Schumer urges FDA to quickly address drug shortage crisis

WASHINGTON, D.C. | Standing at Nathan Littauer Hospital — one of the many New York hospitals suffering from the cancer drug shortage and even larger generic drug shortage across the nation — U.S. Senate Majority Leader Charles E. Schumer called for immediate action from the Food and Drug Administration (FDA) to address the more than 295 critical drugs in short supply and urged Congress to take swift action to protect patients and doctors in the Capital Region and across Upstate New York. Schumer also revealed his new four-prong legislative plan to repair the nation's drug supply chains and thwart future crises, explaining that with drug shortages already impacting Capital Region patients, legislative action will be necessary to address systemic problems and avoid delay in treatments for patients who need them. "Capital Region hospitals and medical providers across the country are currently suffering from some of the worst drug shortages they've ever seen, running low on critically needed cancer drugs as well as common generics, drugs used to treat asthma, and antibiotics used to treat infections. With this systematic issue already impacting Upstate New York patients, I am not only calling on the FDA to act immediately and do everything in its power to mitigate this shortage, but I am also urging Congress to take action and solve this issue for good," said Sen. Schumer at a June 26 press conference. "We need long-term legislative solutions that will repair the nation's drug supply chains once and for all, that way we can thwart any threat of future crises and ensure that every New Yorker has access to the medication they need." "Like many providers, St. Mary's Healthcare in Amsterdam is feeling the effects of drug shortages that are impacting more classes of medications — and more patients. These shortages are taxing the resources of our pharmacy team, which must devote precious time to identifying and acquiring suitable therapeutic alternatives. In some cases, including potentially life-threatening situations, there is no other equivalent option," said Jeff Methven, president and CEO of St. Mary's Healthcare Amsterdam. "St. Mary's and our community are extremely grateful to Senator Schumer for his leadership on this critical issue and for his unceasing efforts to ensure our patients have access to the care they deserve." Schumer said that shortages of cancer drugs and common, generic prescription drugs are approaching record levels in across the country, including Upstate New York. Drug shortages increased 30 percent from 2021 to 2022, and by the end of 2022, there was 295 critical drugs in short supply, including both hospital-based and pharmacy-based drugs. The Capital Region and Upstate New York over the past year have experienced shortages of numerous cancer drugs, ADHD medicine, anesthetics used during surgery, albuterol inhalers for asthma, amoxicillin, saline and much more. Schumer said that the core reasons for these shortages include: Insufficient Manufacturing: There are not enough manufacturers and supply-chain security. American generic drug manufacturing facilities are only operating at 51 percent capacity, and 40 percent of drugs have a single manufacturer supplying the market. Schumer said that even minor supply chain interruptions, failed FDA safety checks or production issues can upend entire drug markets and threaten drug availability. Lack of Transparency: Neither the FDA nor industry has end-to-end visibility of the full generic drug supply chain – including raw materials, component manufacturers, finished dosages and purchasers – thereby obscuring the scope and drivers of drug shortages. Purchasing organizations are also not required to report certain critical data, such as increasing demand. This opacity limits the government's ability to proactively identify and mitigate future drug shortages. Reliance on Foreign Companies: Between 2010 and 2015, the number of generic import drug ingredient manufacturers registered with the FDA more than doubled. A recent study found that 90 to 95 percent of generic sterile injectable drugs in the U.S. rely on key starting materials from China and India. Further, it is harder for the United States to demand high-quality safety standards in overseas manufacturing plants. Schumer's four-prong legislative plan will craft legislation based on the following goals: Giving more transparency and insight into drug shortages. The administration, doctors, hospitals and patients need to know when a shortage is coming, when demand is outpacing supply, where companies are sourcing their raw materials from, when there are safety issues and more. More information means more opportunities to fix vulnerabilities before they become problems. Making sure there are enough manufacturers producing drugs at enough volume to have reserve and contingency supplies. Improving production safety and quality. Numerous shortages are caused by safety and quality control problems at manufacturing plants, and improving safety and quality standards would help avoid those problems in the first place. Incentivizing domestic manufacturing and onshoring. It creates a series of vulnerabilities and problems when the country's generic drug market is so reliant on foreign actors; bringing that supply chain back to the United States will reduce shortages and create good-paying new jobs for Americans. Schumer said that U.S. drug shortages hit near-record highs earlier this year. According to the American Society of Health System Pharmacists — which tracks drug supply issues — there were 301 active shortages in the U.S. during the first three months of 2023 — the biggest total in nearly a decade. Like many healthcare providers across the country, Schumer said that doctors and pharmacists in the Capital Region and across Upstate New York are feeling the effects of these drug shortages and finding it harder to shield patients from the impact. These shortages are not limited to any one class of medication, and more and more classes of drugs are being affected by the day. Schumer said that while some drug shortages can be mitigated by prescribing a different medication form or a therapeutic alternative, that process is both challenging and time consuming and not always the perfect replacement for the drug that is in short supply. Additionally, some drugs that are not available have no other replacement option. This drug shortage problem is creating additional work on Upstate New York's limited pharmacy resources, requiring pharmacists to be active in identifying (and in many cases forecasting) potential shortages and pivoting to determine suitable therapeutic equivalents and alternative options for patients. Schumer is also fighting to get the Centers for Medicare and Medicaid Services (CMS) to finalize a recent proposed rules change that would have a massive nearly $200 million yearly impact on hospitals across the Capital Region and an estimated annual nearly $1 billion impact on hospitals throughout Upstate New York. Schumer, a long-time advocate on the issue, personally wrote to CMS Chiquita Brooks-LaSure to detail how the reimbursement rate that CMS pays Capital Region hospitals has been too low for far too long and rallied with healthcare leaders in Albany this past May to get this long overdue change finalized. Schumer broke down how changing the Medicare Wage Index payments will be game-changing for hospitals in the Capital Region, highlighting that Nathan Littauer Hospital would receive an increase of over $5.5 million and St. Mary's would receive an increase of $10.6 million every year.

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Schumer urges FDA to quickly address drug shortage crisis

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