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

Gluten-Free Labeling Consumers Can Count On

By: Virginia A. Cox 

Celiac disease is a serious health issue that can lead to critical complications if not treated. 

While there is no cure for celiac disease (CD), there is one way to manage it – following a gluten-free diet. The only choice for the up to three million Americans living with CD is to adhere strictly to a gluten-free diet, avoiding proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. To do otherwise is to risk gradually damaging the intestines, preventing the absorption of vitamins and minerals and leading to a host of other health problems, including nutritional deficiencies, osteoporosis, miscarriages, and cancer. 

Without a standard definition of “gluten-free,” people with gluten-related health problems can never be certain if a food is likely to be tolerated by them. So as a person living with CD for over a decade, I’m delighted to say that today, FDA is mandating a new rule on food labeling that will help people with CD – people just like me –be able to trust what the words “gluten-free” mean on their food purchases. Not only will this help those with CD manage their disease more carefully, but it will also improve life for many others who are gluten intolerant or gluten sensitive. 

Food manufacturers have come a long way in providing terrific options for those who need to eat a gluten-free diet. And by providing a clear definition of the term “gluten free” for all manufacturers to follow, this rule will help ensure that all of the “gluten-free” claims on food products are reliable, consistent, and truthful. 

This is a very big deal. A celiac patient without access to proper treatment – a strict, gluten-free diet – could suffer severe health problems. I suffered from stomach issues my whole life and was constantly misdiagnosed with ulcers even as a young child. Since my correct diagnosis, I have worked hard to avoid gluten, but it is challenging. This new rule will help all of us with CD better manage our diets and our health. 

According to the National Foundation for Celiac Awareness, one of every 133 Americans has CD, and 83 percent are undiagnosed or misdiagnosed with other conditions. But as consumers and health care professionals become more aware of the disease and how to cope with it, and more confident that they can trust that those products labeled gluten-free meet a standard definition, the better off we’ll all be. 

CD can affect anyone; it doesn’t discriminate against race, age or gender. It can make eating, which I consider one of life’s great pleasures, a minefield, a thrice-daily event that is fraught with anxiety and peril. 

It’s not the FDA’s job to tell people what they should and shouldn’t eat, but it is our responsibility to make sure that people can trust what the labels say on the foods they do choose to eat. I am proud to say that today we have taken a huge step towards helping all of us with CD or any kind of gluten-sensitivity confidently manage our health. And that is good for everyone. 

Virginia A. Cox, J.D., is Associate Commissioner of FDA’s Office of External Affairs.

 

Dietary Supplements Containing Unsafe Food Additive Destroyed

By: Daniel Fabricant, Ph.D. 

In a victory for consumers, a Texas-based distributor of dietary supplements has destroyed its stock of two dietary supplements containing the stimulant dimethylamylamine (DMAA). 

In addition, a major distributor of the products – GNC Inc. - agreed to destroy the supplements in its possession after the Food and Drug Administration (FDA) obtained seizure orders for GNC facilities in three states. GNC has already destroyed its DMAA products in two of the three states, and we expect the products in the third state to be destroyed this week. 

The products – OxyElite Pro and Jack3D, distributed by USPlabs – had an estimated retail value of more than $8.5 million. Dietary supplements containing DMAA – an amphetamine derivative – are advertised as useful for losing weight, enhancing athletic performance and building muscle. Reports implicate DMAA in the narrowing of blood vessels and arteries, which can elevate blood pressure and lead to serious medical conditions, including heart attack, seizures, psychiatric disorders and even death. FDA has received reports of more than 100 illnesses associated with products containing DMAA, including six deaths. 

A noteworthy aspect of this case is that FDA invoked its administrative detention authority to protect consumers. This authority was recently amended so that it can be used more easily. 

Here’s the backstory: 

The quickest method for getting risky products off the market remains voluntary compliance. USPlabs was one of 11 companies to receive warning letters from FDA in 2012 telling them that DMAA is illegal and should not be sold. Ten of the companies quickly agreed to stop using the stimulant as an ingredient in their dietary supplements, but USPlabs challenged the legal theories we had advanced. 

Unlike drugs, dietary supplements do not need to be approved by FDA for safety and effectiveness before they are sold. In order for FDA to ban a compound in a dietary supplement, FDA is required to undertake a series of lengthy scientific and legal steps.  When FDA opts to proceed through enforcement action rather than by issuing a regulation, the process of taking a product off the market typically begins with warning letters and can proceed to a seizure action or an injunction. 

Our scientists investigated USPlabs’ contentions only to conclude that DMAA was an unsafe food additive that couldn’t be used in supplements. In April 2013, FDA sent a response letter to the company giving it 15 days to take corrective action. 

