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.

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.

Salute to Science: FDA’s Student Poster Symposium

By: Margaret A. Hamburg, M.D.

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

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

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

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

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

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

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

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

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.

Resolving Disputes Concerning FDA and Medical Devices

By: David S. Buckles, PhD, FACC, and Lawrence “Jake” Romanell 

Disagreements are inevitable in science, medicine – and even life. As part of a regulatory agency committed to public health, the FDA’s medical devices center occasionally confronts scientific and policy disagreements among our staff and with the various stakeholders we strive to serve. 

Disputes can occur at any stage of a particular interaction, from an initial inquiry or pre-submission review to a final regulatory decision on an application or submission.

David S. Buckles, PhD, FACC

As Ombudsmen for FDA’s medical devices center, our office investigates complaints from outside the FDA and facilitates the resolution of disputes between FDA’s medical devices center and the industry we regulate. Since part of our job is maintaining impartiality and neutrality, we are a good starting point if you have a complaint, question, or dispute of a scientific, regulatory, or procedural nature. Given the inevitably of disputes, what we find important is how we deal with those disagreements. 

Legislation passed last year by Congress introduced the term “significant decision” to our regulatory lexicon and included certain expectations of how we are to deal with disagreements over such decisions. FDA has proposed its interpretation of what constitutes a “significant decision” in a question and answer draft guidance document, entitled, “Center for Devices and Radiological Health Appeals Processes: Questions and Answers about 517A.” This draft guidance is available for public comment. We believe that when it comes to disputes, all stakeholders play an important role in resolution. Therefore, we strongly encourage interested parties to provide comments and suggestions to improve our appeals process to help us meet our goal of providing a fair, equitable, predictable and transparent means for seeking resolution of disputes. 

In our current experience, differences of opinion that arise before a final decision is reached can usually be resolved through discussion, or even, occasionally, mediation. If interactive discussion with a lead reviewer, team leader or Consumer Safety Officer does not move the ball forward, we have found that outreach by the stakeholder to engage Branch and Division management in the discussion usually has a good chance of success. We have never yet had a senior manager turn us down when we’ve asked them to take a look at a situation, and we strongly encourage stakeholders to make a good faith effort to connect with management at least through the Division level before considering more formal approaches. 

Lawrence "Jake" Romanell

When discussion and interaction through the Division level fails to resolve a dispute, stakeholders usually have several options. By far the most common approach is to request internal agency supervisory review as provided in the Code of Federal Regulations, at 21 CFR 10.75. When a request is made for internal agency review of a decision of an FDA employee, the decision is subject to review by the FDA employee’s supervisor. Generally, such a request for internal agency review is filed with the manager at the next organizational level above the level that either signed the document in dispute or was substantively involved in the decision. 

In the past several years FDA’s Center for Devices and Radiological Health has come a long way in standardizing the appeal process and setting consistent expectations, both internally and externally, to ensure that stakeholders with a legitimate dispute receive a fair and impartial hearing by senior management. Our updated guidance documents will make our process even more clear—and clarity helps make for smoother decisions. 

Wasn’t it Gandhi who said that honest disagreement is often a good sign of progress? 

David S. Buckles, PhD, FACC, and Lawrence “Jake” Romanell, are in FDA’s Center for Devices and Radiological Health, Office of the Ombudsman

Inspiring Young Voices on Type 1 Diabetes

By: Margaret A. Hamburg, M.D.

As FDA Commissioner I frequently learn about exciting and promising new developments in science and medicine to treat disease and improve lives. Some involve advances in science and technology and others relate to the development of improved ways of doing business that promote innovation. But the most inspirational moments relating to these developments are when I have the chance to meet with people who deal personally with the challenges of a particular disease or condition and to hear first-hand what is needed in terms of education and research and development, as well as the difference that FDA’s work can make in their lives.

Earlier this week, I had just such an opportunity, when I met with officials and representatives from the JDRF, formerly known as the Juvenile Diabetes Research Foundation, who were in town for their annual Children’s Congress. 

It was a delight to meet with the group’s President and CEO, Jeffrey Brewer and several other top officials of the organization, with whom FDA has a strong working relationship. But the highlight of the meeting was when we heard from three children with diabetes and their parents who accompanied the group’s leaders. Ten year old Willa Spalter from California, nine year old James Cravero from Iowa, and thirteen year old Fallon Blackbull from New Mexico were among 150 children who were in town to meet with government officials and share their stories of life with diabetes in order to stimulate efforts to develop policies to cure, treat and prevent the disease.

