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

 

“Breakthrough” Designation … Another Powerful Tool in FDA’s Toolbox for Expediting the Development and Review of Promising New Drugs for Serious Conditions

By: Janet Woodcock, M.D.

Janet Woodcock, M.D. is the Director of FDA’s Center for Drug Evaluation and Research

In fiscal year 2012, FDA approved 35 novel new drugs, also known as “new molecular entities.” Among these new products were drugs to treat patients with unmet medical needs, such as a groundbreaking treatment for a form of cystic fibrosis, the first FDA-approved human cord blood product for hematopoietic reconstitution, used to help patients with blood forming disorders, and the first drug to treat advanced basal cell carcinoma (a form of the most common skin cancer).

To enable our ongoing efforts to bring innovative drug products to the public as efficiently as possible, FDA relies heavily on several expedited development and review tools such as fast track designation, the accelerated approval pathway and priority review designation. For instance, 56 percent of the novel drugs approved by the Center for Drug Evaluation and Research in calendar year 2012 used some combination of these tools to speed promising therapies to patients with serious conditions. And any given drug may have received multiple expedited program designations. (See a brief summary of how each of these tools helps FDA shorten the development and review of promising new therapies.)

In July 2012, a provision in the new law called the Food and Drug Administration Safety and Innovation Act, or FDASIA for short, gave FDA another powerful expedited development tool, known as the “breakthrough therapy” designation. This new designation is now helping FDA assist drug developers expedite the development of new drugs with preliminary clinical evidence that indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. Although the designation is not yet even a year old, FDA has received 62 requests to grant this new designation to products under development. We have been very active on this subject, meeting with companies and discussing ways to expedite the drug development process for drugs that show striking early results. We have already granted the breakthrough designation to 20 potential innovative new drugs that have shown encouraging early clinical results.

Drug developers should have a clear understanding of all of FDA’s expedited development and review tools. To help industry better understand each tool, including when the tools can be used and the features of each, we have just published an industry draft guidance titled Expedited Programs for Serious Conditions — Drugs and BiologicsAmong other important information, the draft guidance describes FDA’s policies and the threshold criteria for each expedited program, defines and discusses important concepts, including serious condition, unmet medical need, and available therapy, and provides some general considerations for products utilizing an expedited program, such as manufacturing and product quality, nonclinical considerations, and clinical inspection considerations.

The breakthrough therapy designation gives us another tool in our “toolbox” to help expedite the development and review of new drugs to treat patients with serious medical conditions and little or no treatment options. We’ll continue to use the new breakthrough therapy designation and our existing tools to help make our expedited programs even more effective.

We’ve said it before — and I believe it’s worth repeating — our decision-making on whether to approve a drug always involves an evaluation of many factors, such as the seriousness of the disease.  However, ultimately any drug approved must show that its benefits outweigh its risks and regardless of which expedited development or review program or programs are used, FDA does not compromise its safety or efficacy standards in exchange for rapid approval. Like all drugs we approve, those approved after having been designated as breakthrough therapies will meet our usual rigorous standards for safety and effectiveness.

Janet Woodcock, M.D. is the Director of FDA’s Center for Drug Evaluation and Research

FDA Announces First Decisions on New Tobacco Products

By Mitch Zeller, J.D.

Mitch Zeller, J.D., Director of FDA's Center for Tobacco Products

In March, I became director of the FDA’s Center for Tobacco Products (CTP) after spending more than three decades working on FDA-related issues, including a seven-year stint at FDA from 1993-2000.  From 1997-2000 I was director of the agency’s first Office of Tobacco Programs. Since I’ve rejoined FDA, CTP has made great progress on multiple fronts. I look forward to discussing my strategic goals and priorities in a future blog post, but today I want to share some information about one immediate priority—decisions regarding tobacco product reviews.

Today, for the first time since FDA received the authority to regulate certain tobacco products, the agency has authorized the marketing of two new tobacco products through the substantial equivalence (SE) pathway, while denying the marketing of four other new products.

These actions are unprecedented and mark the start of other forthcoming decisions related to the marketing of new tobacco products. Substantial equivalence is one pathway manufacturers can use to market a new tobacco product. To do so, a manufacturer must establish that their product has the same characteristics as a valid previously marketed tobacco product, what we call a predicate product, or, if the new product has different characteristics, that it does not raise different questions of public health.

SE submissions require rigorous review. FDA has a responsibility to protect public health, and to do so, we work to ensure that any new tobacco product brought to market through the SE pathway will not present more harm to public health than a valid predicate product identified by the manufacturer.

Today’s SE orders allow the marketing of two new Lorillard Tobacco Company tobacco products: Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box. The agency has found these two products to be substantially equivalent to predicate products, based on the company’s submissions and other readily available science and information that demonstrate that each product will not present more harm to the public health than the predicate.

