Statements on Introduced Bills and Joint Resolutions

Floor Speech

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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 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, ______

By Mr. INHOFE:

S. 2731.

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