Category Archives: Drugs

FDA Commemorates 30th Anniversary of the Orphan Drug Act

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By: Gayatri R. Rao, M.D., J.D.

Gayatri R. Rao, M.D., J.D., is Director of FDA's Office of Orphan Products Development

When President Reagan signed the Orphan Drug Act 30 years ago, he enacted a critically important piece of health care legislation. The passage of this Act on January 4, 1983, was monumental because it created—for the first time—incentives to develop desperately needed medical products for Americans suffering with rare diseases. Until that point, development of such products was very limited. For instance, in the decade leading up to the passage of the Orphan Drug Act, only 10 industry-supported products for rare diseases were brought to market.

The Office of Orphan Products Development (OOPD) was formed at FDA more than 30 years ago, prior to the passage of the Orphan Drug Act, because FDA recognized that rare diseases, when taken together, posed a significant national public health issue. Once the Orphan Drug Act was passed, OOPD became responsible for administering the incentive programs created to spur the development of medical products for rare diseases, namely the Orphan Drug Designation Program and the Orphan Products Grants Program. These products include drugs, biologics, medical devices, and medical foods for the treatment of rare diseases.

As FDA commemorates the passage of this important legislation, we look back over the last 30 years with pride. Since its passage, over 2700 products in development have been designated as orphan drugs through the Orphan Drug Designation Program and over $290 million has been awarded to clinical studies through the Orphan Products Grants Program.  These programs, along with the critical, collective efforts of the Center for Drug Evaluation and Research’s (CDER) Rare Diseases Program, and those of many individuals across FDA, have helped to bring over 400 orphan products for rare diseases to the market.

We also commemorate the more than 30 years of dedicated service from every member of the rare disease community:

  • the patient advocates, who spurred national awareness about the challenges that people with rare diseases face and who continue to support families, educate the community, and drive research into their diseases;
  • the legislators who heard the voices of rare disease advocates and worked to champion the passage of the Orphan Drug Act;
  • the research community, which continues to leverage resources and foster collaborations among academia and industry stakeholders;
  • the clinicians, who support the medical needs of families with rare diseases and work to advocate on behalf of the community;
  • and industry, including pharmaceutical and biotech companies, angel investors, and venture capitalists who, in the spirit of the Orphan Drug Act, have come together to develop products for rare diseases.

Our many successes give us a reason to celebrate 30 years of hard work to provide diagnostic or treatment options to those with rare diseases. But we are keenly aware that there is still a challenging road ahead. We at FDA remain firmly committed to working with the rare disease community to tackle those challenges and to find new diagnostic tools and treatments for the millions of patients with rare diseases.

Gayatri R. Rao, M.D., J.D., is Director for The Office of Orphan Products Development

New Drug Attacks Resistant TB

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By: Margaret A. Hamburg, M.D.

Having seen first-hand the threat to public health posed by multi-drug resistant tuberculosis (MDR TB), which cannot be cured by many of the most powerful drugs usually used to treat the disease, I’m pleased that another weapon has been added to the arsenal for fighting this deadly, contagious disease.

Margaret Hamburg, M.D.TB is a disease caused by germs that are spread from person to person through the air. TB usually affects the lungs, but it can also affect other parts of the body, such as the brain, the kidneys, or the spine. A person with TB can die if they do not get treatment.

The critical need for new interventions is real and fortunately we now have a new drug—approved in only six months through an expedited pathway — to treat this. Bedaquiline, sold under the brand name Sirturo, is the first drug developed specifically to treat multi-drug resistant tuberculosis involving the lungs — Mycobacterium tuberculosis. It will be used in combination with other drugs when other TB drug treatment regimens will not be effective.

Sirturo has a new mechanism of action: It inhibits an enzyme needed for replication of the M. tuberculosis bacteria and represents an important new development for some patients with particularly difficult to treat forms of tuberculosis

TB is one the world’s deadliest diseases, and is more prevalent now than at any time in history. Last year, nearly 9 million people worldwide became sick with TB, and 1.4 million died. A total of 10,528 cases were reported in the U.S. last year, according to the Centers for Disease Control and Prevention.

