[Congressional Record Volume 165, Number 197 (Tuesday, December 10, 2019)]
[Senate]
[Pages S6944-S6945]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




   THE OVER-THE-COUNTER MONOGRAPH SAFETY, INNOVATION, AND REFORM ACT

  Mr. CASEY. Madam President, today, the Senate passed S. 2740, the 
Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019, 
which will completely overhaul and improve how the Food and Drug 
Administration--FDA--regulates over-the-counter--OTC--or 
nonprescription, drugs. These medicines are used by Americans every 
day, but our regulatory system has been stuck in the 1970s and has not 
kept pace with innovation or the need to ensure appropriate consumer 
protections. Senator Johnny Isakson and I have been working on this 
legislation since 2016.
  This legislation creates a modern regulatory system for OTC drugs, 
providing the FDA with new resources to be able to review changes to 
existing OTC drugs and allow the marketing of new OTC drugs. FDA will 
have the authority to take swift action to protect the American public 
if a serious problem arises and to make changes to how OTC drugs are 
allowed to be sold if the science indicates that the steps are 
necessary to ensure that these products are used safely.

[[Page S6945]]

  The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 
2019 establishes a streamlined administrative process which allows the 
FDA to modify a drug's safety labeling to address new health risks. The 
act is intended to modernize and accelerate regulatory procedures 
applicable to OTC drugs and will also allow for increased innovation. 
However, patient safety and manufacturer accountability are of equal 
importance. As such, nothing in this act is intended to change, 
diminish, or prohibit a manufacturer from performing any duty or 
complying with any requirement to warn consumers that exists under 
State or Federal law or to prevent any labeling changes pursuant to any 
other applicable provision of the Federal Food, Drug, and Cosmetic Act 
or FDA regulation. It is imperative that consumers have accurate 
information regarding the safety of over-the-counter drugs, and this 
bill is intended to improve that process while maintaining the existing 
rights of consumers to access the courts and hold manufacturers 
accountable when harmed.
  This legislation has bipartisan support and also broad support from 
key stakeholders in public health, healthcare, and industry. I am 
deeply grateful for the work of my colleagues, notably Senator Johnny 
Isakson--the bill's sponsor; and the chairman and ranking Member of the 
Committee on Health, Education, Labor, and Pensions, Senator Lamar 
Alexander and Senator Patty Murray, and their staffs for their 
continued support for this important effort. As a result of our work, 
American consumers will be able to have greater confidence in their 
over-the-counter drugs and will benefit from new innovation in the 
years to come.
  Mrs. MURRAY. Mr. President, I thank Senator Casey for his leadership 
on this important issue and agree wholeheartedly with his statement on 
S. 2740, the Over-the-Counter Monograph Safety, Innovation, and Reform 
Act of 2019.
  Mr. BURR. Madam President, I want to take a few moments to explain 
why I am opposed to the OTC reform legislation offered by Senator 
Isakson. Senator Isakson and I worked together on many pieces of FDA 
legislation, and I have no doubt that he worked tirelessly to draft 
this bill in the best interest of patients. I will miss working closely 
with my colleague from Georgia to improve the lives of the millions of 
Americans touched by the U.S. Food and Drug Administration's work each 
day.
  I want to be clear that I agree reforms are needed within the over-
the-counter drug division at the FDA. I simply disagree on the way in 
which this legislation provides the resources to achieve these reforms 
because I do not believe it will result in my colleague's desired 
outcome. Here is why.
  I reformed the FDA in 1997 with the passage of the FDA Modernization 
Act, which I like to call FDAMA. One of the foundational principles of 
that legislation was to bring more certainty, predictability, and 
accountability to an agency that had lost its way, failing to bring new 
drugs and medical devices to market in the United States in a timely 
manner. Twenty-two years later, I am starting to see the implementation 
of major provisions of this law. Two decades after its passage, the FDA 
is finally putting key policies into practice that Congress demanded. 
Two decades is an unacceptable amount of time for Americans to wait.
  One of the components of FDAMA was the reauthorization of certain 
user fee programs. Over these past two decades, we have seen FDA's user 
fee agreements increase with each 5-year cycle, bringing more resources 
into the agency to review drug, biologic and device applications.
  When the drug industry first agreed to user fees in 1993, the fee to 
file a new drug application with the FDA was $100,000. Today, that fee 
is $2.1 million. To that end, FDA has struggled to uphold its end of 
the deal, falling behind in its commitment to hire the number of 
individuals the agency needs to actually review the applications that 
cost millions of dollars to file. The FDA continues to increase the 
amount of user fee dollars it requires to review applications, eroding 
the balance of congressional oversight provided by the appropriation of 
taxpayer dollars to the agency.
  I would caution my colleagues that we are currently experiencing the 
effects of a center at the FDA that receives 100 percent of its funds 
from user fees, the Center for Tobacco Products. The CTP has had 10 
years and received over $5 billion in user fee resources. It has yet to 
finalize a single governing regulation for the products Congress tasked 
the CTP with regulating. Meanwhile, youth rates of vapor product use 
continue to increase and 2,000 Americans have fallen ill from the use 
of unregulated products. I have spoken many times on my concerns with 
the growth and development of FDA user fee programs because they have 
not resulted in the development of an FDA that keeps its promises. I 
promise my colleagues that the user fee program included in this bill 
will not be any different.
  While the Senate has wrestled with solutions to high drug costs for 
the last 18 months, we are voting to approve a bill that increases the 
development costs for one of Americans' cheapest options for care. The 
over-the-counter user fee bill provides millions of dollars in new 
industry funds to reform the OTC system at FDA, and the agency is 
asking for tens of millions of dollars to deal with a backlog of OTC 
monographs or recipes to create over the counter medications.
  User fee dollars are intended to go toward the review of 
applications, but I can assure my colleagues this is not the full story 
at the Agency today. Last year alone, $133 million in drug user fees 
went toward administrative expenses at the FDA, funds that may 
otherwise help to invest in new treatments or cures for Americans. This 
is very simple math, the more user fee programs we provide to the FDA, 
the less the FDA is accountable and responsive to Congress.
  Through FDAMA and more recently in the 21st Century Cures Act and the 
2017 FDA user fee bill, I worked to rebalance the focus of the FDA, to 
reaffirm its authorities to regulate the cutting edge science facing 
the agency, and to better leverage and strategically invest its 
existing resources. So I cannot support legislation that degrades the 
progress we have made at the FDA.

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