Biden looks to broaden HHS powers to bolster domestic drug manufacturing

As drug shortages mount in the U.S. with little relief in sight, President Joe Biden has rolled out a slew of efforts to bolster the nation’s supply chains.

Monday, during the first meeting of the new White House Council on Supply Chain Resilience, President Biden unveiled nearly 30 actions to safeguard production networks across industries. Chief among those actions, Biden intends to leverage the Defense Production Act (DPA) to make more essential medicines at home and thwart future drug shortages, according to a White House fact sheet.

The move comes as shortfalls of drugs such as amoxicillin, penicillin, Adderall and certain chemotherapies vex doctors and patients across the country. Currently, the FDA lists around 143 drugs as being in shortage on its online database.

The issue has drawn the attention of lawmakers on both sides of the aisle, as well as FDA Commissioner Robert Califf, M.D., who in August called the spate of shortages a “national security risk.”

Now, Biden plans to use the DPA to broaden the authorities of the Department of Health and Human Services (HHS) to tee up investment in domestic manufacturing of essential meds, medical countermeasures and more.

HHS has already earmarked $35 million to fuel domestic manufacturing of key starting materials for sterile injectable medicines, according to the White House fact sheet.

Further, HHS will appoint a new Supply Chain Resilience and Shortage Coordinator, with the aim to “institutionalize” that work to advance the department’s supply chain focus over the long term.

Lastly, the Department of Defense (DOD) is on deck to release a new report on pharmaceutical supply chain resilience. The report will be aimed at reducing reliance on “high-risk foreign suppliers,” the fact sheet states.

Meanwhile, condemnation of the U.S.’ reliance on foreign drug suppliers has become a common refrain during conversations about the recent shortage trend.

Earlier this month, Republican lawmakers James Comer and Lisa McClain sent a letter to FDA Commissioner Califf hoping to get to the bottom of the problem. The lawmakers blamed the shortage spree, in large part, on an “over-reliance” on foreign manufacturing. They noted at the time that 70% of some 4,000 facilities manufacturing drugs for the U.S. were located overseas in 2022.

But to hear FDA’s Califf tell it, part of the problem comes down to an imbalance between the branded and generic drug markets.

Back in August, during a meeting of the Alliance for a Stronger FDA, Califf identified an “innovator industry,” where he thinks "the prices are too high,” and the opposing generics industry, where “a lot of the prices are too low.” 

“What I mean by that is that the price has been driven down below the cost of manufacturing and distributing the drug,” he said. “And we have an industry which is continuing to leave the U.S. because it’s not viable to run the business.”

While the FDA has made headway working with foreign and domestic manufacturers in recent months, the agency has argued that it can’t solve the shortage trend by itself.

Though the FDA does have a hand in mitigating cancer drug shortages, for instance, its abilities are limited, Richard Pazdur, M.D., the director of the FDA’s Oncology Center of Excellence, told The Cancer Letter in May. He cited an industry failure to invest in building capacity as the root cause of shortages.