When Pain Relievers Cause Pain, Society Must React

Posted on April 3, 2013 by FDA Voice

By: Margaret A. Hamburg, M.D.

Powerful prescription drugs called opioids make life tolerable for terribly ill patients who are wracked with pain. How ironic, and sad, that those same medications increasingly are misused and abused, thus causing pain, rather than relieving it.

In fact, abuse, misuse and addiction to opioids is a public health crisis of enormous, and devastating, proportion. In 2010, an estimated 16,651 peopled died because of inappropriate use of prescription opioid drugs, a 313 percent increase over the past decade.

Yesterday, while speaking at the National Rx Drug Abuse Summit, I found renewed faith that together we can turn the tide. More than 800 people from communities across the country, representing all levels of government, philanthropic organizations and the private sector, came with a commitment to do their part.

I told the Summit that FDA is certainly striving to do its part. Our multi-pronged approach is targeted at critical points in the lifecycle of an opioid product.

This comprehensive approach includes:

Encouraging basic research about the science surrounding pain including the development of effective and appropriate treatment.
Facilitating and incentivizing the development of abuse-deterrent formulations. We’ve issued a draft guidance document to assist industry in developing opioids that could, for example, be more difficult to crush and inhale, or dissolve and inject.
Modifying opioid labeling for safety, accuracy, and clarity. FDA has made many changes to opioid medication labels in an effort to improve their use, and today they contain some of the most restrictive language that can be found in a drug label. But we recognize that some are calling for further limitations on the use of these products, particularly in the context of non-cancer pain, including limiting the recommended duration of treatment; setting a maximum daily dosage limit; and restricting the use of these drugs to patients with severe pain (as opposed to “moderate to severe” pain). If additional improvements could make the labels more effective, it’s important we explore them as part of our overall efforts to improve the safety of opioids. We recently held a public meeting to get input on opioids labeling and we’re currently considering potential changes.
Working to achieve greater prescriber education and patient education. We required manufacturers of extended-release and long-acting opioids—those with the highest potential for abuse—to offer training for all U.S. licensed prescribers. The first training programs came on line on March 1, 2013, based on a syllabus that FDA created. Manufacturers are also providing prescribers with educational information to give to their patients.
Supporting mandatory training of prescribers before they register with the Drug Enforcement Agency and receive their license to prescribe a controlled substance, and hoping to see passage of necessary legislation to support that goal.
Addressing innovative ways to package and store opioids to prevent diversion, and;
Improving the availability of products that treat abuse and overdose. Emergency medical personnel are trained to administer naloxone, an injectable medicine that can rapidly reverse an opioid overdose. We know there is widespread interest in exploring the broader uses of this product and are currently encouraging new technology such as intranasal or autoinjector formulations that would be easier to use in non-medical settings such as the home.

We are also open to working with outside groups on these challenging issues. For example, we are working with Brandeis University to determine how to analyze data on problematic prescribing patterns, which among other things could help identify doctors working for “pill mills.”

And we do all of this keeping in mind that we must strike a balance between the risks associated with misuse, abuse and addiction and the potential benefits of these products in helping patients who suffer from pain.

There can be no doubt that there is much to be done…and we must act now. These are not simple issues and there are no easy answers. Given the complexity of the issues surrounding the abuse, misuse and addiction to prescription painkillers, real progress will require dedication, persistence and the full engagement of all parties. We can, and must, do better.

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

FDA Must Have New Authorities to Regulate Pharmacy Compounding

Posted on March 22, 2013 by FDA Voice

By: Margaret A. Hamburg, M.D.

The deadly outbreak of fungal meningitis associated with a compounded medication was a horrible tragedy, and I’ve asked myself many times if and how it could have been prevented. I speak for everyone at FDA when I say that our hearts go out to the many victims, including those still struggling with this devastating infection, and their loved ones.

While our investigation of this deadly outbreak has been a top priority, our responsibility at FDA is also to help make sure this doesn’t happen again. We are currently deploying resources to work with states to inspect certain state-licensed pharmacies that produce sterile drug products that we believe may present the highest risk. Over the past two months, we have inspected over 30 facilities and will continue to work to protect public health.

