I have met with patients, doctors and other medical professionals in Maine who are very concerned about the shortages of critical drugs that have caused serious problems around the country, including forcing some medical centers to ration drugs alter treatment plans, or postpone elective surgeries.

Many of the drugs in short supply are vital, used in hospitals and cancer centers for anesthesia, chemotherapy, and infections. There also are continuing shortages of drugs used in emergency rooms and intensive-care units. Oncologists have told me of situations where they are forced to change a patient's chemotherapy regime midcourse because they suddenly encounter a shortage of a particular drug. For some drugs, such as the leukemia drug cytarabine, there are no effective substitutes.

In a survey by the American Hospital Association, more than 80 percent of hospitals reported that have had to delay treatment due to shortages, and nearly 70 percent said patients received less effective substitutes. Pharmacists and technicians can each spend about 17 hours a week managing drug shortages, increasing labor costs by $216 million a year.

The causes of drug shortages have varied but generally fall into four main categories: 1) shortages of raw materials or manufacturing difficulties, such as contamination problems or equipment failures; 2) reduced factory capacity due to industry consolidations; 3) companies dropping older, less profitable drugs, leaving manufacturing in the hands of fewer companies; and 4) regulatory and legislative factors such as the absence of FDA authority to require manufacturers to provide notice of an anticipated withdrawal of a drug from the market.

As a member of the Special Committee on Aging and founder of the Senate Diabetes Caucus, I have been concerned about the effect these shortages are having on Americans of all ages. I am pleased that the President recently signed the Food and Drug Administration Safety and Innovation Act that includes bipartisan provisions that I authored, along with Sens. Amy Klobuchar (D-MN) and Bob Casey (D-PA), that will require drug manufacturers to give early notification to the Food and Drug Administration of any incident that would likely result in a drug shortage. This new law will provide the FDA with tools to better manage, and we hope prevent, shortages of life-saving medications. 

Requiring manufacturers to give the FDA advance warning when a drug will not be available will help both doctors and patients. This builds on a successful model – 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 nearly 200 drug shortages in 2011, up from 38 drug shortages in 2010.

In addition to giving the FDA the ability to require early notification when a shortage arises, the law we authored directs the FDA to expedite inspections and reviews of manufacturing sites or new products that could be helpful in addressing a drug shortage.

Giving the FDA the information and tools it needs to help address and prevent drug shortages just makes sense. This new law will help make certain that 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 that they need.