Colleen Labbe:            Hi, I'm Colleen Labbe from the CDER Office of Communications. 

 

Most people, if not all, have taken an antibiotic at one time or another. We might take them for things like a urinary tract infection, a strep throat or a sinus infection, but we may have also taken them when they aren't indicated. For instance, the common cold or the flu, both of which are caused by viruses, will not respond to an antibiotic. Still, why is this misuse of antibiotics so concerning? Today, I'm talking with CDER Director Dr. Janet Woodcock about the issues surrounding antibiotic misuse, as well as the emergence of antibiotic-resistant bacteria and how the two are related. Dr. Woodcock, thanks for being here today.

 

Janet Woodcock:        Happy to be here.

 

Colleen Labbe:            Let's provide some context. When antibiotics were first introduced in the 1940s, they transformed healthcare. Suddenly, deadly illnesses caused by bacteria could be cured. Many lives were saved, but what has happened since then?

 

Janet Woodcock:        Well, when people take antibiotics, the bacteria that are sensitive to the medicine are killed and then you can get better, but there's some residual bacteria that, resist the medicine, and they can be left to grow and multiply. And over time, as people have used antimicrobials, we have seen more and more bacteria become resistant to them, and it's become very widespread. Now we have some bacterial infections that are actually resistant to nearly all of our antibiotics that we have, and this is a very serious situation. According to the CDC, antibiotic-resistant bacteria cause at least 2 million illnesses and 23,000 deaths in the United States this year today.

 

Colleen Labbe:            Wow! So, why is overuse of antibiotics so harmful? Why is it such a bad idea to take an antibiotic for a viral infection like a cold or the flu?

 

Janet Woodcock:        Well, first of all they don't work for cold or flu, so it would do you no good because the viruses won't respond. But second of all, they have side effects like any other drugs, and, you're still having those risks. Third, we harbor healthy bacteria. They're called the human microbiome-- both in our gut and all over our body. And when we take unnecessary antibiotics, we kill some of the beneficial bacteria, and we may alter our microbiome in ways we still don't understand very well.

 

Colleen Labbe:            Okay, so what is FDA doing to address this issue? How is the agency helping to encourage the development of new effective antibiotic drugs?

 

Janet Woodcock:        Well, we are doing a lot of different activities both to try to combat development of resistance and also develop new drugs. So we have labeling regulations that address the proper use of antibiotics, and those are directed at healthcare professionals, and they're required statements that tell them they should only be used to treat infections are caused by bacteria and to counsel people about proper use. Unfortunately, many patients come in and demand antibiotics. They're under the misimpression that it will help their viral illness. And then we encourage the development of new drugs, as well as better tests for testing whether you have a bacterial infection and what kind. This can help a lot because then you can target your antibiotic, if it's a bacterial infection, to the proper bacteria and so you don't have to use as many antibacterials. So, we're also trying to streamline guidances and requirements for clinical studies to get a new antibiotic approved so that can be most efficient. And then, recently Congress passed a law called GAIN—the Generating Antibiotics Incentives [Now] Act—which tries to stimulate development of new antibiotics and antifungals, and certain drugs are designated as qualified infectious disease products, and they can receive priority review from the FDA and are eligible for fast-track designation. We have designated quite a few candidates under this program. And then most recently, in December, the 21^st Century Cures Act was passed, and within that was a provision that establishes a new approval pathway for antibacterial drugs that are intended to treat serious or life-threatening infections in patients who don't have other treatment options but are very targeted interventions. And that pathway will put those sort of on a very fast track for getting onto the market but only for a very small segment of people with infectious diseases. And then of course, we work with the CDC and partner with them on a public awareness campaign—Get Smart, Know When Antibiotics Work—and that offers health information to public to try to decrease the inappropriate demand for these.

 

Colleen Labbe:            Okay, so, what are some way we as consumers can help to mitigate the rise of antibiotic-resistant bacteria?

 

Janet Woodcock:        Well, one thing that many of us don't do correctly, I think, that's very important, take any prescribed antibiotic medication exactly as directly and complete the full course of the drug even if you are feeling better. Uh, many people may save some of the drug and stop taking it early and save it in case they feel sick later. This is a way to help the growth of resistant bacteria, or if you take the antimicrobial drug intermittently for example, and don't save them. Don't give them to other people. They do have side effects. They can cause serious problems in some people. And don't take, in the same vein, don't take antibiotics that have been prescribed for someone else because you think it will help your condition. This may not be appropriate for what you have. It may delay the correct treatment and could allow you to actually get worse or expose you to side effects of that drug. And talk to your healthcare professional.

 

Colleen Labbe:            Great. These are really good reminders, Dr. Woodcock. Thanks for sitting down with me today.

 

Janet Woodcock:        Very happy to do so. Thank you.

 

Colleen Labbe:            Great.