[Congressional Record Volume 165, Number 197 (Tuesday, December 10, 2019)]
[Senate]
[Pages S6915-S6916]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



     Over-the-Counter Monograph Safety, Innovation, and Reform Act

  Mrs. MURRAY. Mr. President, last week, when I joined my colleagues to 
recognize Senator Isakson, I mentioned that when Johnny says he is 
going to get something done, you know it will get done. The bill we are 
getting ready to pass today in a few hours, the Over-the-Counter 
Monograph Safety, Innovation, and Reform Act, which he has worked on 
with Senator Casey, proves it once again.
  Every day, people head to their local pharmacy or retail store for 
over-the-counter medications to deal with a cough or a sore throat or a 
stomach ache. Every day, parents across the country turn to the 
medicine cabinet after someone comes home with a scrape or a bug bite 
or poison ivy. Every day, there are countless other health concerns 
people look to treat quickly, safely, and effectively with over-the-
counter drugs. That is why this legislation is so important.
  The pace of scientific discovery seems to speed up every day, but the 
over-the-counter monograph system--the system for how these drugs are 
regulated and brought to market--has not kept pace. The current system 
has not changed, actually, since 1972, and it sorely needs to. Right 
now, even after the science has made clear that small changes to the 
monograph, or recipe, for an over-the-counter drug might make it safer 
or more effective, it can take years for those changes to be approved 
under the current outdated process. Even small changes to a drug label, 
including changes regarding important new safety information, can be 
held up for years.
  The Over-the-Counter Monograph Safety, Innovation, and Reform Act 
takes long-needed steps to address this problem and streamline the way 
over-the-counter drugs are regulated and brought to market. These 
changes will allow the Food and Drug Administration to do more to 
protect public health and make sure over-the-counter drugs, 
ingredients, and labels reflect the latest science. It will also 
encourage the development of new products to better meet the needs of 
patients. The legislation allows the FDA to collect user fees for 
reviewing over-the-counter drugs to make sure it has the resources it 
needs to do this important job.
  Many families rely on over-the-counter drugs each day for a lot of 
different reasons. It is very important that these medications and the 
labels we turn to for information about them are safe, that they are 
effective, and

[[Page S6916]]

that they are as up-to-date with the latest science as possible. Thanks 
to the efforts of Senator Isakson and Senator Casey, this bill we will 
vote on this afternoon will help accomplish that by updating the over-
the-counter monograph system for the first time in decades. I know how 
important this bill has been to Senator Isakson and how he has worked 
so hard on it for many years. I want to tell him how grateful I am. I 
want him to know that I am particularly grateful for his commitment to 
getting this done for families back in Georgia and across the country.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Massachusetts.