When the company said it would continue to sell the remaining stock of supplements containing DMAA, the state of Texas temporarily embargoed both products and FDA in turn invoked its administrative detention authority. Before Congress passed the FDA Food Safety Modernization Act of 2011 (FSMA), FDA could detain food only if an authorized agency representative had credible evidence or information that the article of food presented a “threat of serious adverse health consequences or death to humans or animals.”  But under FSMA, FDA can now detain food if an authorized agency representative has reason to believe that the product is adulterated or misbranded. If this standard is met, FDA can detain foods for up to 30 days, halting any shipments of suspect products while the agency considers other legal steps such as seizure or injunction. 

In this case, before the 30 days were up, USPlabs agreed to destroy its remaining stock. It had already committed in April 2013 to stop putting DMAA in the products. 

At GNC facilities in Pennsylvania and Arizona, FDA oversaw the destruction of GNC’s stores of OxyElite Pro and Jack3D, and the company has agreed to destroy its remaining supply in South Carolina. 

However, some products with DMAA may remain available on the Internet or store shelves while we continue working on this problem. 

Consumers are advised to read the label of any dietary supplement in their possession and discard the product if the label states it contains DMAA. Also, make sure to check FDA’s DMAA web page. DMAA may still be present in your supplement but under a different name. The website contains the full list of names that are commonly used for DMAA. So be sure to read your labels carefully. 

Finally, FDA asks health care professionals and consumers to report any adverse reactions to products containing DMAA to FDA’s MedWatch program either by:

•             completing and submitting an adverse event report online at www.fda.gov/medwatch/report.htm; or 

•             downloading and completing the adverse event reporting form, then submitting it via fax at 1-800-FDA-0178. 

Daniel Fabricant, Ph.D., is Director of FDA’s Division of Dietary Supplement Programs

Proposed Rules Will Strengthen Global Food Safety

By: Margaret A. Hamburg, M.D.

It’s a small world.

Every day, there’s a good chance that some of the food you’re eating came from another country. Fifteen percent of the food we eat, including nearly 50 percent of the fresh fruit and 20 percent of vegetables, is imported each year.

Margaret Hamburg, M.D.That’s why it’s so important that we do everything we can to help ensure that foods exported to the United States are safe for you and your family. To that end, two new rules that we propose today focus on preventing food safety problems before they happen.

These rules would make importers more accountable for food safety, and would enhance our ability to monitor conditions and standards in foreign facilities that produce and process food.

While we will continue to rely on inspections at U.S. ports of entry to keep contaminated foods from entering our country, under these proposed rules, we will significantly enhance our ability to identify issues before food gets to our shores.

The bipartisan Food Safety Modernization Act (FSMA), signed by President Obama in January 2011, calls for a new level of accountability for everyone involved in the food supply chain, even if that chain begins halfway around the world.

So, in accordance with FSMA, we are proposing these rules:

  • The Foreign Supplier Verification rule will require importers to verify that foreign suppliers are producing food in a manner consistent with U.S. standards. Under the proposed rule, in general, importers would be required to identify potential hazards associated with each food and verify that appropriate steps have been taken to adequately control those hazards.
  • The Accredited Third Party Certification proposed rule would establish a system to strengthen the quality and credibility of safety audits and certifications for food exported to the United States.

These two proposed rules build on two other FSMA rules proposed earlier this year focused on ensuring the safety of produce and food facilities.

In the century that has passed since President Theodore Roosevelt signed the Food and Drugs Act of 1906, food safety has been a driving force for FDA and part of our core mission.

We know that to protect American consumers, our work doesn’t stop at national borders. The world may be changing, but FDA’s mission to continue to ensure the safety of the food supply for you and your family has not.

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

FDA’s Special Agents: On the Job to Protect the Public

By: John Roth

As noted in my previous three posts, FDA’s Office of Criminal Investigations (OCI) is an integral part of FDA’s mission to protect the public’s health. Our top-flight special agents –who have investigative authority similar to other federal law enforcement agencies – give the FDA unique fact-finding tools and provide for strong, industry-wide deterrence. Their work is different from, but enhances, the regulatory inspectors and investigators that make up the bulk of FDA’s field operations. 

Who are these special agents? They are federal law enforcement officers and they have experience: our average agent has been in federal law enforcement for over ten years, a necessary requirement given the sophistication required to work the wide range of OCI cases. 

Each special agent undergoes specialized training to be effective in their job, including firearms and personal safety training, advanced Special Agent training, and training in FDA law.  Throughout their career, OCI agents will keep up to date on the latest trends by participating in what is called “in-service training.”  Additionally, agents will take specialized training in other areas of federal law enforcement, including cybercrime investigations, computer forensics, financial tracing/asset forfeiture investigation, polygraphy, leadership and management, and advanced law enforcement techniques.

As you can see from this training regimen, we demand a lot from our agents – these skill areas are exceedingly complex. Moreover, agents must also learn such intangible skills as being able to work well with others, remain alert and focused, and hone that age-old requirement for any law enforcement officer: good instincts and a devotion to old fashioned shoe-leather doggedness. 

Our agents are located in more than 37 offices nationwide, from Hawaii to Puerto Rico, and work with law enforcement counterparts in many countries, as well as international organizations like Interpol, Europol, and the Permanent Forum on International Pharmaceutical Crime. 

