FDA is asking the public to send in ideas for combating drug shortages

Posted on February 13, 2013 by FDA Voice

By: Valerie Jensen

FDA has made progress over the last year or so in preventing and resolving shortages of important drugs — including chemotherapies, anesthetics and antibiotics. Nevertheless, the agency believes that even more can be done and is therefore turning to the American public for advice, as explained in a Federal Register notice published this week. What the public tells FDA will help inform the agency’s development of a strategic plan that will ultimately enhance FDA’s response to preventing and mitigating drug shortages.

FDA has long been tackling the problem of drug shortages, and since October 2011, has stepped up its efforts to encourage drug and biological product manufacturers to report if they know of any circumstances that could lead to a drug shortage, including temporary interruptions in manufacturing. Such early notification is the agency’s most powerful tool to address drug shortages—we can’t work to prevent, mitigate, or resolve a shortage if we don’t know about it. Along these lines, FDA supported efforts to expand the FD&C Act’s early notification requirements as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), enacted on July 9, 2012. Happily, these efforts have been paying off. For example:

The number of shortages is now less than half of what it used to be. There were 117 in 2012, down from 251 in 2011.
Many more shortages are now being averted. We prevented 195 in 2011. Last year, we prevented 282.

We expect the requirements in FDASIA to further enhance FDA’s efforts to work with manufacturers and other stakeholders to prevent or alleviate shortages. When notified of a potential or actual shortage, FDA can take a number of actions, as appropriate, including: expediting inspections and reviews of regulatory submissions, working with the manufacturer to solve the underlying problem contributing to the shortage, identifying alternative manufacturing sources, exercising enforcement discretion for the shipment of a critically needed drug with special instructions to healthcare providers, and using enforcement discretion for the temporary importation of non-U.S. product.

One shortage of a drug that improves or saves the life of even one patient is one shortage too many. More can be done to prevent shortages.

As required by FDASIA, FDA has also formed an internal Drug Shortages Task Force to develop a strategic plan to enhance the agency’s efforts to address and prevent drug shortages. Among other things, the strategic plan will include blueprints for enhanced coordination, communication, and decision making within FDA and with other federal agencies; and plans for effective communication in the event of a shortage, including who should be alerted about potential or actual drug shortages and what information should be shared.

FDA wants to hear from all interested stakeholders on the strategic plan. The agency published a Federal Register notice, posted Feb. 11, which provides additional information and seeks input on six targeted questions related to the Strategic Plan and to preventing and mitigating drug and biological product shortages. Comments will be accepted through Thursday, March 14, 2013.

Valerie Jensen, a pharmacist and expert on drug shortages, is associate director at FDA’s Center for Drug Evaluation and Research

Flu Vaccines Still Available; Supplies Being Monitored

Posted on January 14, 2013 by FDA Voice

By: Margaret A. Hamburg, M.D.

There is still time to get an influenza vaccine that could protect you during the remainder of the 2012-2013 flu season.

FDA has approved influenza vaccines from seven manufacturers, and collectively they have produced an estimated 135 million doses of this season’s flu vaccine for the U.S. So far, more than 128 million of those doses have been distributed, though not all of those doses have been administered yet, according to our sister agency, the Centers for Disease Control and Prevention (CDC).

We have received reports that some consumers have found spot shortages of the vaccine. We are monitoring this situation and will update you at our Website and at www.flu.gov.

Consumers who are planning to be vaccinated can visit the latter site, click on “Flu Vaccine Finder,” enter their zip code and find a list of the clinics, supermarkets, pharmacies and other vaccine providers in their neighborhoods. Before you go, it’s wise to call ahead to confirm availability.

Health care providers can also search for vaccine by using the Influenza Vaccine Availability Tracking System (or IVATS), which is available online at http://www.preventinfluenza.org/ivats/ivats_healthcare.asp.

If you already have the flu, be assured that FDA is working to make sure that medicine to treat flu symptoms is available for all who need it. We do anticipate intermittent, temporary shortages of the oral suspension form of Tamiflu—the liquid version often prescribed for children—for the remainder of the flu season. However, FDA is working with the manufacturer to increase supply and reminding health care professionals that FDA-approved instructions on the label provide directions for pharmacists on how to compound a liquid form of Tamiflu from Tamiflu capsules.

