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.

On the Road with Mike Taylor, Day 2: Frank Talk in Farm Country

By: Michael R. Taylor

We spent a second day in onion country on Monday, Aug. 12, visiting farms, food processing and packing companies, and an irrigation system. Idaho, Oregon and Washington are the top onion-producing states and we learned a lot about how onions are grown, harvested, packed and processed and how irrigation water is delivered to these high desert landscapes.

Paul Skeen, farmer and president of the Malheur County Onion Growers in Oregon, shows Mike Taylor how water is siphoned from the canal for furrow irrigation of bulb onions.

And then we listened to the concerns of farmers and others involved in the production of our foods who question whether certain standards in the Produce Safety Rule that FDA proposed in January 2013 will work in their production settings.

In this region, growers and other stakeholders in the produce industry are focused in particular on proposed regulations related to the quality of irrigation water. FDA is proposing numerical criteria for the level of E.coli in irrigation water, which has been shown to be a pathway for disease-causing bacteria.

Their reservations were plain to see when more than 150 of them came out to the Four Rivers Cultural Center in Ontario, Ore., on Monday for a listening session. In addition to my team at FDA, I was joined by Katy Coba and Celia Gould, directors respectively of the Department of Agriculture in Oregon and Idaho, and other state officials from all three states. There were also representatives from academia and the produce industry.

The room was so full that people were standing in the back; many of them had taken a break from their farming duties to attend. Person after person stepped up to speak at the open mike. These growers believe their crops are safe and are concerned about the impact the regulations would have on their businesses. Representatives of industry made the point that more data is needed before some of these regulations are put into effect.

And I was there to tell them all that they have FDA’s attention. Yes, their crops may have a low overall risk of contamination, and we are committed to issuing only those standards that are necessary for public health protection. But at the same time, we need to prevent illnesses from happening—that’s what the proposed Produce Safety Rule, mandated by the 2011 FDA Food Safety Modernization Act (FSMA), is all about.

Katy Coba (in red shirt), director of the Oregon Department of Agriculture talks to Mike Taylor and others visiting the Warm Springs Irrigation System and Owyhee Pipeline in southeastern Oregon.

We gave assurances that the proposed rule provides the opportunity for alternative ways to meet certain safety standards if those ways are scientifically proven to be effective. I hope we convinced them that we want to figure this out in a practical way—together. This trip is not just an exercise for us – we really want to learn what works on the ground-level. What we take away from this trip will have a big impact on the shape the regulations take.
FSMA is about food safety but it’s also about making sure consumers have access to a plentiful supply of fruits and vegetables, which are important for a healthy diet.  It’s about giving the public confidence in the safety of the food supply and having a stable, safe marketplace.

It was an emotional meeting and one filled with raw, honest discussions. There will be more sessions like this as we involve other stakeholders in the process of building practical, effective food-safety regulations.

As an aside, this trip has not been without a few small bumps. Our bus broke down Monday night—fortunately in a service station that had snacks—and now we’re caravanning by car. And when I’ve tried my hand at some farming tools, I’ve gotten mixed reviews. One farmer watching me try to install an irrigation siphon hose offered this sage advice: “Don’t quit your day job.”

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

Cutting the Wires: FDA Provides Industry Guidance

By: Bakul Patel

The medical device industry has gone wireless. 

Many medical devices today perform at least one function by using wireless technology to support health care delivery. In telemedicine, for example, a wireless device can enable real-time monitoring of patients from a distance – data from a patient-worn or implanted medical device goes directly to the health care professional. The transfer of data is immediate, accelerating communication, decision time and when necessary, intervention. 

However, the stakes can get high. 

What if a diabetic’s blood glucose monitor malfunctions and sends a wrong glucose reading to a doctor because another wireless device in the clinic interfered with its signal? What if a signal is completely interrupted from a monitor that the patient depends on to transmit time-sensitive health care data?  In such cases, the proper functioning of wireless medical devices can mean the difference – literally – between life and death. 

