At several congressional hearings this year, ideas for addressing drug shortages were as numerous as the number of drugs in short supply.
The rationing of major chemotherapies has added to the urgency of 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 boost supplies of such crucial generic drugs has grown this year after public meetings returned to their districts and reports of grim visits to their local hospitals. “People are dying because of this,” Rep. Debbie Dingell, D-Michigan, said at a news conference. an audience.
President Biden announced in November his intention to use his executive authority to expand federal capacity to invest in domestic manufacturing to alleviate some drug shortages, including those of morphine, insulin and vaccines against the flu. He also created a ministerial 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 have leaked:
Setting a floor price for life-saving drugs
A dozen generic industry executives said in interviews that their market was driven by unsustainable prices, driven down in part by middlemen companies. These middlemen compete to attract hospital customers, sometimes based on who can offer the lowest drug prices.
Generic drug industry executives have suggested setting a minimum price — sometimes called a floor price — for generic drugs, particularly for injectable drugs that are the trickiest to produce and regularly 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 addressing prizes that would reward drug manufacturers with the best results in terms of quality and stability.
“We pay too little for some of these drugs,” said Dr. Wosińska. “We have to pay more for reliability and manufacturing quality. “It’s not just about paying more.”
Think about government manufacturing
The American Medical Association recently updated its policy on drug shortages, recommending that nonprofit organizations or governments play a role in bolstering supplies, particularly in the case of low-cost and generic drugs. difficult to manufacture.
The group, which represents thousands of doctors, urged the U.S. government to consider manufacturing certain drugs, citing the examples of Sweden, Poland and India. In a similar vein, Senator Elizabeth Warren, Democrat of Massachusetts, reintroduced a bill to create a federal drug manufacturing office that would oversee and encourage government production of certain drugs officially in shortage.
Add Transparency to the Supply Chain
About a dozen people at the FDA are monitoring and trying to prevent shortages. They also attack those they could not prevent. The agency has asked Congress to require drugmakers to report demand-related emergencies. It also requested permission to require more information – such as disclosing the origin of base ingredients – on the drug’s label.
Several groups said the government could create incentives for hospitals or other supply chain players to create a strategic reserve of key medicines. The American Cancer Society said this month in a letter to Congressional leaders that the buffer stock would protect against disasters like a hurricane, war or an unexpected event.
But the group warns in its letter that the solution would be limited, “if the cause of the shortage is due to chronic and unsustainable market conditions” that push companies to stop making drugs.
Make more drugs in the United States
The idea of relocation -Or reporting drug manufacturing – and investment in existing domestic generic drug manufacturing facilities is coming back steadily. Proponents note that heavy reliance on other nations creates national security vulnerability. An estimated 83 percent of active ingredients in generic drugs are manufactured overseas.
Critics of this idea argue that domestic production is not a panacea. They highlight recent bankruptcies among to generic drug manufacturers in the United States, as well as the tornado that ravaged a Pfizer generic drug factory earlier this year.
Offer more small batch manufacturing
Last winter, the Children’s Hospital Association, which represents 220 hospitals, anticipated a major disruption in the supply of albuterol treatments, given to children having difficulty breathing. They turned towards STAQ Pharma, an Ohio pharmaceutical pharmacy that manufactures custom batches of medications. The company increased production and helped ease the shortage. Such efforts are only permitted if a drug is on the FDA’s official shortage list.
The American Society of Health-System Pharmacists, a professional group, you proposed that the FDA provide more information on the quality of these compounding pharmacies. Otherwise, hospitals may be reluctant to rely on them, given the historic problems of the New England Compounding Center, which was linked to 64 deaths after patients received contaminated injections. The disaster led to criminal charges and civil regulations; the FDA has since tightened requirements for these facilities.