Improving Patient Care by Making Sure Devices Work Well Together

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By: Bakul Patel 

Interoperability refers to the ability of medical devices to interact and for electronic health record systems to talk to each other using a common vocabulary. It is similar to the concept of “plug and play” computer attachments like a web cam or mouse, which are made so that products can operate with different brands and models of computers.

While it may seem abstract, successful interoperability among medical devices can improve patient care, reduce errors, and lower costs.

As medical devices become increasingly connected to other medical devices, hospital information systems and electronic health records, there is a growing expectation that they will be interoperable – and that the data they transmit will be secure.

A few examples illustrate the need: 

  • An infusion pump that administers medication to a patient also connects to the hospital’s electronic health record system where the physician inputs orders for specific amounts of medication to be delivered at specific times. If the infusion pump and the electronic health record are not interoperable, with clocks that are synchronized, medication errors could occur. 
  • A patient in surgery is connected to a ventilator and a central monitoring station. If the two devices are not interoperable, the monitor may send a false alarm, or fail to send a needed alarm. Either error could increase the risk to the patient. 
  • Two patients with different medical conditions both have electrocardiogram (EKG) monitors attached to check their hearts’ electrical activity. Both monitors are connected to the same computer system that records the data for later review by a physician. It’s critical that the computer system and the EKG monitors are interoperable so transmission errors do not confuse one patient’s data with the other patient’s data.

Making sure devices are interoperable requires the creation, validation, and recognition of standards that help manufacturers develop products that are harmonious and can “plug and play.”  

We at the FDA have been hard at work on this issue with hospitals, health care providers, manufacturers, standards development organizations, and other interested parties. A 2012 summit organized by FDA and the Association for the Advancement of Medical Instrumentation (AAMI), for example, brought together 266 experts from many disciplines to further the goal of improving patient care and cybersecurity — while at the same time fostering innovation — through interoperability.

As a first step, FDA has recognized a set of voluntary standards that will help manufacturers create devices that work well together and are secure.

We hope this first set of voluntary standards will encourage further efforts to identify standards and create new ones for our review, because improving the care of patients through medical devices increasingly depends on those devices and information systems being “interoperable.”

Bakul Patel is senior policy advisor in FDA’s Center for Devices and Radiological Health.

Innovative New Drugs Are Reaching Patients at a Fairly Constant Rate: New FDA Study Reports on 25-year record of approvals

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By: Mike Lanthier

So much has been said and written about the supposed innovation gap in drug discovery that it’s generally been accepted as truth and a topic of deep angst for the pharmaceutical industry.

And yet, if you take a hard look at the data, as we did, you’ll find it isn’t true. The fact is, the way data is collected has been masking some important facts.

Conventional wisdom suggests that the pace of drug innovation should be measured by tallying the number of FDA-approved novel new medicines, known as new molecular entities (NMEs). When the number of NME approvals increases from year-to-year, media reports generally proclaim that drug innovation is on the rise; when the number dips, concerns are often raised about FDA’s drug review performance and the health of the industry as a whole.

However, while the number of NME approvals in a given year provides something of value regarding the output of novel new drugs, this perennial focus on the quantity of drug approvals may not be sufficient to provide a meaningful measure of “innovation.” This is true primarily because not all NMEs are equally innovative. For instance, one NME may offer an important new way to treat a disease, while another may work in a way that is similar to drugs already on the market.  

To help move beyond this “one-size-fits-all” approach and provide deeper insights into what trends in NME approvals can tell us about innovation, FDA examined NME approvals over the 25 years from 1987 to 2011. We identified three distinct subcategories of novel new drugs: 1) first-in-class, which represents novel drugs that use new mechanisms to treat or prevent disease 2) advance-in-class, drugs that work in ways similar to, but demonstrate significant advantages over, existing drugs, and 3) addition-in-class, essentially representing new drugs that work and perform similarly to ones we already have on the market. 

Using this measure, we found that the number of NME’s approved every year is largely driven by changes in total approvals of drugs in the addition-to-class category. Indeed, a lot of the much-hyped decline in drug approvals from historic highs observed in the mid-1990s occurred because fewer of these addition-to-class drugs were being approved. In contrast, year in and year out, approvals of the crucial first-in-class drugs have remained essentially the same.  

