FDA Takes Action against Zika Virus

By: Robert M. Califf, M.D., and Luciana Borio, M.D.

Zika virus was first identified in 1947 in Uganda and for decades only sporadic cases and a few outbreaks were recognized in a number of locations, including parts of Africa, Asia, and the Pacific. Since 2015, the situation has changed dramatically, with 48 countries and territories reporting a first outbreak of Zika virus as of July 2016. In the United States, cases of Zika virus disease acquired by the bite of an infected mosquito have only been reported in U.S. territories; to date, cases of Zika virus infection reported in the continental United States have involved travelers and in some instances their sexual contacts. However, given the number of Zika cases among travelers visiting or returning to the United States and the increased mosquito activity in the summer months, we expect that imported cases could result in local spread of the virus in some areas of the United States.

Robert Califf

Robert Califf, M.D., is Commissioner of the U.S. Food and Drug Administration

The FDA is taking important steps to rapidly respond to the Zika virus outbreak. We are engaged with our partners across the U.S. Government, the private sector, and the international community—including the World Health Organization and ANVISA (the Brazilian Health Regulatory Agency)—to help minimize the impact of this outbreak.

Protecting Tissues and the Blood Supply

One of the FDA’s first actions was to take important steps to help protect the safety of the blood supply. The FDA issued guidance in February 2016 recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, were potentially exposed to the virus, or have had a confirmed infection. The guidance also recommends that areas with active Zika virus transmission, like Puerto Rico, obtain whole blood and blood components from areas of the United States without active virus transmission unless a blood donor screening test for Zika virus is used. Because there were no blood donor screening tests available for Zika virus at the time, HHS arranged for and funded shipments of blood products from the continental U.S. to Puerto Rico to ensure an adequate supply of safe blood for residents until a blood donor screening test became available. The FDA worked closely with developers in a highly accelerated time frame to make available an investigational test for blood screening in March 2016. The availability of this investigational test, which has been in use in Puerto Rico since early April, has allowed blood establishments to safely collect blood in areas with active Zika virus transmission. A second investigational blood screening test was made available in June 2016. Together, these tests have also enabled blood donor screening to be put in place in areas of the United States where local virus transmission is anticipated, but not yet detected, helping to maintain the safety of the blood supply.

Dr. Lu Borio

Luciana Borio, M.D., is FDA’s Acting Chief Scientist

Zika virus also poses a risk for transmission by human cells, tissues, and cellular and tissue-based products (HCT/Ps) such as corneas, bone, skin, heart valves, and semen used for medical, surgical, or reproductive procedures. Because of this risk, the FDA issued guidance recommending that donors of HCT/Ps be considered ineligible if they were diagnosed with Zika virus infection, were in an area with active Zika virus transmission, or had sex with a male with either of those risk factors, within the past six months.

Supporting Diagnostic Development

The ability to accurately detect and diagnose Zika virus infection is critical for a robust response to this public health threat. The FDA is actively working with manufacturers to support their diagnostic development programs, helping to ensure that their tests are properly validated before they are used to inform patient care. This collaboration has been very successful, and since the beginning of the year, we have authorized the use of five diagnostic tests for Zika virus under FDA’s Emergency Use Authorization authority—four tests to diagnose active infection and one test to assess whether individuals who may have recently been exposed to Zika were actually infected. This test is especially important for women given the link between Zika virus infection and microcephaly and other poor pregnancy outcomes in babies of mothers who were infected with Zika virus during their pregnancy.

Strategies to Suppress Mosquito Population

FDA—as well as our colleagues at EPA— are reviewing the use of innovative strategies to help suppress the population of virus-carrying mosquitoes to help mitigate the threat of vector-borne epidemics, such as Zika virus, which is thought to spread to people primarily through the bite of an infected Aedes aegypti mosquito.

Recently, the FDA released for public comment a draft environmental assessment (EA) submitted by Oxitec, Ltd. (Oxitec). The EA assesses the potential environmental impacts of a proposed field trial of the company’s genetically engineered (GE) Ae. aegypti mosquitoes. The FDA also released for public comment a preliminary Finding of No Significant Impact (FONSI) agreeing with the conclusion in Oxitec’s draft EA that the proposed field trial of the company’s GE mosquitoes would not result in significant impacts on the environment.

The goal of the proposed field trial is to determine whether released Oxitec GE mosquitoes will mate with local wild-type Ae. aegypti and suppress their population at the release site. The FDA is reviewing the thousands of comments received during the public comment period before determining whether to finalize the EA and FONSI or prepare an environmental impact statement (EIS). Oxitec will not proceed with the field trial of the GE mosquitoes until FDA issues its final EA and FONSI or EIS. Oxitec’s GE mosquitoes are one possible approach that could be incorporated into an integrated vector control program to help mitigate the threat of vector-borne epidemics; however, it is too early to say with any certainty whether such an approach would be successful.

