FDA and Health Canada: Working Together for an Efficient Pathway for Drug Applications

By:  Robert Yetter, PhD 

At FDA, we work closely with national regulatory agencies around the world on issues relating to the safety, efficacy and availability of medical products. An exciting example of such collaborative efforts is the Common Electronic Submissions Gateway (or CESG), an outcome of the US-Canada Regulatory Cooperation Council (RCC). Through a cooperative research and development agreement, FDA worked with our counterparts in Health Canada, to share technology that will make it more efficient for industry to submit applications to both the U.S. and Canada for the approval of pharmaceutical and biological products. A common infrastructure would enable industry to submit to both countries using the same electronic format for technical documents. 

Robert YetterThe RCC Initiative was announced in February 2011 by President Barack Obama and Prime Minister Stephen Harper. Its goals are to promote economic growth, job creation and benefits to consumers and businesses through increased regulatory transparency and coordination. The electronic submissions gateway is one such project designed to meet those goals. 

So just what is this gateway? It’s an electronic “post office” that uses secure Internet connections to receive electronic versions of medical product applications and related documents from industry sponsors seeking regulatory approval. The technology was developed under contract, and implementation at FDA was led by the Center for Biologics Evaluation and Research.  FDA’s Electronic Submissions Gateway (ESG) has been in operation since 2006. It has now been modified to accommodate submissions from both Canada and the U.S. using the same interface and technology, and subsequently sending those submission transmissions to one or both regulatory authorities. 

The collaboration on the Common Electronic Submissions Gateway has the potential to yield long-term positive outcomes for both FDA and Health Canada. The collaboration continues the work between the two regulatory partners to streamline both agencies’ submission requirements while maintaining consistency in regulatory requirements. It could also lead to cost reductions for regulated industry, which would not have to follow separate technical requirements for submission to the two countries. 

We’re very proud of our work with Health Canada to make this technology accessible in a relatively short amount of time, going from concept to delivery in 26 months. This is yet another example of the steps FDA is taking as part of our Global Initiative, which envisions enhanced collaboration with our regulatory partners. 

Robert Yetter, PhD, is the Associate Director for Review Management in FDA’s Center for Biologics Evaluation and Research

Another Strong Year for Novel New Drug Approvals

By: John K. Jenkins, M.D.

Last year marked another strong year for FDA approvals of novel new drugs, known as new molecular entities (NMEs).  In 2013, FDA’s Center for Drug Evaluation and Research (CDER) approved 27 NMEs last year – about the same as the 26 average NME approvals per year since the beginning of this decade.

John JenkinsMore important than the quantity of novel new drugs approved in 2013 is their quality – and the important new roles many of these drugs can serve in advancing medical care and the health of patients. We now have new safe and effective treatments for a wide range of serious medical conditions, such as late-stage breast cancer, chronic hepatitis C, metastatic melanoma, mantle cell lymphoma, chronic lymphocytic leukemia, homozygous familial hypercholesterolemia, pulmonary arterial hypertension, and many more. Some of these medications offer new hope to patients who previously had few or no treatment options.

Here are a few highlights of these approvals:

  • One-third of the NMEs approved in 2013 were identified by FDA as “first-in-class,” for example, drugs that use a new and unique mechanism of action for treating a medical condition;
  • One-third were also approved to treat rare or “orphan” diseases that affect 200,000 or fewer Americans who often have few or no drug treatment options;
  • Almost half of the 27 NMEs approved last year (13 of 27), were designated in one or more categories of Fast Track, Breakthrough, Priority Review, or Accelerated Approval. Each of these designations helps speed the development and/or approval process and is designed to help bring important medications to the market as quickly as possible;
  • Although FDA’s regulatory processes differ widely from those of foreign regulatory authorities, almost three-quarters (74%) of the NMEs approved by FDA in 2013 were approved first in the United States before any other country.