In other words, if the focus is placed on the more innovative drugs, no evidence of an innovation gap in drug discovery exists, as explained in a paper I co-published with other FDA officials.

While these findings are heartening, there is still great need for further drug innovation.  Recently we’ve seen successful drug innovation in areas of special need, including the first-ever drug to treat the underlying cause of cystic fibrosis in certain patients; new and effective ways to treat various forms of cancer; and drugs to treat lupus and tuberculosis, conditions that until recently had not seen a new drug therapy approved in several decades. However, for many diseases there are simply not enough FDA – approved drug therapies – and for some diseases, none are available. 

FDA continues to work with patients and drug developers to help identify areas of unmet medical need, particularly from the patient perspective. Over the next five years, under the new Patient-Focused Drug Development initiative, FDA will hold public meetings on about 17 additional medical conditions to gain better understanding of patients’ perspectives on the severity of these diseases and their current treatment options. FDA also has a new designation called “Breakthrough Therapy” for new drugs that have the potential to offer a substantial improvement over existing therapies for patients with serious or life-threatening diseases in development. The intent is to provide timely and frequent communication with drug sponsors to help expedite the development and review of these innovative therapies. 

As always, FDA will continue to approve safe and effective new drugs as efficiently as possible, with an emphasis on products that have potential for the biggest beneficial impacts on U.S. public health. And when it comes to assessing the success of our efforts and drug innovation as a whole, one thing remains clear: It’s not just about quantity of drugs, it’s also about quality. 

Mike Lanthier is an Operations Research Analyst on the Economics Staff in FDA’s Office of Planning

Gluten-Free Labeling Consumers Can Count On

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By: Virginia A. Cox 

Celiac disease is a serious health issue that can lead to critical complications if not treated. 

While there is no cure for celiac disease (CD), there is one way to manage it – following a gluten-free diet. The only choice for the up to three million Americans living with CD is to adhere strictly to a gluten-free diet, avoiding proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. To do otherwise is to risk gradually damaging the intestines, preventing the absorption of vitamins and minerals and leading to a host of other health problems, including nutritional deficiencies, osteoporosis, miscarriages, and cancer. 

Without a standard definition of “gluten-free,” people with gluten-related health problems can never be certain if a food is likely to be tolerated by them. So as a person living with CD for over a decade, I’m delighted to say that today, FDA is mandating a new rule on food labeling that will help people with CD – people just like me –be able to trust what the words “gluten-free” mean on their food purchases. Not only will this help those with CD manage their disease more carefully, but it will also improve life for many others who are gluten intolerant or gluten sensitive. 

Food manufacturers have come a long way in providing terrific options for those who need to eat a gluten-free diet. And by providing a clear definition of the term “gluten free” for all manufacturers to follow, this rule will help ensure that all of the “gluten-free” claims on food products are reliable, consistent, and truthful. 

This is a very big deal. A celiac patient without access to proper treatment – a strict, gluten-free diet – could suffer severe health problems. I suffered from stomach issues my whole life and was constantly misdiagnosed with ulcers even as a young child. Since my correct diagnosis, I have worked hard to avoid gluten, but it is challenging. This new rule will help all of us with CD better manage our diets and our health. 

According to the National Foundation for Celiac Awareness, one of every 133 Americans has CD, and 83 percent are undiagnosed or misdiagnosed with other conditions. But as consumers and health care professionals become more aware of the disease and how to cope with it, and more confident that they can trust that those products labeled gluten-free meet a standard definition, the better off we’ll all be. 

CD can affect anyone; it doesn’t discriminate against race, age or gender. It can make eating, which I consider one of life’s great pleasures, a minefield, a thrice-daily event that is fraught with anxiety and peril. 

It’s not the FDA’s job to tell people what they should and shouldn’t eat, but it is our responsibility to make sure that people can trust what the labels say on the foods they do choose to eat. I am proud to say that today we have taken a huge step towards helping all of us with CD or any kind of gluten-sensitivity confidently manage our health. And that is good for everyone. 

Virginia A. Cox, J.D., is Associate Commissioner of FDA’s Office of External Affairs.