People with active TB must take several drugs on a regular basis for 6 to 12 months; for drug resistant TB the treatment regimens are longer and more complicated. If treatment is inadequate or incomplete, the disease can become resistant to certain drugs, meaning those medications don’t work anymore. It then becomes more difficult or sometimes impossible to treat or cure these patients, putting them and others at serious health risk.

Of course, drugs have risks too. Given the significant potential risks of Sirturo, a boxed warning will be included in the label for the drug alerting patients and health care professionals about the increased rate of mortality observed in patients who received bedaquiline compared to patients who received treatment of their resistant TB with other drugs. The boxed warning will also describe the risk of Sirturo’s effects on the heart that can infrequently result in abnormal heart rhythms, leading in some instances, to death.

There is no question that we need more and better treatments for drug-resistant TB. And we’ll continue to need new drugs as the disease mutates or changes.  Meanwhile, Sirturo is a welcome addition to the drugs that we have available to treat patients who have multi-drug resistant TB who need this drug as part of their treatment regimen.

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

 

Strategies for More Successful Drug Trials

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By Bob Temple, M.D.

Bob Temple, M.D. is Deputy Director for Clinical Science in FDA’s Center for Drug Evaluation and Research

Bob Temple, M.D., Deputy Director for Clinical Science

In recent months, drug developers have succeeded in bringing important drugs to market for cystic fibrosis, cancer and other conditions by employing strategies for achieving greater clinical trial success.

Today FDA is issuing a draft guidance that spells out how drug developers can use such strategies, known as clinical trial enrichment, to greatly increase the likelihood that data collected during a clinical trial will demonstrate that an effective drug is effective. These are potentially powerful strategies for the pharmaceutical industry because appropriate use of enrichment could result in smaller studies, shortened drug development times, and lower development costs.

Here’s how it works. Before any promising drug can come to market in the United States, drug developers must provide sufficient evidence that the product is safe to use on patients (that is, that the benefits of the drug outweigh its known risks), and is effective in treating a specific disease or medical condition.

Evidence is typically collected by enrolling patients in a clinical trial and then randomly assigning them to two groups: one group that will receive the drug and the other group that doesn’t.

Those who employ an enrichment strategy enroll patients who are likely to demonstrate an effect, based on their demographics, clinical histories or other characteristics.

Anyone familiar with clinical trial selection knows that rudimentary enrichment strategies have long been common. After all, investigators don’t simply study a random sample of the overall population. Instead they try to find a population most suitable for studying the drug.

One way to do this is to decrease what might be called “noise.” For example, including people who don’t really have the disease being studied, or including people who won’t take the medicine or complete the study, will make an effect harder to show.

There are two other kinds of enrichment: prognostic enrichment and predictive enrichment. Prognostic enrichment involves choosing patients for a study who will have the disease manifestations the drug is intended to prevent. For example, a study of a lipid-lowering drug intended to decrease the rate of heart attacks might choose a population likely to have an increased risk of heart attacks, such as being diabetic. Choosing patients of that kind makes it more possible to see an effect if there is one.

Predictive enrichment is particularly exciting and involves use of some aspect of the patient’s physiology, genetics or past responses to identify patients who can respond to the treatment.

Conducting a clinical study in a patient population that has a larger than average response to treatment can greatly reduce the number of patients needed in the study and can direct the treatment to the patients in whom the drug actually works.

The cystic fibrosis drug Kalydeco (ivacaftor) is an example of this successful strategy. The drug works only in the 4 percent of CF patients with a specific genetic abnormality. If the drug had been studied on the entire CF population, it would have been impossible to detect the drug’s effect.

An enrichment strategy was also used successfully in studies of of Xalkori (crizontinib) for patients with a late-stage form of lung cancer.

While enrichment won’t save a drug that doesn’t work, it will help find one that will.

Bob Temple, M.D., is Deputy Director for Clinical Science in FDA’s Center for Drug Evaluation and Research

Patients to Benefit from Novel Medicines

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By: Margaret A. Hamburg, M.D.

At FDA, we face a careful balancing act between the need to bring innovative new drugs to patients quickly while taking care that these medicines are safe and effective.

