Food and Drug Administration Safety and Innovation Act--Motion to Proceed--Continued

Floor Speech

BREAK IN TRANSCRIPT

Ms. COLLINS. Mr. President, I rise in support of the Food and Drug Administration Safety and Innovation Act, which will help speed safe and effective drugs and medical devices to the patients who need them. This bipartisan, consensus bill was developed through a long and collaborative process involving the FDA, stakeholders, and Senators from both sides of the aisle. I commend the chair and ranking member of the HELP Committee for their tremendous leadership and hard work on this very important bill.

The legislation we are considering today reauthorizes existing user fee programs for prescription drugs and medical devices and creates new user fee programs for generic drugs and biosimilar biological products. In addition, the bill reauthorizes programs that have helped make medicines safer for children, upgrades the FDA's tools to police the global supply chain, increases incentives for the development of new antibiotics, and expedites the development and review of certain drugs for the treatment of serious or life-threatening diseases and conditions.

I particularly want to commend my colleagues for including provisions based on legislation I sponsored with Senator Klobuchar to address the shortages of drugs that are causing significant disruptions in care and putting patients at risk.

I continue to hear from doctors, emergency medical personnel, and other medical professionals in Maine who are extremely concerned about this issue. Many of the drugs in short supply are vital, used in hospitals and cancer centers for anesthesia, chemotherapy, and treatment of infections. There are also continuing shortages of drugs used in emergency rooms and intensive-care units.

These shortages are causing serious problems around the country, including forcing some medical centers to ration drugs or postpone elective surgeries. Oncologists have told me of situations where they were forced to change a patient's chemotherapy regime midcourse because they suddenly encountered a shortage of a particular drug. Moreover, for some drugs, there are no effective substitutes.

This crisis is widespread, with more than 80 percent of hospitals reporting that they have had to delay treatment due to shortages. That is why I joined my colleague from Minnesota in sponsoring the Preserving Access to Life Saving Medications Act to give the FDA tools to better manage, and hopefully prevent, shortages of life-saving medications, including requiring manufacturers to provide an ``early warning'' when a drug will not be available.

Providing early warning when a drug will not be available will help both doctors and patients. It builds on the successful model of the FDA's Drug Shortage Program which encourages manufacturers to report potential or existing shortages so that problems can be addressed or other manufacturers can ramp up production. Through this voluntary approach, the FDA was able to avert almost 200 shortages last year.

The legislation we are considering today will give the FDA the information and tools it needs to help address and prevent drug shortages. It will also promote innovation, improve safety, and increase access to the drugs and devices that are critical to our health. Again, I commend Senators Harkin and Enzi for their leadership and encourage all of my colleagues to join me in supporting this important legislation.

BREAK IN TRANSCRIPT

Source