 

Dietary Supplements Containing Unsafe Food Additive Destroyed

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By: Daniel Fabricant, Ph.D. 

In a victory for consumers, a Texas-based distributor of dietary supplements has destroyed its stock of two dietary supplements containing the stimulant dimethylamylamine (DMAA). 

In addition, a major distributor of the products – GNC Inc. - agreed to destroy the supplements in its possession after the Food and Drug Administration (FDA) obtained seizure orders for GNC facilities in three states. GNC has already destroyed its DMAA products in two of the three states, and we expect the products in the third state to be destroyed this week. 

The products – OxyElite Pro and Jack3D, distributed by USPlabs – had an estimated retail value of more than $8.5 million. Dietary supplements containing DMAA – an amphetamine derivative – are advertised as useful for losing weight, enhancing athletic performance and building muscle. Reports implicate DMAA in the narrowing of blood vessels and arteries, which can elevate blood pressure and lead to serious medical conditions, including heart attack, seizures, psychiatric disorders and even death. FDA has received reports of more than 100 illnesses associated with products containing DMAA, including six deaths. 

A noteworthy aspect of this case is that FDA invoked its administrative detention authority to protect consumers. This authority was recently amended so that it can be used more easily. 

Here’s the backstory: 

The quickest method for getting risky products off the market remains voluntary compliance. USPlabs was one of 11 companies to receive warning letters from FDA in 2012 telling them that DMAA is illegal and should not be sold. Ten of the companies quickly agreed to stop using the stimulant as an ingredient in their dietary supplements, but USPlabs challenged the legal theories we had advanced. 

Unlike drugs, dietary supplements do not need to be approved by FDA for safety and effectiveness before they are sold. In order for FDA to ban a compound in a dietary supplement, FDA is required to undertake a series of lengthy scientific and legal steps.  When FDA opts to proceed through enforcement action rather than by issuing a regulation, the process of taking a product off the market typically begins with warning letters and can proceed to a seizure action or an injunction. 

Our scientists investigated USPlabs’ contentions only to conclude that DMAA was an unsafe food additive that couldn’t be used in supplements. In April 2013, FDA sent a response letter to the company giving it 15 days to take corrective action. 

When the company said it would continue to sell the remaining stock of supplements containing DMAA, the state of Texas temporarily embargoed both products and FDA in turn invoked its administrative detention authority. Before Congress passed the FDA Food Safety Modernization Act of 2011 (FSMA), FDA could detain food only if an authorized agency representative had credible evidence or information that the article of food presented a “threat of serious adverse health consequences or death to humans or animals.”  But under FSMA, FDA can now detain food if an authorized agency representative has reason to believe that the product is adulterated or misbranded. If this standard is met, FDA can detain foods for up to 30 days, halting any shipments of suspect products while the agency considers other legal steps such as seizure or injunction. 

In this case, before the 30 days were up, USPlabs agreed to destroy its remaining stock. It had already committed in April 2013 to stop putting DMAA in the products. 

At GNC facilities in Pennsylvania and Arizona, FDA oversaw the destruction of GNC’s stores of OxyElite Pro and Jack3D, and the company has agreed to destroy its remaining supply in South Carolina. 

However, some products with DMAA may remain available on the Internet or store shelves while we continue working on this problem. 

Consumers are advised to read the label of any dietary supplement in their possession and discard the product if the label states it contains DMAA. Also, make sure to check FDA’s DMAA web page. DMAA may still be present in your supplement but under a different name. The website contains the full list of names that are commonly used for DMAA. So be sure to read your labels carefully. 

Finally, FDA asks health care professionals and consumers to report any adverse reactions to products containing DMAA to FDA’s MedWatch program either by:

•             completing and submitting an adverse event report online at www.fda.gov/medwatch/report.htm; or 

•             downloading and completing the adverse event reporting form, then submitting it via fax at 1-800-FDA-0178. 

Daniel Fabricant, Ph.D., is Director of FDA’s Division of Dietary Supplement Programs

Proposed Rules Will Strengthen Global Food Safety

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By: Margaret A. Hamburg, M.D.

It’s a small world.

Every day, there’s a good chance that some of the food you’re eating came from another country. Fifteen percent of the food we eat, including nearly 50 percent of the fresh fruit and 20 percent of vegetables, is imported each year.

