FDASIA at Year Two

By Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.Anniversaries are a time for stock-taking and today, on the second anniversary of the Food and Drug Administration Safety and Innovation Act or FDASIA, I’m pleased to report on the progress we’ve made implementing this multi-faceted law.

To date, we have completed nearly all of the deliverables we had scheduled for the first two years after FDASIA became law. And many of the new authorities under FDASIA are already having a positive impact on health. It’s difficult to cover all of our FDASIA work, but here are some highlights:

Preventing Drug Shortages: Drug shortages, which can have serious and immediate effects on patients and health care professionals, reached an all-time high in 2011, the year before FDASIA was enacted. In response to a Presidential Executive Order in December of that year, FDA issued an interim final rule to amend and broaden FDA regulations requiring certain manufacturers to give early notification of production interruptions that could cause drug shortages. FDASIA further broadened this requirement by requiring that other prescription drug manufacturers provide notification and also gave FDA additional authorities. In October 2013 FDA proposed a rule to implement these authorities and issued a strategic plan for addressing drug shortages. So far, with the help of early notifications, FDA was able to prevent 282 shortages in 2012 and 170 shortages in 2013. The number of drug shortages that did occur has also declined.

Promoting Innovation: FDASIA includes many provisions designed to encourage innovation. We have held meetings on the use of meta-analyses in drug applications; put in place a plan for implementing a benefit-risk framework for drug reviews, and issued a variety of guidance documents covering such topics as drug studies in children, abuse-deterrent drug development, antibacterial drug development and expedited review and development programs for serious diseases.

This latter guidance provided information that sponsors needed to know about our new Breakthrough Therapy designation that was part of FDASIA. This option exists for new drugs intended to treat a serious or life-threatening disease that, preliminary clinical evidence suggests, could provide a substantial improvement over available therapies. As of June 23, we had granted 52 requests for this designation, and of those, approved four new drugs and two new indications for previously approved drugs.

As part of our implementation of the FDASIA-related provisions related to medical devices, we proposed a strategy and recommendations for a risk-based health information technology (health IT) framework that would promote product innovation while maintaining appropriate patient protections and avoiding regulatory duplication; issued a proposed rule for implementing FDASIA’s streamlined new procedures for reclassifying a device; and published a final rule on a medical device unique identification or UDI with implementation in accordance with the timetable set in the law. UDIs will help the FDA identify product problems more quickly, better target recalls and improve patient safety. The riskiest medical devices will start bearing their UDI by September 24th.

Establishing and Strengthening User Fee Programs: An important element of FDASIA was reauthorizing user fees for prescription drugs and medical devices and creating new user fee programs for generic drugs and biosimilar biological drugs. User fees on some types of applications offer an important source of funding to support and maintain key activities, including FDA’s staff of experts who review the thousands of product submissions we receive every year. Since FDASIA took effect, review times for medical devices have been declining.  Our prescription drug user fee program is meeting or exceeding almost all of our performance goals agreed to with industry. We have acted on 54 percent of the generic drug applications, or amendments and supplements to generic drug applications which were pending in our inventory as of October 1, 2012. This helps ensure that consumers can have access to more low-cost drugs. And we have been able to provide advice concerning most of the 93 submissions from companies who are developing biosimilar biological drugs under a pathway that could also ultimately lower costs for consumers.

Enhancing Patient Engagement: A hallmark of FDASIA was a series of provisions intended to tap the patient perspective. Our Patient-Focused Drug Development Program allows us to more systematically obtain the patient’s perspective on a disease and its impact on the patients’ daily lives, the types of treatment benefit that matter most to patients, and the adequacy of the available therapies for the disease. In accordance with FDASIA, we have held patient meetings on eight diseases and have plans for meetings on 12 more. We have learned a great deal from patients in terms of their views of the symptoms of their condition, their feelings about how it affects their life, and their thoughts on ideal treatments and on participation in clinical trials to aid future drug development.  A FDA Voice blog post on patient reports captures these patient perspectives and much more.

