Considering Women’s Needs in Developing Medical Devices: Here’s ‘HoW’

By: Michelle McMurry-Heath, MD, Ph.D. 

Women differ from men in anatomy, physiology, risk factors and disease symptoms. They are also likely to use more medical devices over the course of their lives than men do.

That is why FDA is actively trying to learn more about how medical devices uniquely affect women, and how women can be better served by them.

This month we published a snapshot of how FDA is doing with such efforts. A congressionally-required report (Section 907 of the Food and Drug Administration Safety and Innovation Act) looked at the inclusion and analysis of women and other demographic subgroups in clinical studies supporting the approval of medical devices and other FDA-regulated medical products. After reviewing 2011 product applications, including 37 premarket approval applications, or PMAs, for devices, we found that in the majority of cases, sponsors provide information about women, conduct subset analyses and share information with the public in a variety of ways.

One specific activity highlighted in the report was a workshop sponsored earlier this summer by the Center for Devices and Radiological Health (CDRH) to formally launch a new program designed to more closely look at medical device use and the health of women (HoW). The three main goals of HoW are to:

  • Improve the availability, consistency and communication of information to patients and providers that is specific to women’s needs for the safe and effective use of medical devices.
  • Address identified gaps and unmet needs through targeted resources.
  • Foster the development of innovative strategies, technology and clinical study models.

Nearly 200 representatives from industry, academia, health care, federal agencies, patient and advocacy groups, gathered to discuss the issues related to medical devices and health in women and to brainstorm about effective strategies to address clinical research needs in this population.

This work builds on a December 2011 draft guidance, also highlighted in this month’s 907 report. That guidance outlined CDRH’s proposed expectations regarding sex-specific enrollment in clinical studies, data analysis, and reporting of study information. Ideally, the final guidance will provide a clear decision-making framework for when and how to analyze and communicate data involving women in device clinical studies.

The CDRH HoW program also plans to complement this by developing, in partnership with other stakeholders, strategies for communicating information about differences to the people who most need to know: health care professionals, clinical investigators, the medical device industry, and most importantly, patients.

With these activities, we are laying the groundwork for making sure the unique health needs of women are considered in research agendas and device innovation. The goal is to strengthen the focus of FDA, industry and the clinical community in developing medical devices designed to meet the unique clinical needs of women, and to communicate new information as we learn more about how differences affect treatment options and outcomes.

Now, with the issuance of the 907 report, and an accompanying docket to receive comments from the public, we hope to gain an even more in-depth understanding about demographic subgroups. The input we receive will become the starting point for developing an Action Plan, to be released next year.

These are all important steps towards ensuring that medical devices developed will take into account the unique needs of women.

Michelle McMurry-Heath, M.D., Ph.D., is the Associate Director for Science at the FDA’s Center for Devices and Radiological Health

FDA Scientists Showcase Cutting-Edge Research

By: David G. White, Ph.D.

It’s an impressive sight – 161 posters representing the work of FDA scientists involved in researching food safety and animal health.

This third annual food and veterinary science conference taking place at FDA yesterday and today demonstrates the depth and scope of research conducted by FDA scientists using the most sophisticated, state-of-the-art technology available in the world.

Our research portfolio is rich and diverse for a good reason. We need answers to help us meet our regulatory responsibilities, whether it’s making sure the food you eat, the food your pet eats or the cosmetics you may use are safe. This means knowing how to prevent contamination in produce and other foods, which is the reason behind the FDA Food Safety Modernization Act.  It also means having the right technology to detect contamination to keep harmful products out of the marketplace. 

Several posters, for example, detail how we are at the forefront in our use of a technology called DNA biochips, or microarrays – small, solid supports (glass slides, silicon chips or nylon membranes) onto which thousands of different microscopic gene sequences are immobilized, or attached, at fixed locations. Such microarrays are used to quickly compare the DNA in a sample to previously-identified DNA.

Our scientists have custom-made chips that, for example, contain the DNA of every strain of five pathogens that cause foodborne illness, like E. coli and Salmonella. They’ve also identified and catalogued over 2,900 genes in harmful bacteria that are responsible for antibiotic resistance.