Margaret Hamburg, M.D.That’s why it’s so important that we do everything we can to help ensure that foods exported to the United States are safe for you and your family. To that end, two new rules that we propose today focus on preventing food safety problems before they happen.

These rules would make importers more accountable for food safety, and would enhance our ability to monitor conditions and standards in foreign facilities that produce and process food.

While we will continue to rely on inspections at U.S. ports of entry to keep contaminated foods from entering our country, under these proposed rules, we will significantly enhance our ability to identify issues before food gets to our shores.

The bipartisan Food Safety Modernization Act (FSMA), signed by President Obama in January 2011, calls for a new level of accountability for everyone involved in the food supply chain, even if that chain begins halfway around the world.

So, in accordance with FSMA, we are proposing these rules:

  • The Foreign Supplier Verification rule will require importers to verify that foreign suppliers are producing food in a manner consistent with U.S. standards. Under the proposed rule, in general, importers would be required to identify potential hazards associated with each food and verify that appropriate steps have been taken to adequately control those hazards.
  • The Accredited Third Party Certification proposed rule would establish a system to strengthen the quality and credibility of safety audits and certifications for food exported to the United States.

These two proposed rules build on two other FSMA rules proposed earlier this year focused on ensuring the safety of produce and food facilities.

In the century that has passed since President Theodore Roosevelt signed the Food and Drugs Act of 1906, food safety has been a driving force for FDA and part of our core mission.

We know that to protect American consumers, our work doesn’t stop at national borders. The world may be changing, but FDA’s mission to continue to ensure the safety of the food supply for you and your family has not.

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

FDA’s Special Agents: On the Job to Protect the Public

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By: John Roth

As noted in my previous three posts, FDA’s Office of Criminal Investigations (OCI) is an integral part of FDA’s mission to protect the public’s health. Our top-flight special agents –who have investigative authority similar to other federal law enforcement agencies – give the FDA unique fact-finding tools and provide for strong, industry-wide deterrence. Their work is different from, but enhances, the regulatory inspectors and investigators that make up the bulk of FDA’s field operations. 

Who are these special agents? They are federal law enforcement officers and they have experience: our average agent has been in federal law enforcement for over ten years, a necessary requirement given the sophistication required to work the wide range of OCI cases. 

Each special agent undergoes specialized training to be effective in their job, including firearms and personal safety training, advanced Special Agent training, and training in FDA law.  Throughout their career, OCI agents will keep up to date on the latest trends by participating in what is called “in-service training.”  Additionally, agents will take specialized training in other areas of federal law enforcement, including cybercrime investigations, computer forensics, financial tracing/asset forfeiture investigation, polygraphy, leadership and management, and advanced law enforcement techniques.

As you can see from this training regimen, we demand a lot from our agents – these skill areas are exceedingly complex. Moreover, agents must also learn such intangible skills as being able to work well with others, remain alert and focused, and hone that age-old requirement for any law enforcement officer: good instincts and a devotion to old fashioned shoe-leather doggedness. 

Our agents are located in more than 37 offices nationwide, from Hawaii to Puerto Rico, and work with law enforcement counterparts in many countries, as well as international organizations like Interpol, Europol, and the Permanent Forum on International Pharmaceutical Crime. 

No agent can go it alone, of course, and we rely on an outstanding supporting cast to help us: our “can-do” support staff, who make running a complex nationwide law enforcement program look effortless, the unmatched scientific and public health experts in the FDA centers and the civil-side inspectors and compliance officers in the field, who we rely on for help with complex, scientific cases, and finally prosecutors in the Department of Justice, who have embraced the FDA public health mission. 

My three previous FDA Voice posts highlighted several of the more significant, colorful, and sometimes tragic cases with which OCI has been involved. The first post looked at how we use our top-flight federal agents to work undercover in investigating shadowy overseas drug counterfeiters. The second post looked at high-profile instances of non-compliance right here in the United States – with our work resulting in a $1.4 billion fine. The third post looked at the callous and utter disregard for life caused by corporate actors, which necessitated a criminal response. Yes, these cases involved detailed, complex organization and a range of professional skills. 