But our authorities are limited and not the right fit for FDA to provide appropriate and efficient oversight of this growing industry. There should be legislation that establishes appropriate, minimum federal standards for firms that compound sterile drug products in advance of or without a prescription and ship them interstate. FDA must have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations. Even during this time of heightened awareness, our inspectors are being delayed in their work or denied full access to records at some of the facilities we are inspecting.

And serious problems at compounding pharmacies continue to occur. Just this week there have been two recalls of sterile compounded and repackaged drug products. In one recall, the presence of floating particles, later identified to be a fungus, were reported in five bags of magnesium sulfate intravenous solution, resulting in a nationwide recall of all sterile drug products produced by the pharmacy. In the other recall, all sterile drug products from a second pharmacy were recalled as a result of reports that five patients were diagnosed with serious eye infections associated with the use of repackaged Avastin.

There is a legitimate role for traditional pharmacy compounding. Every day, thousands of pharmacists practice traditional pharmacy compounding—mixing a drug in response to a valid prescription for an individual patient’s need. For example, these drug products could be liquids for patients who can’t swallow pills, or they could be made without certain allergens. These operations are licensed and primarily regulated by the states.

However, a new breed of specialty pharmacy compounding has evolved that has outgrown the law, and can pose a threat to the health of the public. New legislation is needed that specifically addresses such compounding and the now-established safety concerns.

These pharmacies produce medications in advance of or without obtaining a prescription and distribute them across the country. They make drug products that are intended to be sterile and must be made to exacting standards to prevent dangerous contamination. The magnitude and complexity of these operations have outpaced the current patchwork of state laws that differ in prescription requirements and quality control rules.

I firmly believe that new legislation is necessary to help FDA effectively oversee firms engaged in widespread distribution of sterile compounded drug products in advance of or without receiving a prescription. To that end, FDA is working with Congress, states, industry, and all interested stakeholders to develop a basic framework to protect public health. The Senate committee with jurisdiction over this issue has been working hard on a bipartisan basis to craft such a framework, and we are hopeful that their efforts will yield strong legislation for patients across the nation.

In the new framework, FDA believes that certain high-risk sterile compounding facilities should be subject to federal oversight to ensure that the compounding of sterile drug products at those facilities can be done without putting patients at undue risk, including:

requiring compliance with federal quality standards that are appropriate for the compounding of riskier products and exposure of larger numbers of patients,
requiring federal registration of the compounding facilities that will be subject to federal quality standards so FDA knows where they are and what drug products they are making, and
requiring these higher-risk compounding pharmacies to report to FDA serious adverse reactions to their drugs of which they become aware so that we can act before potential problems get out of hand.

And for all pharmacy compounding, FDA believes certain basic protections should be in place. These include:

clear authority to examine a pharmacy’s records to more quickly locate the cause of an outbreak or other violations of the law, and
prohibiting compounding of the most complex and highest risk products—drugs and biologics that should only be made for patients by an FDA-registered drug manufacturer under an approved new drug application. The manufacturer will have demonstrated in this application that the product is safe and effective and can be safely made according to the highest quality standards.

FDA supports and would like to explore with Congress several other ideas, such as requiring compounded drug products to have clear label statements identifying the nature and source of the product. The labeling statements would provide prescribers and consumers with valuable information about the products they are using or taking so that they can make informed judgments about their use. Of course, funding will be necessary to support the inspections and other oversight activities outlined in this framework. We look forward to working with Congress to explore funding mechanisms, which could include registration or other fees, as Congress has authorized and FDA has successfully implemented in other settings.

Protecting Americans from unsafe and contaminated drugs is not just an important responsibility for FDA—it is part of our core mission. We must be able to identify dangerous practices before they result in actual harm and, when necessary, intervene to minimize the damage and prevent such tragedies in the future.

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

Saluting Dr. Janet Woodcock: an FDA Advocate for Arthritis Sufferers

Posted on March 20, 2013 by FDA Voice

By: Margaret A. Hamburg, M.D.

Physicians who work at FDA have typically trained in one or more medical specialties — areas of concentration which shape their interests and inform the regulatory work they do here to protect and promote the public health.