It is FDA’s role to assure that before such wireless medical devices are introduced into the marketplace, that they have been properly tested. It is essential that manufacturers first consider and test potential limitations of the wireless connectivity associated with their devices to prevent malfunctions that could harm patients. 

There are many factors to consider. For example, is there enough bandwidth (the range of available frequencies) available? In an environment crowded with different kinds of wireless devices, is there a possibility that interference could critically affect the device’s function? 

Today, FDA published the final guidance entitled, “Guidance for Industry and Food and Drug Administration Staff; Radio Frequency Wireless Technology in Medical Devices,” to help industry navigate such challenges. Our recommendations cover devices that are implanted or worn on the body, and others intended for use in locations such as hospitals, homes, clinics, and clinical laboratories. They cover such considerations that relate to the design, testing, deployment  and maintenance of safe, reliable, and secure wireless medical devices and systems. 

For example, designers and manufacturers of wireless medical devices should consider whether these devices can function properly in the environments where they are intended to be used. Another consideration is wireless coexistence. Given the limited availability of the radio frequency spectrum, wireless technologies may compete for access to the same spectrum. As a result, coexistence issues may pose risks that could result in medical device signal loss or delay that can be life-threatening. 

This guidance reflects FDA’s ongoing commitment to the practice of regulatory science; that is, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. In this instance, FDA worked closely with the Federal Communications Commission (FCC), which in 2009 was charged by Congress to develop a National Broadband Plan to ensure every American has access to wireless technology and to delineate the respective areas of expertise and jurisdiction between the agencies. 

In a prior meeting with FCC, FDA Commissioner Margaret A. Hamburg, M.D., said that while the benefits of RF wireless technology are clear, “to harness the full power of these benefits, we must navigate a delicate balance between innovation and safety and effectiveness.” 

We hope this guidance accomplishes just that. Our goal is to help industry develop a range of innovative, safe, and effective medical devices that incorporate wireless technology, which can, in turn, help reduce health care costs, enhance quality, and benefit patients and providers alike.

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

On the Road with Mike Taylor: Touring the Pacific Northwest

By Michael R. Taylor

FDA Deputy Commissioner Michael Taylor talks with Clinton Wissel, farmer and president of the Idaho Onion Growers Association.

FDA Deputy Commissioner Michael Taylor talks with Clinton Wissel, farmer and president of the Idaho Onion Growers Association.

I am touring Idaho, Oregon and Washington this week with a team of FDA colleagues to learn about agriculture in this part of the country and to discuss with farmers, representatives of the food industry, agricultural extension scientists, and state agriculture officials the most effective ways to keep produce safe for you and your family.

In January 2013, FDA proposed the Produce Safety Rule mandated by the 2011 FDA Food Safety Modernization Act (FSMA). This rule will set science-based safety standards for the production and harvesting of fruits and vegetables. Here in the Pacific Northwest, the proposed regulations of particular concern relate to the quality of irrigation water.

Although this part of the country is high desert, we have been driving by acres and acres of farmland, lush with a great diversity of crops. And this bounty is only possible because of irrigation systems managed by and for growers. The contrast is stark when you see land that isn’t irrigated – it’s dry, brown and strewn with sagebrush.

FDA Deputy Commissioner Michael Taylor visits the New York irrigation canal delivery system in Boise, Idaho

The FDA team visited the New York irrigation canal delivery system in Boise, Idaho, on Sunday, Aug. 11, 2013. Irrigation districts deliver water via canals to farm acreage. Shown from left: Tim Page, manager of the Boise Project Board of Control, FDA Deputy Commissioner Michael Taylor, Vern Case, director of the Wilder Irrigation District, and John Davis of the Treasure Valley Grape Growers.

Understandably then, farmers have questions and concerns about FDA’s proposed requirements governing irrigation water. Our goal at FDA is to enact food safety standards that are practical and work across a diversity of crops. As a result, we don’t take a “one-size-fits-all” approach to regulation. The rule provides growers the opportunity to use alternatives to some of our proposed standards for verifying that their irrigation practices are not introducing a food safety hazard.