Finally, Title VII of FDASIA provided FDA with numerous new authorities to protect the drug supply chain. We thought now was a good time to provide the public with a more detailed description of our work on Title VII, so we asked Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations and Policy, to write a separate blog on that topic.

FDA laid out a three-year plan for implementing FDASIA and we’re on our way to achieving our stated goals. To help the public follow our progress, we set up a dedicated webpage—the FDASIA-Track. It provides useful links to each action and is updated on a regular basis.

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

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

Johns Hopkins and UCSF-Stanford join FDA’s Centers of Excellence in Regulatory Science and Innovation

By: Stephen M. Ostroff, M.D.

If you’ve been following my blog series about the Office of the Chief Scientist (OCS), you know about a critical component of nearly all FDA efforts to promote innovative approaches to developing and evaluating our regulated products – collaboration! This week FDA made two new additions to its network of academic partnerships known as Centers of Excellence in Regulatory Science and Innovation (CERSIs).

Stephen OstroffThe first partner brings together a team of leading scientists at the University of California at San Francisco (UCSF) in a joint effort with Stanford University. The second, Johns Hopkins University, builds on a long history of collaboration with FDA. Both partners received FDA funding through a competitive application process to establish CERSIs that will promote cross-disciplinary regulatory science training, scientific exchanges, and leading-edge research focused on FDA science priority areas.

This latest expansion of our CERSI network is an exciting development. The specialized, cutting-edge science required for FDA’s increasingly complex mission makes it imperative that we leverage available knowledge and infrastructure from collaborative partners in academia. These partnerships enrich the breadth and depth of FDA expertise, enabling us to base our regulatory decisions on the most current scientific evidence. They also enable FDA to bring its expansive experience to academia, ensuring that the new scientific approaches being developed at these institutions can be applied in a way that increases their usefulness for evaluating FDA-regulated products. And most important of all, patients and consumers will ultimately benefit from the investment.

Like those FDA previously established at the University of Maryland and Georgetown University, CERSIs are part of FDA’s effort to promote a vibrant, collaborative, regulatory science culture that enables us to tackle the scientific challenges presented by breakthroughs in medical product development and to improve food safety and quality.

As with the others, the joint UCSF-Stanford and the Johns Hopkins CERSIs will be managed by OCS’s Office of Regulatory Science and Innovation, together with teams of scientists from across FDA. Each new CERSI brings specific goals and unique strengths to enhancing FDA’s regulatory research and review.

The UCSF-Stanford CERSI will bring West Coast representation to the CERSI network and enable FDA to access UCSF’s powerhouse in quantitative sciences and pharmacology. Pre-eminent teams of scientists from both institutions and FDA scientists will be working together to develop and offer courses and workshops in drug development and regulatory science through UCSF’s American Course in Drug Development and Regulatory Sciences (ACDRS).

This CERSI will also offer scientific exchanges and training that target three of FDA’s regulatory science priority areas: transforming toxicology to improve product safety, improving clinical studies and evaluation, and harnessing diverse data through information sciences to improve health outcomes. In addition to FDA funding, the UCSF-Stanford CERSI is leveraging funds from the two academic institutions, through courses like the ACDRS, and from a recent Burroughs Wellcome Foundation Award in Innovation in Regulatory Sciences.

The Johns Hopkins CERSI will focus on three core FDA strategic priorities: clinical evaluations, social and behavioral science, and food safety. The university’s internationally recognized faculty in these areas and its geographic proximity to FDA will facilitate intellectual exchange among university faculty, FDA staff, and scientists. FDA staff can take advantage of workshops, symposia, courses, certificate programs, and a Master’s degree in Regulatory Science as well as others areas close to FDA’s strategic goals. Johns Hopkins is also known as a leader in innovative approaches to educational and life-long learning, including Internet-based courses that will be available to FDA scientists and staff worldwide.

Collaborating with our academic partners is crucial to our ability to expand the scientific foundation and infrastructure FDA needs to deliver on the promises of using 21st century science and technology to fulfill our regulatory mission.

