Possible Ways to Alleviate 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 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, Representative Debbie Dingell, a Michigan Democrat, said at 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:

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 Wosiska, a former economist for the Food and Drug Administration and deputy director for policy at the Duke-Margolis Center for Health Policy, proposed a price-responsive plan that would reward drug makers with the best records for quality and stability.

Too little is paid for some of these drugs, says Dr. Wosiska. We have to pay more for reliability, quality manufacturing. It’s not just about paying more.

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 the government’s manufacture of certain officially licensed drugs. inadequate.

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 request more information such as the disclosure of the sources of key ingredients on the label of medicines.

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 to congressional leadership that the buffer stock would protect against disasters such as a hurricane, a war or an unexpected event.

But the group warns in the letter that the solution will be limited, if the cause of a shortage is due to chronic unsustainable market conditions that prompt companies to stop producing drugs.

The idea of ​​restoring or returning drug manufacturing and investing in existing local generic drug manufacturing facilities comes up regularly. 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 point to recent bankruptcies among generic drug makers in the United States as well as the tornado that struck a Pfizer generic drug plant earlier this year.

Last winter, the Childrens Hospital Association, which represents 220 hospitals, expected a major supply disruption to albuterol treatments, which are given to children with breathing difficulties. They turned 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 provide 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 has been linked to 64 deaths after patients received contaminated injections. The disaster led to criminal charges and civil settlements; the FDA has since tightened requirements on such facilities.

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