Margaret Hamburg, M.D.A new FDA report shows that in the case of 35 novel drugs, called new molecular entities, we were able to strike that balance. These innovative drugs, many of which target devastating diseases, were approved by the agency in FY 2012, which ended September 30. That’s the same number of novel drug approvals as in FY 2011.  

Most of these 35 drugs were approved in theUnited Statesbefore they were approved in other countries, and all but one was approved within its target review date. This is thanks in part to the use of several authorities designed to enable quicker-than-usual action for drugs that treat serious or life-threatening diseases and that may fill an unmet medical need. FDA also permitted shorter, smaller, or fewer clinical studies when justified, which can reduce the length and cost of drug testing and bring drugs to market sooner.

If you go beyond the statistics, you will find the reality: elderly men and women whose sight may be saved, children who will breathe more easily, and cancer patients whose lives may be extended.

One of these 35 medicines is the first drug available to treat advanced basal cell carcinoma, a form of the most common skin cancer. Another is the first for the bone marrow disease myelofibrosis, which impairs the body’s ability to produce normal blood cells.

The list of novel drugs demonstrates numerous scientific advances and innovative approaches. For example, one is the first approved drug made from the blood of the human umbilical cord.  Another groundbreaking treatment targets a gene defect in certain cystic fibrosis patients rather than just treating the symptoms of the life-threatening disease. Another helps the body process a commonly used chemotherapy drug that can cause kidney failure and death in high and sustained concentrations.

It is also important to note that these faster approval times do not mean that the agency relaxed its review standards regarding patient safety. FDA continued its focus on assuring drug safety prior to approval as well as monitoring their safety after approval.  This included the implementation of the new drug adverse event system, FDA Adverse Event Reporting System (FAERS), which has modernized the agency’s ability to process more than one million adverse event reports received each year. It also included the agency’s Sentinel Initiative—FDA has been using a pilot of that program called Mini-Sentinel—to access electronic health information from 159 million patients and perform rapid assessments when there is an early signal that there may be a safety problem with a drug on the market.

For more about the novel medicines approved this fiscal year see the report at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm. Most importantly, these new drugs will offer hope to some of the millions of patients awaiting critical treatments.

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

Advancing “Breakthrough” Drug Therapies

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By:  Janet Woodcock, M.D.

Thanks to a recent law that went into effect on July 9, 2012, FDA now has a new program to help expedite the development of new drugs that could potentially offer a substantial improvement over existing therapies for patients with serious or life-threatening diseases. The new law is designed to get “breakthrough” therapies developed as quickly and safely as possible so they can be available to treat the patients who need them. We’re excited about it!  In fact, although the law is only a few months old, we’re already putting it to use. Recently we identified the first therapy to receive this special designation. And it likely won’t be long before we have more. Several other drug developers have already made inquiries and there is lots of interest in the pharmaceutical industry in taking advantage of this new development tool.  

Janet Woodcock, M.D.The law is called the Food and Drug Administration Safety and Innovation Act, or FDASIA for short. It defines a “breakthrough” therapy as one that is “is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.” In other words, a breakthrough drug is one that may offer important new benefits for patients with serious or life-threatening disease who are especially in need of new safe and effective treatments. 

This new option will complement the three programs we have used for many years to help speed up the development and FDA review of especially important new drug therapies.  They’re called “expedited drug development and review” programs, named Fast Track, Priority Review and Accelerated Approval. Each one is different, but for simplicity, think of them as various ways of bringing potentially important new therapies to patients sooner.  These programs have been very successful and are part of the reason that FDA leads the world in first approvals of innovative new drugs.

We’re delighted now to have another tool to help expedite the development and approval of products with the “breakthrough” designation. We’ll continue to use our existing tools and the new “breakthrough” authority to make our expedited drug development process even more effective, with the ultimate goal of benefiting patients with unmet medical needs.

I’d like to assure the American public of one important aspect of all of FDA’s development and review programs and procedures. We always decide whether to approve a drug after evaluating whether its benefits outweigh its risks. Regardless of which development or review program we use, FDA never compromises its safety or efficacy standards in exchange for rapid approval. That means that those drugs approved under the new “breakthrough” designation will meet our usual rigorous standards for safety and effectiveness. We intend to continue to maximize the value of our new breakthrough therapy designation. So stay tuned!