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

Setting the Bar for Blood Glucose Meter Performance

By: Courtney Lias

Courtney Lias is Director of the Division of Chemistry and Toxicology Devices within the Office of In Vitro Diagnostics and Radiological Devices at FDA’s Center for Devices and Radiological HealthMany of the nearly 19 million Americans diagnosed with diabetes must monitor their blood glucose (sugar) frequently throughout the day using an at-home meter to make sure that their blood glucose is within a safe range. The ability to measure blood glucose at home has given people with this serious and chronic condition the ability to better control their blood sugar and thus avoid potential complications.

In the last 10 years there has been much advancement in the development of glucose meters. They are now smaller, require a smaller blood sample for each test and produce faster results.  However, their accuracy has improved little.

At FDA’s public meeting in March 2010 on this topic, the clinical and patient communities challenged the agency to improve performance of glucose meters. Feedback gathered from that meeting directly informed the creation of two draft guidance documents released this week. These documents set forth recommendations, which are justified to help ensure that these important devices are designed to be more accurate and reliable for the patients who need them. To address this need, this week we are proposing new recommendations for labeling, meter performance evaluation, manufacturing controls, and cleaning and disinfection procedures to help improve the accuracy and performance of blood glucose meters.

FDA recognized the need to optimize the safe use of blood glucose meters in two distinct settings: self-monitoring using devices purchased over-the-counter, and use in a clinical setting by health care professionals. FDA believes that by distinguishing where these devices are used, they can be better designed to meet the needs of their intended populations and ensure greater safety and efficacy.

Historically, devices used in these two settings have been studied using the same methods and standards. However, it has become increasingly clear that meters used in these different settings have unique characteristics and different design specifications. For example, critically ill patients in health care settings may have physiological variables, like abnormal oxygen levels, that could interfere with the accuracy of the blood glucose meter. Patients who use over-the-counter glucose meters and test strips at home vary in age, how much they know about how to use blood glucose tests, and other critical factors that might affect the  accurate use of the device.

To distinguish between FDA recommendations for blood glucose meters used in health-care facilities, and those intended for self-monitoring by lay-persons, the agency is issuing separate draft guidances for each one, that is:

  • prescription-use blood glucose meters, for use in point-of-care professional health-care settings, and
  • blood glucose devices purchased over-the-counter, intended for self-monitoring by lay-persons.

We believe that these recommendations will help ensure that glucose meters meet critical standards for accuracy in the hands of people with diabetes, who rely on them to manage their disease. Please help us in this effort by providing specific comments to these draft guidance documents to let us know if you agree with our recommendations or whether you have suggestions to further improve them.

Improving the quality of blood glucose meters will not solve all challenges for those who live with diabetes, but it may help millions of people to avoid complications and better achieve their health goals.

Courtney Lias is Director of the Division of Chemistry and Toxicology Devices within the Office of In Vitro Diagnostics and Radiological Devices at FDA’s Center for Devices and Radiological Health

New Law Enhances Safety of Compounded Drugs and Protection of the Drug Supply Chain

By: Margaret A. Hamburg, M.D.

Since last year’s tragic meningitis outbreak and subsequent events involving compounded drugs, Congress has been hard at work to pass new legislation to provide FDA with the appropriate authorities for regulating compounded drugs to help make these products safe for the American public.

Margaret Hamburg, M.D.Over a much longer period of time, efforts have been made in Congress to enhance the security of the drug supply chain and protect consumers from exposure to counterfeit, stolen, contaminated or otherwise harmful drugs.

I am pleased that the Drug Quality and Security Act can help FDA protect public health in both of these critical areas.

One part of the new law offers a step forward in FDA’s oversight of certain entities that prepare compounded drugs. The new law will enable these compounders to register with the FDA to become “outsourcing facilities,” making them subject to certain other requirements including Federal quality standards, known as current good manufacturing practice. These facilities will also be subject to inspection by FDA on a risk-based schedule. If compounders register with FDA as outsourcers, hospitals and other health care providers will be able to provide their patients with drugs that were compounded in facilities that are subject to FDA oversight and federal requirements for current good manufacturing practice, among others. To that end, we will be encouraging healthcare providers and health networks to consider purchasing compounded products from facilities that are registered with FDA and subject to risk based inspections.

Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the law, or they will be regulated by FDA as conventional drug manufacturers.

Generally, the state boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state licensed pharmacies, including traditional pharmacy compounding. And FDA will continue to cooperate with state authorities to address pharmacy compounding activities that may be in violation of the Federal Food Drug and Cosmetic Act.

Another part of the new law enables certain prescription drugs to be traced as they move through the U.S. drug supply chain. The goal is to protect the public from exposure to counterfeit, stolen, or otherwise harmful drugs. This will require manufacturers, repackagers, wholesale drug distributors, and dispensers (other than most licensed health care practitioners) to provide product and transaction information with each sale and notify the FDA and other stakeholders of illegitimate products, which will result in improved detection and removal of potentially dangerous drugs from the supply chain.

Starting four years after enactment of the law, manufacturers, followed by repackagers, will be required to affix a unique product identifier to each drug package that contains the drug’s national drug code (NDC), serial number, lot number, and expiration date. Starting six years after enactment of the law, wholesale drug distributors, followed by dispensers, may only trade products that  are encoded with product identifiers and will be able to verify the product identifier if they determine that they have  suspect product. Ten years after enactment, supply chain stakeholders and FDA will benefit from an electronic, interoperable system which will facilitate the efficient exchange of product and transaction information for prescription drugs at the individual package level. The system, when fully implemented, will enable verification of the legitimacy of the drug product identifier down to the package level, enhanced detection and notification of illegitimate product, and improved efficiency of recalls.

The Drug Quality and Security Act is a significant step toward having new and stronger drug quality and safety laws. While the law does not provide FDA with all the additional authorities sought, these provisions are a sign of progress.

We are committed and prepared to implement the new law that will help us to further protect public health.

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

Personalized Medicine: The Future is Now

By Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.The difference between science and science fiction is a line that seems ever harder to distinguish, thanks in part to a host of astonishing advances in medical science that are helping to create a new age of promise and possibility for patients.

Today cancer drugs are increasingly twinned with a diagnostic device that can determine whether a patient will respond to the drug based on their tumor’s genetic characteristics; medical imaging can be used to identify the best implantable device to treat a specific patient with clogged coronary arteries; and progress in regenerative medicine and stem cell therapy using a patient’s own cells could lead to the replacement or regeneration of their missing or damaged tissues. Given these trends, the future of medicine is rapidly approaching the promising level of care and cure once imagined by Hollywood in futuristic dramas like Star Trek.

But these examples are not science fiction. They are very real achievements that demonstrate the era of “personalized medicine” where advances in the science of drug development, the study of genes and their functions, the availability of increasingly powerful computers and other technologies, combined with our greater understanding of the complexity of disease, makes it possible to tailor treatments to the needs of an individual patient. We now know that patients with similar symptoms may have different diseases with different causes. Individual patients who may appear to have the same disease may respond differently (or not at all) to treatments of that disease.

FDA has been playing a critical role in the growth of this new era for a number of years. Even before I became FDA Commissioner the agency was creating the organizational infrastructure and putting in place the regulatory processes and policies needed to meet the challenges of regulating these complex products and coordinating their review and oversight. It has been my pleasure to serve at FDA during this next exciting period and to help ensure that the agency continues to prioritize this evolution by anticipating, responding to, and encouraging scientific advancements.

I am very pleased to be able to present a new report by FDA as part of our ongoing efforts in this field. Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development describes many of the exciting developments and looming advances in personalized medicine, lays out the historical progress in this field, and examines FDA’s regulatory role: from ensuring the availability of safe and effective diagnostic devices, to addressing the challenges of aligning a drug with a diagnostic device, to post-market surveillance.