Facilitating Medical Product Development

There are currently no vaccines or treatments for Zika virus that have been shown to be safe and effective. Facilitating the development and availability of vaccines is one of the highest priorities for the FDA and the international community. The FDA continues to actively engage with commercial and government developers, including the NIAID and BARDA, to advance the development of investigational vaccines for Zika virus as soon as possible. We are also working with ANVISA to assist in their efforts to expedite the development of vaccines for Zika virus. As was recently reported, a commercial company announced plans to begin evaluating the first investigational Zika virus vaccine in a Phase I clinical study.

Unfortunately, during outbreak situations, fraudulent products claiming to prevent, treat or cure a disease almost always appear. FDA is monitoring for fraudulent products and false product claims related to Zika virus and will take appropriate action to protect consumers when necessary.

More than 120 FDA staff from across the Agency are  responding to the Zika virus outbreak, working together to address the complex range of issues that this evolving epidemic continues to present in order to protect and promote the public health, both domestically and abroad. This type of teamwork exemplifies the capacity of people at FDA to rally together to solve problems, often with little explicit credit other than the satisfaction of meeting the mission of promoting and protecting the public health. There are many fundamental scientific questions that need to be addressed with respect to Zika virus, and our scientists are working to help answer some of these questions in our own laboratories. We stand ready to use our expertise and authorities to the fullest extent to help facilitate the development and availability of products that may help mitigate the Zika virus outbreak.

Visit our Zika response web page for more information, including the latest Zika virus response updates from FDA.

Robert Califf, M.D., is Commissioner of the U.S. Food and Drug Administration

Luciana Borio, M.D., is FDA’s Acting Chief Scientist

FDA Unveils Multilingual Health Fraud Protection Initiative for Consumers

En Español

By: Jonca Bull, M.D., and Jason Humbert, R.N.

Jonca Bull

Jonca Bull, M.D., FDA’s Assistant Commissioner, Office of Minority Health

Consumers are constantly bombarded by advertisements for fraudulent medical treatments and cures — dangerous scams that often target the most vulnerable populations. FDA is fighting back with its own enhanced educational initiative. And we’re urging health professionals and community leaders to help.

During National Consumer Protection Week, from March 6-12, FDA is launching a new multimedia and multilingual initiative, including a new video (see below) and a consumer article, all translated into English, Spanish, Simplified Chinese, Korean, Vietnamese, and Tagalog. The purpose of these materials? Alerting consumers of the dangers of imported tainted products falsely marketed as dietary supplements, and providing tips on how to prevent health fraud scams.

We invite you to share this information with your patients and networks. Additionally, please visit www.FDA.gov/SupplementSafety for information in Spanish and some Asian languages on how to prevent health fraud. You also will find tips and advice by visiting the FDA Health Fraud Scams page.

Sellers of tainted medical products are mostly from the United States, but often sell products that originate overseas and target certain ethnic groups. Sometimes the labels are in languages other than English and such products may be sold at flea markets, swap meets, ethnic stores, or from the homes of individuals.

Jason Humbert

Jason Humbert, R.N.,CDR, U.S. Public Health Service, FDA’s National Health Fraud Coordinator, Office of Regulatory Affairs, Office of Enforcement and Import Operations

Companies also recruit friends, family members and co-workers to market products through word-of-mouth. They advertise on TV and radio, in magazines and newspapers, through direct mail and social media channels such as Facebook, Twitter, and Instagram and through e-commerce platforms.

Sellers prey on underserved populations and people with limited English proficiency who are prone to fall victim to health fraud scams due to limited or inadequate access to health care services, language barriers, low health literacy, and cultural beliefs.

Health fraud scams are a multimillion dollar industry involving the marketing of drugs, medical devices, biologics and cosmetics. Bogus products can cause serious or fatal injuries, and can harm consumers further by delaying the proper diagnosis and treatment of health conditions.

Fraudulent products are often offered to prevent, treat, or cure conditions such as obesity, diabetes, arthritis, cancer, and HIV. Some scammers encourage their clients to stop using their prescribed medications and replace them with their products without consulting their physicians first.

FDA has found that many of these products are mislabeled, and in some instances contain active ingredients that shouldn’t be available without health care provider oversight.

Consumers can report adverse reactions to FDA MedWatch by calling 1-800-FDA-1088 (1-800-332-1088) to request a report form, or file a complaint online. Patients’ names and reports are kept confidential. Additionally, consumers can anonymously report fraudulent products marketed on the Internet through FDA’s website. Consumers who don’t speak English can report problems with the help of their local Consumer Complaint Coordinator.

Jonca Bull, M.D., is FDA’s Assistant Commissioner, Office of Minority Health

Jason Humbert, R.N.,CDR, U.S. Public Health Service, is FDA’s National Health Fraud Coordinator, Office of Regulatory Affairs, Office of Enforcement and Import Operations

Making Progress in Protecting Consumers from Unsafe Supplements

By: Stephen Ostroff, M.D.

An estimated 200 million Americans take dietary supplements to maintain or improve their health. Protecting consumers from unsafe or contaminated dietary supplements is extremely important to FDA.

Acting FDA Commissioner, Stephen Ostroff, M.D.We’ve recently taken a number of important steps to prevent illnesses and deaths from unsafe supplements, and, while our current authority over supplements is arguably limited, we are doing what we can to strengthen our existing oversight. I’d like to give you a picture of the challenges, achievements and opportunities regarding the regulation of these products, beginning with the challenges.

