Michelle Andrews
Fri, 06 Oct 2023 09:00:00 +0000

“Under ‘Crooked Joe’ Biden, there has been a catastrophic increase in shortages of essential medicines.”

Former president and current Republican presidential candidate Donald Trump, in a July 24 campaign video

In a recent campaign video, former President Donald Trump blasted President Joe Biden for “a catastrophic increase” in drug shortages.

“It’s a mess,” Trump said in the video, adding that new drug shortages were up last year by 30%, with “295 active drug shortages” by the end of 2022.

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

But is Biden responsible, or is Trump’s claim an oversimplification?

We contacted the Trump campaign for answers, but got no reply. So, we poked around on our own. What we found didn’t align with Trump’s claims. By some measures, drug shortages increased more on Trump’s watch than on Biden’s.

Where to Place the Blame?

Trump’s statistics were in the ballpark. According to a March report by the Senate Committee on Homeland Security and Governmental Affairs, cited in the video’s 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.

But our calculations suggest the report’s math was off. The report stated an increase of “approximately 30%,” but it was closer to 20%. Likewise, new drug shortages grew from 114 to 160 in 2022, a 40% increase, not the “nearly 30%” cited in an earlier version of the report, which Trump apparently relied on.

The Senate panel’s report is based on data from the FDA and the society. The pharmacy group works with the University of Utah Health’s Drug Information Service to track drug shortages.

The society’s shortage information derives from pharmacists’ and patients’ 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’s shortage tallies are bound to be different from the society’s. For instance, the FDA reported that new and active drug shortages grew from 124 in 2021 to 135 in 2022, a 9% increase.

But Biden isn’t the only president whose administration has contended with rising drug shortages. And his numbers to date aren’t the worst.

Active drug shortages grew from 195 in 2016 to 264 in 2019 — when Trump was president. That’s a 35% increase, according to the society’s figures. During Biden’s first 3½ years in office, that same category of shortages increased 12%, from 276 to 309.

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 — 186 — in 2018, when Trump was president.

The point isn’t that Trump managed drug shortages badly then or that Biden is handling them badly now, experts said.

“I don’t think you can tie this to any administration or specific person,” said Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists.

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

The Complexity of Medication Supplies

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

A Health Affairs article published this past January described the current system’s 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.

Experts acknowledge that relying on overseas drug manufacturers can lead to quality control and oversight problems, because it’s 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 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 — with an emphasis on minimizing China’s role in the production of medications — to return manufacturing of all essential medicines to the United States, “where they belong.”

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 this year and stopped making more than 70 generic drugs. After a tornado hit its Rocky Mount, North Carolina, plant in July, Pfizer temporarily shuttered the facility. The company said Sept. 25 that it had restarted production at the plant.

“Bringing all manufacturing back to the United States not only isn’t feasible, because we don’t have the raw materials, but that also creates a reliance on a single geographical area,” said Soumi Saha, senior vice president of government affairs at Premier, a large group-purchasing organization for hospitals and other health providers. “What you need is global diversification.”

Marta Wosińska, a health care economist at the Brookings Schaeffer Initiative on Health Policy, agreed with Saha — domestic manufacturing isn’t a panacea. “Domestic production is no guarantee of having a stable supply chain,” she said. “Most shortages are caused by quality problems in both the United States and overseas.”

Trump also criticized Biden for “shamefully” not following through on an executive order Trump signed that directed federal agencies to identify ways to maximize domestic production of essential medicines.

The White House didn’t respond to questions about the status of Trump’s order. But spokesperson Kelly Scully in a statement pointed to the five executive orders Biden issued since taking office “focused on strengthening the resilience of critical supply chains,” including those for pharmaceuticals.

Our Ruling

Trump said there was a “catastrophic increase” in drug shortages under Biden’s watch. Trump was correct that drug shortages have ticked upward. But Trump’s statements blaming Biden for those shortages are inaccurate and lack context.

Not only have significant drug shortages increased during other presidential administrations — including Trump’s — 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.

We rate this claim False.

sources

United States Senate Committee on Homeland Security & Governmental Affairs, “Short Supply: The Health and National Security Risks of Drug Shortages,” March 2023

The White House, “Strengthening the Supply Chain for Cancer Drugs,” Sept. 12, 2023

American Society of Health-System Pharmacists, Drug Shortages Statistics, accessed Sept. 8, 2023

Food and Drug Administration, “Report to Congress: Drug Shortages, CY 2022”

Food and Drug Administration, FDA Drug Shortages, accessed Sept. 8, 2023

American Society of Health-System Pharmacists, FDA and ASHP Shortage Parameters, accessed Sept. 14, 2023

American Society of Health-System Pharmacists, Drug Shortages FAQs, accessed Sept. 14, 2023

Health Affairs, “Building Resilience Into US Prescription Drug Supply Chains,” Jan. 30, 2023

National Academies for Sciences, Engineering, and Medicine, “Untangling Why Critical Drug and Medical Supply Shortages Keep Happening,” Jan. 31, 2023

Association for Accessible Medicines, “Report: 2023 U.S. Generic and Biosimilar Medicines Savings Report,” September 2023

University of Southern California’s Leonard D. Schaeffer Center for Health Policy & Economics, “Blame Capitalism? Why Hundreds of Decades-Old Yet Vital Drugs Are Nearly Impossible to Find,” July 20, 2023

Stat, “FDA Will Allow Troubled Chemotherapy Maker to Resume Distribution of Cancer Drugs in Short Supply,” June 6, 2023

NBC News, “How One U.S. Drugmaker Contributed to the Escalating Drug Shortage Crisis,” July 16, 2023

Pfizer, “Pfizer Announces Post-Tornado Relief Plans for Rocky Mount Community and Manufacturing Facility,” July 21, 2023

National Academies for Sciences, Engineering, and Medicine, “Building Resilience into the Nation’s Medical Product Supply Chain,” 2022

Federal Register, Executive Order: “Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States,” Aug. 6, 2020

Food and Drug Administration, Executive Order 13944 “List of Essential Medicines, Medical Countermeasures, and Critical Inputs,” May 23, 2022

Brookings Institution, Securing Pharmaceutical Supply Chains (panel discussion), March 15, 2023

House Energy and Commerce Committee, “Chairs Rodgers and Guthrie Announce Legislative Hearing on Drug Shortages,” Sept. 7, 2023

Specialty Pharmacy Continuum, “Drug Shortages Reach 10-Year High: ASHP Report,” June 9, 2023

Interview, Michael Ganio, senior director of pharmacy practice and quality, American Society of Health-System Pharmacists, Sept. 11, 2023

Interview, Erin R. Fox, associate chief pharmacy officer, shared services, University of Utah Health, Sept. 8, 2023

Interview, Soumi Saha, senior vice president of government affairs, Premier Inc., Sept. 11, 2023

Interview, Chanapa Tantibanchachai, press officer, FDA, Sept. 13, 2023

Interview, Kelly Scully, White House spokesperson, Sept. 15, 2023

Interview, Marta Wosińska, health care economist at the Brookings Schaeffer Initiative on Health Policy, Sept. 25, 2023

Interview, Jeremy Kahn, media relations director, FDA Office of the Commissioner, Sept. 27, 2023

——————————
By: Michelle Andrews
Title: Trump Misplaced Blame When He Said Drug Shortages Were Biden’s Fault
Sourced From: kffhealthnews.org/news/article/trump-biden-drug-shortages-blame/
Published Date: Fri, 06 Oct 2023 09:00:00 +0000

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