In my own case, I earned a degree in internal medicine and then focused on infectious diseases, eventually advocating for reforms to confront the dangers of modern bioterrorism, and looking for ways to counter the threat of naturally occurring infectious diseases, such as HIV, pandemic flu, and drug resistant TB.

So, too, it is with the inimitable Janet Woodcock, M.D.

Dr. Woodcock first joined FDA in 1986, and in her years at this agency has served in numerous capacities, including FDA deputy commissioner and chief medical officer. Today, she is director of the agency’s highly-respected Center for Drug Evaluation and Research.

At its recent annual Advocacy Summit, the Arthritis Foundation presented Dr. Woodcock with its Floyd B. Odlum Making a Difference Award, which honors an individual, organization, corporation, or government agency that has helped to make a difference in the lives of people and families with arthritis.

Striking one in every five adults, arthritis is the nation’s leading cause of disability. And it’s not just a disease of old age. Two-thirds of people with arthritis are under the age of 65, including 300,000 children.

Those numbers are not lost on Dr. Woodcock, who began her medical career as a rheumatology specialist, and ever since has been helping to shape and inform the advancement of arthritis treatments.

Dr. Woodcock has been a key figure in the revolution of rheumatoid arthritis therapies, from drugs that broadly address arthritis inflammation to today’s highly-effective, targeted, treatments. She is also helping to shape FDA’s regulatory framework for an abbreviated path to market for biosimilar drugs, those that are shown to be, among other things, highly similar to an already-approved biological product.

Once these drugs become available, they could increase choices for patients and reduce what those patients pay for certain arthritis therapies. Throughout her tenure, Dr. Woodcock has been an active liaison with the rheumatology community, crafting guidance on the development of arthritis medications, partnering on ways to measure a product’s safety and effectiveness, and studying products once they go to market.

In ensuring that safe drugs continue to be developed and become available to the many arthritis sufferers across the country, Dr. Woodcock has remained constant in her dedication to alleviating the pain and suffering of arthritis patients, and so many others. She has insisted upon scientific rigor in the work FDA does.

She has herself said, “I am continually challenged to make sure that FDA’s regulatory process remains the world’s gold standard for drug approval and safety.”

Those who know Dr. Woodcock would agree with me when I say she is a force to be reckoned with. We thank her for that, and along with the Arthritis Foundation, we salute her for all that she does to advance public health.

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

Students Bring Energy and Good Ideas to the Table

Posted on March 15, 2013 by FDA Voice

By: Jesse Goodman, M.D., M.P.H.

Graduate students who won a faculty-judged “America’s Got Regulatory Science Talent” competition at the University of Maryland recently filled my office with some of their ideas and energy.

Their winning ideas, and their commitment and excitement, bode well for the future of the sciences involved in ensuring that medical products are safe and effective. Perhaps above all, the problems that inspired their ideas provided powerful reminders that consumers should be engaged by health professionals and involved in their own care, including understanding the names and purposes of any medicines they are taking.

Jane Kalinina and Neha Patel, who are both pursuing degrees in law and pharmacy, saw the need for better patient awareness and understanding while working in pharmacies.

“Patients regularly called and asked, ‘What am I taking this for?’” said Kalinina. Citing a typical example, she described a patient who had been confusing her hypertension and diabetes medicines, and thus had been taking the wrong amount of each.

Such problems, they noted, are particularly problematic among the elderly, who often take multiple medicines and may see multiple doctors who may not always be aware what their colleagues have already prescribed.

Kalinina and Patel’s idea to help potentially better inform patients include the name of the condition a prescription medicine treats right on the bottle. In researching this idea, they learned that the State of California recently implemented just such an approach, with plans to evaluate potential benefits due in 2014. Kalinina and Patel plan to track this program and its evaluation and, if benefits are confirmed, hope to see the approach adopted nationally. Their idea won third place in the competition sponsored by the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI).

Second place was awarded to five doctoral students in Pharmaceutical Health Services Research: Patience Moyo, Mehmet Burcu, Sarah Dutcher, Xinyi Ng and Dinci Pennap. Their proposal was aimed at reducing the risk of harmful drug interactions through enhancing links among doctors, health systems and pharmacists, so that pharmacists have access to complete records of medicines being prescribed.