One challenge is sheer volume. The dietary supplements industry is one of the fastest-growing in the world. When the Dietary Supplement Health and Education Act (DSHEA) was passed by Congress in 1994, annual sales of dietary supplements totaled about $5.8 billion. Since then, sales have risen six-fold to about $35 billion annually. Large volumes of supplements are also now sold on the Internet. The significant growth in the dietary supplements industry, and the various ways supplements reach consumers, outpace FDA’s resources to regulate this industry.

Moreover, tracing these products can be difficult because supply chains are often fragmented, with a single product sometimes passing through numerous suppliers, manufacturers and distributors of all kinds, sizes, and locations (including those overseas). Ultimately, when proper quality control and recordkeeping procedures are not followed across the supply chain, it can be difficult to guarantee what ingredients in what amounts are in the final product, and whether the ingredients are safe or even qualify as dietary supplements.

Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed to consumers. However, we do have the authority to take enforcement actions after a product is on the market – only when we can establish that the dietary supplement is adulterated (e.g., unsafe); misbranded (e.g., misrepresentations are made on the product labeling); or cannot be marketed as a dietary supplement (e.g., an unapproved new drug). We monitor the marketplace through market surveys, undercover buys, label reviews, a review of reports of illness or deaths, and product testing. When necessary, we take actions to protect public health, including issuing public warnings, taking legal action, and working with the company to recall the product. But all this must be done based on evidence and within the bounds of our legal authority and limited resources.

Despite these constraints, our actions have produced important results over the past year. Here are just a few key accomplishments:

  • At the request of FDA, this month U.S. Marshals seized almost 90,000 bottles of dietary supplements labeled as containing kratom. Kratom has been indicated to have both narcotic and stimulant-like effects.
  • Use of pure powdered caffeine products has already resulted in the deaths of two teenagers. We took action to help prevent harm, including deaths, from the use of these products, by issuing warning letters to five distributors of these potentially dangerous products.
  • In 2015, FDA identified products containing BMPEA, DMBA and picamilon that are unlawfully marketed and issued a series of warning letters to 24 companies that marketed dietary supplements containing these ingredients. The companies that received the warning letters market products that are either misbranded for falsely declaring the ingredients as dietary ingredients or marketing products containing new dietary ingredients without the required pre-market notification.
  • We worked closely with our government partners, including the Department of Justice, the Federal Trade Commission and the U.S. Postal Inspection Service, on a year-long sweep to identify potentially unsafe products and/or products containing undeclared ingredients. In November 2015, that sweep culminated in civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products.
  • We issued more than 100 consumer alerts warning about products falsely marketed as dietary supplements that were found to contain active pharmaceutical ingredients.
  • We conducted more than 600 inspections of dietary supplement firms in the U.S. and other countries. We also worked with companies on voluntary compliance actions, such as removing illegal claims, destroying inventory and ceasing distribution.

I am excited about the opportunities that await us in this area, and the plans we’re making for the future. For example, within FDA, we have established the new Office of Dietary Supplement Programs and are working on increasing the visibility, capacity and staffing for that new office. This will include hiring permanent leadership to sharpen our focus on potential safety problems and to support regulatory actions.

We want to expand our use of criminal investigation and enforcement tools to address serious safety-related violations and cases of intentional fraud; and further build strategic investigatory and enforcement collaborations with the Federal Trade Commission, Department of Justice, and state governments, including state health departments and attorneys general.

Ultimately our top priority is to protect the consumers who want to improve, not damage, their health and have a right to expect that dietary supplements will be safe for them and their families.

Stephen Ostroff, M.D., is Acting Commissioner of the U.S. Food and Drug Administration

FDA 2015: A Look Back (and Ahead) – Part 2: Medical Product Safety and Oversight

By: Stephen M. Ostroff, M.D.

In my first look back on FDA’s 2015 accomplishments, I focused on our achievements in medical product innovation and our constant drive to make safe, effective and innovative products available. Because FDA’s responsibility covers the entire life cycle of products, in this second year-end blog post, I will review FDA’s impact on medical product safety and oversight.

Acting FDA Commissioner, Stephen Ostroff, M.D.Responding to Ebola

In a world where disease knows no borders FDA’s response to the Ebola epidemic in West Africa demonstrates how we use our scientific expertise and regulatory authorities to the fullest extent possible to address a tragic public health crisis of global impact. Our response involved collaborating with partners across government, pharmaceutical and diagnostic companies, international organizations like the World Health Organization, and our international regulatory counterparts. We played a key role in expediting the availability of diagnostic tests and investigational therapeutics and vaccines, as well as investigating fraudulent products marketed to diagnose, prevent and treat Ebola. And many FDA commissioned corps officers of the U.S. Public Health Service served on the front lines, deployed in a humanitarian mission to provide care to patients at the Monrovia Medical Unit in Liberia, one of the West African nations that were hard hit by the outbreak.