But let me emphasize: OCI is doing this work every day. In fact, about every 30 hours, throughout the year, we are gaining a conviction, in crimes ranging from street level pharmaceutical diversion schemes to corporate fraud. In Fiscal Year 2012, OCI agents were responsible for cases that yielded over $4.9 billion in fines and restitution – monies that are paid directly to the U.S. Government or to specific victims of the criminal acts we investigate – an average of over $22 million per special agent. 

FDA’s Office of Criminal Investigation is the only federal law enforcement agency whose mission is exclusively directed at protecting the public’s health. And, criminal enforcement is a critical part of FDA’s enforcement and compliance strategy, a strategy designed to protect people from dangerous products, fraudulent schemes, and unscrupulous criminals. 

Through these four FDA Voice posts, I hope that we have made our OCI team better known to our FDA colleagues and to the public. The vast majority of the FDA-regulated entities respond to FDA’s ordinary regulatory tools. However, OCI stands ready and on watch to locate, investigate, and bring to justice those individuals and entities who disregard and break our public health laws. 

John Roth is Director of FDA’s Office of Criminal Investigations

Spirit of Cooperation Informs Guidance for Egg Producers

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By: Michael R. Taylor, J.D. 

To make sure that the eggs you serve your family for breakfast are safe to eat, FDA went directly to the source: the farm. 

What we learned in visits to farms across the country gave us a real sense of some egg producers’ practical needs and the challenges they face. 

This knowledge helped us craft a draft guidance that represents FDA’s latest action related to the “Egg Safety Rule”, a multi-phase 2009 regulation enacted to help keep eggs safe from the bacterium Salmonella Enteritidis (SE), the most common cause of foodborne illness outbreaks tied to consumption of shell eggs. 

The new guidance is specifically intended to help those egg producers who provide their poultry with outdoor access comply with the rule’s various requirements such as biosecurity, rodent and pest control, cleaning and disinfection and refrigeration. 

Egg producers who allow outdoor access face different environmental realities from facilities that keep their hens inside. The new guidance provides suggestions on how egg producers with 3,000 or more laying hens can protect their poultry from predators, pests, wild birds and other animals and comply with the new egg regulation, yet still provide hens outdoor access. (Egg producers with fewer than 3,000 laying hens and egg producers who sell all of their eggs directly to consumers are exempt from the Egg Safety Rule.) 

Before issuing the draft guidance document, FDA did its homework, talking to producers and regulators at state, regional and local meetings to explain our rules and to get first-hand information. In addition, recognizing that there are a wide variety of poultry house styles designed to provide hens with outdoor access, we visited eight poultry farms in California, Texas, Arkansas, Washington, Wisconsin, Indiana, Michigan and Massachusetts in August and September 2012. The farms we visited included operations producing eggs which are certified organic by the U.S. Department of Agriculture’s National Organic Program (NOP). The farms utilized many of the house styles producers are using. Prior to these visits, FDA worked very closely with colleagues at USDA’s NOP in order to understand NOP standards and jointly visited several organic egg farms in Pennsylvania. 

In effect, we were on a fact-finding mission to see for ourselves how these farms operate and to better understand the unique challenges these producers face. We gained a better understanding of these challenges and used this knowledge to develop a draft guidance document specifically addressing the challenges and concerns we observed. 

We strive not just to be regulators, but to work cooperatively with industry as fellow problem solvers. In this instance, producers were concerned about their ability to meet the requirements of the Egg Safety Rule, were eager to ask discerning questions that made us rethink some of our initial thoughts on how to approach the guidance, and were reassured when they learned that we intended to focus on practical, reasonable advice. 

FDA is committed to working hand-in-hand with the people who produce our foods. This approach helps ensure that we understand production processes, and put forth the best advice we can to protect consumers, whose health is our first consideration. 

We firmly believe that producers can provide hens with outdoor access and still be in compliance with the Egg Safety Rule. 

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

FDA Uses Web Tool to Better the Odds for Food Safety

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By: Ted Elkin

When most people hear the words, “Monte Carlo,” they may think about high-stakes gambling.

We, however, think about reducing the risk in food safety through the use of FDA-iRISK, an innovative Web-based food safety modeling tool developed by the Food and Drug Administration and our partners.