Any Tamiflu shortages should be reported to FDA’s Center for Drug Evaluation and Research at drugshortages@fda.hhs.gov.

The flu season usually peaks in January or February, but can extend as late as May. CDC recommends that all adults and children who are at least 6 months old receive a flu vaccine each year, with fall being the optimal time to get it. It takes about two weeks for the vaccine to “kick in,” meaning the time it takes for your body to develop an immune response to provide protection from the flu.

Although the last year’s flu season was relatively mild, this season is turning out to be more severe. On the positive side, the vaccine is well matched this season to the circulating virus strains that are causing influenza. FDA’s preparations for this flu season began last year. In February, working with the World Health Organization and CDC to review influenza disease surveillance and laboratory data, and with the input of our advisory committee, FDA selected the influenza strains for the vaccine that is currently being used in the U.S.

So if you haven’t been already, get vaccinated. And mark your calendars for next fall; plans for the 2013/2014 flu season and the vaccine that will fight it are already underway.

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

World AIDS Day

Posted on November 30, 2012 by FDA Voice

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

FDA’s Mini-Sentinel exceeds 100 million lives (and counting)… A major milestone in developing a nationwide rapid-response electronic medical product safety surveillance program

Posted on June 29, 2012 by FDA_Voice

By: CDR Melissa Robb

Having secure access to the electronic healthcare data of patients is an essential 21^st Century tool for detecting potential safety problems with medical products once they are in common use.

This is because studies conducted prior to approval may not be able to detect rare problems or problems that might emerge following long-term use of a product.

Congress recognized this need for additional information in the FDA Amendments Act (FDAAA) of 2007 when it authorized FDA to develop a nationwide rapid-response electronic surveillance system for monitoring the safety of FDA-regulated medical products such as drugs, vaccines, other biologics, and medical devices. FDA calls this the Sentinel System.

Now FDA is proud to report that it has met and EXCEEDED the legislation’s goal of achieving secure access to data from 100 million patients by July 1, 2012. In fact, FDA met that goal in December, 2011, and currently has secure access to data concerning approximately 126 million patients nationwide derived from 17 different data partners.

To better understand how the Sentinel System will work, FDA has been conducting a pilot program, dubbed “Mini-Sentinel,” that incorporates access to these 100 million-plus records. So far FDA has used Mini-Sentinel to conduct more than 120 data requests to gather safety information on various medical products.

As an example of the promise of this system, consider FDA’s recent use of the Mini-Sentinel pilot to help inform our ongoing safety analysis of the blood pressure drug olmesartan. FDA had received reports through our Adverse Event Reporting System (AERS) suggesting that olmesartan was associated with more cases of celiac disease than other “sartan” drugs in its class (losartan, irbesartan, telmisartan, valsartan). Celiac disease is a potentially dangerous condition in which the small intestine is damaged and the patient cannot absorb nutrients. FDA, through Mini-Sentinel, submitted a query request to the data partners for specific information on the number of patients with celiac disease who had taken these drugs. The resulting data report allowed FDA to determine that celiac disease did not occur significantly more often with patients who had taken olmesartan than with those who had taken other “sartan” drugs.

While the Sentinel System holds much promise, it is intended to supplement, not replace, FDA’s existing safety surveillance tools, including AERS, which relies on individual reports filed by manufacturers, health care providers and patients. When weighing risk against benefit of a medical product, FDA compiles information from a variety of sources before making a regulatory decision.

FDA is committed to maintaining the highest world-wide standards of safety surveillance capabilities. The Sentinel System is our next step forward towards that goal. Stay tuned. As always, we’ll keep you informed on progress.

CDR Melissa Robb is FDA’s Associate Director for Regulatory Affairs, Office of Medical Policy Initiatives

BLOOD SUBSTITUTES: Working to Fulfill a Dream

Posted on June 18, 2012 by FDA_Voice

By: Abdu I. Alayash, Ph.D., D.Sc.

The first recorded human blood transfusion occurred in Europe during the 17th Century. Those early attempts were usually fatal, since scientists had not yet discovered blood types; nor did they have available the transfusion technologies and techniques we now take for granted.

Today, FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for ensuring that blood and blood products used for transfusions in the United States are safe and effective. But sometimes blood is simply not available in certain extreme situations, such as accidents or battlefield trauma, or in certain cases of blood incompatibility.