Addressing Transmission of Infections from Duodenoscopes

This year we took steps to help protect the public from the risk of transmitted infections, including antibiotic-resistant infections, from duodenoscopes. Duodenoscopes are complex devices used during endoscopic retrograde cholangiopancreatography (ERCP), a potentially life-saving procedure to diagnose and treat blockages in the pancreas and bile ducts. In the United States, duodenoscopes are used in more than 500,000 ERCP procedures each year.

Last February, the FDA issued a safety communication to raise awareness about the risk of transmitted infections from duodenoscopes, after it determined that the design of these devices may impede effective reprocessing, even when the manufacturer’s reprocessing instructions are followed correctly. Reports also indicated that some healthcare facilities may not have adequately followed the manufacturer’s reprocessing instructions. To address these concerns, the FDA has been working with the device manufacturers to ensure that the reprocessing instructions for their duodenoscopes are put through the most rigorous testing. The Agency held a public advisory committee meeting in May to discuss the scientific challenges, and it incorporated recommendations for enhancing the safety margin of reprocessing duodenoscopes into a safety communication in August. Also in August, FDA issued Warning Letters to all three duodenoscope manufacturers citing violations found during recent inspections. In October, the FDA ordered the manufacturers to develop postmarket surveillance studies of how the devices are reprocessed in real-world clinical settings.

Our foremost concern is protecting patients, and we are committed to taking steps to assure that duodenoscopes – and all reprocessed medical devices — are safe to use.


We continue to respond effectively to the 2012 outbreak of fungal meningitis linked to contaminated compounded drugs. We are implementing the Drug Quality and Security Act and continuing our inspection and enforcement efforts at compounding facilities nationwide. To that end we have issued numerous policy documents regarding compounding and related activities to provide guidance to industry as we implement the new law. We’ve also held meetings with stakeholders, including pharmacy, physician, and consumer groups, and we have continued our active and successful collaborations with state governments.

Addressing the Opioid Abuse Crisis

Over the last year, we’ve been very focused on the growing epidemic of opioid abuse and addiction and its devastating impact on public health. This focus has required us to strike a delicate balance: ensuring medical treatments are available for patients who are in pain, while addressing the often tragic consequences of abuse and misuse, which all too often overwhelm individuals, families, friends and communities. Our approach is multi-pronged, from encouraging scientific investigation to improving the training of practitioners who prescribe these powerful medicines.

We believe it is vitally important to encourage the development of abuse-deterrent formulations of opioids and to support options for medication-assisted treatment of opioid-dependence. Final guidance for industry regarding the development of abuse-deterrent formulations was issued in April and several abuse-deterrent products have been approved. We are also making strides to treat the consequences of overdoses. In November, FDA approved the first nasal spray version of naloxone hydrochloride, to provide a route of delivery in addition to injection for this life-saving medication that can stop or reverse an opioid overdose. And we are working with our federal partners to improve access to naloxone.

While we cannot solve this complex problem alone, we remain committed to making the best use of our regulatory authorities and working with our partners both in and outside government to reduce the risks associated with opioids. To continue to achieve that, we have been engaging in a comprehensive review of our many current activities related to opioids and identifying which measures can and should be strengthened and what further measures are needed to address this crisis during 2016.

Ensuring the safety of the medical products we regulate requires us to manage a wide-range of issues across multiple scientific disciplines; and to employ scientists with the knowledge to solve today’s complex regulatory challenges. The last year brought many challenges, and just as many solutions.

In my final post, I will address some of our accomplishments in the area of food, tobacco product regulation, and antimicrobial resistance.

Stephen M. Ostroff, M.D., is Acting Commissioner of Food and Drugs

FDA Enforcement: Protecting Consumers and Enhancing Public Confidence

By: Howard Sklamberg, J.D. and Michael R. Taylor, J.D.

Under the Federal Food, Drug, and Cosmetic Act, companies producing food, including dietary supplement products, for American consumers have a legal responsibility to make them safe. Most companies take this responsibility seriously. FDA will work collaboratively with companies that are making a good faith effort to produce safe products and meet regulatory requirements.

Howard Sklamberg

Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

But when companies fail to meet their responsibility and violate the law in a way that jeopardizes public health, FDA can—and will—move decisively. This fall, for example, a federal court case in New Jersey illustrates the careful field work, close teamwork, and skillful investigation that are hallmarks of FDA criminal enforcement, which plays a vital role in food and dietary supplement safety.

The case involves Raw Deal, Inc., a manufacturer of dietary supplements based in Flanders, N.J. On September 9, Raw Deal’s owner and president, Barry Steinlight, pled guilty to one count of conspiracy to commit wire fraud involving a scheme to introduce adulterated and misbranded products into interstate commerce. Steinlight was sentenced to 40 months in prison and ordered to forfeit $1 million in profits from the fraudulent scheme.

Then, today the company’s former executive vice president, Catherine Palmer, was sentenced to a year’s probation and a criminal forfeiture of $100,000, after she pled guilty to obstructing an FDA investigation.

