WASHINGTON [12/5/2023] — President Biden’s new plan to curb drug shortages by boosting domestic drug production won’t expand the supply of the chemotherapies that are currently in shortage, an administration official confirmed. The limited scope surprised experts, who told STAT Biden could have included those drugs in the effort.
The 15 cancer drugs in short supply account for only a little more than 10% of the drugs on FDA’s shortage list. But chemotherapies are far more crucial than many other drugs experiencing shortages, which include injections of amino acids and multivitamins, and sterile water. Gut-wrenching stories about cancer patients being switched to less-effective drugs have caused cancer doctors to agitate for government solutions.
Biden announced last week that he plans to use the Defense Production Act to get companies to make essential medicines and their ingredients in the United States. The administration will spend $35 million to boost domestic production of key starting materials for drugs that hospitals commonly use and are prone to shortages.
The plan is based out of the Administration for Strategic Preparedness and Response, an office of the health department in charge of the medical response to disasters and public health emergencies. It works off of a list of essential medicines that is maintained by the Food and Drug Administration.
But that essential medicines list does not include any of the 15 chemotherapies on the separate list of shortage drugs that the FDA also maintains, an FDA spokesperson confirmed. Both the Biden and Trump administrations used the Cold War-era law during the pandemic to boost domestic production of ventilators and protective equipment.
The plan that Biden announced this week is a continuation of that approach, and the administration is leaving open the possibility of using the Defense Production Act to shore up shortages of other drugs in the future, an HHS spokesperson said.
“The $35 million in DPA investments announced on November 27 are targeted toward sterile injectables that went into shortage during the pandemic,” an HHS spokesperson said. “For these and other important drugs, including those that treat cancer, the Administration will continue to work through the FDA, the Department of Health and Human Services, and other agencies to address and prevent drug shortages and mitigate impacts to people requiring treatments.”
Laura Bray, founder of Angels for Change, which helps patients find drugs in short supply, said she is happy the administration is tackling the problem of drug shortages. Increasing domestic production is just one way to help ease shortages, and it’s unrealistic to do all of them at once.
“We have spent years fighting about where to start,” she said. “Where is irrelevant as long as we start and it helps patients.”
Biden’s most recent announcement aside, the administration has taken other measures to alleviate shortages of three cancer drugs. The FDA is allowing Chinese imports of cisplatin, which is a commonly used chemotherapy. It is also working with generic drug companies to boost production of cisplatin, carboplatin and methotrexate.
Three experts were surprised to hear that the plan Biden announced last week does not include chemotherapies. The Defense Production Act has been used for problems unrelated to defense since it was enacted during the Korean War, according to Columbia Law School Professor Joel Dodge. Biden last year even invoked the law to speed production of infant formula. Healthcare is also one of the law’s sixteen “critical infrastructure” sectors in the economy.
“I see little reason why the DPA couldn’t be invoked to shore up chemotherapy supply,” Dodge said.
Marta Wosińska, a senior fellow in economic studies at The Brookings Institution, said it’s encouraging that Biden’s plan calls for a coordinator that seems to be outside of ASPR. Although it’s not clear how much authority or funding that coordinator will have, it could open the door to drugs and ingredients outside of ASPR’s purview.
“They seem to be broadening the scope to be thinking about supply chains more broadly than just the ASPR piece,” she said during a STAT event in Washington last week.
There’s some debate over the extent to which onshoring helps curb shortages. The trade group Securing America’s Medicines and Supply, which advocates for boosting domestic production, praised Biden’s plan and urged the administration to boost domestic production even more. David Sanders, the group’s executive director, said the U.S. is “dangerously reliant” on foreign manufacturing for critical drugs.
“The situation is likely to get worse before it gets better unless we as a nation take bold action to address this crisis,” Sanders said.
However, others are less optimistic about onshoring as a solution to drug shortages. They said the policy is more about reducing America’s vulnerability to foreign countries, which is important and somewhat related to shortages, but it’s not the primary concern.
There are about 17,000 drugmaking facilities, excluding the production of starting materials and excipients, and most of those are outside of the United States, Wosińska said. So even as a geopolitical maneuver, the United
States must be strategic in how it uses onshoring. If a domestic facility making finished drugs or active pharmaceutical ingredients uses starting material from China, the United States is still not self-sufficient.
“One of the concerns that I have about the onshoring discussion is that it can very easily become a feel-good strategy,” she said.
Saleem Farooqui, executive vice president of generics and IV fluids at Fresenius-Kabi, said the government must fix the market regardless of where drugs are made. If the government were to encourage domestic production, those facilities would be dealing with the same problems that are causing shortages today. Prices for generics are driven so low that drugmakers can’t afford to maintain production facilities, which leads to them either being shut down by regulators or voluntarily leaving the market.
Vimala Raghavendran, the senior director of the U.S. Pharmacopeia’s Pharmaceutical Supply Chain Center, said geographic diversity creates resilient supply chains. But that doesn’t mean drugs must be made in the United States.
“In fact, just in the last year, we had a tornado hit one plant, another plant shut down for bankruptcy, a third plant decided to discontinue production.” she said, “All of this happened in the U.S.”
https://www.statnews.com/2023/12/05/cancer-drug-shortages-biden-plan
About the Author
John Wilkerson
Washington Correspondent
John Wilkerson is a Washington correspondent for STAT who writes about the politics of health care.
john.wilkerson@statnews.com
@john_wilkerson