Drug Shortages

Floor Speech

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Ms. COLLINS. Mr. President, let me first begin my remarks by commending my friend and colleague from Minnesota for leading the way on this very important bill.

There are so many issues that divide us in this Chamber. Surely, this is an issue that should unite us. It is not a Democratic issue. It is not a Republican issue. It is an issue of serious consequence to the American people and to our health care system. I would hope--and the reason Senator Klobuchar and I have come to the floor today--that we can act immediately to pass our bill, get it through the House, and send it to the President.

Physicians, pharmacists, and patients throughout the country are struggling to cope with the surge in shortages of needed drugs which is causing significant disruption in health care and putting patients at risk. I share with my colleague from Minnesota her concern about this critically important problem.

According to the U.S. Food and Drug Administration, the number of drug shortages has nearly quadrupled over the last 6 years, jumping from 61 products in 2005 to a record 231 by the end of November of last year. And there appears to be no end in sight.

Many of the drugs in short supply are vital. They are used in hospitals and cancer centers for anesthesia, for chemotherapy, and for the treatment of infections. There are also continuing shortages of drugs used in emergency rooms and in intensive care units.

I have met with several doctors and other medical professionals and pharmacists in Maine who are extremely concerned about this issue. They have told me that these shortages are causing serious problems around our State and across our Nation, including forcing some medical centers to ration drugs or postpone elective surgeries. Even more tragic, oncologists have told me of situations where they have been forced to change a patient's chemotherapy regime midcourse because they suddenly encountered a shortage of a particular drug. Moreover, for some drugs, such as the leukemia drug Cytarabine, which Senator Klobuchar mentioned as well, there are no effective substitutes.

This crisis is widespread. In a survey by the American Hospital Association, more than 80 percent of our hospitals reported that they have had to delay treatment due to the shortages. Just think what that is like for a patient who has received the diagnosis of cancer and has started treatment and then finds out the lifesaving drug they need is not available. It is hard enough to cope with the devastating diagnosis. To add to that the fact that the drug you need isn't available is just too much to bear. More than half of our hospitals have said they could not provide some of their patients with the recommended therapy.

Drug shortages are also adding to the cost of care. Hospital pharmacists are having to spend additional time--some 8 to 12 hours per week--dealing with shortages, increasing labor costs by an estimated $216 million a year.

That is why I joined with my colleague from Minnesota in cosponsoring the Preserving Access to Life-Saving Medications Act. Our bill will provide the FDA with better tools to better manage and, we hope, prevent shortages of lifesaving medications.

First and foremost, it takes the very commonsense step of requiring pharmaceutical manufacturers to notify the FDA of the discontinuance, interruption, or other adjustment in the manufacture of a drug that would likely lead to a shortage. Providing early warning when a drug will not be available will help both physicians and their patients. It builds on its successful model--the FDA's Drug Shortage Program--which encourages manufacturers to report potential or existing shortages so that the problems can be addressed or other manufacturers can ramp up their production. Through this voluntary approach, the FDA was able to avert 195 shortages last year.

Our bill also directs the FDA to provide up-to-date public notification of any shortages, and it directs the FDA to work with manufacturers to establish contingency plans to address drug shortages due to manufacturing problems, such as the shortage of raw materials or reduction in production capabilities.

Our legislation would give the FDA the information and the tools it needs to help address and prevent drug shortages. This, in turn, will help to ensure that our hospitals and health care professionals are able to provide the best care medical science allows.

Most important, it will help ensure that patients have access to the medications they need when they need them most.

I am proud to join with my colleague from Minnesota in sponsoring such an important initiative. I urge our colleagues on the HELP Committee to act quickly to report this bill and the full Senate to act without delay to approve it as well. Surely, this is an issue that should bring this Chamber together and that we should act on immediately.

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