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

World AIDS Day

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By: CDR. Steve L. Morin, R.N., B.S.N.

World AIDS Day has been observed in the United States on December 1 since 1995. When I look back at early World AIDS Day observances, I remember them as a way of raising awareness of the men, women and children who had no advocates, no representation, no medicines, and practically no hope. They eventually died from the disease early in the epidemic.

In the beginning, World AIDS Day was an important platform for the HIV/AIDS community to help raise awareness among the many people who had never known or even met anyone living with HIV/AIDS. In those early years, the focus was on finding a treatment and keeping those diagnosed with the disease alive. 

Last year marked 30 years since AIDS was first reported in the Center for Disease Control and Prevention’s Mortality and Morbidity Weekly Report (MMWR), emerging as a permanent part of our lives. Today, when I think about World AIDS Day, I think of it as a day to acknowledge how far we have actually come in the fight against HIV/AIDS. We’ve come so far—not only in treatment, but also in preventing new infections, and reducing or eliminating the stigma associated with this disease. 

The Food and Drug Administration supports the fight against HIV/AIDS by promoting medical innovation, protecting the blood supply, and reviewing and regulating new and existing medical products, including devices used in prevention, such as condoms and medical gloves. Doctors, nurses, pharmacists, scientists and many others at FDA have worked hard in 2012 to make sure that there are safe and effective medical products and devices available to fight HIV/AIDS. I am happy to say that this year there were four major advances in the battle against HIV. 

  • Truvada is the first HIV drug approved for prophylactic (preventive) use. It has been shown to reduce the risk of sexual transmission of the HIV virus to uninfected adults.
  • OraQuick In-Home HIV Test is the first rapid home-use oral HIV test kit that does not require sending a sample to a laboratory for analysis. This test has the potential to identify previously undiagnosed HIV infections, especially if used by those unlikely to visit a doctor’s office or clinic.
  • Stribild is the first HIV medicine to combine four separate drugs and is the third HIV drug that can be taken once daily.
  • The number of antiretroviral drugs tentatively approved or approved for use under the President’s Emergency Program for AIDS Relief, or PEPFAR, has surpassed 150. PEPFAR is a program to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.

So today, as World AIDS Days approaches, I ask that you take a moment to remember the combined effort of patients, researchers, industry, FDA and other government agencies contributing to the successes in fighting HIV/AIDS. There are currently 36 approved therapies for treating HIV/AIDS in the United States. As new therapies are added to the list of treatments, patients’ quality of life has improved, with fewer side effects and simpler therapeutic regimens that make adhering to therapy easier. People living with HIV are now able to focus on life rather than death. Until there is a cure, we will continue to work together for an AIDS-free world.

CDR. Steve L. Morin, R.N., B.S.N., is a Health Programs Coordinator in FDA’s Office of Special Health Issues

A New Law Advances Public Health: New Web Page Tracks Progress

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By: Malcolm Bertoni and Leslie Kux

After Congress passes a law that affects how FDA carries out its public health mission, we must begin the task of implementing the law — that is, putting the law into effect and enforcing it.

For a major piece of legislation like the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July, this is a complex undertaking.  

Malcolm Bertoni

FDASIA is a 140-page law divided into 11 separate sections, officially known as “titles,” which address different aspects of drug and device law. FDASIA reauthorizes and makes some changes to user fee programs that provide FDA with the resources we need to maintain a predictable and efficient review process for human drugs, biological products (such as vaccines), and medical devices.  

FDASIA also creates two new user fee programs:  one for generic drugs and another for biosimilar biologics. These new programs will allow FDA to enhance its efforts to ensure that American consumers have more timely access to safe, high quality, affordable medicines. The law also gives the agency new authority to protect the safety of the drug supply chain, which is so important when these products arrive from all corners of the world; to combat drug shortages; and to improve products used to treat children. The law includes many other provisions, including those involving drug innovation and device regulation.

The requirements of the individual provisions vary; some direct FDA to write new regulations or guidance documents that will help industry meet the law’s requirements, while some call for the agency to issue reports or develop strategic plans. Some provisions set specific timetables for action, others don’t.