All of us at FDA are pleased and proud to be part of a team that helped bring these new drugs to market as safely and efficiently as possible. As always, while striving for efficiency in our review and approval of applications for new drugs, compromises were not made in our standards. To be approved, each NME had to demonstrate that it was safe and effective before being approved.

My colleagues and I look forward to another productive year serving the American public!

For more details about 2013’s approvals, please visit The Novel New Drugs Summary at: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM381803.pdf

John K. Jenkins, M.D., is Director, Office of New Drugs, at FDA’s Center for Drug Evaluation and Research

Gregory Reaman Helps Make the World a Better Place for Children

By: Richard Pazdur, M.D.

I am privileged to work every day with many physicians and other health care professionals dedicated to advancing public health for all Americans. One of them is Dr. Gregory Reaman, who has been awarded the Leukemia & Lymphoma Society’s prestigious Return of the Child Award. Greg has devoted his career to finding better ways to treat and improve the outcomes for children with cancer.

Richard Pazdur, M.D.This award, presented in December in New Orleans, is given each year to a person who has made a major and lasting scientific or humanitarian contribution to the better understanding, management or treatment of pediatric hematological malignancies. (Hematological malignancies are the types of cancer that affect the blood, bone marrow and lymph nodes.)

Greg was honored for his exceptional leadership and accomplishments in the field of pediatric hematology and oncology during his lengthy career as a clinician and academic researcher and, since 2011, as a member of my team here at FDA. His primary work has focused on clinical trials for children with acute lymphoblastic leukemia (ALL) and the early phases of developing experimental drugs for children. Greg’s leadership in these areas has led to significant improvements in the care of children with ALL, as well as the facilitation of new drug development for children with cancer.

Dr. Gregory Reaman accepts award

Dr. Gregory Reaman (left) accepts The Return of the Child Award Presented by LLS CEO John Walter

Greg is a previous recipient of the Leukemia & Lymphoma Society’s Tree of Life Award, which honors those who have played a major role in improving the quality of life of patients and their families. Through these and many other efforts, his extensive research has helped to advance how pediatric blood cancers are treated today.

At FDA, where he is associate director of oncology sciences, Greg is using new mechanisms created by recent laws to facilitate public discussion and promote drug research and development for children with cancer.

Greg is also executive director emeritus and senior attending physician at Children’s National Medical Center in Washington, D.C. Throughout his distinguished career, Greg has held other leadership positions at Children’s and at the National Childhood Cancer Foundation. He is also a tenured professor of pediatrics at the George Washington University School of Medicine and Health Sciences. 

I know of no greater endeavor in life than to dedicate one’s work to making this world a better place for children, and I know of no individual more deserving of an award for such efforts than Greg. I know I speak for my entire staff and all of us at FDA when I congratulate Greg on his achievements.

Richard Pazdur, M.D., is director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research

We Moved Forward on Many Fronts This Year

By: Margaret A. Hamburg, M.D.

At the FDA, the agency that I’ve had the privilege to lead for the past five years, I am gratified to report that we have a lot to be proud of this year. In fact, this past year’s accomplishments on behalf of public health have been as substantial as any in FDA’s recent history.

Margaret Hamburg, M.D.We moved significantly forward, for example, in creating a system that will reduce foodborne illness, approving novel medical products in cutting-edge areas of science, and continuing to develop our new tobacco control program. We worked successfully with Congress and with regulated industry to reach agreement on a number of difficult issues, while continuing to use the law to the full extent possible to protect consumers and advance public health.

While there were many significant actions and events to recognize, below are some of the highlights of 2013.

In the foods area, there were many new actions this year that will have a long-standing impact on improving our food supply for consumers. Throughout the year we have been proposing new rules to reach the goals set forth by the FDA Food Safety Modernization Act (FSMA). These science-based standards will help ensure the safety of all foods produced for our market, whether they come from the U.S. or from other countries.