It is important to emphasize that an SE decision does not mean that the agency considers a product to be safe, nor is it FDA-approved. The SE decision only means that a new product does not raise different questions of public health as compared to the predicate product.

FDA is also issuing the first not substantially equivalent, or NSE, orders denying marketing of four new tobacco products after finding that the products have different characteristics from their predicate products and that the applicant did not adequately show that the new products did not raise different questions of public health.

FDA has been working diligently to review all pending SE submissions. We know it’s taken time, but expect the process will move more quickly in the future as everyone involved gains more experience. FDA has offered feedback to the industry on the requirements for substantial equivalence and will continue to offer such feedback. We have also created a new webpage that tracks SE decisions to date and provides general information on FDA’s pathways to market new tobacco products. Our goal is to work through the remaining SE submissions in a consistent, transparent and predictable manner.

Mitch Zeller, J.D., is the Director of FDA’s Center for Tobacco Products.

The Road Ahead for Ensuring Access to Quality Drugs for All Americans … New Laws Under “FDASIA” Will Help Pave the Way

By: Howard Sklamberg

In January, I became director of FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Compliance, giving me the responsibility – and great privilege — of playing a lead role in FDA’s work to help protect the American public from unsafe and ineffective drugs. It’s a big job, filled with many challenges.

Fortunately, after three years of service with FDA, most recently as the agency’s deputy associate commissioner for regulatory affairs (our field operation), and 12 years before that as a prosecutor with the Justice Department, I feel prepared to help the agency meet these challenges head on.

I’d like to take an opportunity to share my priorities, as well as my views and perspectives on the goals and challenges ahead for FDA, as we continue to work to ensure access to quality drugs in the United States.

Tragically, last October’s outbreak of fungal meningitis from contaminated methylprednisolone injections that killed over 50 Americans and sickened hundreds more directed FDA’s attention to the immediate public health priority of evaluating the quality of sterile compounded drugs and preventing further incidents. Our efforts have included proposing a new legislative framework for federal oversight, inspecting high-risk compounding facilities that produce sterile drugs, and working more closely with our state partners.

As important as our efforts are in the compounding arena, our compliance challenges extend to many other critical areas, many of which are related to the new and growing global marketplace for pharmaceutical products.

Today, nearly 40 percent of the drugs Americans take are imported and nearly 80 percent of the active ingredients come from overseas sources. A growing number of clinical trials that test the safety and effectiveness of potential new drugs are also moving overseas, making FDA oversight more challenging. Counterfeit drugs are proliferating around the world and sometimes even entering the U.S.supply chain. The ever burgeoning worldwide use of the Internet continues to spawn avenues for illegal online sales of medicines of unknown safety and quality. Also, poor manufacturing practices that lead to facility shut-downs often contribute to shortages of important drugs. We must ensure that wherever drugs are made, wherever their ingredients are from, or wherever and however they are tested and sold, that they meet FDA’s strict standards of quality and that they remain in adequate supply.

Despite these challenges, there’s good news. The Food and Drug Administration Innovation and Safety Act of 2012 (FDASIA) gave FDA powerful new tools to enhance our compliance and enforcement activities including stronger authorities and funding to support the inspection of foreign manufacturing facilities. For example, FDASIA facilitates our ability to partner with and work more effectively with foreign regulatory agencies. FDASIA also gave FDA more authorities to control the drug supply chain.

However, laws on the books do not automatically translate into effective change without effective implementation and enforcement of these laws. So, in addition to continuing our critical work with Congress on appropriate and effective oversight of compounding that exceeds the bounds of traditional pharmacy compounding, my other key priority is to work to implement FDASIA’s provisions, keeping CDER focused globally and armed with the best set of tools possible to do the job. Although we have much more work to do, a vision of enhanced capabilities of ensuring quality drug products for the American public is well in sight.

I have the distinct privilege and responsibility of being part of a fantastic team of dedicated FDA staff that’s really making a difference, and I look forward to continuing to serve the American public in working to ensure access to quality drugs.

Howard Sklamberg is Director of FDA’s Center for Drug Evaluation and Research’s Office of Compliance

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

Avandia: Hearing all Sides in Scientific Debate

By: Janet Woodcock, M.D.

Janet Woodcock, M.D. is the Director of FDA’s Center for Drug Evaluation and Research

Janet Woodcock

This week the FDA will convene two advisory committees to discuss the results a readjudication, or independent review, of the results of a large, long-term study on whether patients are at greater risk of heart attack or death when taking the diabetes drug Avandia (rosiglitazone).

The fact that FDA is holding the joint meeting has been the subject of some controversy, even criticism aimed at the agency. Some question why we’re having the meeting at all, while others eagerly await the results.

Given the public interest in Avandia, the extensive history of the product, and the continued uncertainty of the risk surrounding this drug, FDA is holding this meeting to have a transparent, public discussion with experts across multiple scientific disciplines on the results of the readjudication of the study.

