\n\tMichelle Andrews<\/span><\/p>\n

\u201cUnder \u2018Crooked Joe\u2019 Biden, there has been a catastrophic increase in shortages of essential medicines.\u201d<\/p>\n

Former president and current Republican presidential candidate Donald Trump, in a July 24 campaign video<\/a><\/p>\n

In a recent campaign video<\/a>, former President Donald Trump blasted President Joe Biden for \u201ca catastrophic increase\u201d in drug shortages.<\/p>\n

\u201cIt\u2019s a mess,\u201d Trump said in the video, adding that new drug shortages were up last year by 30%, with \u201c295 active drug shortages\u201d by the end of 2022.<\/p>\n

The continued availability of lifesaving drugs is a concern in this country. Reports of shortages of medicines on which many Americans rely \u2014 from widely used cancer medications<\/a> like cisplatin to over-the-counter painkillers such as Children\u2019s Tylenol<\/a> \u2014 have been widespread in recent years. The shortages have caused treatment delays or forced clinicians to substitute alternatives in place of preferred therapies.<\/p>\n

But is Biden responsible, or is Trump\u2019s claim an oversimplification?<\/p>\n

We contacted the Trump campaign for answers, but got no reply. So, we poked around on our own. What we found didn\u2019t align with Trump\u2019s claims. By some measures, drug shortages increased more on Trump\u2019s watch than on Biden\u2019s.<\/p>\n

Where to Place the Blame?<\/strong><\/p>\n

Trump\u2019s statistics were in the ballpark. According to a March report<\/a> by the Senate Committee on Homeland Security and Governmental Affairs, cited in the video\u2019s footnotes, the number of active drug shortages in 2022 did hit 295 at the end of 2022. The count was 246 at the end of 2021, according to the American Society of Health-System Pharmacists.<\/p>\n

But our calculations suggest the report\u2019s math was off. The report stated an increase of \u201capproximately 30%,\u201d but it was closer to 20%. Likewise, new drug shortages grew from 114 to 160 in 2022, a 40% increase, not the \u201cnearly 30%\u201d cited in an earlier version of the report, which Trump apparently relied on.<\/p>\n

The Senate panel\u2019s report is based on data from the FDA and the society. The pharmacy group works with the University of Utah Health\u2019s Drug Information Service to track drug shortages.<\/p>\n

The society\u2019s shortage information derives from pharmacists\u2019 and patients\u2019 reports of supply issues that affect how pharmacies prepare or dispense drugs, or influence patient care, often locally. The FDA, with its national scope, declares a drug shortage when demand or projected demand exceeds supply, as projected by drug manufacturers. So, the FDA\u2019s shortage tallies are bound to be different from the society\u2019s. For instance, the FDA reported that new and active drug shortages grew from 124 in 2021 to 135 in 2022, a 9% increase.<\/p>\n

But Biden isn\u2019t the only president whose administration has contended with rising drug shortages. And his numbers to date aren\u2019t the worst.<\/p>\n

Active drug shortages grew from 195 in 2016 to 264 in 2019 \u2014 when Trump was president. That\u2019s a 35% increase, according to the society\u2019s figures. During Biden\u2019s first 3\u00bd years in office, that same category of shortages increased 12%, from 276 to 309.<\/p>\n

New drug shortages peaked at 267, in 2011, during the Obama administration, the society reported. Some experts credit an executive order that Obama signed that year directing the FDA to broaden its shortage reporting as a turning point. Since that 2011 high, the U.S. recorded the next-largest number of new drug shortages \u2014 186 \u2014 in 2018, when Trump was president.<\/p>\n

The point isn\u2019t that Trump managed drug shortages badly then or that Biden is handling them badly now, experts said.<\/p>\n

\u201cI don\u2019t think you can tie this to any administration or specific person,\u201d said Michael Ganio, senior director<\/a> of pharmacy practice and quality at the American Society of Health-System Pharmacists.<\/p>\n