We also took important steps towards reducing artery-clogging trans fat in processed foods, and understanding the health impact of arsenic in rice. With a final rule that defines when baked goods, pastas and other foods can be considered free of gluten, people with celiac disease can have confidence in foods labeled “gluten free.” And we are studying whether adding caffeine to foods may have an effect on the health of young people and others.

There have likewise been many accomplishments in advancing the safety and effectiveness of medical products. We worked closely with Congress on the recently enacted Drug Quality and Security Act, which contains important provisions relating to the oversight of human drug compounding. The law also has provisions to help secure the drug supply chain so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs.

Using tools provided by last year’s landmark Food and Drug Administration Safety and Innovation Act (FDASIA), we are continuing to improve the speed and efficiency of medical product reviews, including those involving low-cost, high quality generic drugs and innovative new medical devices. The average number of days it takes for pre-market review of a new medical device has been reduced by about one-third since 2010. The percentage of pre-market approval applications that we approve has increased since then, after steadily decreasing each year since 2004.

We launched a powerful new tool to accelerate the development and review of “breakthrough therapies,” allowing FDA to expedite development of a drug or biologic (such as a vaccine) if preliminary clinical evidence indicates that it may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. This offers real opportunities to get promising drugs more quickly to patients who need them. In fact, using this new approach, FDA recently approved two advanced treatments for rare types of cancer and one for hepatitis C. We have also strengthened efforts to ensure product quality, increased protection of the drug supply chain, and reduced drug shortages.

We confronted the growing misuse of powerful opioid pain relievers by advising manufacturers on how to make these drugs harder to abuse with formulations that are more difficult to crush for inhalation or dissolve for injection. And we recommended that hydrocodone combination products be subject to stricter controls to help prevent abuse. 

We took an important step towards fighting the development of antibiotic-resistant bacteria by implementing a voluntary plan to phase out the use of antibiotics to enhance the growth of food-producing animals, and to move any remaining therapeutic uses of these drugs under the oversight of a licensed veterinarian. So-called “production” use is considered a contributing factor in the development of bacteria that are resistant to the antibiotics used in human medical treatment.

In many areas of our work we are supporting the emerging field of personalized medicine. Advances in sequencing the human genome and greater understanding of the underlying mechanisms of disease, combined with increasingly powerful computers and other technologies, are making it possible to tailor medical treatments to the specific characteristics, needs, and preferences of individual patients.

Many cancer drugs today are increasingly used with companion diagnostic tests that can help determine whether a patient will respond to the drug based on the genetic characteristics of the patient’s tumor. In May, FDA approved two drugs and companion diagnostic testing for the treatment of certain melanoma patients with particular genetic mutations.

Advances in science and technology are also seen in the creation of new medical devices. For example, 3-D printing - the making of a three-dimensional solid object from a digital model – was once considered the wave of the future. But in February, FDA cleared for marketing a device created by 3-D printing – a plate used in a surgical repair of the skull that is built specifically for the individual patient.

While we have worked hard to get therapies to patients, we are at the same time using the tools available to us to remove unsafe and dangerous products from the market. In November, we used new enforcement tools provided by the food-safety law to act quickly in the face of a potential danger to public health presented by certain OxyElite Pro products. These supplements had been linked to dozens of cases of acute liver failure and hepatitis. After FDA took action, the manufacturer agreed to recall and destroy the supplements.

Finally, we made significant progress in implementing the letter and spirit of the Family Smoking Prevention and Tobacco Control Act. We have signed contracts with numerous state and local authorities to enforce the ban on the sale of tobacco to children and teens; conducted close to 240,000 inspections; and written more than 12,100 warning letters to retailers. And, in the first quarter of 2014 we will launch a public education campaign aimed at reducing the number of young people who use tobacco products.

All of us take great pride in the skill and vigor with which we overcame the year’s challenges and new demands. And so, as the year draws to a close, I extend my gratitude to the employees at the FDA who work tirelessly on behalf of the American public year in and year out. To all of our stakeholders, my heartfelt wishes for a joyous holiday season and a safe and healthy 2014.