Outside collaboration and information sharing is essential for this field to flourish. On Tuesday, the American Association for Cancer Research and AdvaMedDX held a fruitful daylong conversation on personalized medicine to treat cancer. I was one of the speakers, participating in a conversation with Dr. Francis Collins, the head of the National Institutes of Health. Our discussion focused in part on current status of drug and diagnostic co-development and the challenges and potential of whole genome sequencing, where data can be collected on a patient’s entire genetic makeup at a reasonable cost in a reasonable amount of time.

FDA is committed to fostering these cooperative efforts, as it will require the full force of government, private industry, academia and other concerned stakeholders to maximize our efforts and fully realize the promise of personalized medicine. Our new report outlines that commitment, and helps chart the way forward so that more people can live long and prosper.

Margaret A. Hamburg is the Commissioner of the Food and Drug Administration

Hearing the Concerns of Maine Growers Striving for Agricultural Diversity

This is the fifth in a series of blogs by Deputy FDA Commissioner Michael Taylor on his multi-state tour to see agricultural practices first-hand and to discuss the produce-safety standards that FDA is proposing.

By Michael R. Taylor

Mike Taylor Visits Bob Spear's Family-Owned Farm Stand

Mike Taylor and colleagues visit the farm stand owned by the Spear family. Bob Spear (center, in the red shirt) is a farmer and a former Maine commissioner of agriculture. He is flanked by Taylor and his wife, Janet Spear.

We arrived Sunday in Portland, Maine, the first stop in our visit to growers and other food producers in New England. The green of Maine in the summer could not be more different from our trip last week to the mountainous desert of the Pacific Northwest.

In Maine, the scale and kind of farming are also different, as are the concerns about FDA’s plans to create science-based, food safety standards. The local-food movement is an important part of the culture here, and a great source of pride.

Many growers are trying to be successful by diversifying or by using innovative business models. Bob Spear, a farmer in Waldoboro and a former Maine commissioner of agriculture, is a good example. He sells much of his crop through his own beautiful farm store, which he and his wife Janet designed, and through community farmers’ markets or directly to stores.

Recently, he has found an excellent new use for some of the winter squash he produces. In the past, he culled and discarded squash with surface blemishes that make then unsuitable for retail sale even though they are perfectly good. Now, rather than throw them out, Spear peels and cuts the squash and sells it to local schools for their lunch programs. It’s a good source of income for him and it’s a good source of fresh, local produce for the schools.

But the fact that he uses his packing house to prepare that produce would make him subject to FDA’s Preventive Controls for Human Foods rule for those activities, in addition to our Produce Safety Rule for other activities. Both rules were proposed in January 2013 as part of the FDA Food Safety Modernization Act. The proposed preventive controls rule would set safety requirements for facilities that manufacture, process, pack, or hold food for people.

Will that discourage innovative approaches like the one Bob Spear has taken? Processing raw commodities creates an opportunity for introducing contamination, but we have to be sure our rules are as practical as possible for each situation.

We heard many variations on this theme of innovation, both in our visits to farms and in a listening session Monday morning in Augusta. Some revolved around the law’s exemption from most of our proposed produce safety rules for farmers whose average food sales are less than $500,000 a year and who sell the majority of that direct to consumers or to retailers or restaurants in the same state, or not more than 275 miles away from them. This exemption, coupled with the fact that FDA has proposed not to cover farms with $25,000 or less in food sales, would mean that many of Maine’s small farmers would not be covered by the rule. In fact, nationwide, we estimate that of 190,000 potentially affected produce farms, 110,000 (almost 60 percent) would not be covered because of their size and manner of distribution.

But exemptions and limitations naturally raise additional questions about how they will be applied. For example, what about dairy farmers who want to try a small produce operation? Would doing so put them over the $500,000 mark when added to their dairy sales? The law says the exemption is based on “food” sales, not produce sales, and this is how FDA has proposed to apply it. Folks in Maine are concerned that this will discourage farmers from diversifying.