Many factors \u2014 from natural disasters and manufacturing problems to slim profit margins on generic drugs \u2014 can contribute to shortages. Lingering drug shortages from before the pandemic, \u201ccompounded with shortages due to covid and poor quality at U.S.-based companies like Akorn pharmaceuticals<\/a>, have really contributed to the very large numbers of shortages we have right now,\u201d said Erin Fox, associate chief pharmacy officer<\/a> at University of Utah Health.<\/p>\n

The Complexity of Medication Supplies<\/strong><\/p>\n

For decades, the U.S. has suffered periodic drug and medical device shortages. Disruptions at any point in the complex supply chain<\/a> involving people, production, technologies, and policy decisions can ripple throughout the system, causing scarcities that may last years.<\/p>\n

A Health Affairs article<\/a> published this past January described the current system\u2019s complexity. More than 20,000 prescription drugs and more than 13,000 facilities worldwide are registered to make drugs or their active ingredients. More than three-quarters of active pharmaceutical ingredients are made outside the United States, the authors said.<\/p>\n

Experts acknowledge that relying on overseas drug manufacturers can lead to quality control and oversight problems, because it\u2019s harder for the FDA to inspect plants overseas. For example, after an FDA inspection last December that found numerous manufacturing problems, Intas Pharmaceuticals in India<\/a> voluntarily suspended production and distribution of its products that were destined for the United States. The company was allowed to distribute some drugs, including critical cancer drugs, that are in short supply, with strict third-party oversight. In the video, Trump also zeroed in on this concern. He pledged \u2014 with an emphasis on minimizing China\u2019s role in the production of medications \u2014 to return manufacturing of all essential medicines to the United States, \u201cwhere they belong.\u201d<\/p>\n

But the United States experiences manufacturing problems and weather emergencies, just as everywhere else in the world does. For example, Lake Forest, Illinois-based drugmaker Akorn filed for bankruptcy<\/a> this year and stopped making more than 70<\/a> generic drugs. After a tornado hit<\/a> its Rocky Mount, North Carolina, plant in July, Pfizer temporarily shuttered the facility. The company said Sept. 25 that it had restarted production<\/a> at the plant.<\/p>\n

\u201cBringing all manufacturing back to the United States not only isn\u2019t feasible, because we don\u2019t have the raw materials, but that also creates a reliance on a single geographical area,\u201d said Soumi Saha<\/a>, senior vice president of government affairs at Premier, a large group-purchasing organization for hospitals and other health providers. \u201cWhat you need is global diversification.\u201d<\/p>\n

Marta Wosi\u0144ska, a health care economist at the Brookings Schaeffer Initiative on Health Policy, agreed with Saha \u2014 domestic manufacturing isn\u2019t a panacea. \u201cDomestic production is no guarantee of having a stable supply chain,\u201d she said. \u201cMost shortages are caused by quality problems in both the United States and overseas.\u201d<\/p>\n

Trump also criticized Biden for \u201cshamefully\u201d not following through on an executive order<\/a> Trump signed that directed federal agencies to identify ways to maximize domestic production of essential medicines.<\/p>\n

The White House didn\u2019t respond to questions about the status of Trump\u2019s order. But spokesperson Kelly Scully in a statement pointed to the five executive orders Biden issued since taking office \u201cfocused on strengthening the resilience of critical supply chains,\u201d including those for pharmaceuticals.<\/p>\n

Our Ruling<\/strong><\/p>\n

Trump said there was a \u201ccatastrophic increase\u201d in drug shortages under Biden\u2019s watch. Trump was correct that drug shortages have ticked upward. But Trump\u2019s statements blaming Biden for those shortages are inaccurate and lack context.<\/p>\n

Not only have significant drug shortages increased during other presidential administrations \u2014 including Trump\u2019s \u2014 experts generally agree that there are multiple, complex, and interlocking factors that cause them, meaning no one person is at fault, not even the president.<\/p>\n

