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

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

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

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

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

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

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

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

This work builds on a December 2011 draft guidance, also highlighted in this month’s 907 report.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

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

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

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

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

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

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.

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.

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

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

Working together for new solutions to cancer in children

By: Margaret A. Hamburg, M.D. 

One of the greatest pleasures I have as FDA commissioner is the opportunity to meet with so many who are making a real difference in the world of health care, including researchers, doctors, drug industry leaders, foundations, and advocates for patients and families, including most recently the Alexandria Summit for Oncology. 

The group’s two-day meeting in New York City addressed a range of topics related to the challenges and advances in treatments for cancer and featured many of the leading scientists and researchers in the field, including my colleague Dr. Richard Pazdur, the director of FDA’s Office of Hematology and Oncology Products. 

Last night I had the chance to speak to the group about developments in treating pediatric cancer. I was joined by Nancy Goodman, a passionate and effective advocate, who is the founder of a patient advocacy group called Kids and Cancer. Nancy is helping to influence discussion on this topic, and her inspiring work gives enduring meaning to the life of her son Jacob, who died of cancer in 2009. 

Pediatric medicine is an area that has long faced historic obstacles, the result of the tension between our eagerness to respond as quickly as possible to treating and developing treatments for diseases in children, and our desire to protect children from potentially dangerous side effects, particularly in the early stages of research when effectiveness is not fully known. 

Today, we are in the midst of some exciting advances in the development of improved and better treatments for cancer that we expect can and will translate into new treatments for children with cancer. Scientific progress isn’t the only reason for these advances.  Regulators, researchers and industry are also thinking and acting in new ways that are allowing us to accelerate our investigation and approval process.  

Over the past 20 years we have evolved from a view that we must protect children from research, to a view that we must protect children through research, in order to assure their access to new and effective medications. Research studies are the only way to truly determine the safety and efficacy of medication in children and to avoid possible harm when children are given drugs approved only for adults. 

Recent laws have created new mechanisms to prioritize drug research and development for children, resulting in a dramatic increase in pediatric drug trials. We are already seeing progress, with more drug companies hiring pediatric experts, and some large pharmaceutical companies developing pediatric centers of excellence. 

FDA is working to promote earlier consideration and approval of treatments for children. But increased emphasis is also needed on discovery and development, which must come from the industry and the academic research community. The potential offered by our science has never been greater. We want to turn this potential into expanded treatments, new drug availability, and hopefully new cures. That’s why the enthusiasm and creativity this Summit generates is so promising. 

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

 

FDA’s Latest Efforts in Patient-focused Drug Development … Now in Full Swing!

By: Richard M. Klein

Patients are very much at the center of what FDA does, and the agency has long sought input from patients and caregivers regarding their treatment options and needs. For many years, FDA has included the patient perspective at advisory committee meetings and during the review of new medical products in selected meetings with FDA and product developers.

More recently, FDA has encouraged and fostered the use of patient-reported outcome measures in clinical trials, such as impact on quality of life or pain control, to support labeling claims in medical product development. We are excited about our current efforts to expand the role of the patient perspective: the agency’s Patient-Focused Drug Development initiative. Part of FDA’s commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), this initiative will gather patients’ perspectives on the impact of a condition on daily life and the available therapies to treat that condition.  

Understanding a condition’s severity and its treatment options is a part of the benefit-risk assessments that help FDA make decisions about the medical products it regulates. As part of this commitment, FDA will hold at least 20 public meetings over the next 5 years, each focused on a different disease area. The information discussed in these meetings will be summarized for consideration by FDA review divisions when making regulatory decisions in that therapeutic area. 

Our first meeting, with chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) patients, was held on April 25. CFS/ME are debilitating diseases for which there are currently no FDA-approved treatments. At the meeting, we heard directly from patients, their caretakers, and patient advocates about the symptoms that matter most to them, the impact their disease has on their daily lives, and their experiences with treatments they have tried.  A complete video of the meeting and a transcript of the proceedings are posted on our website. We are also preparing a summary report about this meeting to be posted on the Web. We established a public docket that will remain open through August 2, 2013, so the public can provide additional written comments. 

Our second meeting, being held today, is focusing on HIV-AIDS. Although more than 30 drugs have been approved to treat patients with this disease, much remains to be learned from patients about how well the drugs they are currently taking for HIV-AIDS are working, what symptoms the drugs are not fully addressing, and how the therapies are affecting them. The meeting will also provide an opportunity for patients to express their thoughts about the evolving science of “HIV cure research” and their decisions about participating in the research. We are very interested in hearing from patients how FDA can communicate better about how that research might affect them. 

Our next meeting, scheduled for June 28, will focus on lung cancer. Exact dates for other future meetings have not yet been set, but we’ve already selected 13 additional disease areas (for a total of 16 for fiscal years 2013-2015) and listed them on our website. The remaining meeting topics will be selected by the end of fiscal year 2015. Each of the meetings will be webcast for those who cannot attend. The webcast recording and transcript of each meeting will be available on FDA’s website. We will open a public docket for each meeting so people can submit written or electronic comments.  

We want patients to be involved. It is important to FDA to hear from patients, caregivers, and patient advocates. We welcome everyone’s comments and will try to keep people as informed as possible throughout the process through our website. 

The patient perspective is an important part of the drug development process. Through social media, the Internet, and advocacy groups, patients have become more informed about how drugs and devices are developed. FDA is committed to using this information to help foster the development and availability of safe and effective drugs that meet the needs of the American public. 

Richard M. Klein is Director of the Patient Liaison Program in FDA’s Office of Health and Constituent Affairs.

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