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Schumer Announces Support For New Legislation Requiring The FDA To Work With Drug Companies To Ensure Adequate Availability Of Life-Saving Drugs And Prevent Supply Chain Interruptions

Lack Of Raw Materials, Increase In Demand For Certain Drugs, And Drug Companies’ Production Choices All Contributing To Shortages At Corning & Elmira Hospitals

Schumer: This Bill Ensures That Doctors Have The Life- Improving and Life-Saving Medicine They Need To Deliver Top- Notch Medical Care


Today, U.S. Senator Charles E. Schumer announced his support for new legislation that would create an early warning system within the Food and Drug Administration (FDA) to help ward off shortages of life-saving drugs. The Preserving Access to Life-Saving Medications Act would require drug makers to immediately notify the FDA when a raw material shortage, manufacturing problem, or production decision is likely to cause a drug shortage. The early notification would allow the FDA to work with other manufacturers, both domestic and international, to find new sources and ensure that the supply chain is not interrupted. Schumer’s support for the bill comes as a number of hospitals and doctors at Elmira and Corning hospitals and across the country have reported shortages of anesthetics, cardiac drugs, chemotherapy agents and other medicine that is essential to patient care. Physicians have been forced to substitute therapeutically equivalent medicines because of drug shortages, which can increase costs to patients and the system and elevating the possibility of errors. One analysis suggested the increase in health care costs due to the need for substitutions could be as much as $200 million each year nationwide.


“With drug shortages on the rise, hospitals, physicians, pharmacists and patients cannot be the last to know when an important drug will be unavailable to them,” said Schumer. “This common-sense solution will minimize that risk by creating an early warning system from drug makers to the FDA, so that hospitals in the Southern Tier and all throughout New York will have the medicine they need to deliver top-notch medical care. Patients should never have to hear a doctor tell them they’re out of medicine – this bill would ensure continuity across the supply chain to make sure that doctors are equipped with the drugs they need to fight today’s illnesses.”??

This year, pharmacists and other health care providers have been reporting unprecedented shortages of prescription drugs. Experts cite a number of factors behind the shortages, including scarcity of some raw materials, manufacturing problems, and unexpected demand. Business decisions within the pharmaceutical industry are also a factor, such as cutting back on the production of low-cost generic drugs in favor of more profitable brand-name drugs. The frequency and impact of drug shortages have risen to critical levels, more than tripling since 2005, and affecting all segments of healthcare. According to a report from the Premier Health Alliance, in 2010, over 240 drugs were either in short supply or completely unavailable and more than 400 generic equivalents were backordered for greater than five days. From 2009 to 2010, the number of newly reported shortages rose from 166 to 211. Physicians in the Southern Tier have noted that shortages of drugs in hospitals and clinics are occurring at an alarming rate.


S. 296, the Preserving Access to Life-Saving Medications Act, introduced by Senator Amy Klobuchar (D-MN), would give the FDA the ability to require early notification from pharmaceutical companies when a factor arises that may result in a shortage. These factors may include changes made to raw material supplies, adjustments to manufacturer production capabilities, and certain business decisions such as mergers, withdrawals, or changes in output. The bill would also direct the FDA to provide up-to-date public notification of any shortage situation and the actions the agency would take to address them. This bill shifts shortage reporting responsibility from providers to manufacturers; requires all manufacturers to report upcoming drug shortages to the FDA; increases manufacturer accountability by requiring them to anticipate and notify of future manufacturing stoppages, but does not impose fines or other sanctions for reporting; and allows providers to better anticipate impending shortages so both providers and patients can prepare for alterations in treatment regimens. This early warning system would allow the FDA more time to work with domestic and international manufacturers in order to provide increased availability of life-saving drugs.


Schumer was joined by Guthrie Corning Hospital President and COO Shirley Magana, St. James Mercy Hospital President and CEO Mary LaRowe, and Corning Mayor Richard Negri.


Physicians in the Southern Tier at Elmira and Corning Hospitals have been working to deal with shortages of a variety of drugs including:


  • Anesthesia related items: Neostigmine, Glycopyrrolate, Propofol, Rocuronium, and Metoclopramide


  • Cardiac related items: Furosemide Injection, Diltiazem Injection, Norepinephrine Injection


  • Electrolyte Replacement: Calcium Chloride Injection, Calcium Gluconate Injection, Sodium Phosphate Injection, Sodium Acetate Injection, Potassium Phosphate Injection, Sodium Chloride Injection


  • Chemotherapy related items: Leucovorin, Bleomycin, Oxaliplatin, Cisplatin, Doxorubicin


  • Others: Promethazine, Dexamethasone, Fosphenytoin, phenytoin


In addition, Schumer noted that Southern Tier hospitals have reported nearly cancelling elective surgeries, which were only allowed to go forward when substitute drugs were located. Hospitals have also noted that they have had to delay and rearrange chemotherapy treatment schedules because of drug shortages. In many cases, the drugs in question have been on the market for several years, or even decades. Treatment plans have been created and established based on the availability of these drugs, making it extremely difficult for physicians to adjust to their absence.

Schumer points out that these drug shortages require costly resources and time to alleviate. Because there is currently no warning system, pharmacists and physicians are forced to do work-around, substitutions, and occasionally must even secure the drug from an alternate source - the “gray market” – due to the short supply or complete unavailability from wholesalers.  Though not illegal, Pharmacy Directors aim to avoid using this alternate source, based on safety and cost concerns. The ‘gray market’ is made up of distributors who purchase medicine and medical supplies and markup prices, sometimes by as much as 335% according to the Premier Health Alliance survey, before selling to hospitals and doctors.


The legislation is endorsed by the Healthcare Association of New York State (HANYS), Greater New York Hospital Association, the American Hospital Association, the American Society of Clinical Oncologists, the Institute for Safe Medication Practices, the American Society of Health System Pharmacists, and the American Society of Anesthesiologists.


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