Rho(D) Immune Globulin (Human)(Grifols)

So far, in 2024 alone, 48 more drugs have been added to ASHP's shortage tracker. As lawmakers, biopharma companies and others try to stabilize vulnerable pharma supply chains, drug shortages have become about as bad as they’ve ever been in the U.S. That’s according to the American Society of Health-System Pharmacists (ASHP), which has released new data showing there were 323 drugs in shortage in the U.S. as of 2024’s first quarter—the highest number recorded since ASHP began tracking shortage data back in 2001. So far, in 2024 alone, 48 more drugs have been added to the organization’s shortage tracker. Drug shortages have been a blight on the U.S. healthcare system for several years now. In particular, doctors, pharmacists and patients have had to contend with inadequate stocks of chemotherapies, attention-deficit hyperactivity disorder (ADHD) meds, antibiotics like amoxicillin and other in-demand medicines. The ongoing supply dilemma has prompted responses and inquiries from lawmakers as well as the Biden Administration, which last year unveiled plans to help bolster domestic production of pharmaceuticals and other products facing protracted supply squeezes. The FDA, for its part, currently lists 153 drugs as actively being in short supply. Turning to ASHP’s data, the organization noted that both basic and critical meds have emerged on the shortage list, including oxytocin, Rho(D) immune globulin, standard-of-care chemotherapy, pain and sedation medications, and ADHD medications. The group blamed certain supply shortages, in part, on quota changes at the Drug Enforcement Administration (DEA), alongside allocation practices set up in the wake of opioid legal settlements, which have exacerbated supply constraints on the controlled substances that currently comprise 12% of all active shortages. The top five drug classes behind the current spate of shortages are, in order, central nervous system (CNS) drugs, antimicrobials, hormone agents, chemotherapies and fluids and electrolytes, according to ASHP. Forty-six percent of the drugs in shortage in 2024’s first quarter were injectables. ASHP also recorded responses from manufacturers about what they believe is behind the shortage spree. Sixty percent of manufacturers claimed the causes were unknown or would not provide data. Another 14% blamed supply-and-demand tensions, while production and business decisions each accounted for 12% of the manufacturers’ responses. A slim 2% of manufacturers suggested the shortage issue came down to raw material problems. Drug shortages have been a constant thorn in the industry’s side for several years now, prompting multiple responses from lawmakers in that time. Earlier this month, the House Committee on Oversight and Accountability announced a public hearing set for this afternoon to “hold [FDA Commissioner Robert Califf] accountable for what the FDA is doing to address ongoing crises," including the shortage issue. Meanwhile, back in February, Democratic members of the same Oversight Committee launched an investigation into Sandoz, Teva and Pfizer for their respective roles in amoxicillin, Adderall and oncology drug shortages. The issue has prompted action outside the political sphere too, with the American Society of Clinical Oncologists (ASCO) in February pushing for action from Congress. ASCO’s chief medical officer, Julie Gralow, M.D., specifically called for more action in areas like payment and manufacturing, suggesting Congress consider alternative payment methods to relieve “artificially low” reimbursement rates on generic meds. President Joe Biden has committed attention to the issue, as well. In November, the first meeting of the new White House Council on Supply Chain Resilience, Biden revealed intentions to leverage the Defense Production Act (DPA) to make more essential medicines in the U.S. and circumvent future drug shortages, according to a White House fact sheet released at the time.