Possible ways to alleviate the drug shortage

At several congressional hearings this year, there were as many ideas to fix the drug shortage as scarce drugs.

The rationing of key chemotherapies added more 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.

The increase in supplies of such key generic drugs increased this year after lawmakers returned from town hall meetings to their districts and reported grim visits to their local hospitals. People are dying because of this, Michigan Democratic Representative Debbie Dingell said at a hearing.

In November, President Biden announced a plan to use his executive authority to expand the ability of federal officials to invest in domestic production to ease some drug shortages, including morphine, insulin and flu shots. He also created a cabinet-level council focused on the shortage 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 passed:

Dozens of generic drug industry executives said in interviews that their markets are burdened by unsustainably low prices, pushed in part by intermediary firms. These brokers compete for hospital customers, sometimes based on who can offer the lowest drug prices.

Generic drug executives proposed setting a minimum price, sometimes called a price floor, for generic drugs, especially those injectable drugs that are the most sensitive to manufacture and routinely run out of.

Marta Wosiska, a former Food and Drug Administration economist and associate director of health policy at Duke-Margolis, has proposed a pricing plan that rewards drugmakers for the best quality and stability.

They paid too little for some of these drugs, Dr. Wosiska said. We have to pay more for reliability and build quality. 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 increasing procurement, especially for low-cost generic drugs that are challenging to manufacture.

A group representing thousands of doctors called on the US government to consider manufacturing some medicines, following the examples of Sweden, Poland and India. At the same time, Senator Elizabeth Warren, Democrat of Massachusetts, reintroduced a bill to create a federal pharmaceutical manufacturing agency that would monitor and encourage the production of certain drugs that are officially in short supply.

About a dozen people at the FDA are watching and trying to avoid a shortage. They also deal with the ones they couldn’t prevent. The agency has asked Congress to require drugmakers to report on the increase in demand. It also petitioned the authorities to require additional information, such as the disclosure of the origin of basic ingredients on drug labels.

Several groups have said the government could create incentives for hospitals or other actors in the supply chain to create a strategic reserve of essential drugs. The American Cancer Society said in a letter to congressional leaders this month that buffer stocks protect against disasters such as hurricanes, war or an unexpected event.

However, the group warned in the letter that the solution would be limited if the shortage is caused by chronic unsustainable market conditions that cause companies to stop making the drugs.

The idea of ​​relocating or bringing back pharmaceutical manufacturing and investing in existing domestic generic drug manufacturing facilities is routinely brought up. Proponents point out that relying heavily on other nations creates a national security vulnerability. An estimated 83 percent of the active ingredients of generic drugs are manufactured abroad.

Critics of the idea say that domestic production is not a panacea. They point to the recent bankruptcies of US generic drug makers and the tornado that ripped through Pfizer’s generics plant earlier this year.

Last winter, the Children’s Hospital Association, which represents 220 hospitals, predicted a major supply disruption in albuterol treatments given to children with breathing problems. They turned to STAQ Pharma, an Ohio-based pharmacy that makes custom batches. The company increased production and helped reduce shortages. Such actions are only permitted if the drug is on the FDA’s official deficiency list.

The American Society of Health-System Pharmacists, a trade group, has suggested that the FDA provide more information about the quality of such pharmacies. Hospitals might otherwise be hesitant to trust them given the history of problems at the New England Compounding Center, which involved 64 deaths after patients received tainted injections. The disaster led to criminal charges and civil settlements; The FDA has since tightened the requirements for such devices.

#ways #alleviate #drug #shortage
Image Source : www.nytimes.com

Leave a Comment