October 12, 2023

KFF Well being Information: Trump Misplaced Blame When He Mentioned Drug Shortages Had been Biden’s Fault

“Beneath ‘Crooked Joe’ Biden, there was a catastrophic enhance in shortages of important medicines.” –  Former president and present 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 enhance” in drug shortages.

“It’s a large number,” Trump stated within the video, including that new drug shortages have been up final 12 months by 30%, with “295 energetic drug shortages” by the tip of 2022.

The continued availability of lifesaving medicine is a priority on this nation. Experiences of shortages of medicines on which many Individuals rely — from widely used cancer medications like cisplatin to over-the-counter painkillers corresponding to Children’s Tylenol — have been widespread in recent times. The shortages have triggered therapy delays or pressured clinicians to substitute alternate options instead of most popular therapies.

However is Biden accountable, or is Trump’s declare an oversimplification?

We contacted the Trump marketing campaign for solutions, however obtained no reply. So, we poked round on our personal. What we discovered didn’t align with Trump’s claims. By some measures, drug shortages elevated extra on Trump’s watch than on Biden’s.

The place to Place the Blame?

Trump’s statistics have been within the ballpark. In accordance with a March report by the Senate Committee on Homeland Safety and Governmental Affairs, cited within the video’s footnotes, the variety of energetic drug shortages in 2022 did hit 295 on the finish of 2022. The rely was 246 on the finish of 2021, in line with the American Society of Well being-System Pharmacists.

However our calculations recommend the report’s math was off. The report acknowledged a rise of “roughly 30%,” nevertheless it was nearer to twenty%. Likewise, new drug shortages grew from 114 to 160 in 2022, a 40% enhance, not the “almost 30%” cited in an earlier model of the report, which Trump apparently relied on.

The Senate panel’s report relies on knowledge from the FDA and the society. The pharmacy group works with the College of Utah Well being’s Drug Info Service to trace drug shortages.

The society’s scarcity data derives from pharmacists’ and sufferers’ stories of provide points that have an effect on how pharmacies put together or dispense medicine, or affect affected person care, usually domestically. The FDA, with its nationwide scope, declares a drug scarcity when demand or projected demand exceeds provide, as projected by drug producers. So, the FDA’s scarcity tallies are certain to be totally different from the society’s. As an illustration, the FDA reported that new and energetic drug shortages grew from 124 in 2021 to 135 in 2022, a 9% enhance.

However Biden isn’t the one president whose administration has contended with rising drug shortages. And his numbers thus far aren’t the worst.

Energetic drug shortages grew from 195 in 2016 to 264 in 2019 — when Trump was president. That’s a 35% enhance, in line with the society’s figures. Throughout Biden’s first 3½ years in workplace, that very same class of shortages elevated 12%, from 276 to 309.

New drug shortages peaked at 267, in 2011, throughout the Obama administration, the society reported. Some consultants credit score an government order that Obama signed that 12 months directing the FDA to broaden its scarcity reporting as a turning level. Since that 2011 excessive, the U.S. recorded the next-largest variety of new drug shortages — 186 — in 2018, when Trump was president.

The purpose isn’t that Trump managed drug shortages badly then or that Biden is dealing with them badly now, consultants stated.

“I don’t assume you possibly can tie this to any administration or particular particular person,” stated Michael Ganio, senior director of pharmacy apply and high quality on the American Society of Well being-System Pharmacists.

Many elements — from pure disasters and manufacturing issues to slim revenue margins on generic medicine — can contribute to shortages. Lingering drug shortages from earlier than the pandemic, “compounded with shortages because of covid and poor high quality at U.S.-based corporations like Akorn pharmaceuticals, have actually contributed to the very massive numbers of shortages we now have proper now,” stated Erin Fox, associate chief pharmacy officer at College of Utah Well being.

The Complexity of Treatment Provides

For many years, the U.S. has suffered periodic drug and medical machine shortages. Disruptions at any level within the complex supply chain involving folks, manufacturing, applied sciences, and coverage choices can ripple all through the system, inflicting scarcities which will final years.