We rate this claim False.<\/p>\n

sources<\/h4>\nUnited States Senate Committee on Homeland Security & Governmental Affairs, \u201c Short Supply: The Health and National Security Risks of Drug Shortages<\/a>,\u201d March 2023<\/p>\n
The White House, \u201c Strengthening the Supply Chain for Cancer Drugs<\/a>,\u201d Sept. 12, 2023<\/p>\n
American Society of Health-System Pharmacists, Drug Shortages Statistics<\/a>, accessed Sept. 8, 2023<\/p>\n
Food and Drug Administration, \u201c Report to Congress: Drug Shortages, CY 2022<\/a>\u201d<\/p>\n
Food and Drug Administration, FDA Drug Shortages<\/a>, accessed Sept. 8, 2023<\/p>\n
American Society of Health-System Pharmacists, FDA and ASHP Shortage Parameters<\/a>, accessed Sept. 14, 2023<\/p>\n
American Society of Health-System Pharmacists, Drug Shortages FAQs<\/a>, accessed Sept. 14, 2023<\/p>\n
Health Affairs, \u201c Building Resilience Into US Prescription Drug Supply Chains<\/a>,\u201d Jan. 30, 2023<\/p>\n
National Academies for Sciences, Engineering, and Medicine, \u201c Untangling Why Critical Drug and Medical Supply Shortages Keep Happening<\/a>,\u201d Jan. 31, 2023<\/p>\n
Association for Accessible Medicines, \u201c Report: 2023 U.S. Generic and Biosimilar Medicines Savings Report<\/a>,\u201d September 2023<\/p>\n
University of Southern California\u2019s Leonard D. Schaeffer Center for Health Policy & Economics, \u201c Blame Capitalism? Why Hundreds of Decades-Old Yet Vital Drugs Are Nearly Impossible to Find<\/a>,\u201d July 20, 2023<\/p>\n
Stat, \u201c FDA Will Allow Troubled Chemotherapy Maker to Resume Distribution of Cancer Drugs in Short Supply<\/a>,\u201d June 6, 2023<\/p>\n
NBC News, \u201c How One U.S. Drugmaker Contributed to the Escalating Drug Shortage Crisis<\/a>,\u201d July 16, 2023<\/p>\n
Pfizer, \u201c Pfizer Announces Post-Tornado Relief Plans for Rocky Mount Community and Manufacturing Facility<\/a>,\u201d July 21, 2023<\/p>\n
National Academies for Sciences, Engineering, and Medicine, \u201c Building Resilience into the Nation\u2019s Medical Product Supply Chain<\/a>,\u201d 2022<\/p>\n
Federal Register, Executive Order: \u201cCombating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States<\/a>,\u201d Aug. 6, 2020<\/p>\n
Food and Drug Administration, Executive Order 13944 \u201cList of Essential Medicines, Medical Countermeasures, and Critical Inputs<\/a>,\u201d May 23, 2022<\/p>\n
Brookings Institution, Securing Pharmaceutical Supply Chains<\/a> (panel discussion), March 15, 2023<\/p>\n
House Energy and Commerce Committee, \u201c Chairs Rodgers and Guthrie Announce Legislative Hearing on Drug Shortages<\/a>,\u201d Sept. 7, 2023<\/p>\n
Specialty Pharmacy Continuum, \u201c Drug Shortages Reach 10-Year High: ASHP Report<\/a>,\u201d June 9, 2023<\/p>\n
Interview, Michael Ganio, senior director of pharmacy practice and quality, American Society of Health-System Pharmacists, Sept. 11, 2023<\/p>\n
Interview, Erin R. Fox, associate chief pharmacy officer, shared services, University of Utah Health, Sept. 8, 2023<\/p>\n
Interview, Soumi Saha, senior vice president of government affairs, Premier Inc., Sept. 11, 2023<\/p>\n
Interview, Chanapa Tantibanchachai, press officer, FDA, Sept. 13, 2023<\/p>\n
Interview, Kelly Scully, White House spokesperson, Sept. 15, 2023<\/p>\n
Interview, Marta Wosi\u0144ska, health care economist at the Brookings Schaeffer Initiative on Health Policy, Sept. 25, 2023<\/p>\n
Interview, Jeremy Kahn, media relations director, FDA Office of the Commissioner, Sept. 27, 2023<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"
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