Transcript for: FDA’s Oversight of Antibiotic Drug Labeling

Audio interview by GAO staff with Marcia Crosse, Director, Health Care

Related GAO Work: GAO-12-218: Antibiotics: FDA Needs to Do More to
Ensure that Drug Labels Contain Up-to-Date Information

Released: January 2012

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[ Narrator: ] Welcome to GAO's Watchdog Report, your source for news and
information from the U.S. Government Accountability Office. It's January
2012.  Antibiotic drugs fight bacterial infection and save millions of
lives; however, some bacteria are becoming resistant to antibiotics,
causing a growing public health concern. The Food and Drug
Administration, or FDA, is responsible for ensuring that current
information about bacterial resistance to antibiotics is publicly
available. A group led by Marcia Crosse, a director in GAO’s Health Care
team, recently reviewed FDA's oversight of how this information is
conveyed on antibiotic drug labels. GAO's Jeremy Cluchey sat down with
Marcia to learn more.

[ Jeremy Cluchey: ] What prompted GAO to undertake this study?

[ Marcia Crosse: ] Well, in 2007, Congress passed legislation that
included some provisions for FDA that required that they see how the
labels of antibiotics were being maintained and it also contained
provisions that were intended to try to spur the development of
additional antibiotics, and so, GAO was asked to take a look at how FDA
was implementing these provisions and what had happened with the
development of new drugs.

[ Jeremy Cluchey: ] One of the key concepts in this report is
breakpoints. Can you explain what this means?

[ Marcia Crosse: ] Yes, breakpoints reflect the concentration at which
bacteria are categorized as susceptible to treatment with a given
antibiotic, and you want to have current, up-to-date information on that
to make treatment decisions. Physicians need to be able to have that
information to choose an appropriate drug to treat an individual. We
know that bacteria are becoming resistant to treatment by some
antibiotics and so the usefulness of particular drugs is changing across
time and so the breakpoints can help provide physicians with information
to guide treatment.

[ Jeremy Cluchey: ] And what is FDA's role with respect to breakpoints
and drug labels?

[ Marcia Crosse: ] FDA is required to oversee drug labels and these
breakpoints are a part of the label for antibiotics and the statute that
was enacted actually called on FDA to oversee the antibiotic labels with
particular regard to the breakpoints. And, what they did was go out to
try to spur information from manufacturers. They put out new guidance
that actually required manufacturers to update their breakpoints for
their antibiotics annually, and the way that sponsors do that is
submitting information directly to FDA. And, while their guidance called
for this to be done annually, we found that FDA actually had quite a
backlog in their review of the information and since FDA has to agree to
the label changes, these labels were not being updated in a—on anywhere
near an annual basis. In fact, some three and a half years after FDA
began this process, two-thirds of the labels still hadn't been updated.

[ Jeremy Cluchey: ] Your team also assessed how these efforts have
affected new drugs. Can you talk about what you found there?

[ Marcia Crosse: ] There's not a lot of financial incentive for drug
companies to make antibiotics that would be used by an individual for a
short period of time, in comparison with a treatment for a chronic
condition where someone might be on that drug for  months or years. And
so, Congress had included a provision to try to spur some development of
antibiotics, but we found it was a very narrow provision, and in fact,
no drugs had been approved under that provision. So it had not been
effective in spurring the development of new antibiotics.

[ Jeremy Cluchey: ] What is GAO recommending in this report?

[ Marcia Crosse: ] Well, we had a number of recommendations to FDA. We
asked that they expedite their reviews of the information that had been
submitted to them, that they be a little more comprehensive in what they
were doing, and that they put in place some kinds of controls so that
they could more regularly ensure that this information was remaining
current because it's important for patient treatment.

[ Jeremy Cluchey: ] Finally, for taxpayers interested in understanding
how the information on their antibiotic labels is overseen, what's the
bottom line here?

[ Marcia Crosse: ] Well, I think individuals need to understand that
labels can change across time, that FDA has a key role here in
overseeing the labels of drugs, and that they need to be talking with
their physicians if a drug they've been prescribed doesn't seem to be
having the effect that they were expecting or that their physician told
them to expect. So, they need to be watchful and in communication with
their provider.

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[ Narrator: ] To learn more, visit gao.gov, and be sure to tune in to
the next episode of GAO's Watchdog Report for more from the
congressional watchdog, the U.S. Government Accountability Office.