Thursday, May 23, 2024

During congressional hearings this year, a variety of solutions to address drug shortages were proposed as the scarcity of drugs continued to be a serious issue. The shortage of essential chemotherapies added urgency to the crisis.

This year, the momentum to increase the supply of important generic drugs grew as lawmakers returned from town hall meetings in their districts and reported on their visits to local hospitals where they witnessed the devastating impact of these shortages. Representative Debbie Dingell, a Democrat of Michigan, spoke passionately about the issue, stating, “People are dying because of this” at a hearing.

In November, President Biden announced a plan to use executive authority to expand federal authorities’ ability to invest in domestic manufacturing to address drug shortages of critical drugs like morphine, insulin, and flu vaccines. He also created a council focused on shortages and allocated $35 million to prevent shortages of sterile injectable drugs such as propofol or fentanyl, which are used in surgery.

Here are some potential solutions:

A dozen executives in the generic industry have suggested setting a minimum price — sometimes referred to as a price floor — for generic drugs, particularly injectable ones that are most challenging to produce and often in short supply.

Marta Wosińska, a former economist for the Food and Drug Administration, has proposed a plan that would reward drugmakers with the best record for quality and stability.

The American Medical Association has recommended that nonprofits or governments play a role in shoring up supplies of low-cost generic drugs that are challenging to make.

The American Medical Association has urged the U.S. government to consider manufacturing some drugs and Senator Elizabeth Warren reintroduced a bill to create a federal drug manufacturing office to oversee government production of certain medicines in shortage.

The F.D.A. has asked Congress to require more transparency in the supply chain, including reporting surges in demand and disclosing the origins of basic ingredients on the drug’s label.

Several groups have suggested creating incentives for hospitals or others in the supply chain to maintain a strategic reserve of key medications to protect against potential shortages.

There is a growing call to produce more medicines in the U.S. as overreliance on other nations for drug manufacturing has created a national security vulnerability. An estimated 83 percent of the active ingredients in generic medicines are made overseas.

Critics of this idea argue that domestic production is not a guaranteed solution, pointing to recent bankruptcies among U.S. generic drugmakers and unforeseen disasters such as the tornado that hit a Pfizer generic drug plant.

Efforts to increase small-batch manufacturing through compounding pharmacies have proven effective in addressing shortages of specific drugs, and there have been proposals to improve the quality and reliability of such pharmacies to enhance their role in addressing shortages.

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