For the last 30 years, scientists in industry and academic institutions have been trying to develop a portable blood substitute that:

functions as an oxygen carrier in life-threatening situations;
is stable enough to be stored for prolonged periods in different conditions;
and, can be used to treat individuals of any blood type.

To date, product developers have been unable to succeed in developing a blood substitute that is safe enough for FDA to approve its use in humans. That’s because the key element in making an effective blood substitute – hemoglobin – is also at the center of the problem.

Hemoglobin, a protein in red blood cells, is the molecule available to carry oxygen in the human body. Hemoglobin contains the common element iron, which makes it possible for hemoglobin to capture and hold oxygen when red blood cells circulate through the lungs. When the iron in hemoglobin releases oxygen in the tissues, it becomes more prone to a chemical reaction called “oxidation.” Oxidation prevents further binding of oxygen to the iron and the resultant effect on hemoglobin can lead to cellular damage. (We call the result of this reaction “rusting” when it happens to an iron object.) Fortunately, red blood cells contain an enzyme system that prevents oxidation. As a result, oxygen can reversibly bind to the iron on hemoglobin in red blood cells.

But this enzyme system is not available when hemoglobin is removed from red blood cells and becomes “free hemoglobin,” which is used to carry oxygen in the blood substitute products evaluated so far, known as hemoglobin-based oxygen carriers (HBOCs). Iron oxidation is not reversed resulting in the destruction of hemoglobin itself as well as other molecules in the body’s surrounding tissues.

In addition HBOCs have also been associated with severe medical complications, such as high blood pressure, heart attacks and strokes. FDA scientists and others are trying to solve this problem so that safe and effective hemoglobin-based oxygen carriers can finally be brought to market.

Since its inception in 1989, scientists in CBER’s hemoglobin research program have studied the complex chemical reactions of free hemoglobin, in test tubes, cell cultures and animal models. CBER has also studied ways to control those chemical reactions in an effort to help develop a safe form of free hemoglobin for use in a blood substitute. Among our major contributions to the field is a detailed confirmation of free hemoglobin’s chemical toxicity in kidneys, the brain, and in several animal models of transfusion.

: Figure of hemoglobin prepared by Todd L. Mollan, CBER.

In addition, we have experimented with molecules available in nature in an attempt to block free hemoglobin’s destructive chemical reactions within the body. One such molecule is haptoglobin, a naturally-occurring protein in the blood that prevents the damaging reactions of hemoglobin when it is present outside red cells. Our work suggests that it might be possible to control or reverse the toxic effects of free hemoglobin by transfusing patients with haptoglobin at the same time they are transfused with a hemoglobin-based oxygen carrier. We also showed that Vitamin C (ascorbic acid), a natural anti-oxidant, might also have this protective effect.

FDA is continuing this research to support the development of safe blood substitute products that provide new options for saving lives in the operating room and on the battlefield. Our research to facilitate development of safe and effective blood substitute products provides yet another example of FDA’s ability to carry out sophisticated biomedical research and our commitment to medical product innovation.

Abdu I. Alayash, Ph.D., D.Sc., is Chief of Laboratory of Biochemistry and Vascular Biology, OBRR, at FDA’s Center for Biologics Evaluation and Research.

Enabling Innovation for Biological Product Safety

Posted on May 2, 2012 by FDA_Voice

By: Leslie Kux, J.D.

Last year President Obama issued Executive Order (EO) 13563, “Improving Regulations and Regulatory Review.” This EO directs Federal agencies to review existing regulations to determine whether a regulation is outmoded, ineffective, insufficient, or excessively burdensome. One of FDA’s main goals as we implement this Executive Order is revising our regulations to promote innovation and advance the use of new technology.

I’m pleased to announce that, based on a retrospective review, we are finalizing a rule to modernize the agency’s regulations for sterility testing requirements for most biological products, for example, vaccines such as flu vaccines. These regulations have an important public health purpose – to make sure that products such as vaccines do not contain any organisms that could cause illness. During our review, FDA determined that the existing regulations were too narrow in light of new technology and new products. The final sterility rule supports state-of-the-art testing technologies that give accurate and reliable results, often quicker and with less effort than the methods required in the current regulations. The rule will not add any additional regulations to those already followed by the industry and will not place significant burdens on small companies that make these products. Manufacturers can keep their existing procedures for sterility testing or take advantage of modern methods as they become available, provided that the modern methods meet certain criteria.