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

New Law Enhances Safety of Compounded Drugs and Protection of the Drug Supply Chain

By: Margaret A. Hamburg, M.D.

Since last year’s tragic meningitis outbreak and subsequent events involving compounded drugs, Congress has been hard at work to pass new legislation to provide FDA with the appropriate authorities for regulating compounded drugs to help make these products safe for the American public.

Margaret Hamburg, M.D.Over a much longer period of time, efforts have been made in Congress to enhance the security of the drug supply chain and protect consumers from exposure to counterfeit, stolen, contaminated or otherwise harmful drugs.

I am pleased that the Drug Quality and Security Act can help FDA protect public health in both of these critical areas.

One part of the new law offers a step forward in FDA’s oversight of certain entities that prepare compounded drugs. The new law will enable these compounders to register with the FDA to become “outsourcing facilities,” making them subject to certain other requirements including Federal quality standards, known as current good manufacturing practice. These facilities will also be subject to inspection by FDA on a risk-based schedule. If compounders register with FDA as outsourcers, hospitals and other health care providers will be able to provide their patients with drugs that were compounded in facilities that are subject to FDA oversight and federal requirements for current good manufacturing practice, among others. To that end, we will be encouraging healthcare providers and health networks to consider purchasing compounded products from facilities that are registered with FDA and subject to risk based inspections.

Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the law, or they will be regulated by FDA as conventional drug manufacturers.

Generally, the state boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state licensed pharmacies, including traditional pharmacy compounding. And FDA will continue to cooperate with state authorities to address pharmacy compounding activities that may be in violation of the Federal Food Drug and Cosmetic Act.

Another part of the new law enables certain prescription drugs to be traced as they move through the U.S. drug supply chain. The goal is to protect the public from exposure to counterfeit, stolen, or otherwise harmful drugs. This will require manufacturers, repackagers, wholesale drug distributors, and dispensers (other than most licensed health care practitioners) to provide product and transaction information with each sale and notify the FDA and other stakeholders of illegitimate products, which will result in improved detection and removal of potentially dangerous drugs from the supply chain.

Starting four years after enactment of the law, manufacturers, followed by repackagers, will be required to affix a unique product identifier to each drug package that contains the drug’s national drug code (NDC), serial number, lot number, and expiration date. Starting six years after enactment of the law, wholesale drug distributors, followed by dispensers, may only trade products that  are encoded with product identifiers and will be able to verify the product identifier if they determine that they have  suspect product. Ten years after enactment, supply chain stakeholders and FDA will benefit from an electronic, interoperable system which will facilitate the efficient exchange of product and transaction information for prescription drugs at the individual package level. The system, when fully implemented, will enable verification of the legitimacy of the drug product identifier down to the package level, enhanced detection and notification of illegitimate product, and improved efficiency of recalls.

The Drug Quality and Security Act is a significant step toward having new and stronger drug quality and safety laws. While the law does not provide FDA with all the additional authorities sought, these provisions are a sign of progress.

We are committed and prepared to implement the new law that will help us to further protect public health.

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

Ensuring Safe Food and Medical Products: A Partnership with the Mekong Region

By: Margaret A. Hamburg, M.D.

Several years ago I had the opportunity to visit the Mekong Region of Southeast Asia, which includes the countries of Cambodia, Laos, Myanmar, Thailand and Vietnam. I was struck not only by its beauty, dynamism, and diversity, but also by the commitment of health officials there to building strong health systems and cooperating across borders in the face of potential health threats. I learned that by working together with each other and the United States they were able to build an effective rapid response to outbreaks of an emerging pathogen such as the H5N1 influenza virus.

Margaret Hamburg, M.D.I was reminded of my visit this week during my participation at a forum hosted by the Center for Strategic and International Studies entitled “U.S. Health Partnerships in the Mekong Region.” The day’s discussions highlighted the growing strategic importance of the region to the United States and the long-standing and ongoing partnerships between U.S. agencies and regional partners in health and development, including the central focus of the FDA, to ensure the safety of food and medical products in the United States.