First place went to Curtis Gallagher, a doctoral student in molecular medicine at the University of Maryland, Baltimore, who researched “untapped opportunities” to facilitate reporting and monitoring of potential drug side effects and other unanticipated problems.

He noted that about 150 million Americans take at least one prescription. Based on personal experience and a 100-person survey, he found most people did not know about MedWatch, the FDA program where negative events can be reported and are tracked for trends, or found reporting too time consuming. His suggestion was for FDA to develop easier-to-use pull down menus of potential side effects, based on a drug’s FDA labeling, and allow consumers to file through FDA or through other websites consumers typically find when doing a computer search for information on a drug or condition. His ideas are being discussed at FDA.

As our health care system works to develop and refine many new approaches to enhancing the safe use of medications, this advice to consumers remains critical: know what you are taking, and why.

Jesse L. Goodman, M.D., M.P.H., is FDA’s chief scientist. In addition to being responsible for FDA’s cross-cutting scientific and public health efforts, he also provides strategic leadership for FDA’s regulatory science and innovation initiatives.

Don’t Get Scammed: Beware of Health Fraud

Posted on March 5, 2013 by FDA Voice

National Consumer Protection Week runs March 3–9, 2013. This coordinated campaign by federal, state, county and local government agencies, and non-profit partner organizations encourages consumers nationwide to make better-informed decisions.

In this video, the Commissioner of Food and Drugs Margaret A. Hamburg, M.D., and the FDA National Health Fraud Coordinator Gary Coody, R.Ph., discuss health fraud scams and give tips to consumers.

For More Information:

FDA joins with health professional organizations in encouraging prescribers to seek training to safely prescribe opioid pain medicines

Posted on March 1, 2013 by FDA Voice

By: Margaret A. Hamburg, M.D.

More than 15,500 people died in the United States in 2009 after overdosing on narcotic pain relievers. That’s a 300 percent increase over the last 20 years. And for each death, there are an additional ten treatment admissions, 32 emergency department visits and 825 nonmedical users of these drugs.

FDA is extremely concerned about the inappropriate use of opioids, which has reached epidemic proportions in the U.S., becoming a major public health challenge. While much of the problem is attributable to illicit use which can include sharing medication with family and friends or theft of the drug from home medicine cabinets, legitimate use of medications for pain may also lead to unnecessary adverse events, addiction, and death for some patients. Our nation’s front-line health care professionals, especially physicians and other prescribers can play an important role in efforts to reduce this trend.

FDA believes it is critically important to facilitate prescribers’ education about the best uses of opioids, including knowing when and for which patients they should be used.

Therefore, today, FDA issued an open letter to prescribers urging them to take advantage of educational programs designed to promote responsible opioid prescribing, improve pain management, and minimize prescription drug abuse and diversion.

And I’m pleased to announce that the American Medical Association (AMA), the American Academy of Family Physicians (AAFP), the American Academy of Physician Assistants (AAPA) and the American Academy of Pain Management (AAPM) have graciously agreed to distribute the open letter to their members. All are actively engaged in activities, including training, aimed at reducing the misuse and abuse of opioid medication, as are many others.

FDA will also distribute this open letter to our expansive health care news lists and urges all health care professionals to not only read, but also pass the letter along to all of their prescribing colleagues.

Prescriber training is one element of a risk management plan known as a Risk Evaluation and Mitigation Strategy (REMS) required by FDA, and approved in July 2012, to address the misuse, abuse, and addiction related to extended-release (ER) and long-acting (LA) opioid pain medicines.

New educational programs mentioned in the letter address ER/LA opioid prescribing. They are based on a blueprint developed by FDA with input from many stakeholders and will be provided at little or no cost through accredited continuing education activities supported by independent education grants from drug manufacturers. The first prescriber training program is available starting today and others will follow.