Leslie Kux

The successful implementation of FDASIA is one of our top priorities. To ensure its success, FDA set up a steering committee shortly after the law was passed to oversee the task of integrating the requirements of FDASIA into the agency’s ongoing workload. One of the committee’s projects has been to create a table that tracks what FDA must do to comply with the statute.

Today we are making available a website that will allow you to follow the agency’s progress in accomplishing the actions required by the new law. The website includes a table that lists information about FDASIA tasks such as the citation to the section of the law, a description of the task, the statutory due date, and the name of a primary contact person. The table will also include links to pertinent documents as they are completed and published.

Initially, the table will include only those requirements with a due date set by Congress. In 2013, other requirements that were not given a specific due date will be added, along with FDA’s target completion date.

FDASIA is an important law with significant provisions affecting industry, patients, consumers and health care providers. We will be updating the website on a regular basis as part of our commitment to transparency about our FDASIA implementation.

Malcolm J. Bertoni is FDA’s Assistant Commissioner for Planning

Leslie Kux is FDA’s Assistant Commissioner for Policy

Store Medicines Safely While Traveling

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By:  Dale Slavin, Ph.D.

Are you traveling during the holiday season?

In addition to planning where you’re going to stay and what you’re going to do, there is another important consideration: How are you going to store your medicines and vitamins in a way that will keep them out of the hands of young children in your family or the friends or family you’re visiting?

More than 60,000 young children are brought to emergency rooms each year after taking a medicine not intended for them. In recent years, the number of accidental medicine overdoses in young children has increased by 20 percent. Swallowing an adult-strength vitamin can also endanger a child’s health.

To reduce accidental exposure to medicines, FDA has been working on an initiative called PROTECT, led by the Centers for Disease Control and Prevention (CDC). The initiative has created the Up and Away and Out of Sight educational program to help parents understand how to store and safeguard medicines.

With people planning holiday vacations, we want to remind parents and caregivers that they must also take precautions to make sure that kids don’t get into medicines when they’re staying in a hotel or are guests in someone else’s home. A few simple steps followed every time can protect small children.

FDA, CDC, and the PROTECT Initiative have these tips for safely storing medicines while traveling:

  • Put medicines away every time you use them. Remember to never leave medicine or vitamins out on a table, countertop, bedside table, or anywhere your children could reach them.
  • Store your medicines in their original child-resistant containers. Other containers, such as pill organizers and baggies, often lack child-safety features.
  • Always relock the safety cap on a medicine bottle. If it has a locking cap that turns, twist it until you hear the click.
  • While staying in a hotel, secure your medicines and vitamins in a location that your children cannot see or reach, such as a high cabinet or passcode-protected hotel room safe.
  • As a guest in another person’s home, don’t be shy about asking where you should put your medicines and vitamins, and remind others to keep their purses, bags, and coats that have medicines in them up and away and out of the sight and reach of children.

  • Program the national Poison Help number (1-800-222-1222) and other emergency contact numbers into your cell phone so you will have them when you need them. Poison Help Information is online at www.poisonhelp.hrsa.gov.

Dale Slavin, Ph.D., is Acting Director, FDA’s Safe Use Initiative, which works to reduce preventable harm from medications

Fighting Antibiotic Resistance

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By: Rachel Sherman, M.D., and Edward Cox, M.D.

This week is the annual Get Smart About Antibiotics Week, a national campaign sponsored by FDA, the Centers for Disease Control and Prevention (CDC) and other public health organizations, to highlight how important it is to use antibiotics wisely.

Antibiotic resistance is one of the world’s most pressing public health threats. Antibiotics are the most important tools we have to combat life-threatening bacterial diseases, but overuse of these drugs has led to the emergence of drug-resistant bacteria, or “superbugs.”

Key to combating antibiotic resistance is antibiotic stewardship, making sure we use the drugs appropriately—and only when needed—to help preserve their effectiveness in fighting bacterial infections. Doctors and other health care professionals should make sure that the antibiotic and dose they prescribe will be effective in treating the infection. And patients must be sure to take an antibiotic exactly as instructed by their prescriber and complete the entire course of treatment, even if they start feeling better. The way we use antibiotics today has a direct impact on how effective they will be in the future.