The data has numerous applications for consumers. For example, it can rapidly provide information about how to treat foodborne illnesses, because it can show whether a particular strain of a bacteria is genetically-resistant to an antibiotic that a physician might consider prescribing. If it is, the physician can immediately choose another antibiotic that will be more effective. 

Scientists from FDA’s Center for Veterinary Medicine (CVM) are using the technology to monitor the emergence of pathogens that could become resistant to antibiotics due to their use in food-producing animals.

This technology also allows us to define how virulent a particular organism is – that is, its ability to cause disease — and to identify the mechanisms that make the bacteria resistant to antibiotics.

FDA has also invested in a laboratory process that determines the complete DNA sequence – or order of nucleic acids in a DNA molecule – of a pathogen at a single time. This process, whole genome sequencing, combined with DNA chips will allow scientists tracing the outbreak of a foodborne illness to say definitely, “This person was made sick by this kind of produce, grown and packaged by this company.” The proof is in the genetics. For example, E. coli is made up of about 5,000 genes. Each strain will have some genetic differences. If the genes from E. coli found on a certain bag of sprouts matches the genes of E. coli collected from a sick person, the puzzle of what caused an illness can be solved more quickly.

These projects and many others summarized at the conference were all conducted primarily by scientists from three FDA units – CVM, the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs. The conference being held in our headquarters in Silver Spring,Md., on Aug, 27 and 28, 2013, allows scientists from these three centers to share and discuss their work with colleagues across the agency as well as with federal partners at agencies such as the Centers for Disease Control and Prevention and the United States Department of Agriculture.

Our world-class scientists, doctors, and veterinarians include those with specialties in epidemiology, microbiology, chemistry, toxicology, and pharmacology, to name a few. We are also investing in scientists from a great variety of disciplines and specialties critical to carrying out our mandate to ensure food safety.

We’re in the midst of analyzing all current and anticipated research with the aim of prioritizing what we do so that it’s aligned with the most critical steps needed to protect the U.S.food supply. We are doing that in our labs, in the field, and in the offices where strategic plans are made.

As new hazards emerge and as we develop new technologies, our approaches will change in what is a continual challenge to keep pace with new developments.

The conference demonstrates the brilliance and commitment of our researchers. Their work demonstrates great promise for the future of the agency tasked with ensuring the safety of the food supply.

David G. White, Ph.D., is chief science officer and research director at FDA’s Office of Foods and Veterinary Medicine.

FDA takes step to encourage pediatric drug studies

By: Lynne Yao, M.D. 

We all know that children are not just small adults. Many changes occur in children as they grow and develop that can affect how a drug works. In fact, some drugs that work in adults may not work at all in children. There may be different safety concerns compared to when they are used by adults, or they may need to be given in a different dose. That’s why products that are used in children must be studied in children. 

Congress enacted two laws that will increase the study of drugs in children: The Best Pharmaceuticals for Children Act (BPCA) provides an incentive for drug companies to conduct FDA-requested pediatric studies by granting an additional six months of marketing exclusivity. The Pediatric Research Equity Act (PREA) requires drug companies to study their products in children under certain circumstances. When pediatric studies are required, they must be conducted with the same drug and for the same use for which they were approved in adults. 

Before BPCA and PREA became law, more than 80% of the drugs approved for adult use were being used in children, even though the safety and effectiveness had not been established in children. Today that number has been reduced to about 50%. 

Under PREA, FDA can waive studies in children if the studies are not necessary. For example, if the disease for which the drug is being used in adults does not exist in children, such as prostate cancer, FDA would waive studies for children. In some cases, FDA has allowed sponsors to defer pediatric studies, depending on the circumstances. However, deadlines for deferred studies have often been missed. 

Fortunately, FDA now has tools to discourage companies from missing deadlines for deferred pediatric studies. When Congress reauthorized PREA last year as part of the Food and Drug Administration Safety and Innovation Act, or FDASIA, it gave FDA new authorities. FDA can grant extensions for deferred pediatric studies at a sponsor’s request if there is good cause for a delay in completing the studies. For example, if the sponsor has diligently attempted to recruit patients, but is having difficulty recruiting enough pediatric patients to complete the study, FDA can grant a deferral extension. However, if a sponsor has failed to seek or obtain a deferral extension, has failed to submit deferred pediatric studies by the final due date agreed to with FDA, or has failed to request approval for a required pediatric formulation, FDA can send a non-compliance letter to the sponsor and publish the letters on the web. 

