[Congressional Record Volume 165, Number 171 (Tuesday, October 29, 2019)]
[Senate]
[Pages S6245-S6246]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. COLLINS (for herself and Ms. Smith):
  S. 2723. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
reduce drug storages, and for other purposes; to the Committee on 
Health, Education, Labor, and Pensions.
  Ms. COLLINS. Mr. President, I rise today to introduce legislation 
with my colleague from Minnesota, Senator Tina Smith, to help prevent 
drug shortages. Our legislation has the support of the American 
Hospital Association, the American Society of Anesthesiologists, the 
American Society of Clinical Oncology, the American Society of Health-
Systems Pharmacists, Premier, and the Institute for Safe Medication 
Practices.
  I often hear from patients, pharmacists, and physicians who find 
themselves caught in the middle of a drug shortage, with very little 
certainty of when the problem might be resolved.
  For example, Wayne is a kidney and bladder cancer patient who called 
my Portland office about a shortage of BCG. Wayne received several 
treatments, went into remission, and then was declined additional 
preventive treatments that his doctor recommended due to this shortage. 
Wayne sees his physician every 90 days, but he lives with the constant 
fear that his bladder cancer could return, and the time and uncertainty 
between his appointments weigh heavily on him.
  I have also heard from patients living with a rare immunological 
disorder called Mast Cell Activation Syndrome who were affected by an 
IV Benadryl--diphenhydramine--shortage, as well as an Epi-pen shortage. 
One of these patients, a former nurse, spoke about the helplessness her 
family felt in trying to manage the shortage and was incredulous that 
shortages like these could be happening in a country like ours. She 
said, ``I am an in-charge kind of person, but I cannot fix this.''
  Physicians and hospitals try their best to manage these shortages 
behind the scenes but are understandably frustrated. Drug shortages add 
$230 million a year to U.S. drug costs and $216 million a year in 
increased labor costs. One of Maine's largest health systems reports 
that they address approximately two new impactful shortages a week and 
have had to commit 3.5 unbudgeted full time employees to address them.
  Another health system was experiencing 11 critical shortages and 30 
less critical, ongoing shortages. For one drug, the hospital pharmacist 
was able to procure a supply of the drug in shortage but had to switch 
to a more expensive product at ten times the cost.
  Our legislation, the Mitigating Emergency Drug Shortages Act of 2019, 
takes several steps to help FDA manage drug shortages. In the event of 
a likely drug shortage, our legislation gives FDA the authority to 
prioritize

[[Page S6246]]

review of abbreviated new drug applications and manufacturing 
inspections. It also improves the timely and effective coordination 
between those conducting manufacturing inspections and the FDA Office 
of Drug Shortages.
  Our bill strengthens reporting requirements for pharmaceutical 
companies to disclose the root causes and expected duration of 
shortages. It also requires manufacturers to have contingency and 
redundancy plans to ensure the ongoing supply of essential medications. 
This is critical as we learn the lessons from Hurricane Maria in 2017 
in Puerto Rico. Approximately 10 percent of drugs prescribed in the 
United States are manufactured in Puerto Rico.
  Our bill also requires the Departments of Health and Human Services 
and the Department of Homeland Security to conduct a risk assessment of 
national security threats associated with the lack of adequate domestic 
capacity and capability for the manufacturing and distribution of 
certain critical drugs, their active pharmaceutical ingredients--APIs--
and associated medical devices used for preparation or administration. 
Today, China and India are the world's largest suppliers of active 
pharmaceutical ingredients.
  Finally, our legislation requires the Secretary to develop 
recommendations to incentivize manufacturers to enter the market for 
shortages as well as improve consumer notification of drug shortages.
  I thank Senator Smith for joining me in this effort to help combat 
this stubborn and persistent problem for patients and physicians. I 
encourage my colleagues to support its adoption.
  Thank you,
                                 ______