These eloquent and inspiring young people offered compelling personal stories about their struggles with the disease, which, shockingly, included having it properly diagnosed. In fact, the doctors failure to diagnose their disease until the symptoms became life-threatening highlights the very real need for more education, not simply of the public or Congress, but of the medical community itself.

As I listened to these young people I was pleased to learn how FDA’s work is making a difference in their lives and the lives of others with juvenile diabetes. Perhaps most exciting are the remarkable strides being made to develop a safe and effective “artificial pancreas.” This innovative device type automatically monitors blood glucose and provides appropriate insulin doses in people with diabetes who use insulin. It can be life-changing for individuals with insulin-dependent diabetes, helping them reduce dangerously high and low blood sugar levels and lowering the risk for future diabetes-related complications.

To advance the development of this revolutionary type of system, we have worked to foster discussions between government and private researchers and have sponsored public forums to promote rapid and efficient development of artificial pancreas devices.  Additionally, at the FDA we have prioritized the review of artificial pancreas research studies and have provided clear guidelines to industry on performance and safety standards for these systems — efforts that we hope will shorten overall study review time and ultimately get these devices into the hands of researchers and users more quickly. Most recently, we approved clinical studies for artificial pancreas devices to take place at diabetes camps this summer. This is a major milestone, as it will represent the first time in the U.S. that we have been able to study artificial pancreas devices in camp settings, where children participate in camp activities and wear the artificial pancreas during the day and night.

It was gratifying to hear how Willa, James and Fallon each participated in trials related to the artificial pancreas. They know better than anyone the benefits that come from pushing this agenda and making sure the best science is available to take on juvenile diabetes. 

I am so pleased to have had the opportunity to meet with these three courageous and inspiring young people. Hearing their stories and watching how they bravely and competently manage their diseases will provide me and my colleagues additional motivation in our work on behalf of these and other children.

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

FDA, Small Businesses, and the Common Goal of Advancing Public Health

By: Margaret A. Hamburg, M.D.

When federal agencies celebrated “Small Business Week” last month, FDA had special reason to pay tribute. It is well known that the U.S. biomedical industry plays an essential role not only in advancing the health of individuals, but also the health of the overall economy. Less well appreciated is that small businesses account for much of this activity.  A new FDA report issued to Congress this week describes the multitude of ways we work with small businesses to support their innovative ability to craft new treatments, medicines, and devices that improve the health of all Americans. 

Margaret Hamburg, M.D.The outreach efforts described in this report are vital, because small businesses not only have a unique role but also unique needs in their involvement with a regulatory body like the FDA. That’s why we’re working on a number of fronts to strengthen the ability of small businesses to engage and to help ensure that they are not disadvantaged by their size.

One way we do this is by reducing or even waiving user fees for small businesses that meet certain criteria. Sometimes a startup company might have a groundbreaking product, but lacks the financial resources to cover the full cost of user fees, which are paid to the FDA to help cover the cost of product reviews. Encouraging this kind of small business innovation is the reason FDA participates in the Small Business Innovation Research (SBIR) Program, which funds research and development projects that have potential for commercialization and public benefit. Since 2008, FDA has awarded 36 SBIR grants with the average grant being just over $170,000. Small businesses are also eligible to apply for more broadly available FDA grants, such as Orphan Product Grants, which address rare diseases and disorders, and are tailored to meet the focus and needs of small firms.

Perhaps even more important to small businesses than funding is information. FDA works hard to maintain a variety of communications with small businesses. Seminars, webinars, and workshops open to, and often specifically designed for, small businesses are offered throughout the year free of charge. Links to these event listings can be found in Appendix D of the report. FDA’s product centers also have dedicated small business offices that give companies direct points of contact, which are identified in our new report. These offices provide technical support and education to small companies, hold meetings to hear the views and perspectives of small businesses, develop informational materials, and provide an accessible channel through which small businesses can acquire information from FDA. I hope small businesses will take advantage of these resources and reach out to FDA’s small business contacts.

Small businesses also benefit from early communication with FDA during the product review process. This early communication is especially valuable in FDA’s Rare Disease Program in which most product sponsors are small firms and the product evaluations can be particularly complex for companies with limited resources. Our centers have found that early communication between FDA and product sponsors gets safe and effective products to consumers faster. 