Others look at the $500,000 exemption ceiling as a disincentive to grow their produce business. Why should they try to become more successful when their reward will be additional regulatory requirements? In addition, one person I talked to asked what happens if an unexpected jump in sales puts them over the $500,000 sales level. Would they have to be in instant compliance with the produce safety rule? In finalizing the proposed rules, we will try to find practical answers to questions like that.

Just as we saw in the Pacific Northwest, some growers are worried that the cost of meeting food safety regulations will be excessive and could even put them out of business. Our pledge in working toward the final rules is to make them as practical as possible so that we achieve food safety in a way that is workable across the great diversity of American agriculture, from the Pacific Northwest to New England.

Walt Whitcomb, Marilyn Meyerhans and Mike Taylor at Lakeside Orchards

Maine Commissioner of Agriculture Walt Whitcomb, left, Marilyn Meyerhans, owner of Lakeside Orchards, and Mike Taylor.

As we move forward with these regulations, the Cooperative Extension System will be a valuable resource for growers. These federally funded, university-based offices are staffed by experts available to help agricultural producers and small business owners in communities across the country with practical, research-based information. I had a chance to talk with John Rebar, who leads extension in Maine and participated in our listening session. He is committed to food safety and the welfare of Maine’s farmers and will be a great partner in doing this right.

You know the reputation folks in New England have for rugged individualism. Some of the people we met here seemed a bit skeptical of our intentions at first, thinking that we might be big-government bureaucrats going through the motions. I hope we convinced them that our interest is genuine.

Even so, after our visit to the beautiful Lakeside Orchards in Manchester, Maine, I thought it was brave for the restaurant where we had lunch to display this sign: “Welcome FDA.” (And it was an excellent meal!)

Keep watching this space. I will be filing more FDA Voice blogs this week to keep you up to date on what I learn in my travels to New Hampshire, Vermont and Massachusetts.

For more photos of my multi-region tour, visit Flickr.

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

FDA Goes 3-D

By Steven K. Pollack, Ph.D., and James Coburn, M.S.

Dr. Steven Pollack (left) holds a 3D-printed RoboHand, a prosthetic for children with amnionic banding syndrome, an illness that can prevent fingers from developing in children. Research engineer James Coburn (right) uses the 3-D printer (background) in his work in the FDA lab.

Dr. Steven Pollack (left) holds a 3D-printed RoboHand, a prosthetic for children with amnionic banding syndrome, an illness that can prevent fingers from developing in children. Research engineer James Coburn (right) uses the 3-D printer (background) in his work in the FDA lab.

This Snap-Together RoboHand Prosthetic, sized for a small child, was created at FDA with a 3-D printer.

The Snap-Together RoboHand prosthetic was invented by South African carpenter Richard van As and made available for free on the Internet. Before printing, the hand can be individually sized, and all connecting pieces are also printed. The device can now be printed for less than $100.

A hospital in Michigan implants a 3-D printed medical device into a 3-month-old boy with a rare bronchial condition and saves a young life.

A man has 75 percent of his skull replaced with a 3-D printed implant.

3-D printing—the process of making a three-dimensional solid object of virtually any shape from a digital model—is making headlines these days, and the technology, once considered the wave of the future, is rapidly becoming part of the present.

It’s spurring innovation in manufacturing, dramatically reducing the time required to design new products and allowing designs to be built that were not possible before.

Here at FDA, we’re using it to expand our research efforts and expand our capabilities to review innovative medical products. In fact, 3-D printing is fast becoming a focus in our practice of regulatory science—that is, the science of developing new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA-regulated products.

With 3-D printing, the conversion from a virtual computer model to a physical object can occur almost in real time. The printer translates virtual models into digital cross-sections for use as a blueprint for printing, laying down successive layers in different shapes.

FDA Research Engineer James Coburn operates a RapMan kit 3D printer.

James Coburn adjusts the tension on the feed mechanism for the ABS plastic filament that is the raw material for the RapMan kit 3D printer.

