From the U.S. Government Accountability Office, www.gao.gov

Transcript for: Changes in Over-The-Counter Drug Regulations  

Description: Over-the-counter drugs are made available to consumers
without a prescription. Until recently, the FDA regulated most
over-the-counter drugs using a process established almost 50 years ago
(in the 1970s). Today we talk to GAO's John Dicken, a health policy
expert, about new legislation that significantly changes this process. 

Related GAO Work: GAO-20-572, Over-The-Counter Drugs: Information on
FDA's Regulation of Most OTC Drugs

Released: July 2020

[Intro Music]

[John Dicken:] The new legislation gives opportunities for FDA to
modernize and streamline its processes for over the counter drugs
standards.

[Holly Hobbs:] Hi, and welcome to GAO's Watchdog Report, your source for
news and information from the U.S. Government Accountability Office. I'm
Holly Hobbs.
 
Over the counter drugs are made available to consumers without a
prescription and include items such as sunscreen, aspirin, hand
sanitizer, and more. Until recently, FDA regulated most over the counter
drugs using a process established almost 50 years ago, in the 1970s.
However, new legislation enacted in March has significantly changed this
process. Today, we talk to John Dicken, an expert on healthcare policy
and a Director on our healthcare team. Thank you for joining us, John.

[John Dicken:] Thank you.

[Holly Hobbs:] So, John, what is changing in FDA's review process under
this new legislation?

[John Dicken:] Well, the new legislation, the CARES Act, really reforms
and helps modernize the way that FDA regulates over the counter drugs in
the United States. What has not changed is that FDA is still responsible
for ensuring that over the counter drugs are considered, that they're
safe and effective for consumers to use in the United States. But there
are a couple of key changes in the way that FDA does that. One is that
FDA will be able to update and make standards for what over the counter
drugs can be sold through a more administrative process that's much more
streamlined than the lengthy regulatory process that they have been
using, up to this point. And then, secondly, it provides the ability for
FDA to collect user fees, starting next fiscal year, which should, over
time, allow FDA to hire more staff and have more resources for focusing
on the regulation of over the counter drugs.

[Holly Hobbs:] And what issue or issues are these changes looking to
solve?

[John Dicken:] We've long heard, and FDA has indicated, that the prior
process for regulating over the counter drugs was burdensome. It often
would take many years to develop the standards, or update standards, as
to what over the counter drugs could be marketed. We heard examples, and
then saw examples that often would take six years or more, and that
there were many un-finalized rules for changes or innovations to what
over the counter drugs could be offered. FDA indicates that the new
administrative process should be much faster and be able to update these
and allow for more innovative drugs to be available safely, within a few
years.

[Holly Hobbs:] What determines whether something is considered as an
over the counter drug versus a drug that needs a prescription, and how
many over the counter drugs are there?

[John Dicken:] Over the counter drugs are--those are generally
considered to be safe and effective, that the general public can use
without going through treatment for a health professional. There's a
wide range of products available. FDA's estimated roughly 100,000 drugs
are marketed as over the counter drugs, Common thing--such as,
sunscreen, hand sanitizers, aspirin, just a few examples that people use
regularly as over the counter products.

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[Holly Hobbs:] So, it sounds like FDA will still be playing an important
role in monitoring over the counter drugs, to ensure that they're safe.
But that the changes to FDA's review process could be significant. John,
what, if anything, is the impact to consumers?

[John Dicken:] The effect should be that it continues to be comfort,
that the products are available are ones the consumers can use. They're
safe and effective. But with this more streamlined process and with the
user fees, that FDA may be able to respond more promptly, to either
safety concerns or new, innovative drugs that are being made available
in the U.S.

[Holly Hobbs:] John, last question. What is the bottom line of this
report?

[John Dicken:] Well, FDA has long stated that the rule-making process
and resource constraints have limited their ability to timely regulate
over the counter drugs and respond to safety issues. So, the new
legislation gives opportunities for FDA to modernize, to update, and
streamline its processes for over the counter drug standards and provide
the user fees, that can supplement their resources, to be able to
effectively regulate over the counter drugs.

[Holly Hobbs:] That was John Dicken, talking about GAO's recent review
of over the counter drugs. Thank you for your time, John.

[John Dicken:] Thank you.

[Holly Hobbs:] And thank you for listening to the Watchdog Report. To
hear more podcasts, subscribe to us on Apple Podcast, and make sure you
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doing. For more from the congressional watchdog, the U.S. Government
Accountability Office, visit us at GAO.gov.

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