expedited approval of drugs; improving FDA’s tools for monitoring and communicating clinical benefits and risks and reforming the agency’s management practices. A review of all four categories suggests that, together, FDA, Congress, industry and patient groups have made significant progress towards addressing these recommendations since the PCAST report was released in September 2012, although some critical challenges remain.

Public-private partnerships: Just like PCAST, FDA believes that bridging the gap between drug discovery and development can only be achieved through creative collaborations. Public-private partnerships enable stakeholders to leverage expertise and resources for the conduct of mutually beneficial research activities in the precompetitive domain. And indeed, our Center for Drugs is involved in 22 science-driven, public-private partnerships that promote development of research tools, platforms, clinical databases and predictive models to advance knowledge of disease and safety profiles of drugs – some of which were funded under legislation authorized in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). The recent approval of Zykadia, for patients with a certain type of late-stage (metastatic) non-small cell lung cancer, benefited from FDA’s collaborative efforts with industry, health advocacy organizations and others to identify the molecular underpinnings of cancer that would make it possible to classify and treat cancer by specific subtype.

Expedited review: Even before the PCAST report was issued, FDA had a number of expedited development and review programs in place. Accelerated approval allows for approval of drugs for serious conditions that fill an unmet need based on the drug’s effect on a surrogate endpoint that is thought to predict clinical benefit. This can speed access to a potentially important new drug, where it might take years of study to demonstrate a survival benefit or other longer-term outcome. Fast track allows sponsors with drugs that qualify to have more frequent meetings and communications with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval. Priority review shortens the review time for certain promising drugs from 10 months to six months.

Nearly half of the 27 novel drugs approved by FDA last year took advantage of these expedited pathways, which were expanded and enhanced with the help of Congress under FDASIA. Also of note, these novel drugs were approved in as little time as 4.5 months, without compromising our high standards for safety and efficacy.

In a demonstration of the significant progress that can be made when all stakeholders come together, Congress, FDA, industry and patient groups joined together to create the Breakthrough Therapy Designation in FDASIA. This new pathway is designed for those drugs intended to treat serious or life-threatening diseases or conditions where there is preliminary clinical evidence that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint or set of endpoints. A drug that receives Breakthrough Therapy designation is eligible for all Fast Track designation features; intensive guidance on an efficient drug development program, beginning as early as Phase 1; and the commitment from FDA’s review staff, including senior managers, to work closely together throughout the drug development and review process. To explain the concepts underlying these expedited programs and help companies decide whether these expedited review programs will fit their drug, we issued a draft guidance document last June and will be issuing a final guidance soon. So far we have received 178 breakthrough designation submissions, granted 44 designations, and already approved six of the designated drugs, four of which were new molecular entities and two were for new indications for already approved drugs.

PCAST also recommended that FDA implement a drug approval pathway under which sponsors could propose, early in the development process, to study a new drug for initial approval that would be reserved for use in a specific subgroup of patients, this would thus allow a narrower development program than required for traditional approvals. While FDA has existing authority to approve products for subpopulations, in practice, drug development protocols generally evaluate risks in a broader population, resulting in larger, lengthier trials. FDA agrees that a more clearly defined Special Medical Use or Limited Population pathway could encourage novel limited population development protocols and complement FDA’s existing efforts to get drugs to small populations in need faster.  Legislation focused on a pathway for drugs for serious or life-threatening bacterial infections in patients with unmet medical need – a particular area of unmet medical need highlighted in the PCAST report – has been introduced to address this issue and we welcome the opportunity for continued discussions with stakeholders.

Communicating risks and benefits: To help guide our review process for both standard and priority review drugs, we are implementing a structured Benefit-Risk Assessment framework, as agreed to as part of our successful negotiation with industry on user fees to fund drug review activities. Information on the current statement of knowledge regarding the condition and the available therapies, the drug’s individual benefits and risks and their frequency, and any efforts that could mitigate the safety concerns are put together in a table. We are currently seeking to integrate this framework into our existing review templates and memos. The purpose is to ensure better communication of the review teams thinking during review and, most importantly, FDA’s decision-making when the agency approves a product.