Last year, we wrote about federal-court convictions in the Peanut Corporation of America (PCA) case involving Salmonella-tainted peanuts and peanut products. In that case, two former officials of, and one broker for, PCA were prosecuted for practices that led to a deadly 46-state outbreak of Salmonella poisoning in 2009.

Michael R. Taylor

Michael R. Taylor, J.D., FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Today, we are highlighting the Raw Deal prosecution, which demonstrates our enforcement work in the dietary supplement field. The convictions arose from illegal practices by the firm, which included manufacturing adulterated and misbranded products by using fillers to cut costs, reusing returned and contaminated products, and falsifying batch records and certificates of analysis.

This story begins more than four years ago. Over the course of those years, FDA undertook a number of enforcement activities before criminal charges were filed by the U.S. Department of Justice:

  • In August 2011, FDA’s Office of Criminal Investigations (OCI), now headed by Director George Karavetsos, received an anonymous complaint that Raw Deal was manufacturing dietary supplements with fillers such as wheat-based products and the food additive Maltodextrin. The complainant also informed OCI that the manufacturer resold returned products that contained such contaminants as E. coli bacteria, lead and mold.
  • During the OCI investigation, FDA’s Office of Regulatory Affairs’ New Jersey District Office received four anonymous letters that described Raw Deal’s adulteration scheme, including the creation of false certificates of analysis.
  • The District Office conducted a compliance inspection and found that the manufacturer substituted ingredients without informing customers of the presence of fillers. As a result, the District Office issued Raw Deal a Warning Letter citing misbranding and adulteration violations.
  • OCI later determined that Raw Deal did not heed this warning and instead continued misbranding and adulterating its products. OCI then obtained and executed a search warrant at the manufacturing facility, with some of the samples collected subsequently revealing the presence of Salmonella, a bacterium frequently associated with foodborne illnesses.
  • This resulted in a Class I recall of certain Raw Deal products in March 2014. This recall classification means the products could cause serious health problems or death.

This case is just one example of FDA enforcement in action. Companies are given the opportunity to correct violations but if they don’t, there are serious consequences. Indeed, during the past two years, FDA criminal enforcement has resulted in 407 cases opened, 348 arrests, 305 convictions, and $694,131,579 in fines and restitutions.

Of note in this case is an excerpt from U.S District Court Judge Esther Salas’ remarks at Steinlight’s sentencing hearing:

“There is nothing more sacred than consumers having some peace of mind that people who are selling these supplements are doing it the right way, and are abiding by the laws and regulations that are put forth to protect the consumer…and my sentence has to be one that promotes respect for the law. Because what the FDA does is so critical…they are making sure that the products that we consume and the products that we use are safe for consumption, are safe for usage. And I am going to sentence you to a sentence, sir, that continues to give them the teeth they need, the power they need, to send a message to our society.”

Criminal enforcement actions protect consumers by punishing violators and deterring bad behavior by others. Strong enforcement helps industry too – by maintaining a level playing field for the production of safe foods and products.

FDA is strongly committed to working with companies that take their safety responsibilities seriously – and equally committed to dealing strongly with those that don’t.

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

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

Destroying Certain Imported Drugs: A New Rule to Protect Patients

By: Howard Sklamberg and Melinda K. Plaisier

Recently, FDA published the final rule implementing section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA). This new rule, which will take effect on October 15, 2015, provides FDA with an administrative process for the destruction of certain drugs refused admission to the United States. Why is this important? These drugs can pose a serious public health risk to consumers in the United States.

Howard Sklamberg

Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

On July 9, 2012, President Obama signed FDASIA into law. Title VII of FDASIA provides FDA with important new tools to help the agency better protect the integrity of the drug supply chain. One of those new tools is in section 708, which grants FDA the authority to use an administrative procedure to destroy a drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that was refused admission into the United States.

The majority of refused drug products subject to FDA’s new destruction authority come into the United States via international mail. Some of these mail parcels may include one or more drugs that are unapproved, adulterated, and/or misbranded, including counterfeit drugs and drugs that purport to be dietary supplements.

These drugs can pose a serious public health threat to consumers in the United States because they:

  • might not contain the active ingredient that patients need for treatment of their disease;
  • might have too much or too little of an active ingredient;
  • might contain the wrong active ingredient; and/or
  • might contain toxic ingredients.
Melinda Plaisier

Melinda K. Plaisier, FDA’s Associate Commissioner for Regulatory Affairs

In addition, drugs that are represented and sold as dietary supplements can contain hidden or deceptively labeled active pharmaceutical ingredients, some at levels much higher than those found in FDA-approved drugs. Such products can cause harm and have been associated with serious adverse events for consumers. Other purported dietary supplements, although they may not contain harmful ingredients, are promoted to prevent or treat serious diseases but have not been proven safe and effective for that purpose.

Prior to this rule, drugs imported via an International Mail Facility (IMF) that were refused admission because they appeared to violate the law were generally sent back to the U.S. Postal Service (USPS) for export. There has been little deterrence to prevent sellers from sending drugs that violate the law or resending previously refused drugs into the United States via the IMFs to circumvent import regulatory systems.

