Possible ways to alleviate drug shortages


At several congressional hearings this year, ideas to address drug shortages were as numerous as the number of drugs in short supply.

Rationing of key chemotherapies added urgency to the crisis.

Two of these drugs, carboplatin and cisplatin, are inexpensive and used to treat up to 20 percent of cancer patients, according to the National Institutes of Health.

The push to shore up supplies of such crucial generic drugs grew this year after lawmakers returned from town hall meetings in their districts and reported grim visits to their local hospitals. “People are dying because of this,” Rep. Debbie Dingell, D-Mich., said in an audience.

President Biden announced a plan in November to use his executive authority to expand federal authorities' ability to invest in domestic manufacturing to alleviate some drug shortages, including 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 leaking:

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

Generic industry executives suggested setting a floor price (sometimes called a floor price) for generic drugs, particularly for injectables that are more delicate to produce and typically in short supply.

Marta Wosińska, a former Food and Drug Administration economist and deputy policy director at the Duke-Margolis Center for Health Policy, proposed a plan that addresses prices that would reward drugmakers with the best track record of quality and stability.

“We pay very little for some of these drugs,” said Dr. Wosińska. “We need to pay more for reliability and manufacturing quality. It's not just about paying more.”

The American Medical Association recently updated its policy on drug shortages, recommending that nonprofit organizations or governments play a role in shoring up supplies, especially for low-cost generic drugs that are difficult to manufacture.

The group, which represents thousands of doctors, urged the US government to consider manufacturing some drugs, citing the examples of Sweden, Poland and India. In a similar move, Sen. Elizabeth Warren, D-Mass., reintroduced a bill to create a federal drug manufacturing office that would oversee and encourage government production of certain medications that are officially in short supply.

About a dozen people at the FDA monitor and try to prevent shortages. They also take care of those they couldn't avoid. The agency has asked Congress to require drugmakers to report surges in demand. It also sought permission to require more information (such as disclosure of the origin of basic ingredients) on the drug's label.

Several groups have said the government could create incentives for hospitals or other supply chain players to build a strategic stockpile of key drugs. The American Cancer Society said this month in a letter Congressional leadership said that buffer stock would protect against catastrophes like a hurricane, war, or unexpected event.

But the group warned in the letter that the solution would be limited, “if the cause of the shortage is due to chronic and unsustainable market conditions” that prompt companies to stop making drugs.

The idea of relocation – either bring back drug manufacturing and investment in existing domestic generic drug manufacturing facilities are issues that arise routinely. Advocates point out that relying heavily on other nations creates a national security vulnerability. An estimated 83 percent of the active ingredients in generic drugs are manufactured abroad.

Critics of the idea say domestic production is no panacea. They point out recent bankruptcies between generic drug manufacturers in the United States, as well as the tornado that destroyed a Pfizer generic drug plant earlier this year.

Last winter, the Children's Hospital Association, which represents 220 hospitals, anticipated a major disruption to the supply of albuterol treatments, which are given to children with breathing difficulties. They Turned to STAQ Pharma, an Ohio compounding pharmacy that manufactures custom batches of medications. The company increased production and helped alleviate shortages. Such efforts are only permitted if a drug is on the FDA's official shortage list.

The Health System Pharmacists Association, a trade group, has proposed that the FDA provide more information about the quality of these pharmaceutical compounds. Otherwise, hospitals might hesitate 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 caused criminal charges and civil agreements; The FDA has since tightened requirements for such facilities.

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