Launched in October 2012, FDA-iRISK uses mathematical logic and Monte Carlo simulation (a computer program named for the gambling mecca) to integrate data and generate results that compare and rank risks of the contamination of foods by various hazards.  Unlike a traditional risk assessment of a single food and a single contaminant, FDA-iRISK allows users to compare multiple hazards – microbial or chemical – in multiple foods.

How does FDA-iRISK work?

Through extensive outreach to and collaboration with partners, we developed built-in templates and other features that allow the user to create real-world (or hypothetical) food safety scenarios.

The user provides the data for seven elements: the food(s), the hazard(s), the population of concern (for instance, elderly or immune-compromised), the production or processing system being used for the food, the consumption patterns, the dose response (what level of exposure will have a health impact), and how the health effects are to be calculated.

This allows the user flexibility, for instance, to look at the impact of potential interventions at various stages of the food production system as well as the populations affected.  And it’s easy to use.

Of particular benefit to the user is FDA-iRISK’s ability to generate reports that measure the health impact of an intervention in terms of the widely used public health metric, DALYs (“Disability-Adjusted Life Years,” meaning years of healthy life lost to illness or death).  This measure lets us know the “bang for the buck” of a particular intervention.

FDA-iRISK is quickly gaining acceptance and use in the food safety community.  As of the middle of May, almost 500 users had established accounts with FDA-iRISK and they came from every continent. Because it is web-based, FDA-iRISK is available to anyone in the world who sets up an account, and it is free to use.

Therefore, the knowledge and sharing power of FDA-iRISK is exponential.  As more users use it and generate reports that are then available to the other users, a more consistent, well documented, systematic, structured and quantitative picture of risk in the food supply will emerge, as well as scenarios for reducing risk.

“Information provided by iRisk can aid in developing global scientific exchanges aimed at maintaining and developing agricultural markets around the world,” according to Jamilah (Fagbene) Cassagnol, an international trade specialist at the U.S. Department of Agriculture.

FDA-iRisk is supported by an exceptional project team. FDA staff members Sherri Dennis, Yuhuan Chen, David Oryang, Regis Pouillot, Karin Hoelzer and Susan Cahill developed the tool in collaboration with Risk Sciences International, RTI International and the Institute of Food Technologists.

Ultimately, for food safety, Monte Carlo shouldn’t mean taking a gamble.  Rather, it’s all about using a quantified, standardized and transparent methodology to better understand what interventions and controls will reduce the risk and improve our public health.

Ted Elkin is Director, Office of Analytics and Outreach, at FDA’s Center for Food Safety and Applied Nutrition.

FDA Reminds Consumers to Always Use Acetaminophen Safely

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By: Dale Slavin, PhD

On several occasions, the FDA has asked its expert advisory committees for advice about acetaminophen, which is used to treat pain and fever. Based on this advice and extensive review of the available scientific evidence, the FDA continues to believe that acetaminophen’s benefits outweigh its risks. With that said, however, no medicine is without any risk, and that includes acetaminophen.

Hundreds of over-the-counter (OTC) and prescription medicines contain acetaminophen. Many people taking these products may not be aware they contain this active ingredient. Taking too much acetaminophen can damage your liver. So it’s important to check your products, both OTC and prescription, before taking to see if they contain acetaminophen and to make sure you know how to take safely.

It’s important to know what’s in your medicine so you don’t take more than one medicine containing acetaminophen at the same time by mistake. Acetaminophen can be found alone in OTC products, or in combination with other ingredients. The OTC products that combine acetaminophen with other ingredients often treat the pain and fever that come with conditions like a cold and the flu.  In prescription medicines, acetaminophen is combined with other ingredients to help relieve moderate to severe pain.

Each year, hundreds of people suffer from liver damage associated with taking too much acetaminophen.  Symptoms of acetaminophen overdose may take several days to appear, and the symptoms may seem like the flu or a cold.

To make sure you don’t get too much acetaminophen, look at the labels of all the medicines you plan to use. On OTC medicines the word “acetaminophen” appears on the front of the package and on the Drug Facts label under the “Active Ingredient” section. On prescription medicines, the label may spell-out “acetaminophen” or have a shortened version of it, such as “APAP,” “acet,” “acetamin,” and “acetaminoph.” If you aren’t sure if your medicine contains acetaminophen, ask your health care professional for help.