No agent can go it alone, of course, and we rely on an outstanding supporting cast to help us: our “can-do” support staff, who make running a complex nationwide law enforcement program look effortless, the unmatched scientific and public health experts in the FDA centers and the civil-side inspectors and compliance officers in the field, who we rely on for help with complex, scientific cases, and finally prosecutors in the Department of Justice, who have embraced the FDA public health mission. 

My three previous FDA Voice posts highlighted several of the more significant, colorful, and sometimes tragic cases with which OCI has been involved. The first post looked at how we use our top-flight federal agents to work undercover in investigating shadowy overseas drug counterfeiters. The second post looked at high-profile instances of non-compliance right here in the United States – with our work resulting in a $1.4 billion fine. The third post looked at the callous and utter disregard for life caused by corporate actors, which necessitated a criminal response. Yes, these cases involved detailed, complex organization and a range of professional skills. 

But let me emphasize: OCI is doing this work every day. In fact, about every 30 hours, throughout the year, we are gaining a conviction, in crimes ranging from street level pharmaceutical diversion schemes to corporate fraud. In Fiscal Year 2012, OCI agents were responsible for cases that yielded over $4.9 billion in fines and restitution – monies that are paid directly to the U.S. Government or to specific victims of the criminal acts we investigate – an average of over $22 million per special agent. 

FDA’s Office of Criminal Investigation is the only federal law enforcement agency whose mission is exclusively directed at protecting the public’s health. And, criminal enforcement is a critical part of FDA’s enforcement and compliance strategy, a strategy designed to protect people from dangerous products, fraudulent schemes, and unscrupulous criminals. 

Through these four FDA Voice posts, I hope that we have made our OCI team better known to our FDA colleagues and to the public. The vast majority of the FDA-regulated entities respond to FDA’s ordinary regulatory tools. However, OCI stands ready and on watch to locate, investigate, and bring to justice those individuals and entities who disregard and break our public health laws. 

John Roth is Director of FDA’s Office of Criminal Investigations

Spirit of Cooperation Informs Guidance for Egg Producers

By: Michael R. Taylor, J.D. 

To make sure that the eggs you serve your family for breakfast are safe to eat, FDA went directly to the source: the farm. 

What we learned in visits to farms across the country gave us a real sense of some egg producers’ practical needs and the challenges they face. 

This knowledge helped us craft a draft guidance that represents FDA’s latest action related to the “Egg Safety Rule”, a multi-phase 2009 regulation enacted to help keep eggs safe from the bacterium Salmonella Enteritidis (SE), the most common cause of foodborne illness outbreaks tied to consumption of shell eggs. 

The new guidance is specifically intended to help those egg producers who provide their poultry with outdoor access comply with the rule’s various requirements such as biosecurity, rodent and pest control, cleaning and disinfection and refrigeration. 

Egg producers who allow outdoor access face different environmental realities from facilities that keep their hens inside. The new guidance provides suggestions on how egg producers with 3,000 or more laying hens can protect their poultry from predators, pests, wild birds and other animals and comply with the new egg regulation, yet still provide hens outdoor access. (Egg producers with fewer than 3,000 laying hens and egg producers who sell all of their eggs directly to consumers are exempt from the Egg Safety Rule.) 

Before issuing the draft guidance document, FDA did its homework, talking to producers and regulators at state, regional and local meetings to explain our rules and to get first-hand information. In addition, recognizing that there are a wide variety of poultry house styles designed to provide hens with outdoor access, we visited eight poultry farms in California, Texas, Arkansas, Washington, Wisconsin, Indiana, Michigan and Massachusetts in August and September 2012. The farms we visited included operations producing eggs which are certified organic by the U.S. Department of Agriculture’s National Organic Program (NOP). The farms utilized many of the house styles producers are using. Prior to these visits, FDA worked very closely with colleagues at USDA’s NOP in order to understand NOP standards and jointly visited several organic egg farms in Pennsylvania. 

In effect, we were on a fact-finding mission to see for ourselves how these farms operate and to better understand the unique challenges these producers face. We gained a better understanding of these challenges and used this knowledge to develop a draft guidance document specifically addressing the challenges and concerns we observed. 

We strive not just to be regulators, but to work cooperatively with industry as fellow problem solvers. In this instance, producers were concerned about their ability to meet the requirements of the Egg Safety Rule, were eager to ask discerning questions that made us rethink some of our initial thoughts on how to approach the guidance, and were reassured when they learned that we intended to focus on practical, reasonable advice. 

FDA is committed to working hand-in-hand with the people who produce our foods. This approach helps ensure that we understand production processes, and put forth the best advice we can to protect consumers, whose health is our first consideration. 

We firmly believe that producers can provide hens with outdoor access and still be in compliance with the Egg Safety Rule. 

Michael R. Taylor, J.D., is Deputy Commissioner for Foods and Veterinary Medicine