Management reforms: PCAST urged a variety of management reforms, some involving staff and some involving infrastructure. We are actively modernizing our information technology platforms to advance innovation and prepare for the enormous data sets that drug sponsors are submitting from clinical studies using genome sequencing and as part of the user fee agreements we are piloting a process change that improves communication during the review process.

Much progress has been made on the PCAST recommendations through FDASIA, user fee agreements, collaborative efforts with stakeholders and the agency’s own efforts to continue to improve. And yet, we recognize that challenges remain to advance policies that enhance biomedical innovation and encourage the translation of exciting discoveries into effective therapies. FDA intends to continue working on the PCAST recommendations along with our other partners in the innovation ecosystem.

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

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

Ensuring Pharmaceutical Quality Through International Engagement

By: Howard Sklamberg, J.D.

As we’ve written and spoken so much about, the FDA has had to transform itself from a domestically-focused regulatory agency into a 21st century global health organization.  This transformation has come in the face of economic and technological changes that have revolutionized how we carry out our mission. We live in a world where other countries increasingly produce—at least in part—the food and medical products our consumers and patients use in their daily lives.

Howard SklambergProducts the FDA regulates now come from more than 150 countries—many with much less sophisticated regulatory systems than our own. In this international marketplace, 40 percent of our finished drugs are imported, and approximately 80 percent of the manufacturers of active pharmaceutical ingredients used in the United States are located outside our borders.

Ensuring the quality of products in a global environment is a tall order. At every stage in the production of pharmaceutical products, and all along the global supply chain, things can go wrong.  Products can be improperly formulated, manufactured, or packaged. They can be contaminated or counterfeited. And the challenges are multiplied when the supply chain stretches around the world.

FDA is on the ground, around the world, inspecting facilities, developing relationships and providing advice.

But securing the global supply chain requires more than that. It calls for a cooperative and worldwide endeavor. It means working with our regulatory counterparts abroad to build capacity. It means harmonizing our standards for the sake of safer products and greater efficiency. It means engaging with industry and with regional and international organizations.

The Food and Drug Administration Safety and Innovation Act (FDASIA), which Congress enacted in 2012, included some important provisions designed to improve the safety and integrity of imported drugs sold in the United States. Some of the provisions are focused on FDA’s inspectional activities overseas. For example, FDASIA increases FDA’s ability to partner with foreign regulatory authorities to leverage resources through increased information-sharing and recognition of foreign inspections.

We now have more than 60 agreements with foreign counterparts to share certain information in inspection reports and other non-public information that can help us make better decisions about the safety of foreign products.

This type of collaboration not only increases our ability to evaluate pharmaceutical facilities, but allows experts to learn from each other. The result: an outcome whose sum total exceeds its individual parts.

That is exactly why today we announced an initiative to expand on our existing work to ensure that the public has access to quality pharmaceuticals. Through this initiative, and in cooperation with the European Commission (EC) and the European Medicines Agency (EMA), FDA will aim to deepen our reliance on trusted regulators outside of the U.S. who provide equivalent public safety and quality protection.

This mutual reliance initiative builds on our existing relationships with the EC, the EMA, and member states of the European Union. Under this new initiative, the goal is to increase our exchange, with the EC and the EMA, of information that is critical to making decisions that protect the public health. And together we will be more efficient and effective in targeting our resources for inspecting pharmaceutical operations.

This is the latest step in our continuing efforts to improve the quality of pharmaceutical products – a step that will deploy a dedicated FDA team to work with our European counterparts on a host of issues. The team, which will focus full time on pharmaceutical quality, will include experts from our Center for Biologics Evaluation and Research, our Center for Drug Evaluation and Research, and our Office of Global Regulatory Operations and Policy.

As a public health regulatory agency with a global presence, we look forward to strengthening our mutual reliance and capitalizing on our shared interests. The initiative we embraced today signals yet another important step forward for pharmaceutical quality here in the U.S.—and around the world.

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

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