But as we take care to use existing antibiotics wisely, we realize that we will always need new antibiotics.  Bacteria will continue to evolve and develop resistance to the drugs we have now. Unfortunately, research and development for new antibiotics has been in decline in recent decades, and the number of new antibiotics has been falling steadily since the 1980s.

To address this decline, FDA recently established a new internal task force to help support the development of new antibiotics. The Antibacterial Drug Development Task Force is a multi-disciplinary group of FDA scientists and clinicians working with experts from all over the country to establish new ways of developing safe and effective new antibiotics.

We’ve already held several meetings to discuss the challenges to creating new antibiotics and explore possible solutions.  And although still in the early stages of meeting the challenges, as co-chairs of the task force, we are encouraged by the frank and open discussions we are having with experts from academia, industry, professional societies, patient advocates and our fellow government colleagues.

It will take time before new antibiotics are available to treat some currently resistant infections. But if we act now and work together, we can improve antibiotic use and preserve the effectiveness of these important medicines.

Rachel Sherman, M.D., M.P.H., is Associate Director for Medical Policy in FDA’s Center for Drug Evaluation and Research.

Edward Cox, M.D., M.P.H., is Director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research.

We’re Working to Offset Ameridose Impact

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By Margaret A. Hamburg, M.D.

Drug shortages are two words that no one wants to hear—not patients, not health care professionals, and not me.

Margaret Hamburg, M.D.FDA has been working hard to prevent and mitigate drug shortages. In 2011, the number of medications in short supply hit 251. Addressing drug shortages must be a top priority for us at FDA because these are medications that people need to stay healthy, to treat their illnesses, and even, in some cases, to stay alive.

This year, we’ve taken significant steps to expand our efforts and to engage in new ways with industry. Between Jan. 1 and Sept. 30, 2012, FDA worked with drug manufacturers to help avert the shortage of 145 drugs. Many critical medicines used to treat cancer and conditions such as attention deficit hyperactivity disorder (ADHD) are no longer in short supply.

However, drug shortages are still a serious problem, one that may be temporarily impacted by Ameridose LLC’s voluntary recall of all of its unexpired products. Ameridose, located in Westborough, Mass., is managed by some of the same people as the New England Compounding Center—which produced the drug that is implicated in the deadly, multi-state outbreak of fungal meningitis. An inspection of Ameridose was initiated as part of FDA’s ongoing investigation of the outbreak.

FDA recommended that Ameridose recall its sterile drugs because we could not be assured of the sterility of those products. However, this recall may affect supplies of certain life-saving drugs for some health care systems. FDA has identified a number of Ameridose products—including drugs used during surgery and to treat medical conditions that include congestive heart failure—that were on the current drug shortages list before the recall.

We also know that the supply of other drugs may be affected by the Ameridose recall. That’s why FDA is taking proactive steps to minimize the impact this recall may have on current drug shortages, and to prevent other shortages from occurring.

For recalled medications on the current drug shortages list, FDA is taking the same actions it has used successfully to mitigate other shortages.

  • FDA is working with manufacturers of these drugs, requesting that they ramp up production if they are willing and able to do so.
  • For any manufacturers of these drugs that may be experiencing manufacturing or quality problems, FDA is offering assistance to enable them to produce shortage drug products that are safe and high quality.
  •  As with shortages of any critical products, FDA will expedite the reviews of any pending applications that could help with addressing the shortages.
  • FDA is identifying any additional manufacturers willing to initiate or increase production.
  • If manufacturers of critical drugs are not able to meet U.S. patient needs, FDA will explore overseas companies that are willing and able to import foreign drugs to address the shortage. In these instances, FDA evaluates the imported drug to ensure that it is of adequate quality and that the drug does not pose undue risks for U.S. patients.

Since the beginning of the year, the number of advance notifications to FDA of potential shortages has greatly increased. If we know that a problem is on the horizon, we’re able to proactively work with industry, organizations, patients and stakeholders to address it. We have doubled the number of staff members who work in drug shortage prevention and response.

We at FDA are committed to doing everything we can, using all available tools, to prevent or mitigate drug shortages and help keep critically needed products on the market.

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