These changes reflect FDA’s approach to ensuring both biological product safety and getting patients these products as rapidly as possible. The changes also exemplify FDA’s broad vision for advancing regulatory science and its potential to improve public health by developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.

Leslie Kux, J.D., is Assistant Commissioner for Policy in FDA’s Office of the Commissioner

How FDA Ensures the Safety of Blood Products

Posted on February 28, 2012 by FDA_Voice

By: Richard J. Davey, MD

You might be aware that FDA plays a key role in assuring the safety and efficacy of products such as drugs, vaccines and foods. But less well known is the agency’s critical regulatory oversight of our nation’s blood supply.

Blood saves and improves the lives of millions of individuals each year. It is used for transfusions for example, to replace blood loss during surgery, childbirth or following a traumatic injury. Blood and blood products are also a key part of the medical treatment of serious illnesses such as cancer, organ failure, or sickle cell disease. Additionally, blood and blood products are used to prevent and treat many medical conditions, such as infections and blood clotting disorders.

The Office of Blood Research and Review, which is part of FDA’s Center for Biologics Evaluation and Research, regulates both whole blood and blood components for transfusion, as well as various other blood products. FDA works with blood collecting establishments, product manufacturers, health care providers, patient organizations, academic researchers, and other government agencies to ensure a safe and adequate blood supply.

FDA goes to great lengths to ensure that our blood products are safe. FDA reviews and approves new products, conduct research, issue guidances and regulations, conduct inspections of manufacturing facilities, and communicates with manufacturers, consumers and health care providers about blood product safety and efficacy issues. FDA also assists in product recalls when necessary, and works with regulatory agencies in other nations as well as international organizations such as the World Health Organization.

Blood donation is another key area where FDA plays a major role. Beginning with safe donations, we regulate the processes by which blood is collected and manufactured

Each year, nearly 11 million volunteer donors provide about 17,000,000 donations of blood and blood components for transfusion to about 4.5 million recipients, according to the National Blood Collection and Utilization Survey Report. About a third of these volunteers are first-time donors. And, more than 18 million units of Source Plasma are donated each year for use in manufacturing plasma-derived products, such as clotting factors and immune globulins.

To make sure blood and blood products are safe for recipients, FDA has established a system of five layers of safety for donated blood. Maintaining an adequate supply of blood and blood components is vitally important, and to help achieve this goal the U.S. Department of Health and Human Services recognizes and participates in World Blood Donor Day.

We hope this information gives you a better idea of how FDA helps keep blood and blood products safe and available for you and your family. And, we urge you to consider helping to save lives by donating blood today!

Richard J. Davey, MD, is Director of CBER’s Division of Blood Applications, Office of Blood Research and Review

FDA Assists in the Success against Epidemic Meningitis in Africa

Posted on February 13, 2012 by FDA_Voice

By: Marc Kusinitz, PhD

Meningococcal meningitis, a disease that sweeps across sub-Saharan Africa in an area called the meningitis belt, is losing its power to inflict illness and death. Scientists from FDA made a critical contribution in developing the technology needed to manufacture a vaccine against this terrible disease, and at an affordable cost for African nations like Burkina Faso, Chad, Ethiopia, and Niger.

Meningococcal meningitis can be deadly. It kills 10 percent of people it infects within two days after they start showing symptoms. Although an antimicrobial drug saves large numbers of infected individuals, about 10 percent die from the infection and about 10 percent to 20 percent of survivors develop mental retardation, hearing loss, or seizures. In Africa, most meningococcal disease is caused by the group A meningococcus bacteria, and about half of its victims are working-age adolescents and young adults. The disease results in very significant human, social, and economic losses to the affected communities and countries. Vaccination offers the best chance to prevent the disease and epidemic meningitis. However, an existing vaccine didn’t work very well.

Developing a Vaccine:

In 2001, the Bill & Melinda Gates Foundation agreed to fund the Meningitis Vaccine Project (MVP)–a partnership between the World Health Organization and PATH, a non-profit organization based in Seattle, WA that works with collaborating groups to provide health care technologies and strategies to areas of the world that have limited resources.