This week, FDA is publishing the first of these non-compliance letters and the sponsors’ responses. They will be posted to a public FDA web page on an ongoing basis. We believe this important step demonstrates our ongoing commitment to getting these studies done for the benefit of all infants and children. 

Lynne Yao, M.D., is Associate Director, Pediatric and Maternal Health Staff, in FDA’s Center for Drug Evaluation and Research’s Office of New Drugs

Defining Boundaries for Caffeine in Today’s Marketplace

By: Michael R. Taylor

We all know that healthy adults have consumed caffeine in coffee, tea and chocolate for centuries. Caffeine has also been added to certain soft drinks for many years. These uses of caffeine are considered by most people to be safe, but the availability of caffeine in these products has been accompanied by a sense of boundaries and some health-related advice: Coffee has traditionally been thought of as a drink for adults; pregnant women have been advised to limit caffeine intake; and parents have monitored young children’s consumption of caffeinated soda.  

In addition, most of these traditional products have not typically been marketed for their stimulant properties, though it’s no secret that caffeine, whether naturally present or added, is a remarkably effective central nervous system stimulant.  And today’s marketers have caught on to this fact in a big way. Caffeinated “energy” drinks hit the shelves over a decade ago, and, more recently, we have seen caffeine added to non-traditional products like waffles and syrup to snack foods, candy, chewing gum, and a variety of beverages – all marketed to provide “energy” through the presence of widely varying levels of added caffeine.

By breaking far outside the traditional boundaries surrounding caffeine as a component of the food supply, these products pose challenging public health and regulatory questions. They stem from the fact that these products are being marketed explicitly for their stimulant properties, are prone to being consumed under a range of new and different conditions, and are providing caffeine in forms that are attractive and accessible to children and adolescents.

From a public health standpoint, does it matter that a cold energy drink might be chugged by young athletes before or after they engage in high stress activity? Does it matter that caffeine in chewing gum is absorbed directly through the oral cavity? How will the availability of caffeine from a much wider range of products affect total intake? Will new sources substitute for traditional ones or be additive? How will children and adolescents be affected?

The regulatory questions are equally challenging. The legal framework for substances like caffeine is complicated, but one thing is clear: Companies adding caffeine to foods and beverages have an obligation to ensure there is a sound scientific basis for concluding that their uses are safe. FDA’s job is to be sure they have met that obligation. To ensure safety, FDA has the authority to place limits on the amount of caffeine that is added to food, if the science warrants such a step. Working within our statutory and public health mandate, we will take whatever actions are needed in the interest of protecting the health of consumers.  

But an understanding of the relevant science surrounding caffeine comes first and that’s why FDA turned to the Institute of Medicine (IOM), the arm of the National Academy of Sciences charged with providing the federal government with science-based input on health issues.  At FDA’s request, the IOM convened a two-day workshop earlier this month on the potential health hazards of caffeine consumption. We received valuable scientific input and heard diverse perspectives from a wide range of researchers, clinicians, and stakeholders. Caffeine is a widely studied substance, but we learned there are few simple answers to some of the questions raised by its new uses, and there are gaps in the data on some of the questions we are asking. Our commitment is to incorporate what we learned at the workshop into our ongoing scientific assessment and to consider the regulatory needs and options on that basis.  

In the interest of everyone, and drawing on the perspectives of such groups as the American Academy of Pediatrics and the American Medical Association, we think there needs to be a scientifically grounded and common sense approach to the addition of caffeine to the food supply. We applaud the restraint many food companies are exercising as we figure this out, and we will rely on collaboration with the scientific community, consumers, and the food and beverage industry to shape that approach in the context of today’s new uses of caffeine.

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

In Vermont, Innovation Advances Local Food Systems

This is the seventh 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 and preventive controls rule that FDA is proposing as we implement the Food Safety and Modernization Act of 2011 (FSMA). 

By: Michael R. Taylor

Innovation was the theme of our day in Vermont on Wednesday, Aug. 21. We visited food operations that have developed enterprising ways to make the most of local produce markets and to expand the options available to both growers and entrepreneurs.

Mad River Food Hub owner Robin Morris, right, gives a tour of the food distribution and processing facility.

