Possible Ways to Ease Drug Shortages
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 crucial generic drugs grew this year after lawmakers returned from town hall meetings in their districts and reported on somber visits to their local hospitals. “People are dying because of this,” Representative Debbie Dingell, a Democrat of Michigan, said at one hearing.
President Biden announced a plan in November to use his executive authority to expand federal authorities’ ability to invest in domestic manufacturing to ease some drug shortages, including those of morphine, insulin and flu vaccines. He also created a cabinet-level council focused on shortages and set aside $35 million to help prevent shortages of sterile injectable drugs like propofol or fentanyl, which are used in surgery.
Here are some solutions that have been percolating:
Set a price floor for lifesaving drugs
A dozen executives in the generic industry said in interviews that their market was beset 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 prices.
Generic industry executives suggested setting a minimum price — sometimes referred to as a price floor — for generic drugs, particularly for the injectable ones that are most delicate to produce and are routinely 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, has proposed a plan addressing prices that would reward drugmakers with the best record for quality and stability.
“We’re paying too little for some of these drugs,” Dr. Wosińska said. “We need to be paying 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 shoring up supplies, especially in the case of low-cost generic drugs that are challenging to make.
The group, which represents thousands of doctors, urged the U.S. government to consider manufacturing some 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 certain medicines that are officially in shortage.
Add transparency to the supply chain
About a dozen people at the F.D.A. monitor and try to avert shortages. They also deal with ones they could not prevent. The agency has asked Congress to require drugmakers to report surges in demand. It also sought authority to require more information — like disclosure of the origins of basic ingredients — on the drug’s label.
Encourage stockpiling
Several groups have said the government could create incentives for hospitals or others in the supply chain to create a strategic reserve of key medications. The American Cancer Society said this month in a letter to congressional leadership that buffer stock would protect against catastrophes like a hurricane, a war or an unexpected event.
But the group warned in the letter that the solution would be limited, “if the cause of a shortage is due to chronic unsustainable market conditions” that prompt companies to stop making drugs.
Make more medicines in the U.S.
The idea of reshoring — or bringing back drug manufacturing — and investing in existing domestic generic drugmaking facilities comes up routinely. Proponents note that relying heavily on other nations creates a national security vulnerability. An estimated 83 percent of the active ingredients in generic medicines are made overseas.
Critics of the idea say domestic production is no panacea. They point to recent bankruptcies among generic drugmakers in the United States as well as the tornado that ripped through a Pfizer generic drug plant earlier this year.
Propose more small-batch manufacturing
Last winter, the Children’s Hospital Association, which represents 220 hospitals, anticipated a major supply disruption in albuterol treatments, which are given to children struggling to breathe. They turned to STAQ Pharma, an Ohio compounding pharmacy that makes custom batches of medications. The company ramped up production and helped ease the shortage. Such efforts are allowed only if a drug is on the official F.D.A. shortage list.
The Association for Health System Pharmacists, a trade group, has proposed that the F.D.A. provide more information on the quality of such compounding pharmacies. Hospitals might otherwise hesitate to rely on them, given the history of problems at the New England Compounding Center, which was linked to 64 deaths after patients received tainted injections. The disaster led to criminal charges and civil settlements; the F.D.A. has since tightened requirements on such facilities.
