Like many Americans, Laura Bray had no idea the generic-drug market was broken until four years ago, when her then-9-year-old girl, Abby, missed treatment for leukemia because the hospital's supply of a $10 drug ran out.
"We were told that the most important thing that we could do as parents to help her survive was compliance with the drug regimen — every single day, every single time," Bray says. Yet there was no drug to give.
At the time, Bray taught business at a Tampa, Fla., community college and had studied supply chains, so she began researching questions she knew to ask: Who makes the drug that Abby needs, and how much do they make? When is the next shipment available?
Most importantly: Does anyone have unused doses they could share?
No database or source had those answers. Much of the underlying information is considered a trade secret, meaning doctors, pharmacists, regulators and patients like Abby are left guessing when, if or how any particular drug shortage might end.
"I could not believe that our pharmaceutical supply chain — the supply chain that fills the hands that save our people — was not redundant enough, and our tennis shoes supply chain was better managed," says Bray, a mother of three.
Abby was terrified. She asked whether it meant she would die. Her mother met her daughter's gaze and said: "We don't know, but I'm going to try to find it. And sometimes in trying, extraordinary things happen."
That is the genesis of Bray's one-woman nonprofit, Angels for Change, and her crusade to change the drug industry.
A broken system for lifesaving drugs
The vast majority of the medications that Americans take — 90% — are generic. Unlike pricey brand-name drugs, generics are very cheap. Often too cheap for manufacturers to make a profit from, even for lifesaving medicines. So the industry has atrophied for decades, and drug shortages have worsened.
Arecent American Cancer Society survey finds one in 10 patients has been affected by recent drug shortages, including by using substitute drugs or delaying treatment.
Generic drugs, in other words, are critically valuable to patients and yet are treated as having almost no value in the marketplace. Once drugs run out of their patents and can be manufactured and sold as generics, they are usually sold in bundles and unmarked, so pharmacists or patients cannot compare one drug's quality against that of another maker. As a result, the only difference that drugmakers compete on is price.
That has led to extremely low prices, which might sound beneficial for most consumers, except that this dynamic has gone too far.
"The facts are that the price just goes down, down, down, down, down," says David Gaugh, interim CEO of the Association for Accessible Medicines, which represents generic makers. "At some point in time as a company, I've got to make a decision: Can I continue to make this product or not?"
The answer, for an increasing number of companies, is no. The race to rock-bottom generic prices has made it hard for manufacturers to stay in business, in turn creating various problems with drug quality and the lack of redundant supply to buffer the impact of disruptions.
Factories that remain in business are under constant pressure to cut costs and corners. Late last year, for example, Food and Drug Administration inspectors at Intas Pharmaceuticals in India found that the factory cut numerous corners in its quality control process, leading to a shutdown that exacerbated shortages of key cancer drugs in the United States.
Meanwhile, generic makerAkorn shut down in bankruptcy this year, and Teva and others pared down their product lines.
Relying on fewer manufacturers makes shortages more likely. "Companies are not as available to increase supply or to restart products as they were even just five, six years ago," says Gaugh.
One woman's workaround becomes a lifeline for thousands of patients
Laura Bray knew her daughter's leukemia wouldn't wait for the supply chain to improve. So she worked the phones, in search of a hospital, researcher or cancer center with drug supply to spare.
One distributor — McKesson — told her it would transport doses to her daughter, if Bray could locate any. She and friends then called hundreds of children's hospitals until they found an unused vial, "then just duct-taping together solutions," says Bray. "It's insane."
That initial scramble left Bray grateful, but not relieved. She knew other patients faced shortages. She posted advice on Facebook and then set up a website. Desperate calls and emails streamed in, and her nonprofit, Angels for Change, was born.
At first, she handled each incoming request for help, case by case. But as she got to know hospital pharmacists, drug distributors and many others along the drug supply chain, she realized she could help more people by identifying a whole hospital's drug needs and then finding small amounts of supply to fill those gaps.
Bray now has regular conversations with drugmakers, hospital pharmacies and even factory floors. If a factory shuts down production, her sources on the ground can help her estimate when the factory might restart.
She then turns to alternative makers to see whether they can ramp up to meet the sudden increased need: "I'm asking, 'Will you hold back a small amount of supply, 1% of that batch for patients in dire need?'"
In the four years that she has been doing this, now even big players in pharmaceuticals agree: Bray is the industry's accidental expert.
She's the go-to person in the country for patients facing dire drug needs. She's in regular contact with the FDA's Drug Shortage Staff, sometimes alerting it to changes in supply. In essence, she is the human manifestation of the database that she looked for when her daughter's shots ran out.
But — as she points out — there is nothing automated about the painstaking work. "I wish I had a software system," she says, laughing.
She stopped teaching to devote herself full time to Angels for Change, nowfunded by individuals and the McKesson Foundation. She did that, she says, because she's haunted by the thought of other patients and families facing shortages like hers. "There are moments in your life that are just burned in your memory, that changed you," she says. Her work is driven by her own family's trauma, she says.
At first, Bray kept a mental tally of all the people she helped: a 14-year-old violinist. A 5-year-old Spider-Man superfan. Her own inquisitive girl, Abby, now 13 and healthy. Bray has also helped avert drug shortages for hundreds of thousands of other patients by identifying and addressing health systems' inventory needs early.
Yet Bray still feels restless. She wishes Angels for Change no longer had a reason to exist. She worries that the system she created rests on her. "If I was hit by a bus tomorrow, it would all go away," she notes.
An urgent need for systemic changes
Bray is advocating for systemic changes she wants to see made permanent — namely, a commitment from the industry to greater transparency throughout its process, more contractual guarantees to maintain backup supplies of drugs and more coordination between industry and government to better anticipate and respond to shortages.
"These shortages are a self-inflicted wound," says Marta Wosinska, a health economist and senior fellow at the Brookings Institution. She says that clearly manufacturers need to be paid more to stabilize and invest more in their operations. "That requires us to be forward-looking and really changing dynamics in the whole system."
Wosinska argues that the government could offer financial rewards to hospitals, which might then have incentives to pay more for a supply of drugs that is safer and more reliable.
Meanwhile, there are a growing number of startup alternatives. NonprofitCivica Rx, for example, supplies hospitals some generic drugs by contracting at higher prices in order to ensure they can also stockpile supply.Mark Cuban Cost Plus Drug Company has wholesale models to increase access to medicines — brand name, as well as generics.
These days, Bray says she feels optimistic. More policymakers and industry players seem committed to collective action to address the problems. Two years ago, Bray and others across the industry and public health field started theEnd Drug Shortages Alliance, a group that she says is motivated to find those solutions.
She says she hopes the experience of Angels for Change will inspire them. "What I hope it shows everyone is that this is possible to fix."
Carmel Wroth edited this story.
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