Though Americans may not often think about it, the U.S. is increasingly and inextricably linked to the Mekong Region through global supply chains. For instance, about 15% of the seafood we consume in the United States comes from Mekong region countries, arriving on our shores and in our stores after a long and circuitous journey. Consider tuna, which may be caught in the South Pacific, transported to New Zealand for pre-canning, and shipped to Southeast Asia for canning before it finally makes its way to the East Coast of the United States for distribution in this country. 

Why does this matter to FDA? There is a greater likelihood that food will be exposed to pathogens, contaminants or chemical hazards during a journey of this complexity. That’s why we work closely with our regional counterparts in these countries through such organizations as the Association of Southeast Asian Nations (ASEAN) and the Asia Pacific Economic Cooperation (APEC), sharing with them our own regulatory requirements, our knowledge of good manufacturing practices and our laboratory and inspection techniques. Through such information sharing we believe we can prevent tainted or otherwise unsafe foods from reaching our borders. 

But the risk of potentially unsafe food from this area is not our only concern. A significant threat to human safety today involves substandard, falsified and counterfeit medical products that are part of the global supply chain. These products may contain toxic ingredients, or too much or too little of a drug’s active ingredient, and as a result patients could be poisoned or unwittingly receive inadequate treatment for their disease or even no treatment at all. In addition, if too many patients receive only partial treatment, it might foster the development of drug-resistant disease strains. And there’s this too: a high prevalence of substandard and falsified medicines ultimately will erode public trust in the health care system.

Unfortunately, statistics suggest that substandard and falsified products is a problem in the Mekong Region. A recent comprehensive review found that in Southeast Asia, 35 percent of anti-malarial drugs were substandard and 36 percent were counterfeit. And many of the countries in this region have porous borders and face challenges with regulatory oversight and enforcement practices that cannot adequately protect the supply chain. 

FDA is working with the World Health Organization to build a global monitoring system to monitor substandard, falsified and counterfeit medicines, and collaborating with countries in the region to develop and test the system. In addition to cooperating with our regulatory counterparts across the globe on issues of detection, investigation and enforcement, FDA scientists have developed the Counterfeit Detection Device, or CD-3, which can quickly screen for counterfeit products – not just drugs – at any location, including remote communities and border sites. With our international partners, we are currently planning to expand the use of this tool in several field settings, including in the Mekong region.

Building cooperation for this kind of enforcement is essential not just to ensuring the safety of our food and medical products, but as a means of advancing our national security objectives. That’s why meetings like the one I attended this week are so important. They support opportunities to work with our colleagues in the Mekong region on ways to share information and promote stronger, innovative regulatory systems that are critical to the long-term success of our global public health efforts.

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

Working to improve the communication of important drug safety information about generic drugs

By: Janet Woodcock, M.D. 

FDA is taking a step today that is intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients. 

All drug manufacturers are required to keep close tabs on their drugs once they go to market, reviewing all reports of adverse events involving their drug and reporting these findings to FDA. 

But currently, only brand name manufacturers are able to independently update and promptly distribute revised drug safety information, also called labeling, and they can distribute that information before FDA has reviewed or approved the change. These updates, which are submitted in changes being effected supplements, ensure that this important safety information gets to the public as quickly as possible. 

Right now generic companies, who are responsible for over 80% of the prescription drugs dispensed to patients, aren’t able to revise their drug safety information as quickly as the brand name. They must provide supporting information to FDA, which then determines whether safety information for both the brand and generic drugs should be revised before updates can occur. 

Today, FDA is issuing a proposed rule that would allow generic drug manufacturers to independently update and promptly distribute revised product labeling — just like brand name manufacturers – before FDA reviews or approves the change. 

Empowering generic drug companies to update their own drug safety information is intended to provide them the incentive to more actively participate with FDA in ensuring the timeliness, accuracy, and completeness of this information. 

