At several congressional hearings this year, ideas to fix drug shortages were as numerous as the number of scarce drugs.
The rationing of key chemotherapies added urgency to the crisis.
Two of these drugs, carboplatin and cisplatin, are inexpensive and are used to treat up to 20 percent of cancer patients, according to the National Institutes of Health.
Momentum to shore up supplies of such essential generic drugs has grown this year after lawmakers returned from town hall meetings in their districts and reported dismal visits to their local hospitals. “People are dying because of it,” said Representative Debbie Dingell, a Michigan Democrat, in a hearing.
President Biden announced a plan in November to use his executive authority to expand the ability of federal authorities to invest in domestic manufacturing to ease some drug shortages, including morphine, insulin and flu vaccines. He also created a cabinet-level council dedicated to shortages and allocated $35 million to help prevent shortages of sterile injectable drugs such as propofol or fentanyl, which are used in surgery.
Here are some solutions that have come up:
Set a price floor for life-saving drugs
A dozen executives in the generics industry said in interviews that their market has been plagued by unsustainably low prices, pushed down in part by intermediary companies. These middlemen compete for hospital clients, sometimes based on who can offer the lowest drug price.
Generic industry executives have proposed setting a minimum price — sometimes referred to as a price floor — for generic drugs, especially for injectables that are the most dangerous to make and often in short supply.
Marta Wosińska, a former economist for the Food and Drug Administration and deputy director for policy at the Duke-Margolis Center for Health Policy, suggested a plan that responds prices that will reward drug makers with the best record for quality and stability.
“We pay too little for some of these drugs,” said Dr. Wosińska. “We have to pay more for reliability, manufacturing quality. It’s not just about paying more.”
Consider government manufacturing
The American Medical Association recently updated its policy on drug shortages, recommending that nonprofits or governments play a role in stockpiling supplies, especially in the case of cheap generic drugs that are difficult to produce.
The group, which represents thousands of doctors, urged the US government to consider the production of certain drugs, citing the examples of Sweden, Poland and India. In a related move, Senator Elizabeth Warren, a Democrat of Massachusetts, reintroduced a bill to create a federal drug manufacturing office that would oversee and encourage. government production of some drugs that are officially in short supply.
Add transparency to the supply chain
About a dozen people in the FDA monitor and try to prevent deficiencies. They also deal with those they cannot control. The agency asked Congress to require drug makers to report increases in demand. It also sought the authority to require more information — such as disclosure of the sources of key ingredients — on the drug’s label.
Encourage hoarding
Several groups said the government could create incentives for hospitals or others in the supply chain to create a strategic reserve of essential drugs. The American Cancer Society said this month in a letter by congressional rule that the buffer stock will protect against disasters such as a hurricane, a war or an unforeseen event.
But the group warned in the letter that the solution would be limited, “if the cause of the shortage is due to chronically unsustainable market conditions” that prompt companies to stop making drugs.
Make more drugs in the US
The idea of reshoring — o returning drug manufacturing — and investment in existing local drug manufacturing facilities usually comes out. Advocates note that overreliance on other countries creates a national security vulnerability. An estimated 83 percent of the active ingredients in generic drugs are produced abroad.
Critics of the idea say that domestic production is not a panacea. They pointed to the recent bankruptcy part of generic drug makers in the United States as well as the tornado that struck a Pfizer generic drug plant earlier this year.
Suggest smaller batch manufacturing
Last winter, the Children’s Hospital Association, which represents 220 hospitals, expected a major supply disruption to albuterol treatments, which are given to children with breathing difficulties. they turn to STAQ Pharma, an Ohio compounding pharmacy that makes custom batches of drugs. The company increased production and helped reduce the shortage. Such efforts are only allowed if a drug is on the FDA’s official shortage list.
The American Society of Health-System Pharmacists, a trade group, has suggested that the FDA provides more information on the quality of such compounding pharmacies. Hospitals may be hesitant to rely on them, given the history of problems at the New England Compounding Center, which associated with 64 deaths after the patients received the injections. The disaster led to criminal cases and civil communities; the FDA has since tightened requirements on such facilities.
