For about an hour and a half on March 22, four pharmaceutical supply experts outlined ideas to lawmakers to reform the nation's slippery access to critical drugs.
The FDA reports 130 drugs are currently in shortage; the American Society of Health-System Pharmacists says there are 302. Recently, the availability of vital drugs for cancer patients and emergencies has shrunk, and the closure of a U.S. drugmaker could put more out of stock.
The hearing waded through causes of shortages — including manufacturing delays and opaque supply data. Some members on the Senate Committee on Homeland Security and Governmental Affairs pushed back on some pitched solutions, such as changing FDA practices and working to control drug prices.
In 2022, the number of new drug shortages increased by 30 percent, according to a report released by the Senate Committee on Homeland Security and Governmental Affairs hours before the hearing began.
"Colleagues and other hospitals have asked me to respond to the never-ending game of drug shortage Whac-A-Mole," Andrew Shuman, MD, chief of the clinical ethics service center for bioethics and social sciences in medicine for the University of Michigan Medical School in Ann Arbor, said during the hearing.
Erin Fox, PharmD, associate chief pharmacy officer of shared services at the University of Utah's pharmacy college in Salt Lake City, said patients have died because of drug shortages — whether it be medication errors such as incorrect doses of substitute products, emergency drugs being unavailable or alternative treatments having worse outcomes.
"One of the challenges of drug shortages is that it requires hospitals to essentially MacGyver different treatment [...] regimens, which is not necessarily evidence- or data-based," Dr. Shuman said.
Vimala Raghavendran, vice president of informatics product development for U.S. Pharmacopeia, testified that the four main catalysts for drug shortages are:
1. Geographic concentration of active pharmaceutical ingredients anywhere, including the U.S.
Dr. Fox said more transparency is needed for which APIs the U.S. relies on are made in China.
A pre-COVID-19 report found that 80 percent of drug companies making APIs were located outside the U.S., but drugmakers are not required to disclose which products are made in the U.S., India, China or elsewhere.
"Both the pharmaceutical industry and the federal government, including the Food and Drug Administration, lack the information needed to effectively detect and to prevent shortages," Sen. Gary Peters said.
Some committee members focused heavily on comments about where APIs are made, but Ms. Raghavendran said geographic concentration is only one of the four causes of drug shortages.
Sen. Rand Paul, MD, also warned against "irrational anger toward China."
2. Manufacturing complexities of some products, such as sterility requirements for injectables.
Dr. Shuman said "cancer drug shortages represent a tragedy that's happening in slow motion."
In 2018, when etoposide was largely unavailable because of manufacturing delays, he and his team at Michigan Medicine "struggled to make decisions based on projected availability, which patients were already under our care and our best guess at how many new patients would be diagnosed in the coming weeks," he said.
During the strained supply of a drug used for multiple cancers and is older than 40 years, he said his team had enough etoposide for lung and testicular cancer patients and enough for an infant patient after a "heroic pharmacist was able to scrape together enough etoposide from the bottom of the leftover vials."
"But our pharmacists should not be desperately trying to squeeze out a few last drops when a life may be on the line," Dr. Shuman said.
3. Lower-priced drugs, which are often older generics, such as antibiotics and sterile injectables, are more vulnerable to shortages.
"Manufacturers only receive pennies per dose for some of these drugs," Ms. Raghavendran said.
John Goodman, PhD, president of the Goodman Institute for Public Policy Research, and Dr. Fox raised concerns on drug manufacturers valuing selling more lower-priced generics — and thus making more profits — over investing in safer, more reliable practices. Many referred to "a race to the bottom" for drug prices because buyers, including hospitals and GPOs, can see only costs and cannot access the quality history among manufacturers.
"We should incentivize companies to make high-quality, critical-need drugs," Dr. Shuman said, "even if they have been less profitable, historically."
4. Quality concerns.
Dr. Fox said accreditation agencies should publish quality metric ratings for manufacturers, which could incentivize hospitals to pay more for drugs from a safer source.
Also, smaller hospitals with less resources and fewer staff may not know about national scope of drug shortages, or even what drugs nearby hospitals can and cannot access, experts said.
"People's lives are at stake," Dr. Fox said. "It's not just a matter of not buying peanut butter today or not buying a tire; it's having to decide to use a lower-quality product or a product we know won't work as well just because we don't have the access to it in our hospital."
She added that hospital pharmacy teams — with most having at least one full-time employee working exclusively on shortage management and directing medication switches — are forced into time-consuming tasks such as transferring two drugs into syringes instead of saline bags.
More than 15 critical drug products have been in shortage for more than a decade, and most of them are injectable medications and antibiotics, according to the committee's report. The report said drug shortages pose health and national security risks.
"When one company goes out of business, another one can't ramp up [production] without asking permission to make more of a drug," Dr. Paul said at the beginning of the hearing. "If a drug manufacturer closes, the remaining manufacturers — which must react to increased demand — are forced to seek FDA approval to make more of the originally approved amount or to produce quicker than the originally approved timeline.
"This is crazy, and we should stop it."