In fact, some of the parcels returned by USPS were resubmitted for entry into the United States by the sender, with the sticker indicating prior refusal by FDA still attached and visible. This new rule allows FDA to better deter such importation by having an administrative process in place to destroy a refused drug. Rather than returning the drugs to the sender, these drugs will be destroyed. Compared to the volume of entries at IMFs, the agency has limited on-site resources. By deterring violative imports and re-entry attempts, this new process will allow the agency to more effectively focus its limited resources.

Under the final rule, FDA will provide the owner or consignee of the refused drug with written notice and an opportunity to appear and introduce testimony to the agency prior to the destruction. If the drug is destroyed, section 708 provides that the owner or consignee is responsible for the costs of storage and disposal of the drug. However, FDA generally does not intend to pursue recovery of storage and disposal costs against individual consumers who seek to import a drug for their own personal use that is then refused and destroyed.

By enabling FDA to destroy certain drugs, this important action will allow FDA to continue to protect and promote public health.

You can look up the current status of any FDASIA deliverable and sign up to receive Title VII updates using FDASIA-TRACK.

Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy.

Melinda K. Plaisier is FDA’s Associate Commissioner for Regulatory Affairs.

FDA Science Forum 2015: Views of FDA

FDA’s 2015 Science Forum attracted more than 800 people from the scientific community. Here’s what some attendees said about the innovative research going on at the agency and why FDA can be a valuable collaborator in research aimed at transforming food safety and medical product development. If you couldn’t attend the FDA science forum, you can still see all the presentations on our web site.

A Global Fight Against Dangerous Counterfeit and Unapproved Medical Products: From Operation Pangea to FDA’s Global Strategic Framework

By: Howard Sklamberg, J.D., George Karavetsos, J.D., and Cynthia Schnedar, J.D.

Unfolding earlier this month was a global cooperative effort, which included the Food and Drug Administration, to combat the online sale and distribution of potentially counterfeit and illegal medical products. Operation Pangea VIII was a project of massive scope, a lightning move by 115 countries that resulted in more than 2,400 websites being taken offline and the seizure of $81 million worth of potential dangerous illegal medicines and medical devices worldwide.

Howard Sklamberg

Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

It’s a sad and cruel fact that drug and device counterfeiting and adulteration pose serious threats to public health. Unapproved and misbranded prescription drug products and unapproved/uncleared medical devices offered for sale on the Internet are potentially dangerous. The illegal sale of these medicines and devices bypasses both the existing safety controls required by the FDA and the protections provided when these products are used under a licensed practitioner’s supervision.

FDA is dedicated to sustaining and expanding the fight against counterfeits as part of our global strategy that leverages resources and expertise, engages the private and public sectors, and is data-driven and risk-based.

We have developed a Global Strategic Framework for counterfeit and substandard medical products (sometimes known by the acronym SSFFC, for Substandard, Spurious, Falsely-Labeled, Falsified, Counterfeit) to help protect consumers by reducing their exposure to counterfeit and substandard medical products.

The framework is focused on three pillars: Prevention, Detection, and Response.

What’s needed is better prevention of market entry of counterfeit and substandard products. Better detection of these products. And, more efficient response when counterfeit and substandard products are found.

FDA developed this framework in order to lay out a strategic vision of what is needed and how these needs can be met globally. There are areas where our expertise can and does contribute to prevention, detection, and response, but there are other areas where other U.S. federal and local government agencies, foreign counterparts, industry, healthcare professionals, consumer and patients, non-governmental organizations, procurement and donor organizations, standards bodies, and others have a role.

George Karavetsos

George Karavetsos, J.D., FDA’s Director, Office of Criminal Investigations

It is important for all players fighting to combat counterfeit and substandard drugs and devices to understand exactly how to best use our resources, knowledge, and experience, and leverage the work of others. This framework helps shape what roles we can play, minimize duplication of effort, and strengthen our global might in this fight against the criminals.

FDA has many ongoing activities and initiatives that support the framework goals. To better prevent counterfeit and substandard products from entering the market, we are working on improving the transparency, accountability, and integrity of the supply chain. Specifically, we are focusing on good manufacturing, distribution, and pharmacy practices, and we’re working for a convergence of global standards to create a more level playing field for the legitimate supply chain.

We are also implementing the new track and trace law (the Drug Supply Chain Security Act), which outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States, no matter where they originate. This is a collaborative effort whereby FDA is working with drug manufacturers, wholesale drug distributors, repackagers and dispensers (primarily pharmacies) to implement the law and develop the new system over the next eight years. Some of the key goals of this system will be to trace the path of drugs at the package-level through the drug supply chain, help ensure they are legitimate products, and enhance the detection of illegitimate drugs.

Cynthia Schnedar

Cynthia Schnedar, J.D., Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research

To better detect potentially harmful products before they enter the supply chain on their way to patients, we are focusing on improving information-sharing and communication. Also, as part of our effort for better detection, we are improving our surveillance through more efficient investigations of suspect incidents, and more quickly confirming that products are counterfeit. To this end, we have developed new detection technologies, specifically the handheld device, CD3, which uses wavelength detection to detect counterfeit drugs and packaging at our ports of entry.