I encourage you to read the report for more information on how FDA promotes innovative research by small businesses, protects small businesses from unreasonable regulatory barriers, and thereby allows American ingenuity to thrive.

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

Looking Back and Looking Ahead: FDASIA’s One Year Anniversary

By: Margaret A. Hamburg, M.D. 

One year ago today President Obama signed into law the Food and Drug Administration Safety and Innovation Act, bipartisan legislation reauthorizing user fee programs for innovator drugs and medical devices and establishing two new user fee programs for generic drugs and biosimilar biological products. 

Margaret Hamburg, M.D.Coming at a time of continuing budget restraints, this steady and reliable source of funding is essential to support and maintain FDA’s staff of experts who review the thousands of product submissions we receive every year, and do so in a timely and thoughtful manner. Over the years, our user fee programs have ensured a predictable, consistent, and streamlined premarket program for industry and helped speed patient access to new safe and effective products. 

One of our major undertakings since last July has been putting in place the infrastructure for a new generic drug user fee program that will expedite the availability of low-cost, high quality generic drugs. The program has already achieved several significant milestones, including reducing the backlog of generic drug applications, enhancing review efficiencies, and streamlining hiring. Likewise, reauthorization of the medical device user fee program has helped to expedite the availability of innovative new products to market, and the program has already seen a decrease in the application backlog for device submissions. 

But user fees are by no means the only focus of the 140-page law. Additionally, FDASIA includes provisions to strengthen the drug supply chain, enhance engagement with FDA stakeholders, address the problem of drug shortages, and promote innovation. 

Since last July, FDA continues to meet its FDASIA milestones, and is on track to implement more provisions very soon. Consider some of our more significant accomplishments. In the area of innovation, we launched the new breakthrough therapy designation for drugs that may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases and published guidance on the use of this and all of our expedited programs. In the area of engagement, we initiated the Patient-Focused Drug Development Program. The objective of this five-year effort is to more systematically obtain the patient’s perspective on a disease and its impact on patients’ daily lives, the types of treatment benefit that matter most to patients, and the adequacy of the available therapies for the disease. We have already held patient meetings on three major diseases and another is scheduled in September. 

Also, FDASIA is helping FDA take important steps to address the challenges posed by an increasingly global drug supply chain in which nearly 40 percent of finished drugs are imported and nearly 80 percent of active ingredients come from overseas sources. FDA has been able to halt food and devices from distribution if an inspector believes they are adulterated or misbranded, but the agency lacked this authority for drugs. FDASIA has extended the agency’s administrative detention authority to include drugs as well, and the agency is taking steps to implement this authority. In addition, earlier this year the agency pushed for higher penalties for counterfeiting and intentionally adulterating drugs before the federal sentencing commission – and succeeded. These are the first of several provisions that we must implement under Title VII, the section of FDASIA that strengthens FDA’s authorities over the drug supply chain. Later this week I hope many of you will join me at a public meeting to discuss how we might implement some of the other portions of this important section. 

To help the public keep track of our progress on these and other provisions, we’ve established a FDASIA web portal that includes a link to our three year implementation plan, which we intend to update on a monthly basis. 

Implementing FDASIA is a massive undertaking, requiring detailed planning to integrate these tasks with the rest of our workload. FDA is committed to implementing the requirements of FDASIA in a way that provides lasting improvements to public health, and we will meet these objectives as quickly as resources allow. 

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

When Conduct Becomes a Crime

By: John Roth 

In my last post, I explained how FDA’s Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to regulatory action. For Abbott Laboratories and Amgen, the price for regulatory malfeasance was high:  $1.4 billion – yes, billion — paid in criminal and civil penalties to the United States. 

Sometimes, however, the conduct of entities evinces such a complete disregard for the health and safety of the public that a criminal response is necessary. 

A case that still resonates with the FDA and law enforcement community involves the OCI investigation of the conduct of Synthes, a medical device maker, in the marketing of a bone cement product called Norian XR. The product was cleared by FDA for use in certain instances, but was specifically rejected for the use Synthes wanted: injection into the spine as part of a mixture. 

In fact, the FDA-approved label specifically warned against such use. Rather than attempt to get FDA approval through scientifically-validated clinical trials (at a cost of about $1 million, and taking about three years), Synthes decided to convince doctors to perform the procedure and then publish the results, notwithstanding the risks. And certainly, Synthes had reasons to understand the risks. Before the marketing program began, pilot studies showed that the bone cement reacted chemically with human blood in a test tube to cause blood clots. The research also showed, in a pig, that such cement-caused clots became lodged in the lungs.  