The brand manufacturer would be expected to consider the information provided by the generic drug manufacturer as part of its review and evaluation of adverse drug experience information for its drug. 

And to make sure that the drug safety information updates from both generic and brand name companies are readily available to health care professionals and the public, FDA plans to post these updates on its website. 

Faster safety updates and easier access to this information should be a win–win for all involved. 

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

Personalized Medicine: The Future is Now

By Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.The difference between science and science fiction is a line that seems ever harder to distinguish, thanks in part to a host of astonishing advances in medical science that are helping to create a new age of promise and possibility for patients.

Today cancer drugs are increasingly twinned with a diagnostic device that can determine whether a patient will respond to the drug based on their tumor’s genetic characteristics; medical imaging can be used to identify the best implantable device to treat a specific patient with clogged coronary arteries; and progress in regenerative medicine and stem cell therapy using a patient’s own cells could lead to the replacement or regeneration of their missing or damaged tissues. Given these trends, the future of medicine is rapidly approaching the promising level of care and cure once imagined by Hollywood in futuristic dramas like Star Trek.

But these examples are not science fiction. They are very real achievements that demonstrate the era of “personalized medicine” where advances in the science of drug development, the study of genes and their functions, the availability of increasingly powerful computers and other technologies, combined with our greater understanding of the complexity of disease, makes it possible to tailor treatments to the needs of an individual patient. We now know that patients with similar symptoms may have different diseases with different causes. Individual patients who may appear to have the same disease may respond differently (or not at all) to treatments of that disease.

FDA has been playing a critical role in the growth of this new era for a number of years. Even before I became FDA Commissioner the agency was creating the organizational infrastructure and putting in place the regulatory processes and policies needed to meet the challenges of regulating these complex products and coordinating their review and oversight. It has been my pleasure to serve at FDA during this next exciting period and to help ensure that the agency continues to prioritize this evolution by anticipating, responding to, and encouraging scientific advancements.

I am very pleased to be able to present a new report by FDA as part of our ongoing efforts in this field. Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development describes many of the exciting developments and looming advances in personalized medicine, lays out the historical progress in this field, and examines FDA’s regulatory role: from ensuring the availability of safe and effective diagnostic devices, to addressing the challenges of aligning a drug with a diagnostic device, to post-market surveillance.

Outside collaboration and information sharing is essential for this field to flourish. On Tuesday, the American Association for Cancer Research and AdvaMedDX held a fruitful daylong conversation on personalized medicine to treat cancer. I was one of the speakers, participating in a conversation with Dr. Francis Collins, the head of the National Institutes of Health. Our discussion focused in part on current status of drug and diagnostic co-development and the challenges and potential of whole genome sequencing, where data can be collected on a patient’s entire genetic makeup at a reasonable cost in a reasonable amount of time.

FDA is committed to fostering these cooperative efforts, as it will require the full force of government, private industry, academia and other concerned stakeholders to maximize our efforts and fully realize the promise of personalized medicine. Our new report outlines that commitment, and helps chart the way forward so that more people can live long and prosper.

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

A New Plan for Drug Shortages to Build on FDA’s Success

By: Capt. Valerie Jensen, R.Ph. 

I’ve led FDA’s efforts to address hundreds of drug shortages for more than 10 years. During that time, we’ve made progress. Just last year, we cut the number of new shortages by more than half. But more work needs to be done. 

In an effort to enhance FDA’s current approach to drug shortages and bring new ideas to reduce the number of patients who are affected, we provided Congress today with a strategic plan aimed at enhancing efforts to prevent and reduce drug shortages. FDA is actively working, as required by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, to address the public health threat caused by critically needed medications being unavailable for patients. And we will continue that work and build on our progress. 