FDA sought the REMS for ER/LA opioids because these types of pain medicines have clearly emerged as those with the highest potential for harm from misuse, abuse, and unintentional overdose. These widely-used products often contain large amounts of opioids in a single dosage form, sometimes in sufficient quantity to be lethal, especially for a child, and they are a prime target of drug abusers. And that’s why it is so important for physicians and other prescribers to participate in these training programs to enhance their understanding of how to appropriately prescribe these powerful medications to patients that need them – while also keeping them out of the hands of those who could misuse or abuse them.

According to estimates, more than 320,000 prescribers who are registered with the Drug Enforcement Administration wrote at least one prescription for an ER/LA opioid pain medicine in 2011, so we have a lot of prescribers to reach. However, working together to ensure appropriate use of opioids, I am confident we can make great strides in reducing this epidemic.

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

Rare Disorders Without Borders: An International Strategy

Posted on February 28, 2013 by FDA Voice

By: Katherine Needleman, Ph.D.

The development of 200 new therapies for rare diseases and diagnostic tests for most rare diseases would alleviate untold suffering. So with great enthusiasm, FDA’s Office of Orphan Products Development (OOPD) has joined a global effort to make those goals a reality by 2020.

These are the goals of the International Rare Disease Research Consortium (IRDiRC), launched by the European Commission and the U.S. National Institutes of Health in April 2011 to foster collaboration in rare disease research. FDA’s OOPD recently joined IRDiRC’s Executive Committee. When the consortium holds its first major conference in Dublin in April, top experts and researchers from around the world will share information and foster collaborations.

Collaboration is critical. Rare disease resources, including experts, are so limited that we cannot afford to waste a single moment by duplicating work or failing to share promising developments. Products for rare diseases are often called “orphan products” because they generally lack sponsors to develop them.

Some rare diseases affect only a few hundred people, and by FDA’s definition, each one affects no more than 200,000 people in the U.S. Yet taken together, about 7,000 rare diseases afflict about 30 million Americans and a similar number in Europe. In much of the world, they go undiagnosed. Often, they are debilitating or deadly. Many are genetic, so children are often victims.

Today, on Rare Disease Day 2013, the international rare disease community comes together with the theme “Rare Disorders Without Borders,” and FDA continues its commitment to close collaboration with international counterparts, such as the European Medicines Agency.

FDA is the first regulatory agency to join the consortium’s Executive Committee. In addition, FDA is represented on the consortium’s Therapies Scientific Committee by Marc Walton, M.D., Ph.D., in FDA’s Center for Drug Evaluation and Research. We hope to bring regulatory scientific perspectives that help develop great research ideas into great products that meet regulatory approval standards for safety and effectiveness.

FDA has been working to change the orphan status of rare diseases since 1983, with the passage of the Orphan Drug Act. Since then, FDA has approved over 400 products for the treatment of rare diseases, compared to only 10 developed by industry in the decade before the act.

OOPD’s grant program uses its annual budget of approximately $14 million to fund top scored clinical trials of rare disease treatments. The grants program has been successful, as at least 49 OOPD grants supported clinical trials that contributed to agency approval of these products for rare diseases.

Still, for most rare diseases, there are no treatments, or definitive diagnostic tests.

Recent progress in human genomics and newly emerging sciences increase the prospect for treatments or even cures. A new generation of therapies even shows promise for changing the defective genes that result in some rare diseases. These are among the topics that will be addressed at the upcoming conference.

Our OOPD Director, Gayatri Rao, M.D., J.D., will present FDA’s perspective at the IRDiRC meeting while I will be working on the challenges ahead through the Executive Committee as FDA helps ensure that the energy and expertise brought to the conference is harnessed to bring results to patients.

The need is great; the time is now.

Katherine Needleman, Ph.D., is director of the Orphan Products Grants Program of FDA’s Office of Orphan Products Development.

Advancing Science and Building a Healthier Society

Posted on February 26, 2013 by FDA Voice

By: Theresa Castillo

Knowledge and education are critical, but “passion and perseverance” are also needed to eliminate health disparities, Assistant Health and Human Services Secretary Howard Koh, M.D., told a group gathered to pursue the goal of better health for all.