Our first stop was at the Mad River Food Hub in Waitsfield. Food hubs are all about connecting small farms with markets. They distribute locally grown foods in a way that would otherwise be difficult for the owner of a small farm.

Owner Robin Morris has also provided space for the use of small food businesses. People who want to make and sell food but do not have their own facility rent space at Mad River, using the industrial kitchen, cutting room and other facilities there.

It’s an enterprising way to provide a critical service and is a central part of the economic model of a local food system. Small-scale entrepreneurs can get a start in a licensed facility, while keeping costs at a manageable level.

Robin is doing this as a business but also as way to give back to the local food system, whose broad, community-oriented values he strongly embraces. Robin and his team are very tuned in to food safety and part of the service they provide is to support the use of safe practices. Even though many of these small businesses are likely to be exempt from certain requirements under the proposed FSMA rules, they know they also have to meet their customers’ food-safety expectations, and Robin’s team helps them do that.

Later we stopped at Intervale Food Hub in Burlington for a great discussion with Travis Marcotte, Sona Desai and others who are playing leading roles in the food hub movement nationally. In addition to deepening our knowledge of the diverse food hub business models in New England and elsewhere, we had a great lunch in their big old red barn.

Mike Taylor in the hydroponic greenhouse with David Hartshorn, right, owner of Hartshorn Farm.

One of the most interesting stops on our trip was at the Hartshorn Farm in Waitsfield, where owner David Hartshorn has invested in a hydroponic facility in addition to his traditional organic farming operation. Hydroponics is a kind of agriculture that does not use soil – the plants are grown in nutrient-enriched water.

With one hydroponic greenhouse so far, David has a very high-tech system for growing lettuce with amazing efficiency. He estimates that he can grow as much lettuce in one-quarter of a hydroponic acre as he could on 10 acres of farmland. And crops could be grown all year round this way. Such diversification can help keep growers on the land, with real potential for growth. And you’ve got to love David’s entrepreneurial spirit!

Unlike the conversations in Maine and New Hampshire earlier this week, the conversations in Vermont were less about concerns that the federal government will roll over local growers with its proposed regulations, although the “don’t squash the little guy” message still came through.

This day was more about showing FDA how Vermont is using smart and creative tools to make local growers and food producers successful. What they are doing here is truly impressive and bodes well for the robust and highly diverse local food systems in New England.

Our last stop on Aug. 22 was in Massachusetts, where we received a warm reception from a key state partner—Greg Watson, commissioner of the Massachusetts Department of Agricultural Resources.

Commissioner Watson and his colleagues joined us at a listening session at the Plainville Farm in Hadley. More than 150 growers and other stakeholders attended this session and expressed many of the concerns we’ve heard in the other states about the potential impact of these proposed regulations on their operations and on their very livelihood.

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

States Have Important Role in Building Food-Safety Partnerships

This is the sixth 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

 “Live Free or Die” has been New Hampshire’s state motto since 1945, and almost seven decades later it still represents the fiercely independent spirit of the people who live here.

At Dartmouth College, Mike Taylor talks at a listening session on FDA’s proposed food-safety rules.

Washington, D.C., is a company town in many ways and when you live and work there, it’s easy not to see how the federal government is perceived in communities where people are making their living from the land. There’s a wariness of what is seen as federal encroachment in matters that people believe should be handled at the local level.

We have known for some time how important the state role will be in implementing the provisions of the FDA Food Safety Modernization Act, and that was very apparent during our conversations in New Hampshire on Tuesday, Aug. 20. Everyone agrees that keeping the food supply safe is paramount, but accomplishing that — especially in the context of smaller scale, local food systems like we find in New England — will require teamwork that crosses federal and state boundaries.

We were fortunate to be joined in this visit to New Hampshire by Lorraine Merrill, commissioner of New Hampshire’s Department of Agriculture, Markets and Food, and Chuck Ross, secretary of Vermont’s Agency of Agriculture, Foods and Markets.

Lorraine and Chuck joined us in a listening session at Dartmouth College, where the concerns about federal involvement really jumped out. Locally oriented food communities are part of the social fabric and they want to stay that way. For the farmers and many consumers here, it’s all about looking a person in the eye and having confidence in the people you’re working with. Many participants in the listening session had studied the proposed rules carefully and asked important questions about how they would apply to highly-diversified local food systems. They challenged the rules’ practical and economic feasibility as proposed.