That’s why we’re here—to see these farming operations first-hand and understand how water is being used to produce such major crops as onions, and apples and other tree fruits—crops that have a good food safety record. We are exploring how, through various approaches to alternatives and variances, we can satisfy the mandate of our new food safety law in a way that works under the conditions in the desert Northwest.

We are also assuring farmers that our proposed standards are very much works in progress. The public comment period for the Produce Safety Rule has been extended to Nov. 15, 2013. We want farmers and others to know that, after the comment period ends, we will have a lot of thinking to do, and we expect continuing collaboration for a long time to get the rules and their implementation right.

What we learn on this trip—and others like it—will guide us in creating the final version of the Produce Safety Rule. There is no substitute for talking to farmers, walking through fields and sharing meals with the people who actually produce our foods.

Our first stop was Idaho. We arrived yesterday—Aug. 11—in Boise and traveled by bus to the family farm of Clinton and Judy Wissel. Clinton is the president of the Idaho Onion Growers Association in addition to being the patriarch of this farming family.

We walked out into the onion fields and saw how the farm’s drip irrigation system works. Clinton explained that the onions are taken out of the ground and cured in the desert sun, which kills off bacteria.  With adequate scientific support, practices like this may be possible alternatives to meeting the proposed E. coli limit for irrigation water.

We shared barbecue that night with the Wissel family, joined by other representatives of the onion industry and other growers, in addition to state agriculture officials from all three states that we are visiting this week. On the family’s patio, we had the kind of dialog that we’d been hoping for, sharing observations, concerns and background.

The Wissels’ farmhouse is in a beautiful setting; it looks like an oasis. After we said our good-byes, we traveled to our next stop in Ontario, Oregon, passing orchards, hops, onions and other fields. We saw sprinkler, drip and furrow irrigation systems. All the growers and food producers we’ve met so far are very proud that they’ve created this lush farmland out of hard, dry dirt. And they have a right to be proud.

Our goal is to acknowledge that achievement and to work with them in developing standards that work for food safety and are also adaptable to all kinds of produce and growing conditions.

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

Improving Patient Care by Making Sure Devices Work Well Together

By: Bakul Patel 

Interoperability refers to the ability of medical devices to interact and for electronic health record systems to talk to each other using a common vocabulary. It is similar to the concept of “plug and play” computer attachments like a web cam or mouse, which are made so that products can operate with different brands and models of computers.

While it may seem abstract, successful interoperability among medical devices can improve patient care, reduce errors, and lower costs.

As medical devices become increasingly connected to other medical devices, hospital information systems and electronic health records, there is a growing expectation that they will be interoperable – and that the data they transmit will be secure.

A few examples illustrate the need: 

  • An infusion pump that administers medication to a patient also connects to the hospital’s electronic health record system where the physician inputs orders for specific amounts of medication to be delivered at specific times. If the infusion pump and the electronic health record are not interoperable, with clocks that are synchronized, medication errors could occur. 
  • A patient in surgery is connected to a ventilator and a central monitoring station. If the two devices are not interoperable, the monitor may send a false alarm, or fail to send a needed alarm. Either error could increase the risk to the patient. 
  • Two patients with different medical conditions both have electrocardiogram (EKG) monitors attached to check their hearts’ electrical activity. Both monitors are connected to the same computer system that records the data for later review by a physician. It’s critical that the computer system and the EKG monitors are interoperable so transmission errors do not confuse one patient’s data with the other patient’s data.

Making sure devices are interoperable requires the creation, validation, and recognition of standards that help manufacturers develop products that are harmonious and can “plug and play.”  

We at the FDA have been hard at work on this issue with hospitals, health care providers, manufacturers, standards development organizations, and other interested parties. A 2012 summit organized by FDA and the Association for the Advancement of Medical Instrumentation (AAMI), for example, brought together 266 experts from many disciplines to further the goal of improving patient care and cybersecurity — while at the same time fostering innovation — through interoperability.