An important part of our work is understanding the impact on patients. I’ve talked with many patients and caregivers about the effects of drug shortages. It deeply saddens me to hear a mother talk about her new baby boy, born prematurely, who is struggling to survive due to the scarce supply of drugs to meet his nutritional needs. Or a husband whose wife has been battling cancer and her doctor says the hospital is running out of the medication needed to properly treat her. 

I’m often asked, “Why do drug shortages persist?” and “Why are so many lifesaving drugs in shortage?” The majority of these problems stem from quality and manufacturing problems. Therefore, the answers boil down to quality manufacturing. 

While “quality manufacturing” may sound like a simple concept, getting there is a complex process – and one in which FDA and outside stakeholders have important roles to play. 

The strategic plan includes a number of new ideas to address shortages. Many of these strategies focus on enhancing FDA’s response and communication when we become aware of quality or manufacturing issues that could lead to a shortage. Other strategies that FDA is considering include the development of new risk-based approaches to identify early warning signals for manufacturing and quality problems that could lead to production disruptions.

In addition, the strategic plan identifies some preventive measures companies can take that place a greater emphasis on manufacturing quality and stability of supply, thereby eliminating the root causes of most shortages. 

Better manufacturing quality will help eliminate drug shortages over the long-term. But when a manufacturing disruption is likely to occur, early notification by manufacturers is critical. Along with the strategic plan, therefore, FDA is today issuing a proposed regulation implementing the expanded early notification requirements included in FDASIA. This regulation would require that all manufacturers of certain medically necessary prescription drugs give FDA advance notice of a permanent discontinuance or a temporary interruption of manufacturing. It would also extend this requirement to manufacturers of biologic products. 

Advance notification of a potential shortage allows FDA to work closely with manufacturers on the underlying issues, and in many cases, we are able to prevent the shortage. 

FDA envisions all stakeholders coming together to ensure patients have access to the safe, effective, and high-quality medications they rely on and deserve, and we believe the strategic plan we presented to Congress today will make great strides in ensuring that happens.

Capt. Valerie Jensen, R.Ph., is the Associate Director of the Drug Shortages Program in FDA’s Center for Drug Evaluation and Research

 

FDA and Partners Launch e-Learning Course on Evaluating Drug Promotion

By: Thomas Abrams 

You probably have seen many consumer advertisements for prescriptions drugs–on TV, in magazines, or online. While those ads are expensive, did you know that in 2010, pharmaceutical companies actually spent more money advertising to health care professionals than they spent advertising to consumers? Here at FDA, our Office of Prescription Drug Promotion (OPDP) monitors the information that pharmaceutical companies give to health care professionals (HCPs) about prescription drugs. We want to make sure the information your doctor or prescriber receives is truthful and not misleading, because they may use it when deciding what medicines to prescribe to you, their patient. 

We have just launched with Medscape an e-learning course and case studies as part of Bad Ad, a program designed to raise awareness among HCPs and students in various health programs about drug ads and promotional materials that might be untruthful or misleading, and how to report it to FDA. The course offers Continuing Medical Education (CME) credit for physicians and Continuing Education (CE) credit for other HCPs. Although the target audience for the course is HCPs, anyone can take the course. 

In addition, because students are actively engaged in forming clinical practice habits that may last throughout their careers, reaching them now with Bad Ad information could have a strong impact on how they view prescription drug promotion. To help them become discerning readers of drug promotional information, we in OPDP have developed several case studies based on FDA Warning and Untitled letters issued to drug companies. The case studies, which represent common problems, can be downloaded from the Bad Ad website. 

We encourage medical, pharmacy, nursing and other health care related schools to incorporate these cases into their coursework. The cases cover a range of promotional materials including a website, journal ad, and TV ad, and touch upon numerous promotional practices that don’t comply with our regulations. Through the case studies, students will have an opportunity to evaluate and discuss these real-life examples of misleading drug promotion. 

Our new e-learning courses and cases studies are the latest of many ways FDA works to help ensure that your health care professionals have truthful and accurate information when making decisions that affect your health and safety. 

Thomas Abrams is the director of FDA’s Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research