Possible ways to overcome drug shortage

At several congressional hearings this year, fixing drug shortages was as much a consideration as the number of rare drugs.

Rationing of key chemotherapy drugs further exacerbated 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 increase supplies of such critical generic drugs grew this year as lawmakers returned from town hall meetings in their districts and reported disappointing visits to their local hospitals. “People are dying because of it,” Representative Debbie Dingell, Democrat of Michigan, said at a hearing.

President Biden announced a plan in November to use his executive authority to expand the ability of federal officials to invest in domestic manufacturing to ease shortages of certain drugs, including morphine, insulin and flu vaccines. of. 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 used in surgery.

Here are some solutions that are spreading:

A dozen generic industry executives said in interviews that their market is beset by extremely low prices, pushed down in part by middlemen companies. These middlemen compete for hospital customers, sometimes on the basis of who can offer the lowest drug prices.

Generic industry officials suggested setting a minimum price, sometimes called a price floor, for generic drugs, especially for those injections that are the most delicate to produce and routinely in short supply. Are in.

Marta Wościcka, a former Food and Drug Administration economist and deputy director for policy at the Duke-Margolis Center for Health Policy, has addressed prices by proposing a plan that would reward drugmakers with the best records for quality and sustainability.

We’re paying very little for some of these drugs, Dr. Wosiczka said. We need to pay more for reliability, manufacturing 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 supply, especially for low-cost generic drugs that are challenging to make.

The group representing thousands of doctors urged the US government to consider manufacturing some of the drugs, citing the examples of Sweden, Poland and India. In a related move, Senator Elizabeth Warren, Democrat of Massachusetts, re-introduced a bill to create a federal drug manufacturing office that would oversee and encourage government production of certain drugs that are officially in shortage.

About a dozen people at the FDA monitor and try to correct deficiencies. They also deal with those they cannot stop. The agency has asked drug manufacturers to Congress to report on the increase in demand. It also sought the right to demand more information, such as disclosing the origin of base ingredients, on the labels of medicines.

Several groups have said the government could create incentives for hospitals or others in the supply chain to create strategic reserves of key drugs. The American Cancer Society said in a letter to congressional leadership this month that the buffer stock would protect against disasters such as hurricanes, war or force majeure.

But the group warned in the letter that solutions would be limited if shortages are caused by chronic unstable market conditions that lead companies to stop making medicines.

The idea of ​​reviving or scaling back drug manufacturing and investing in existing domestic generic drug manufacturing facilities comes up regularly. Proponents say that excessive dependence on other countries creates a weakness in national security. It is estimated that 83 percent of the active ingredients in generic drugs are made abroad.

Critics of this 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 hit a Pfizer generic drug plant earlier this year.

Last winter, the Children’s Hospital Association, which represents 220 hospitals, feared a major supply disruption of albuterol treatment, which is 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 allowed only if a drug is on the official FDA shortage list.

The American Society of Health-System Pharmacists, a trade group, has proposed that the FDA provide more information on the quality of such compounding pharmacies. Hospitals might otherwise be hesitant to trust them, given the history of problems at the New England Compounding Center, which was 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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