Dr. Koh’s call for even greater commitment was issued to more than 4,500 people who attended the Summit on the Science of Eliminating Health Disparities at the Gaylord National Resort and Convention just outside of the nation’s capital in December 2012. Since then, individuals and groups around the nation have returned to their jobs with new information gained from some of the more than 100 workshops that explored emerging sciences, policies and practices that can help eliminate health disparities that disproportionately affect minority groups.

Here at FDA, we are now in the midst of collaborating with the National Institutes of Health to publish recommendations and best practices that were highlighted at the summit and worthy of adoption on a broader scale. Articles published in peer reviewed journals also will be available at FDA’s Office of Minority Health Web site later this year.

The summit was led by the National Institute on Minority Health and Health Disparities and co-sponsored by FDA’s Office of Minority Health and the U.S. Department of Health and Human Services. Leaders in government, academia, business, medicine, science and public policy joined with advocates and others in the community to learn, share and build new alliances.

The ultimate goal: to share creative and innovative solutions that can be adopted widely to improve health in theU.S.and around the world.

The work on health disparities arises from a critical need. For example, African American men are 2.4 times more likely to die from prostate cancer than non-Hispanic white men, 10 times more likely to die of AIDS, and 60% more likely to die of stroke. Native American women are almost twice as likely to die of diabetes than non-Hispanic white women. And while Asian and Pacific Islanders are less than 5 percent of the population, they account for more than 50% of Americans living with chronic Hepatitis B and associated liver cancer.

The numbers reflect a complex web of causes, including unequal access to health care, environmental issues, genetic differences and lifestyle, to name a few. These variables and more were addressed at the summit.

The breadth of the effort is exemplified by listing even a few of the more than 100 workshop and roundtable titles: “Approaches for Identifying and Addressing Environment Health Disparities,” “Public Policies and Strategies to Address Obesity Prevention,” and “Reducing Health Disparities through Innovation.”

The summit brought together some of the nation’s foremost experts. Speakers included former U.S. Health and Human Services Secretary Louis Sullivan, M.D., NIH director Francis S. Collins, M.D., Ph.D., Mary Woolley, head of Research!America, Kira Fortune, Ph.D. of the Pan American Health Organization, and David Fukuzawa of the Kresge Foundation.

The energy, commitment and knowledge gathered in one place left me inspired and convinced that together, we are on a path that will lead to improving health for all.

Theresa Castillo is a public health advisor in FDA’s Office of Minority Health

Weaving New Threads in FDA’s Global Safety Net

Posted on February 22, 2013 by FDA Voice

By: Margaret A. Hamburg, M.D.

Drugs manufactured in countries around the world account for 40 percent of the medicines we use in the United States. And an astonishing 80 percent of the active ingredients in the drugs we consume come from abroad.

Therefore, it is absolutely essential that we have regulations and procedures in place not just here at home but abroad as well to ensure that the medicines you and I rely on are safe, no matter where they come from. After all, lives and well-being are at stake if drugs are of questionable quality.

One of the greatest threats to safety involves substandard, falsified and counterfeit medical products in the supply chain. For the past several years, FDA has been engaged in global efforts to improve collaboration in preventing, detecting, and responding to this threat.

We have developed strong partnerships with the World Health Organization and the Asia Pacific Economic Community and we also collaborate with such development agencies as the U.S. Agency for International Development and the World Bank.

To further extend our global understanding and impact, in 2011 FDA commissioned a committee at the Institute of Medicine (IOM) to look at how falsified (fake) and poor quality drugs affect the health of people around the world. A report on its findings and recommendations was recently released.

It confirmed FDA’s belief that these fraudulent and inferior drugs are an international problem requiring international cooperation.

Briefly, here are some of the findings of the IOM report.

Neglecting good manufacturing practices is the root cause of poor quality drugs. However, quality practices require resources. Many of the countries in which people sorely need medical help just don’t have the financial wherewithal and other resources to mandate and monitor these good practices.
Bad medicines, whether sold in street markets or on unregulated websites, are a grave public health problem. They often fail to help—and often harm—the very people who most need them. In addition, they may promote antibiotic resistance which harms us all.
Crime and corruption drive the business of falsified medicines, and they are rampant overseas. A month’s supply of the lowest price generic ulcer medicine costs more than three days’ wages for the average government worker in much of Africa, Eastern Europe and the Middle East. The poorest patients have little choice but to buy their medicines from vendors who sell products of questionable quality.
In modern supply chains, medicines can change hands many times, in many countries, before they reach patients. Each exchange provides the opportunity for unscrupulous behavior on the part of manufacturers and distributors.