Dr. F. Marc LaForce led MVP’s effort to develop, test and license a new type of vaccine against group A meningococcus bacteria, that could protect people before an epidemic begins. The new vaccine, called a conjugate, is a chain of sugars connected to a protein that the immune system responds to very well. When MVP hit a hurdle during the development stage, FDA stepped in. Drs. Robert Lee and Carl E. Frasch, two researchers in the Office of Vaccines Research and Review in FDA’s Center for Biologics Evaluation and Research (CBER), had developed an alternative conjugation technology that was more efficient and less costly. Through a technology transfer agreement, FDA provided the technology to MVP via PATH, with help from the National Institutes of Health.

Scientists at CBER also developed reagents for evaluating the vaccine’s performance and safety and developed methods to monitor the manufacturing process. MVP had partnered with the Serum Institute of India Limited, a developing-country vaccine manufacturer, to make the new conjugated vaccine. In December 2003, two scientists from the Serum Institute came to Drs. Lee and Frasch’s FDA laboratory to learn the conjugation method to manufacture the vaccine.

After preclinical animal studies and a series of clinical trials in people in India and Africa’s meningitis belt to assess its safety and effectiveness, the new vaccine, MenAfriVac, was licensed in Dec. 2009 by India for export to Africa. By June 2010, the WHO had prequalified the vaccine for use in global immunization programs.

September 2010. A woman in Mali receives MenAfriVac in an early introduction in preparation for the official vaccine program launch in December. Photo: WHO/Mali

Launching the Vaccination Campaign:

MVP launched its vaccination campaign in Dec. 2010, beginning in Burkina Faso and moving on to Mali and Niger and eventually Cameroon, Chad and Nigeria. By the end of 2011, an estimated 55 million people had been vaccinated with MenAfriVac at a cost of only 40 cents per dose.

The contribution of CBER researchers Carl Frasch and Robert Lee was perhaps best summed up by MVP director Dr. LaForce in a news story about their timely contribution of the conjugation technology that enabled the development of MenAfriVac at a price that Africa could afford: “These guys are heroes.”

FDA’s contributions to a major health care project in Africa underscore the agency’s recognition that infectious diseases know no borders. Protecting human health globally is linked to the agency’s core mission of protecting human health in the United States.

Marc Kusinitz is Senior Science Communications Advisor in FDA’s Center for Biological Evaluation and Research

FDA Voice Interviews Stephen Spielberg, MD, PhD

Posted on January 25, 2012 by FDA_Voice

FDA Voice: Dr. Spielberg, thank you for agreeing to let us interview you for FDA Voice. Can you tell us about your position at FDA and what that entails?

Dr. Spielberg: I am the Deputy Commissioner for Medical Products and Tobacco. In creating this new position, Commissioner Hamburg envisioned that it would “provide high-level coordination and leadership across the Centers for drug, biologics, medical devices, and tobacco products, and support, coordinate and advocate for the work and needs of the Centers.” In my short time at FDA, I have been working with the Center Directors and their staff to understand shared challenges and opportunities to advance regulatory science and practice across all “human products”. Together, we have begun to define areas of mutual interest and synergy where we can work together and with external partners in the public and private sectors to bring the best of science to bear on our public health responsibilities, to advance managerial and operations support to optimize our core tasks, and to assure in everything we do that FDA is at the cutting edge of promoting and protecting the public health.

FDA Voice: Why did you join FDA?

Dr. Spielberg: Throughout my career, I have been involved with FDA. In fact, my MD-PhD training at the University of Chicago, particularly in the Department of Pharmacology, was in the context of former UC faculty (Drs. E.M.K. Geiling and Francis Kelsey) who were intimately involved with creation of FDA by their work on elixir of sulfanilamide (Federal Food, Drug, and Cosmetic Act of 1938) and thalidomide (Drug Amendments of 1962). So, in retrospect, I suppose I “grew up” with knowledge and appreciation of FDA. Over the years, I have served as a member of the Pediatric Subcommittee, the Science Board, rapporteur for ICH E-11, and helped get BPCA and PREA through Congress. At this stage of my career, it is a true honor for me to be able to serve the Agency at a critical time in biomedical science and therapeutics.

FDA Voice: What did you do before joining FDA?

