FDA Works to Reduce Antibiotic Misuse, Resistance

In their most recent podcast, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), discussed the misuse of antibiotics and how this has led to resistance. Since their introduction in the 1940s, antibiotics have saved countless lives, but now, public health has been threatened by the emergence of drug-resistant bacteria.

While many patients are properly prescribed antibiotics, some may also receive the prescriptions for a cold or flu caused by a virus. This occurrence drives antibiotic resistance, according to CDER.

When treated with antibiotics, bacteria that are sensitive to the drug are killed, but there can be residual bacteria that multiplies. Over time and with use of antimicrobials, more and more bacteria have developed widespread resistance to drugs, according to Dr Woodcock.

The CDC reports that antibiotic-resistant bacteria results in more than 2 million illnesses and more than 23,000 deaths each year in the United States. This highlights the need for additional approaches to reduce antibiotic misuse and overuse.

Taking antibiotics for viral infections can lead to significant consequences, including side effects and a disruption of the microbiome in the gut and the body. Antibiotics are known to kill beneficial bacteria, and change the microbiome in ways that are not well-understood, according to the podcast.

In an effort to combat antibiotic-resistant bacteria, the FDA is attempting to increase the development of new drugs and prevent resistance.

The FDA has implemented labeling regulations that address the correct use of antibiotics directed at healthcare providers. There are also required statements that remind prescribers to only treat bacterial infections and how to counsel patients about the proper use of antibiotics, according to Dr Woodcock.

The FDA is also urging investigators to develop novel drugs and tests to determine the cause of infection. This can lead to a more targeted approach to treating the infection and prevent taking more antibiotics than necessary.

“We're also trying to streamline guidance and requirements for clinical studies to get a new antibiotic approved so that can be most efficient,” Dr Woodcock said.

Additionally, Congress recently passed the Generating Antibiotics Incentives [Now] Act, which aims to increase the creation of new antibiotics and antifungals. Under the rule, certain drugs would be able to receive designation as a qualified infectious disease product and receive expedited review.

The 21^st Century Cures Act, approved under former President Barack Obama, law includes a provision that creates a new approval pathway for antibacterial drugs that treat serious or life-threatening infections in patients who have no other treatment options, according to the podcast. The pathway would also put the drugs on a fast track for receiving approval in a small portion of patients.

The FDA and CDC have worked collaboratively to develop the Get Smart, Know When Antibiotics Work public awareness campaign to reduce inappropriate use of the drugs.

As consumers, Dr Woodcock advises patients to take antibiotics like all medications, as prescribed, and finish the course of treatment. Many patients may stop treatment early if they are feeling well, but this practice has played a part in the growth of drug-resistant bacteria.

Also, antibiotics should not be given to patients other than those who it was prescribed for, as the drug can have side effects, according to the podcast.

“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,” Dr Woodcock concluded. “And talk to your healthcare professional.”