Nevertheless, Synthes executives plunged forward with a plan to conduct what amounted to an unauthorized clinical trial of the use of Norian to treat vertebral compression fractures of the spine. Equally appalling, the company marketed uses of the product in contravention of a “Black Box” warning — the most serious warning the FDA can require. 

The ensuing tragedy was inevitable. Three patients injected with the medication died on the operating table. 

Despite this, the company did not recall the product from the market, an action which would have required them to disclose details of the three deaths to the FDA. Equally egregious, Synthes officials deliberately misled the FDA during an official inspection in May and June 2004. 

After painstaking and complex work by OCI investigators, working with their colleagues in FDA’s Office of Regulatory Affairs and the scientists and public health experts in FDA’s Center for Devices and Radiologic Health, in 2010, Synthes pled guilty and paid the maximum fine allowable by law — in excess of $23 million for the company and its corporate parent. In 2011, four executives were convicted and sentenced to prison terms. 

Another similarly tragic case of reckless conduct involved ApotheCure, a compounding pharmacy in Dallas that shipped colchicine injectable solution to a medical center in Portland, Oregon. Colchicine is used to prevent gout attacks and relieve the pain of gout attacks when they occur. In 2007, three patients, within hours of receiving the drug, died. 

FDA testing of vials selected from the shipment revealed some vials as super potent — containing over 640 percent of the level of the drug that was declared on the label. Others were sub potent, containing less than 63% of the declared strength. After an OCI investigation, the pharmacy and its owners pled guilty to criminal charges in 2012. 

The penalties imposed on these two firms, Synthes and ApotheCure, and the responsible individuals cannot bring back the lives of those six innocent individuals. But OCI’s determined work produces results, and as I noted in my first post, “gives the FDA unique fact-finding tools and provides for strong, industry-wide deterrence.” We trust our forceful actions, then and now, continue to deter other companies and individuals from such reprehensible conduct. 

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

MedWatch: Improving on 20 Years of Excellence

By: Margaret A. Hamburg, M.D. 

This week FDA is proudly commemorating the 20th anniversary of MedWatch, a program which collects and reviews reports from health professionals and consumers about possible problems with drugs, medical devices and other products regulated by FDA. 

Margaret Hamburg, M.D.Reports of problems with FDA-regulated products provide information we need to protect consumers.  In the 1950s, FDA was alerted to the fatal blood disorders associated with the antibiotic chloramphenicol as a result of a lone physician’s report. This dramatic illustration of the importance of voluntary reporting prompted our initial efforts to encourage physicians to systematically report adverse medical product reactions. 

MedWatch was launched in 1993 by then-FDA Commissioner David Kessler to expand the voluntary system beyond physicians to include other health professionals such as nurses and pharmacists. 

In a journal article announcing the launch, Dr. Kessler said he hoped the new MedWatch system would encourage health care professionals to regard reporting “as a fundamental professional and public health responsibility.” 

During the past 20 years, MedWatch has prevented serious illnesses and even deaths by alerting FDA to problems. Actions range from removing products from the market to adding warnings of risks on product labels.

During that time, FDA has systematically expanded MedWatch to: 

    • make it easier for providers to report serious events;
    • make it clear to physicians and others what types of reports FDA wants to receive;
    • more widely disseminate information on FDA’s actions that have resulted from adverse event and product problem reporting; and,
    • increase physician understanding and awareness of drug-and device-induced disease.

To continue that tradition, this week FDA’s MedWatch is launching a new, consumer-friendly reporting form with less technical language. Additionally, MedWatch is working with consumer groups to promote more participation in MedWatch. 

Consumers have been encouraged to report side effects, product quality problems and other issues to MedWatch since the program was founded in 1993. However, previous efforts to increase participation have been aimed predominately at health care professionals. But the fact that more consumers are turning to the Internet to research health information created an opportunity that MedWatch is seizing. 

FDA is also launching MedWatchLearn, a web-based learning tool designed to educate students, health professionals and consumers on reporting in a way that provides the best information for reviewers to further investigate a problem. 

I urge consumers and health care professionals to submit reports, and encourage the use of the MedWatchLearn to gain a better understanding of preparing a report that is useful to FDA. Your help is invaluable, and enables us to continue ensuring that the products we regulate are safe and effective. 

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