[Congressional Record Volume 165, Number 197 (Tuesday, December 10, 2019)]
[Senate]
[Pages S6918-S6919]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



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

  Mr. ALEXANDER. Mr. President, every year, Americans make nearly 3 
billion trips to the drugstore, pharmacies, convenience stores to pick 
up over-the-counter products such as allergy medicines, children's 
cough syrup, or simple pain medicines such as aspirin.
  As the Senate Health, Education, Labor, and Pensions Committee was 
working on the 21st Century Cures Act in 2016, I asked Janet Woodcock, 
the Director of the Center for Drug Evaluation and Research at the Food 
and Drug Administration: Are there any changes that really need to be 
made in the FDA's law? This is a train--referring to the 21st century 
cures legislation--that is likely to get to the station. If you have 
something that really needs to be done for the benefit of American 
consumers that you haven't been able to get done, tell us what it is, 
and we will put it on the train.
  Well, Ms. Woodcock, who has been at the FDA for a while, came back to 
me and said the over-the-counter monograph.
  Now, what that means is these are the rules that govern how all drugs 
sold in pharmacies, other than prescription drugs, are approved--the 
allergy medicines, the cough syrups, the simple pain medicines. Those 
haven't been changed since the 1970s, nearly 50 years ago.
  Today the Senate, after all that time, nearly a half century, will 
modernize these rules by passing legislation proposed by Senator 
Isakson and

[[Page S6919]]

Senator Casey. It is called the Over-the-Counter Monograph Safety, 
Innovation and Reform Act.
  I am sure it will get a big vote of approval, and like a lot of other 
very important things that are done in the Senate that are very, very 
difficult to do, it will look easy.
  It hasn't been easy. It has taken a long time--nearly a half century. 
It was the one thing that the FDA said we just can't get done. That was 
in 2016, 3 years ago, and now Senator Isakson and Senator Casey are 
getting it done.
  It is the most important law affecting the safety, innovation, and 
cost of over-the-counter drugs since the 1970s.
  It is a great testament to Senator Isakson's leadership and 
legislative skill. He, of course, is leaving the Senate at the end of 
this year, and this is a fitting tribute to his work.
  In the same way, I thank Senator Casey of Pennsylvania for his 
excellent work, in bipartisan fashion, with Senator Isakson on this 
bill. They both deserve great credit and thanks for getting this update 
across the finish line. It may look easy, but what they have done is 
something that hasn't been changed for nearly a half century and that 
the Food and Drug Administration said was the one thing that needed to 
be done to help consumers to affect the availability, the safety, the 
cost, and the innovation of drugs that are sold across the counter that 
are not prescription drugs.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from New Hampshire.