Senator Collins recently joined Senator Amy Klobuchar on the Senate floor to push for immediate consideration of legislation they have introduced that would provide the U.S. Food and Drug Administration (FDA) with tools to better manage, and hopefully prevent, critical shortages of life-saving medications. First and foremost, their bill would require pharmaceutical manufacturers to notify the FDA of the discontinuance, interruption or other adjustment of the manufacture of a drug that would likely lead to a shortage.
Physicians, pharmacists, and patients in Maine and throughout the country are struggling to cope with a surge in shortages of drugs that is causing significant disruptions in care and putting patients at risk. According to the FDA, the number of drug shortages has nearly tripled over the last six years, jumping from 61 products in 2005 to a record 178 in 2010. And the pace is accelerating, with more than 150 shortages reported already this year.
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.
Senator Collins has met with several doctors and other medical professionals in Maine who are very concerned about this issue. They said 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 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.
And substitution raises a host of other issues. In most cases, the original drug was chosen because it was deemed the most effective for that particular patient. In addition, a substitute may present interaction problems with other drugs the patient is taking that the original drug would have avoided.
As a member of the Special Committee on Aging and founder of the Senate Diabetes Caucus, Senator Collins is very concerned about the effect these shortages are having on all Americans of all ages. The legislation she has introduced, titled the Preserving Access to Life-Saving Medications Act, would give the FDA the information and tools needed to help address and prevent drug shortages. This would help ensure that health-care professionals are able to provide the best care medical science allows. Most important, it would help ensure that patients have access to the medications that they need to treat their conditions.