Dr. Spielberg: I have had a 35 year career as a pediatrician and clinical pharmacologist, including in academic settings in the US and Canada, as well as in the pharmaceutical industry. My research career has focused on human pharmacogenetics and pharmacogenomics, mechanisms of adverse drug reactions, and pediatric/development pharmacology and pediatric clinical trials. In the years prior to coming to FDA, I was Dean of Dartmouth Medical School, and subsequently headed a new personalized medicine program at Children’s Mercy Hospital in Kansas City, MO, as well as working with the Institute for Pediatric Innovation, a non-profit organization focused on advancing therapeutics for children.

FDA Voice: What is the favorite part of your job here at FDA?

Dr. Spielberg: This is a remarkable time to be at FDA. Biomedical science is advancing at an incredible rate. We are now beginning to see the impact of genomic and other science in defining the causes of disease, and in the discovery and development of new therapies. Medicine now is at a place that I could barely have imagined when I began my career, but we have the age old challenges of how to skillfully and wisely use the knowledge we have at any time to advance the health of individual patients and of all patients we serve. At such a time, what could be more challenging and satisfying than being here at FDA and having the opportunity to advance the promotion and protection of the public health.

FDA Voice: If you could tell the American public one thing that you think they don’t know about what your office does to directly benefit them, what would it be?

Dr. Spielberg: Every day, I am impressed by the outstanding, dedicated, hard working people here at FDA. Their focus on our public health mission is remarkable, and it is an honor to work with them.

FDA Voice: Dr. Spielberg, thank you so much for your time!

Stephen Spielberg, MD, PhD, is Deputy Commissioner for Medical Products and Tobacco

What Happens Behind the Scenes before You Receive Your Flu Vaccine

Posted on January 20, 2012 by FDA_Voice

By: Maureen Hess, MPH, RD

You probably think about influenza once a year — during the winter months when flu season rolls in as it does every year. But, for FDA, it’s a year-round initiative; we are on the front lines of making sure there is an adequate supply of safe and effective vaccine every year. And even though the current flu season is just getting started, we are already making preparations for next year.

Woman getting flu shot Vaccination is the single best way to prevent influenza. Influenza is a contagious respiratory disease caused by a number of different influenza viruses, infecting the nose, throat and lungs. Even if you are healthy, you can pass the influenza virus to someone else one day before symptoms begin, and, you can continue to infect others up to five days after getting sick. Therefore, it’s possible for a healthy person to unknowingly spread the virus.

Preparing for influenza season each year is a time-critical, highly orchestrated, collaborative effort by FDA, the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), vaccine manufacturers, and the public health community.

FDA is at the center of the process. Working with the WHO and CDC to review disease surveillance and laboratory data, and with the input of our advisory committee, we select the three influenza strains for the vaccine that will be made available in the United States. Once the strains have been selected, work continues to get vaccine manufactured and distributed well before influenza season starts. We inspect the manufacturing facilities and we prepare and provide the reagents used by vaccine manufacturers to verify the vaccine’s identity and strength.

FDA also evaluates each manufacturer’s vaccine each year for approval and conducts lot release, that is, we perform certain tests and review the results of the manufacturers’ tests on the vaccines prior to vaccine distribution. And, we continue to monitor the safety of the vaccines once they are distributed and used to vaccinate the public. The manufacturing demands are tremendous, especially since a new vaccine must be manufactured each year. And, this new vaccine contains not just one but three new vaccine components each year, specifically, the three strains of influenza virus within the seasonal vaccine: one influenza A (H3N2) virus, one influenza A (H1N1) virus, and one influenza B virus.

Why is FDA focused on influenza? Influenza seasons are unpredictable and present a serious public health issue. Vaccination is one of the most important ways to prevent influenza. Influenza can cause various symptoms, which may include fever, cough, sore throat, headache, body aches and chills and tiredness. And the disease can range from mild to serious: over a 30 year period between 1976 and 2006, estimates of seasonal influenza-associated deaths range from a low of about 3,000 to a high of about 49,000 people.

Vaccines to prevent seasonal influenza have a long and successful track record of safety and effectiveness in the United States. The vaccine won’t give you the flu, and not only should it protect you from getting sick, it can also make your illness milder if you are exposed to a different influenza virus strain that’s not included in the vaccine.

Have you gotten your flu vaccine? It’s not too late!

Maureen Hess, MPH, RD, is Health Science Advisor, Office of Vaccines Research and Review, in FDA’s Center for Biologics Evaluation and & Research