Lastly, to better respond to incidents in the most efficient manner, FDA’s Center for Drug Evaluation and Research is developing more effective ways to notify the public of confirmed incidents and quicker removal of counterfeit products from the marketplace.

As for enforcement, we will continue to rely on our skilled professionals in FDA’s Office of Criminal Investigations (OCI) to lead domestic and global investigations to combat counterfeits. For example, OCI’s involvement in the past seven years of Operation Pangea has resulted in the seizure of more than $172 million in unlawful medical products — a real testament to effective international partnership.

We fully recognize that there are sophisticated, global criminal networks engaged in money laundering and the preparation and transportation of illegal products around the world. Importantly, we are meeting this global threat with international collaboration. FDA’s Office of International Programs has engaged with the World Health Organization’s Global Surveillance and Monitoring System, the World Bank, and the U.S. Agency for International Development in securing drug supply chains, reducing the threat of substandard drugs and strengthening regulatory systems.

We also collaborate with many foreign law enforcement organizations. For example, we have an OCI agent permanently assigned to Europol, based in The Hague, Netherlands. We also have a longstanding and solid partnership with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). More recently, OCI signed with the French National Gendarmerie a Letter of Intent to increase law enforcement collaboration.

Moreover, the stakes have grown higher in the U.S. as judges around the country recognize the risks of unapproved drugs in the U.S. marketplace. In January 2015, for example, a Turkish exporter of illegal drugs was sentenced to 30 months in federal prison for his part in the scheme.

As underscored by Operation Pangea last week, our actions to protect the health of Americans from the online sale of potentially dangerous illegal medical products will continue. In the longer term, our focus will be prevention, detection and response. We will need a more coordinated, domestic and global approach that leverages resources, expertise, tools, and trainings, and engages stakeholders, other regulators, and law enforcement.

Through our framework for strategically safeguarding supply chain security and integrity and combatting counterfeit and substandard drugs and devices, we know we are on the right path with the right goal: Protecting public health by helping to ensure that the prescription medications and devices used by health care professionals and patients are safe, effective and of high quality.

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

George Karavetsos, J.D., is FDA’s Director, Office of Criminal Investigations

Cynthia Schnedar, J.D., is FDA’s Director, Office of Compliance, Center for Drug Evaluation and Research

FDA as part of a coordinated global response on Ebola

By: Margaret A. Hamburg, M.D.

The tragic Ebola epidemic is an extraordinary global public health crisis, and FDA is taking extraordinary steps to be proactive and flexible in our response – whether it’s providing advice on medical product development, authorizing the emergency use of new diagnostic tools, quickly enabling access to investigational therapies, or working on the front lines in West Africa.

Margaret Hamburg, M.D.FDA has an Ebola Task Force with wide representation from across FDA to coordinate our many activities. We are actively working with federal colleagues, the medical and scientific community, industry, and international organizations and regulators to help expedite the development and availability of medical products – such as treatments, vaccines, diagnostic tests, and personal protective equipment – with the potential to help bring the epidemic under control as quickly as possible.

These efforts include providing scientific and regulatory advice to commercial developers and U.S. government agencies that support medical product development, including the National Institutes of Health (NIH), the Office of the Assistant Secretary for Preparedness and Response (ASPR), the Centers for Disease Control and Prevention (CDC), and the Department of Defense (DoD). The advice that FDA is providing is helping to accelerate product development programs.

Our medical product reviewers have been working tirelessly with sponsors to clarify regulatory requirements, provide input on manufacturing and pre-clinical and clinical trial designs, and expedite the regulatory review of data as it is received. FDA has been in contact with dozens of drug, vaccine, device, and diagnostic test developers, and we remain in contact with more than 20 sponsors that have possible products in pipeline.

We also have been collaborating with the World Health Organization and other international regulatory counterparts—including the European Medicines Agency, Health Canada, and others—to exchange information about investigational products for Ebola in support of international response efforts.

Investigational vaccines and treatments for Ebola are in the earliest stages of development and for most, there are only small amounts of some experimental products that have been manufactured for testing. For those in limited supply, there are efforts underway to increase their production so their safety and efficacy can be properly assessed in clinical trials.

As FDA continues to work to expedite medical product development, we strongly support the establishment of clinical trials, which is the most efficient way to show whether these new products actually work. In the meantime, we also will continue to enable access to investigational products when they are available and requested by clinicians, using expanded access mechanisms, also known as “compassionate use,” which allow access to such products outside of clinical trials when we assess that the expected benefits outweigh the potential risks for the patient.

In addition, under the FDA’s Emergency Use Authorization (EUA) authority, we can allow the use of an unapproved medical product—or an unapproved use of an approved medical product—for a larger population during emergencies, when, among other reasons, based on scientific evidence available, there is no adequate, approved, and available alternative. To date, FDA has authorized the use of five diagnostic tests during this Ebola epidemic: one was developed by DoD, two were developed by CDC, and this week FDA issued EUAs for two new, quicker Ebola tests made by BioFire Defense.

