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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 Capital Region Hospitals

Schumer: This Bill Would Ensure That Doctors Have The 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 to help ward off shortages of lifesaving drugs. The Preserving Access to LifeSaving 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 throughout The Capital Region and across the country have reported shortages of anesthetics, cardiac drugs, chemotherapy agents and other medicine that is essential to patient care, according to the Healthcare Association of New York State (HANYS). 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 commonsense solution will minimize that risk by creating an early warning system from drug makers to the FDA, so that hospitals in the Capital Region and all throughout New York will have the medicine they need to deliver topnotch 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 lowcost generic drugs in favor of more profitable brandname 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 Capital Region area have noted that shortages of drugs in hospitals and clinics are occurring at an alarming rate.

S. 296, the Preserving Access to LifeSaving Medications Act, introduced by Senator Amy Klobuchar (DMN), 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 uptodate 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 lifesaving drugs.

Schumer was joined by hospital administrators, St. Peter's CEO Steven Boyle, hospital neonatologist Dr. Stephen Pratt, and Thomas Lombardi, the hospital's Supervisor of Clinical Pharmacy Services as he announced his support for the legislation. Hospitals including Seton Health of Troy, Ellis Medicine of Schenectady, and Albany Memorial and Samaritan Hospitals in Albany have all struggled to secure adequate supplies of drugs that physicians and their patients need.

Physicians in the Capital Region have been working to deal with shortages of a variety of drugs including:

          Propofol - A drug used to reduce anxiety and tension that is commonly used for diagnostic tests and surgical procedures, in conjunction with other anesthetics

          Metoprolol - A beta blocker used to treat high blood pressure, prevent chest pain, and to save the lives of patients who have suffered a heart attack. The drug can also be paired with other medications to treat longterm heart failure.

          Glucagen - A hormone that can be used to fight extremely low blood sugar, as well as in diagnostic tests of the stomach and other parts of the digestive system.

          Chemotherapeutic agents including leucovorin - Used to combat the harmful side effects of chemotherapy, by protecting healthy cells while the chemotherapy drugs like methotrexate target cancerous cells.

In addition, Schumer noted that Capital Region hospitals have reported nearly cancelling elective surgeries, which were only allowed to go forward when substitute drugs were located. 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 workarounds, 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.

Area hospitals have seen the price of colchicine jump from $.04 to $4.79, metoprolol increase from $.02 to $1.10, glucagen go from $67 to $76 and DDAVP inhalers for diabetes patients skyrocket from $35 to $234.86.  Schumer also notes that doctors believe these drug shortages can create longer stays in hospitals, and slower recoveries.

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.