We also heard two compelling consumer voices about the importance of establishing modern standards to prevent foodborne illness: Lauren Bush, who suffered permanent damage to her health from spinach contaminated with E. coli O157:H7, and Gabrielle Meunier, whose son Christopher was hospitalized for seven days after eating Salmonella-contaminated peanut butter.

The challenge we must meet is to create food safety rules that reduce the risk of such terrible incidents, while being workable across the great diversity of American agriculture.

After the listening session, we visited the Co-Op Food Store in Lebanon. Founded in 1936 by Dartmouth College professors and their spouses, the Co-Op now boasts multiple stores and 30,000 members. There is a huge focus on local sources, with farmers’ photos on the walls. Many Co-Op employees have been trained in retail food safety, so the Co-Op clearly has a commitment to keeping their members safe. But it also identifies strongly with the farmers and wants to see them flourish. These go beyond business relationships; they are true partnerships.

At the Edgewater Farm in Plainfield, N.H., Mike Taylor, center, listens to Chuck Ross, secretary of the Vermont Agency of Agriculture, Foods and Markets. At right is farmer Pooh Sprague.

From there we went to the Edgewater Farm in Plainfield. Owners Pooh and Anne Sprague have the kind of diverse operation that you see a lot here. In addition to the family farm, there’s a very nice farm store in which the Spragues sell not only produce grown on their farm but flowers from their fabulous gardens. And while we were talking to Pooh, Anne was packing food for Community Supported Agriculture (CSA), in which subscribers share in the harvest.

Farmers often have complex business models in which they are producing food, selling it directly to consumers, and sometimes selling foods from other farms in their stores. They are legitimately concerned about how the proposed food safety rules will affect the various facets of their operations.

However, there are a lot of misconceptions about these proposals. For example, some farmers feel that the proposed rule would require them to put up fences to keep wildlife out of their fields. Fencing an entire farm would be a big expense and we heard anxiety about that. But fencing is not a requirement under the proposed Produce Safety Rule. Rather, they would have to monitor their fields for animal intrusion and separate out produce that is reasonably likely to have been contaminated.

It’s clear we’ve got a huge job ahead in communicating the nuts and bolts of the proposed food safety regulations, as well as implementing the rules that finally emerge. And that’s where the states will be so important.

It’s about working with people you know. State agriculture departments have food safety responsibilities, but they are also there to support the agricultural system. State agriculture and health officials are on the front line; they have relationships with growers and food producers. Their role includes enforcement, but also education and assistance. The food safety law mandates a federal-state partnership, but even if it didn’t, this just makes sense.

Dealing with people they know at the state level may allay some of the fears that growers and local food retailers have about new federal standards. We will work with Lorraine Merrill, Chuck Ross and other partners to figure out how various institutions at the local, state and federal levels can best collaborate to help the produce community move forward in a way that is good for consumers and feasible for farmers.

Keep watching this space. I will be filing another FDA Voice blog this week to keep you up to date on what I learn in my travels to Vermont and Massachusetts. 

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

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

On the Road with Mike Taylor, Day 4: Looking to the Future

This is the fourth 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 

We did a lot of talking and listening on the fourth day – Wednesday, Aug. 14 – of our tour of the Pacific Northwest. It was an excellent day, as my colleagues and I spent most of it in a six-hour listening session in Yakima, Wash.

Karen Killinger, an associate professor at Washington State University and the University of Idaho, speaks to growers, representatives of the food industry and others at a listening session to discuss proposed produce safety regulations. Seated on the panel are from left: Mike Taylor, Samir Assar, Erick Snellman and Travis Minor of FDA.

There were roughly 175 people at the listening session, many of whom are professionally involved in managing food safety on behalf of the area’s growers. The questions and issues they raised were often technical and very specific to key points in the proposed produce-safety regulations. It was an invigorating discussion.

In the late afternoon we visited more farmland and packing operations, as we did on the fifth and final day – Thursday, Aug. 15. On both days, we saw a diverse array of crops that include apples, pears, onions, peppers, cucumbers, tomatoes, melons, peaches and nectarines. We learned more about different irrigation systems and approaches to using water for both frost protection and to prevent scalding from exposure to the sun.