To help avoid the risk of liver damage, make sure you understand the information provided on the medicine label or the directions given by your health care professional. You’ll need to know:

  • How much you can take at one time
  • How many hours you must wait before taking another dose
  • How many times you can take it each day
  • When you should not take it and when to talk to your health care professional
  • On children’s OTC medicines, the “Directions” section of the Drug Facts label tells you if the medicine is right for your child and how much to give based on his or her age.  If a dose for your child’s age is not listed or you can’t tell how much to give, ask your health care professional what to do.

Acetaminophen can be safe and effective when you use it as directed. Following these tips and remembering to never take – or give – more than one medicine containing acetaminophen in the same day will help lower the risk of liver injury.

And if you do take too much acetaminophen, get medical help right away, even if you don’t feel sick. Call the National Poison Control Center at 1-800-222-1222 or 9-1-1.

For more information on the safe use of acetaminophen and other common pain relievers and fever reducers, visit www.fda.gov/otcpaininfo and www.knowyourdose.org.

Dale Slavin, PhD, is Acting Director of FDA’s Safe Use Initiative

At the Center of Innovative Safe and Effective New Biologics

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By: Karen Midthun, M.D. 

We’ve all read news reports of research achievements that promise exciting and powerful new treatments such as gene therapies to treat diabetes and cell therapies to rebuild failing hearts.  

These medical products are biologics and may seem like the stuff of science fiction. But they could transform the way doctors treat certain illnesses and conditions. Other, more traditional biologics, such as vaccines and blood products, may play an important role in protecting against bioterrorism. 

As the part of FDA that has regulatory authority over many of these products, the Center for Biologics Evaluation and Research (CBER) plays a critical role in their development through its regulatory oversight and research. CBER comprises a variety of offices, including three product offices responsible for 1) gene, cell, and tissue therapies, 2) vaccines and allergy products and 3) blood and blood products. 

Biologics differ from chemically manufactured drugs; they are usually derived from living sources (humans, animals, microorganisms). Work in this field is demanding because of the unique challenges biologics pose to manufacturers as well as to the reviewers at CBER. For example, the sensitive makeup of some biologics (e.g., DNA and cells) means they can’t be sterilized, so great care is needed in manufacturing them. In addition, biologics are complex and often based on new scientific knowledge that CBER reviewers must be familiar with. 

One way CBER meets the challenges of reviewing these products is by conducting its own research, which creates new knowledge and helps advance development of innovative medical products. CBER shares this knowledge by publishing results in peer-reviewed journals, drafting guidance documents to assist in product development, and sharing information through global collaboration and conferences with colleagues in research institutes, government agencies, industry, and stakeholders. Scientists at CBER can bring this added knowledge to their review of new products. CBER research  enhances CBER reviewers’ ability to evaluate a product’s safety and effectiveness—and to spot problems in product development that might not be recognized by manufacturers. 

Thanks to all of this work, CBER has approved important new products over the past couple of years, including 1) the first over-the-counter test that enables consumers to determine their own HIV (the AIDS virus) status in about 30 minutes—in private, 2) five stem cell products derived from cord blood (placenta-umbilical cord) for use in rebuilding the populations of blood forming cells and the immune system; 3) three influenza vaccines that protect against four strains of influenza virus rather than the previous limit of three strains, and 4) two other influenza vaccines, which are produced using mammalian cells or insect cells, rather than with eggs, as is customary. These two new production techniques for influenza vaccine offer the potential for faster startup of the manufacturing process than egg-based manufacturing, as well as the ability to rapidly address an unexpected, spreading epidemic. These vaccines also offer an alternative for individuals who are allergic to egg products. 

Importantly, CBER’s product safety efforts don’t stop after a product goes to market. The Office of Biostatistics and Epidemiology works with collaborators such as Medicare and the FDA Sentinel program on projects that can help evaluate whether certain adverse reactions are caused by approved treatments. 

As medical innovation accelerates in the 21st Century, CBER will continue to be at the forefront of ensuring the development of innovative safe and effective biologics. 

Karen Midthun, M.D., is Director of FDA’s Center for Biologics Evaluation and Research