Category Archives: Vaccines, Blood & Biologics

Hurricane Season Is Here – Be Prepared

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By: Pat El-Hinnawy

Bottles of water? Check.
Food for the family? Check.
Dad’s blood pressure medicine? Check.
Grandma’s heart monitor? Check.

It’s hurricane season again. 

Anyone who lived through or watched Hurricane Sandy last year knows the horrific consequences that can follow major storms.  

As we enter the 2013 Atlantic hurricane season, keep in mind that good planning can help ease the burden on you and your family if and when bad weather comes your way.  

And FDA can help. To make sure you have the products you will need to get through a hurricane and its aftermath — including FDA-regulated products such as your food, medicines and medical equipment, — we have prepared a simple checklist.  It shows what steps to take to protect those products you have and to make the right choices as you prepare for this year’s bad weather. The Federal Emergency Management Agency (FEMA) says it’s always best to start with a plan and an emergency kit. 

Your emergency kit should include enough food, water, medical supplies, pet food and supplies, and equipment to get you through the first 72 hours after a big storm or other natural disaster. 

For more tips on how to protect your FDA-regulated items, see FDA’s Hurricane Safety Checklist. 

After the storm has passed, it’s time to pitch in and put your homes and neighborhood back in working order. In a similar way, our field investigators contact local regulated firms that produce or process food, medicines, medical equipment, vaccines and other medical supplies. 

We work with those firms to make sure their products can still meet FDA’s standards before they’re sent to market. For foods, this means the products are safe, wholesome and correctly labeled. For medical products (medicines, medical equipment, vaccines, etc.) it means they are safe and effective. 

Nathan Beck and Valerie Hall are just two of the many FDA specialists working behind the scenes. They draw on an impressive array of data and equipment to quickly develop maps using FDA’s Geographic Information System (GIS). These maps show field investigators how to get around flooded areas to reach industries affected by a hurricane or other emergency. And they provide crucial information to emergency managers coordinating FDA activities.

Many specialists at FDA headquarters also work to support and coordinate the work in the field. They monitor all affected areas across the country to make sure that our investigators have what they need to get the job done. 

We also regularly train for emergencies, and we practice responding to a wide range of incidents, including hurricanes. Recently, we held a hurricane season training session for more than 200 staffers from around the country. 

No one can control where or when hurricanes may strike.  But at the FDA we can, and do, prepare for major storms – and so can you. 

Pat El-Hinnawy is a Public Affairs Specialist in FDA’s Office of External Affairs

FDA Cracks Down on Flu Product Scammers

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By: Gary Coody, R.Ph.

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

Gary Coody, R.Ph., is FDA’s national health fraud coordinator, FDA Office of Regulatory Affairs, Office of EnforcementThrough our careful monitoring of the Internet, FDA has identified numerous untested and unapproved products being illegally marketed with deceptive claims that they prevent, treat, or cure the flu.

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

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

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

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

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

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

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

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

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

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

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

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

Celebrating African-American Contributions to Public Health

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By: Jonca Bull, M.D.

As a medical doctor and director of FDA’s Office of Minority Health, I am highly conscious of health disparities in the United States. Certain racial and ethnic populations respond differently to some medical products. FDA ensures that these differences are considered in its review of marketing applications for medical products.

But as an American, I am also highly aware how much all of us in this country have in common, a simple truth that emerges with particular clarity during this African American History Month, when we commemorate the 150th anniversary of President Lincoln’s Emancipation Proclamation and the 50th anniversary of the March on Washington.

Jonca Bull, M.D., is Director of FDA’s Office of Minority HealthBoth events have had a profound effect not only on African Americans, but on our entire nation. The Emancipation Proclamation was critical to President Lincoln’s efforts to end the Civil War and advance freedom. The March on Washington brought us Dr. Martin Luther King’s unforgettable call to America to live up to his “dream.” His vision of equality and racial harmony has been a steadfast guide for all Americans as we strive toward “e pluribus unum”— “Out of Many, One”, the ideal enshrined in the Seal of the United States.

This common bond unites us in many other ways.

As an ophthalmologist and a physician, I have a great admiration for the many distinguished African Americans who advanced medical science.

For example, Dr. Charles Drew discovered a method for the preservation of blood that was used extensively during World War II by the British military to save the lives of wounded soldiers. After the war, Drew was appointed the first director of the American Red Cross Blood Bank.

He was only one of many outstanding African-American scientists.

This honor roll includes Percy Julian, an Alabama native who earned a Ph.D. from the University of Vienna, and in 1935 synthesized physostigmine, a drug for the treatment of glaucoma, and cortisone for the treatment of rheumatoid arthritis.

It includes Daniel Hale Williams, the first surgeon to successfully perform open-heart surgery, Dewey Sanderson, the inventor of the urinalysis machine, Otis Boykin, who designed a control unit for the heart pacemaker, and Michael Croslin, who computerized blood pressure devices.

As a civil servant, I celebrate the history of African Americans by remembering their leadership in public health. The first to earn this distinction was Patricia Harris, a Howard University professor, who in 1979 became the Secretary of Health, Education and Welfare. Ten years later, the department was entrusted to the leadership of Dr. Louis Sullivan, the founder of the Morehouse School of Medicine. And in 1993, Dr. Joycelyn Elders, a pediatrician and public health administrator, became the first African-American to be named Surgeon General.

And as an FDA employee, I am proud to be working with many outstanding administrators and scientists of African-American ancestry who every day contribute to the public health and help advance FDA’s mission.

I have mentioned just a few of the distinguished narratives in our history that have been authored by remarkable African Americans—intellectuals, professionals, soldiers and artists of outstanding achievement.

I celebrate these women and men as fellow Americans whose extraordinary spirit, talent and efforts advance better health for all. I celebrate them as an inseparable part of my own proud heritage as an African American citizen.

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

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

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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

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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.

Margaret Hamburg, M.D.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

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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

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

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By: CDR Melissa Robb

Having secure access to the electronic healthcare data of patients is an essential 21st 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

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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.

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

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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.

Syringe plunged into vial 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

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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.

Scientist using pipet with test tube and blood 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. 

Officer donating plasmaFDA 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