Health Affairs article printed this previous January described the present system’s complexity. Greater than 20,000 pharmaceuticals and greater than 13,000 amenities worldwide are registered to make medicine or their energetic substances. Greater than three-quarters of energetic pharmaceutical substances are made exterior the US, the authors stated.

Specialists acknowledge that counting on abroad drug producers can result in high quality management and oversight issues, as a result of it’s more durable for the FDA to examine crops abroad. For instance, after an FDA inspection final December that discovered quite a few manufacturing issues, Intas Pharmaceuticals in India voluntarily suspended manufacturing and distribution of its merchandise that have been destined for the US. The corporate was allowed to distribute some medicine, together with essential most cancers medicine, which can be briefly provide, with strict third-party oversight. Within the video, Trump additionally zeroed in on this concern. He pledged — with an emphasis on minimizing China’s position within the manufacturing of medicines — to return manufacturing of all important medicines to the US, “the place they belong.”

However the US experiences manufacturing issues and climate emergencies, simply as in all places else on the planet does. For instance, Lake Forest, Illinois-based drugmaker Akorn filed for bankruptcy this 12 months and stopped making more than 70 generic medicine. After a tornado hit its Rocky Mount, North Carolina, plant in July, Pfizer briefly shuttered the power. The corporate stated Sept. 25 that it had restarted production on the plant.

“Bringing all manufacturing again to the US not solely isn’t possible, as a result of we don’t have the uncooked supplies, however that additionally creates a reliance on a single geographical space,” stated Soumi Saha, senior vp of presidency affairs at Premier, a big group-purchasing group for hospitals and different well being suppliers. “What you want is international diversification.”

Marta Wosińska, a well being care economist on the Brookings Schaeffer Initiative on Well being Coverage, agreed with Saha — home manufacturing isn’t a panacea. “Home manufacturing isn’t any assure of getting a secure provide chain,” she stated. “Most shortages are attributable to high quality issues in each the US and abroad.”

Trump additionally criticized Biden for “shamefully” not following by on an executive order Trump signed that directed federal companies to establish methods to maximise home manufacturing of important medicines.

The White Home didn’t reply to questions concerning the standing of Trump’s order. However spokesperson Kelly Scully in an announcement pointed to the 5 government orders Biden issued since taking workplace “centered on strengthening the resilience of essential provide chains,” together with these for prescribed drugs.

Our Ruling

Trump stated there was a “catastrophic enhance” in drug shortages beneath Biden’s watch. Trump was right that drug shortages have ticked upward. However Trump’s statements blaming Biden for these shortages are inaccurate and lack context.

Not solely have vital drug shortages elevated throughout different presidential administrations — together with Trump’s — consultants typically agree that there are a number of, complicated, and interlocking elements that trigger them, that means nobody particular person is at fault, not even the president.

We fee this declare False.

sources

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

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

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

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

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

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

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

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

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

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

College of Southern California’s Leonard D. Schaeffer Heart for Well being Coverage & 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 Information, “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

Nationwide Academies for Sciences, Engineering, and Drugs, “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

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

Brookings Establishment, Securing Pharmaceutical Supply Chains (panel dialogue), March 15, 2023

Home Power 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 apply and high quality, American Society of Well being-System Pharmacists, Sept. 11, 2023

Interview, Erin R. Fox, affiliate chief pharmacy officer, shared providers, College of Utah Well being, Sept. 8, 2023

Interview, Soumi Saha, senior vp of presidency affairs, Premier Inc., Sept. 11, 2023

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

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

Interview, Marta Wosińska, well being care economist on the Brookings Schaeffer Initiative on Well being Coverage, Sept. 25, 2023

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

Initially Revealed October 6, 2023

KFF Health News is a nationwide newsroom that produces in-depth journalism about well being points and is likely one of the core working applications at KFF—an unbiased supply of well being coverage analysis, polling, and journalism. Study extra about KFF.

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