Two laboratories in the FDA’s Office of Science and Engineering Laboratories (OSEL) are investigating how the technology may affect the manufacturing of medical devices in the future.

At our Functional Performance and Device Use Laboratory we’ve developed and adapted computer-modeling methods to help us determine the effect of design changes on the safety and performance of devices when used in different patient populations. The 3-D technology enables us to tweak the design in ways large and small, and to see precisely how those tweaks will change both fit and functionality. In an era of increasingly personalized medicine, which involves the development of treatments that are tailored to an individual patient or a group that shares certain characteristics, including anatomical features, it helps us to fine-tune our evaluation of patient-fitted products.

At our Laboratory for Solid Mechanics we’re investigating how different printing techniques and processes affect the strength and durability of the materials used in medical devices. What we’re discovering will be valuable to our reviews of devices down the road; it will help us to develop standards and set parameters for scale, materials, and other critical aspects that contribute to product safety and innovation.

In August 2012, President Obama launched the National Additive Manufacturing Innovation Institute (NAMII), a national effort bringing together industry, universities and the federal government to provide innovation infrastructure to support new technologies and products created with additive manufacturing, the formal term for 3-D printing.

FDA has a long history of researching and regulating innovative technological practices. Regulators regularly review some of the newest technologies coming onto the market and, through our research, FDA has first-hand knowledge of these advanced techniques so we can evaluate advanced technology at an early stage—a crucial step in facilitating innovation and protecting the public health. We will continue to facilitate device innovation and keep on the cutting edge of technology and regulatory science to help ensure that the products we regulate are safe and effective.

To see more photos of how FDA is using 3-D printing technology, visit our Flickr photostream.

Steven K. Pollack, Ph.D. is Director of FDA’s Office of Science and Engineering Laboratories (OSEL) at FDA’s Center for Devices and Radiological Health. James Coburn, M.S. is a Research Engineer in OSEL.

Salute to Science: FDA’s Student Poster Symposium

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.For many people, the hot summer months in the nation’s capital mean a time to depart for the beach or other less humid destinations. But one of the events I look forward to each year takes place during the hottest days of summer, right here on FDA’s White Oak Campus just outside of Washington, DC. It’s when I get to participate in the annual Salute to Science Student Poster Symposium.  Each of the posters on display offers a detailed and stimulating summary of the approximately 100 projects undertaken by FDA student interns during their internships.

Now celebrating its 8th year, the internship program provides high school students, college undergraduates and even postgraduates with a great training ground for the next stage of their scientific education. Each intern takes on a hands-on research topic to pursue under the watchful eye of a scientific mentor from either FDA’s Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM) or from the U.S. Air Force Wind Tunnel, which is located next door to our White Oak Campus.

As I looked over the posters and talked to the students about their projects, I was struck by their scientific sophistication as well as the remarkable range of topics addressed, ranging from a “virtual human head simulator,” which provides electrical stimulation that could be used to design novel neuro-prosthetic devices, optimize treatments, and assess the safety of medical devices such as MRIs, to the evaluation of a laser beam profile on optical properties of intraocular lens implants. The array of work demonstrated not only the promise of these students, but the breadth of scientific work undertaken here at FDA.

I was especially pleased to see so many young women participating in our internship program, given that women make up only 24 percent of the nation’s overall science and engineering workforce. The fact is, FDA is a welcoming place for female scientists and engineers; in addition to me, many of our top scientific positions are held by women.

This internship, and the Commissioner’s Fellowship Program for health care professionals, scientists, and engineers who may not have considered FDA in planning their career path, are helping to lay the groundwork for and train the next generation of FDA scientists.

They are part of our efforts to integrate strong science and research training requirements and programs, cultivate the expert institutional knowledge and innovation necessary to address gaps and challenges posed by novel products and areas, and continue to ensure safety and efficacy in the service of medicine and public health.

I am confident that the bright, creative, enthusiastic, and hard-working students who participated in FDA’s intern program will be part of the next generation of scientific leaders and innovators, and seeing their efforts gives me great hope for the future of this agency, and of the nation.

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