To further augment diagnostic capacity, we have contacted several commercial developers that we know are capable of developing rapid diagnostic tests and have encouraged them to work with us to quickly develop and make available such tests. Several entities have expressed interest and have initiated discussions with FDA.

We also are monitoring for fraudulent products and false product claims related to the Ebola virus and taking appropriate action to protect consumers. To date, we have issued warning letters to three companies marketing products that claim to prevent, treat or cure infection by the Ebola virus, among other conditions. Additionally, we are carefully monitoring the personal protective equipment (PPE) supply chain to help ensure this essential equipment continues to be available to protect health care workers.

And at least 12 FDA employees are being deployed to West Africa as part of the Public Health Service’s team to help with medical care. We are proud that they are answering the call.

As you can see, FDA has been fully engaged in response activities and is using its authorities to the fullest extent possible to continue its mission to protect and promote the public health, both domestically and abroad. Our staff is fully committed to responding in the most proactive, thoughtful, and flexible manner to the Ebola epidemic in West Africa.

I could not be more proud of the dedication and leadership that the FDA staff involved in this response has shown. I therefore want to take this opportunity to thank more than 250 staff, including those soon to be on the ground in West Africa, who have already contributed countless hours to this important effort, and who will continue to do so in the coming days and weeks as we address this very serious situation. I am hopeful that our work and the coordinated global response will soon lead to the end of this epidemic and help reduce the risk of additional cases in the U.S. and elsewhere.

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

FDA Works to Mitigate the West Africa Ebola Outbreak

By: Luciana Borio, M.D.

Luciana Borio, M.D.The world is witnessing the devastating effects of the Ebola virus outbreak in West Africa, the worst Ebola outbreak in recorded history. To date, more than two thousand people in Guinea, Liberia, Nigeria and Sierra Leone have become infected, and more than twelve hundred have died. The stories of so many lives lost, and those of so many others fighting for their lives, are heartbreaking and tragic. We at the Food and Drug Administration are dedicated to helping end this outbreak as quickly as possible. And we are working hard to accelerate the development and production of treatments and vaccines to help prevent future outbreaks like this.

The primary approaches to contain the current outbreak remain standard public health measures. However, this outbreak presents complex challenges, in part because there are no FDA-approved treatments or vaccines for the Ebola virus. FDA has an important role during situations like this.

For example, we are working closely with U.S. government agencies that support medical product development – including the National Institutes of Health, the Biomedical Advanced Research and Development Authority, and the U.S. Department of Defense (DoD) – to speed the development and production of medical products that could help mitigate outbreaks like this. And we are working interactively with medical product sponsors to clarify regulatory and data requirements in order to move investigational products forward in development as quickly as possible. We also are in close contact with the World Health Organization and several of our international regulatory counterparts to exchange information about these investigational products for Ebola treatment, and to exchange information about how FDA works to facilitate development of and access to these products.

The experimental vaccines and treatments in development are in the earliest investigational stages and have not been fully tested for safety or efficacy. Only small amounts of some experimental products have been manufactured for testing, which means few courses, if any, are available for companies to make available for compassionate use in response to this outbreak. We are working closely with our U.S. government colleagues to have experimental treatments and vaccines available for clinical evaluation in the next few months. We are hopeful that, in the future, we will have medical products approved and manufactured for wide-scale use to address the Ebola outbreak. However, these products are not at that stage yet.

In the meantime, FDA is doing all we can to alleviate the situation. FDA has one of the world’s most flexible regulatory frameworks, which includes mechanisms to enable access to available investigational medical products when, based on certain criteria such as the balance between expected risk and benefit to the patient, it would be appropriate to use such products.

For example, under certain circumstances, clinicians may request the use of an Emergency Investigational New Drug (EIND) application under the FDA’s Expanded Access program to access investigational products outside of clinical trials for their patients. And under the FDA’s Emergency Use Authorization (EUA) authority, we can allow the use of an unapproved medical product – or an unapproved use of an approved medical product – for a larger population during emergencies, when there are no adequate, approved and available alternatives.

This month, we authorized the use of an Ebola diagnostic test, developed by DoD, under an EUA to detect the Ebola virus in DoD-designated laboratories. This test can help facilitate an effective response to the ongoing outbreak in West Africa by helping to rapidly identify patients infected with Ebola virus and facilitate appropriate containment measures and clinical care.

It is an unfortunate fact that, during outbreaks like this, fraudulent products that claim to prevent, treat or cure a disease rapidly appear on the market. FDA has learned of several fraudulent products that claim to prevent or treat this Ebola virus infection, including so-called natural remedies. Consumers who have seen these fraudulent products or false claims should report them to us. For our part, we will remain vigilant for fraudulent products and false product claims related to the Ebola virus, and will take enforcement actions as warranted to protect public health.

FDA stands ready to work with companies and healthcare providers to speed product development and to facilitate access to investigational products to treat patients when appropriate. We are fully committed to helping end this outbreak as quickly as possible and to sustaining our efforts to help prevent such outbreaks in the future.

Luciana Borio, M.D., is the Assistant Commissioner for Counterterrorism Policy and Acting Deputy Chief Scientist.