When the drug’s sponsor, GlaxoSmithKline, released the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial in 2010, it said it could find no potential elevated risk of heart attack or death in patients who took Avandia.

But some members of a previous FDA advisory committee, outside experts and even some experts within FDA criticized the trial and pointed to other evidence that raised questions about Avandia’s safety.  So in September 2010 FDA requested an independent review of the study.

As I stated in 2010 when I requested the additional analysis, considering the time and effort spent by thousands of volunteers who participated in RECORD, I believe every effort should be made to learn as much as possible from its results.

The uncertainty about the risk of Avandia is overwhelmingly the most important reason for the differing opinions on the regulatory actions that have been taken on this medication. Therefore, we have an obligation to better understand the trade-offs based on as much scientific evidence as possible.

FDA will consider the recommendations of the advisory committees and the public input in determining if the results of the readjudication in the context of all the relevant available data affect the agency’s assessment of the risks and benefits of Avandia.

There have been, and continue to be, differences of opinion and scientific disputes, which is not uncommon within the agency, stemming from varied conclusions about the existing data, not only with Avandia, but with other FDA-regulated products.

At FDA, we actively encourage and welcome robust scientific debate on the complex matters we deal with — as such a transparent approach ensures the scientific input we need, enriches the discussions, and enhances our decision-making.

Since 2008, FDA has undertaken a series of organizational and management actions to help ensure that all scientific viewpoints are freely expressed, understood, and brought into the drug safety decision-making process, and significant safety issues are managed by multidisciplinary teams that include representatives from the Office of New Drugs, the Office of Surveillance and Epidemiology and all other relevant offices within FDA’s Center for Drug Evaluation and Research. This initiative, known as Equal Voice, emphasizes the basic values of speaking up, listening to and respecting the viewpoints of others in every professional interaction. It is intended to ensure that final decisions are made after all appropriate expertise is brought to bear.

CDER staff who don’t support agency decisions can raise their concerns with senior center leadership. This process may be used to address disputes among medical and scientific disciplines within the center as well as a dispute raised by an individual staffer.

Ultimately, the decisions we make directly affect public health, and we must learn as much as possible and use the information we have to responsibly inform our decisions.

Janet Woodcock, M.D. is the Director of FDA’s Center for Drug Evaluation and Research

Setting the Bar High for FDA

By: Margaret A. Hamburg, M.D.

Rick Pazdur receiving ASCO Public Service Award

Rick Pazdur, accompanied by Margaret Hamburg, receiving ASCO Public Service Award

To say that Rick Pazdur faces enormous challenges in his job is an understatement. To say that he faces each day with energy, insight and resolve still falls short of the mark.

It’s my privilege to tell you that the American Society of Clinical Oncology (ASCO) has awarded Dr. Pazdur with its prestigious Public Service Award for his dedication to improving the lives of people living with cancer.

As director of the Office of Hematology and Oncology Products (OHOP) at FDA, Dr. Pazdur leads a staff of more than 130 oncologists, toxicologists and other specialists.

Their mission is making safe and effective drugs for cancer and hematologic (blood-related) conditions available to the patients who need them. The office is committed to facilitating rapid development, review and action on promising new treatments for these diseases.

Dr. Pazdur sets the bar high. His demand for excellence in his staff as well as in the treatments they review is unparalleled. Ultimately, Dr .Pazdur and his staff must decide whether or not an investigational drug can be tested in a clinical trial and, after testing, be approved for more widespread use. Sometimes, after careful investigation, they conclude that a drug has not been proven effective enough to outweigh the potential risks. These are the types of challenges and the tough decisions that Dr. Pazdur faces on a daily basis. A man of personal integrity with great compassion for those who are ill, he nonetheless is  often the recipient of criticism from patients, advocacy groups, drug companies and others. I have heard him say ruefully, but with characteristic humor, that you can’t win in this job—that if he approves a drug, he’s accused of lowering standards.  And if he doesn’t, he is insensitive to the plight of patients with cancer. Nothing could be farther from the truth.

Since his arrival at FDA in 1999, Dr. Pazdur has worked tirelessly to speed the development and availability of drugs that treat serious diseases, especially when the drugs are the first available treatment or have advantages over existing therapies. He has made a special effort to reach out to patient and advocacy groups, professional associations and foreign regulatory agencies. In 2012, nearly 40 percent of the new molecular entities approved in the Center for Drug Evaluation and Research were to treat cancer, often when few therapeutic options previously existed.

Members of Dr. Pazdur’s staff speak with warmth and enthusiasm of his dedication to cancer patients and his unflagging efforts to streamline the drug approval process. They call him not just a manager, but “a visionary,” and “one of the most unique people I know.” I quite agree.

To one of the most dedicated and accomplished people I know: It’s a pleasure to work at your side, Dr. Pazdur. Congratulations for this well-deserved honor.

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

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