The IOM report recommends that FDA continue to reach beyond our U.S. borders to collaborate with our foreign counterparts in building regulatory strategies for the implementation and control of good manufacturing practices. FDA now has 12 posts around the world that are currently working to do just that with our global partners, as well as with industry and scientific and academic communities in these countries.

The IOM committee believes that we must identify where vulnerabilities exist in the legitimate drug supply chain and identify realistic national and international solutions. The panel also urged Congress to establish a track-and-trace system to keep a record of drugs as they travel from the manufacturer to the patient.

Between social media and up-to-the-second news coverage, the world seems like a much smaller place these days. But as this report makes clear, it’s actually larger than ever, and our challenges to provide a global “safety net” are many and formidable.

The IOM report is an important resource in our quest to strengthen that safety net. For me, this report reinforces the knowledge that when it comes to ensuring the safety of medicines worldwide, we are heading in the right direction.

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

FDA Cracks Down on Flu Product Scammers

Posted on February 15, 2013 by FDA Voice

By: Gary Coody, R.Ph.

The severity of this year’s flu season has brought out the scammers promoting fraudulent flu products.

Through our careful monitoring of the Internet, FDA has identified numerous untested and unapproved products being illegally marketed with deceptive claims that they prevent, treat, or cure the flu.

When FDA staff find these fraudulent products, we send a warning letter to the sellers describing how the product violates federal law and instructing them to respond in writing with a description of how they intend to address the violations. If a seller does not respond within 15 days and continues to sell the product without correcting the violations, the products being sold by U.S. companies may be seized, FDA may notify law enforcement officials in the country abroad where a seller maintains its operation, or the federal government may take other legal actions.

In the past week, the agency has sent nine warning letters to firms marketing fraudulent flu-fighting products, including an online seller marketing a product that claims to be an alternative to the flu vaccine, three firms marketing dietary supplements online (letters co-signed by the Federal Trade Commission), and a firm selling an oral spray online and in major retail stores.

The remaining four warning letters were issued to online firms selling what they claim to be generic and other unapproved versions of oseltamivir phosphate, the active ingredient in Tamiflu. Tamiflu is an FDA-approved brand-name drug, but no generic Tamiflu is approved in the U.S.

FDA advises consumers to beware of online “pharmacies” selling generic versions of Tamiflu. If you buy one of these products, you don’t know what you’re getting—it could be counterfeit, contaminated, or not stored properly to maintain quality. It could also have the wrong active ingredient or no active ingredient at all.

Some of the other fraudulent claims addressed in the warning letters include:

“the most effective alternative to the flu shot”
“natural health and strength can still be yours without flu shots”
“fight cold and flu – naturally!”
“safeguard you from deadly flu viruses.”

Our concern is that a consumer will buy or use a fraudulent product advertised as an “alternative to the flu vaccine” instead of getting the approved vaccine. The vaccine is the best way to prevent getting the flu.

Any time there is a large outbreak of disease, fraudulent products appear on the market. Bogus remedies were rampant during the 1918 flu pandemic, commonly known as the Spanish flu, which killed an estimated 675,000 Americans. Fast forward to 2009, when FDA sent out more than 100 warning letters to sellers fraudulently promoting their products to prevent the H1N1 (swine) flu.

Today, when a health threat emerges, fraudulent products appear almost overnight because the Internet and social media such as Facebook and Twitter have accelerated how quickly hucksters can reach the unsuspecting public.

FDA can’t track down all of these fraudulent products, so consumers need to beware of unapproved products that make false claims. When in doubt about a product, talk to your doctor, pharmacist, or other health care professional.

For more information about health fraud scams, visit www.fda.gov/healthfraud.

Gary Coody, R.Ph., is FDA’s national health fraud coordinator, FDA Office of Regulatory Affairs, Office of Enforcement