As a first step, FDA has recognized a set of voluntary standards that will help manufacturers create devices that work well together and are secure.

We hope this first set of voluntary standards will encourage further efforts to identify standards and create new ones for our review, because improving the care of patients through medical devices increasingly depends on those devices and information systems being “interoperable.”

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

Innovative New Drugs Are Reaching Patients at a Fairly Constant Rate: New FDA Study Reports on 25-year record of approvals

By: Mike Lanthier

So much has been said and written about the supposed innovation gap in drug discovery that it’s generally been accepted as truth and a topic of deep angst for the pharmaceutical industry.

And yet, if you take a hard look at the data, as we did, you’ll find it isn’t true. The fact is, the way data is collected has been masking some important facts.

Conventional wisdom suggests that the pace of drug innovation should be measured by tallying the number of FDA-approved novel new medicines, known as new molecular entities (NMEs). When the number of NME approvals increases from year-to-year, media reports generally proclaim that drug innovation is on the rise; when the number dips, concerns are often raised about FDA’s drug review performance and the health of the industry as a whole.

However, while the number of NME approvals in a given year provides something of value regarding the output of novel new drugs, this perennial focus on the quantity of drug approvals may not be sufficient to provide a meaningful measure of “innovation.” This is true primarily because not all NMEs are equally innovative. For instance, one NME may offer an important new way to treat a disease, while another may work in a way that is similar to drugs already on the market.  

To help move beyond this “one-size-fits-all” approach and provide deeper insights into what trends in NME approvals can tell us about innovation, FDA examined NME approvals over the 25 years from 1987 to 2011. We identified three distinct subcategories of novel new drugs: 1) first-in-class, which represents novel drugs that use new mechanisms to treat or prevent disease 2) advance-in-class, drugs that work in ways similar to, but demonstrate significant advantages over, existing drugs, and 3) addition-in-class, essentially representing new drugs that work and perform similarly to ones we already have on the market. 

Using this measure, we found that the number of NME’s approved every year is largely driven by changes in total approvals of drugs in the addition-to-class category. Indeed, a lot of the much-hyped decline in drug approvals from historic highs observed in the mid-1990s occurred because fewer of these addition-to-class drugs were being approved. In contrast, year in and year out, approvals of the crucial first-in-class drugs have remained essentially the same.  

In other words, if the focus is placed on the more innovative drugs, no evidence of an innovation gap in drug discovery exists, as explained in a paper I co-published with other FDA officials.

While these findings are heartening, there is still great need for further drug innovation.  Recently we’ve seen successful drug innovation in areas of special need, including the first-ever drug to treat the underlying cause of cystic fibrosis in certain patients; new and effective ways to treat various forms of cancer; and drugs to treat lupus and tuberculosis, conditions that until recently had not seen a new drug therapy approved in several decades. However, for many diseases there are simply not enough FDA – approved drug therapies – and for some diseases, none are available. 

FDA continues to work with patients and drug developers to help identify areas of unmet medical need, particularly from the patient perspective. Over the next five years, under the new Patient-Focused Drug Development initiative, FDA will hold public meetings on about 17 additional medical conditions to gain better understanding of patients’ perspectives on the severity of these diseases and their current treatment options. FDA also has a new designation called “Breakthrough Therapy” for new drugs that have the potential to offer a substantial improvement over existing therapies for patients with serious or life-threatening diseases in development. The intent is to provide timely and frequent communication with drug sponsors to help expedite the development and review of these innovative therapies. 

As always, FDA will continue to approve safe and effective new drugs as efficiently as possible, with an emphasis on products that have potential for the biggest beneficial impacts on U.S. public health. And when it comes to assessing the success of our efforts and drug innovation as a whole, one thing remains clear: It’s not just about quantity of drugs, it’s also about quality. 

Mike Lanthier is an Operations Research Analyst on the Economics Staff in FDA’s Office of Planning