'Our patients are in a war'

Over the last few years, drug shortages have become more common  in the United States. According to a new report from the Senate Committee on Homeland Security and Governmental Affairs, drug shortages increased by almost 30% between 2021 and 2022, reaching a five-year high with 295 active shortages at the end of last year.

"Shortages continue to have devastating consequences for patients and health care providers, including medication errors and treatment delays, and in some cases, have led to doctors having to ration lifesaving treatments," the report said. Some of the drugs currently in short supply include antibiotics, children's medications, and several  cancer  treatments.

According to a recent survey from the  Society of Gynecologic Oncology, doctors in 35 states have reported little to no supply of crucial chemotherapy drugs, even at teaching hospitals and large cancer centers.

"Our patients are in a war, and what we're doing is we're taking their weapons away," said Patrick Timmins, a partner of Women's Cancer Care Associate, which ran out of certain chemotherapy drugs on May 9. "It's completely ridiculous that we can't figure out a way, at least in the short run, to get our patients treated, and in the long run to solve these recurring problems."

"This is, in my opinion, a public health emergency," said Amanda Fader, a professor at the Johns Hopkins School of Medicine and president-elect of the Society of Gynecologic Oncology, "because of the breadth of the individuals it affects and the number of chemotherapy agents that are in shortage right now."

Industry experts say the recent bankruptcy and closure of Akorn Pharmaceuticals, which manufactured roughly 100 generic medications, will likely be followed by others, especially as U.S. manufacturers facing growing competition from overseas.

"Shortages are on the rise. We've all seen that," said David Gaugh, interim CEO of the Association for Accessible Medicines, which represents generic drugmakers. "And it is likely going to get worse, not better, very soon."

The federal government is trying to find solutions

The Biden administration has assembled a team to identify long-term solutions to these drug shortages. According to Bloomberg, the White House team tasked with the issue is evaluating the impact of "developing tools that could foresee potential drug shortages before they start, creating quality scores for manufacturing facilities, increasing the FDA's unannounced inspections, robust testing of imported products, and requiring foreign manufacturers to keep electronic records instead of paper ones, since those can be destroyed."

However, the director of government affairs at  Teva Pharmaceutical Industries Ltd wrote on social media that burdensome additional regulations would worsen shortages.

"There's a lot of resistance in the industry to more transparency or anything that requires more cost in this low-margin business," said Elisabeth Reynolds, a Massachusetts Institute of Technology lecturer and former special assistant to Biden.

And while the White House team has been coordinating with FDA, which typically handles U.S. drug shortages, on the issue, agency officials have said it is not equipped to address the significant economic challenges in the generic drug industry because larger market forces are driving these drugmakers out of business.

"We have got to fix the core economics if we're going to get this situation fixed," said FDA Commissioner Robert Califf.

Separately, Kevin Schulman, a professor at Stanford Medicine, has warned the White House about the power of intermediary companies when they contract with generic drugmakers. Although these intermediaries often demand very low prices, they are not held accountable when shortages occur.

"The intermediaries are driving people out of the market," Schulman said. "I think it's a market problem and we need market-level solutions."

Many generic drugmakers, supply chain experts, and patient advocates are also meeting with lawmakers to discuss the problem. Currently, lawmakers are considering tax incentives for generic drugmakers and increased transparency around the quality of generic drugs as a way to improve shortages. There are also four bipartisan Senate bills that address tactics or loopholes that may prevent generic drugs from getting to the market quickly.

"Will we have the resolve and sense of urgency to fix this?" said Laura Bray, an adjunct professor who has been providing information on the drug shortages to the White House and Congress. "It's possible. It can be done. It happens in other supply chains. But we have to focus on it and we have to think about ending it — instead of mitigating it. I think the jury’s out on that." (Jewett, New York Times, 5/17; Griffin et al., Bloomberg, 5/10)

The COVID-19 pandemic revealed the vulnerability and inflexibility of the health care supply chain. Now, leaders face the challenge of rebuilding the supply chain in such a sustainable way that it will not “break” during the next crisis – but without adding unnecessary cost into the system. Explore our toolkit with insight on the future healthcare supply chain, including case studies from high-performing providers and suppliers.