What we’re learning about the diversity of practices will help us get our produce rules right when we finalize them down the road; it also reminds us of the importance of taking a collaborative approach to implementing the rules. The rules will provide a common food-safety accountability, but as we implement the rules, we’ll need to maintain the spirit of partnership embodied in our Northwest experience.

The Pacific Northwest tour included a visit to the packing house at Valley Fruit in Wapato, Wash.

What this entails is working with our state partners, extension services and the produce industry to provide education, training and technical assistance to help farmers comply with the rules and, most importantly, move toward the shared goal of food safety and consumer confidence in food safety. As we did with the development of the proposed rules, implementation must take into account the diversity among growers and commodities, and the importance of working with the produce community as a whole.

Together, we’ll get this right and continue toward the long-term goal of keeping our produce safe for consumers in this country and around the world.

Keep watching this space. I will be filing more FDA Voice blogs next week to keep you up to date on what I learn in my travels to New England. 

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

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

On the Road with Mike Taylor, Day 3: Families and Partnerships

This is the third 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

As I visit farms in the Pacific Northwest this week, I have been truly moved by the passion that these farmers have for their work. This is not just a job to them – it’s their life. It’s their history, too, when the work is passed down from one generation to the next.

Kyle Mathison of Stemilt Growers in Wenatchee, WA, talks with Mike Taylor.

I am struck by the intensity of their desire to connect with me and with my FDA colleagues who have joined me in this tour of Idaho, Oregon and Washington to discuss provisions of the Produce Safety Rule that the agency proposed in January 2013. They want us to understand what they’re doing and why they’re doing it.

The landscape here is amazing — mountainous desert transformed into patchworks of fertile fields by the use of extensive irrigation systems. These systems move water through canals and reservoirs from the snowpack of the Cascade Mountains and deliver it to thousands of high desert farms. Irrigation makes agriculture possible here, which is good for the farmers, but also for consumers since some of the crops grown here would be hard to produce elsewhere. They thrive in this climate.

Cherries are one of those crops and we spent much of Tuesday, Aug. 13, visiting the multi-faceted operations of Stemilt Growers in Wenatchee, Wash. The Mathison family has farmed this land for five generations, since Thomas Mathison – an immigrant from Scotland – homesteaded 160 acres on Stemilt Hill.

We saw how the varieties of cherries are harvested and then drenched in cold water to remove the field heat. We visited the composting facility that sits on 18 acres, and the Stemilt packing house. We discussed the critical role of properly made compost as a source of nourishment for organic production, both in the region and nationally, and the importance of ensuring that food safety and organic standards are compatible. The Mathisons are clearly proud of what they term their “world famous” fruit.

Andy Bary, a Washington State University research scientist, Mike Taylor, Nathaniel Lewis with the Food Safety-Organic Program at the Washington State Department of Agriculture, and Gwendolyn Wyard of the Organic Trade Association examine the compost at Stemilt Growers.

From there we went to a different packing facility, Double Diamond Fruit in Quincy, Wash., that illustrates another theme of this trip – the importance of public-private partnerships with academia, state agriculture agencies and industry to develop and implement best practices.

Karen Killinger, Ph.D., an associate professor at Washington State University and the University of Idaho, has researched ways to reduce the risk of bacterial contamination in the produce packing process. She and her colleagues have worked with Double Diamond Fruit to implement a change in the packing line for apples that was shown to be more effective in killing bacteria.

As I travel this week, I am accompanied by some of the state leaders who will be full partners with FDA in implementing the produce rule and other safety regulations.

The presence of the three directors of the state agriculture departments – Donald “Bud” Hover (Washington), Katy Coba (Oregon) and Celia Gould (Idaho) – reminds me how much we value our state partners. They have a critical role in helping ensure that safety regulations crafted in Washington, D.C., are realistic as written and become a reality in the day-to-day operations of our food producers.

We have also been joined in our bus or in our cars – depending on which vehicles are working on any given day – by industry representatives who are providing input and perspective that will help us craft a final Produce Safety Rule that will be effective for food safety and practical for farmers.

FDA can’t do this alone. I don’t think that’s ever been clearer to me than it has been this week.

Keep watching this space. I will be filing more FDA Voice blogs to keep you up to date on what I’m learning here and in my travels to New England next week.

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.