Drug shortages plague patients. There’s a solution
From 1968 to 2020, people experienced a remarkable increase in life expectancy, from 70 to 78 years. Much of that was due to advances in drugs and vaccines, many of which are now unavailable because of shortages. According to the University of Utah Drug Information Service, in the first quarter of 2024, a total of 323 drugs were in shortage — the highest number ever.
Shortages of important drugs are neither new nor rare. Several years ago, University of Chicago researchers surveyed 719 pharmacists at large and small hospitals across the country and found that all of them reported experiencing at least one drug shortage in the previous year, and 69% had experienced at least 50 shortages in that time. The majority were generic injectable pharmaceuticals commonly used in hospitals, including analgesics, cancer drugs, anesthetics, antipsychotics for psychiatric emergencies, and electrolyte solutions needed for patients on IV supplementation.
Hospitals are scrambling to assure adequate supplies of drugs that are in shortage or to find substitutes for them. The University of Chicago study found that one-third of hospitals had to ration drugs at least once. That means that some patients got the second or third choice of a drug treatment, increasing the likelihood that the drug would be ineffective, be only suboptimally effective, or have unwanted side effects.
Much of this is preventable. To ameliorate drug shortages, we need a policy change that would enable overseas manufacturers to sell products in the United States that already have received marketing approval from certain foreign governments with standards comparable to those of the Food and Drug Administration, and vice versa. In a word: reciprocity.
An approval in one country on the list would be reciprocated automatically by the others (subject to the creation of approved labeling in appropriate format and language and other formalities). That would afford drugmakers in those countries rapid access to the U.S. market, helping to alleviate our shortages and preventing future ones. It might even put downward pressure on drug prices.
Reciprocity would ameliorate other problems as well, such as the FDA dragging its feet on the approval of important drugs and vaccines that have been given the green light elsewhere. For example, Bexsero, a vaccine to prevent meningitis B, was approved in 2013 by the European Union, Australia, and Canada, but not by the FDA until 2015.
Another example was the long delay before the FDA’s 2015 approval of Fluad, a flu vaccine containing an adjuvant that boosts the immune response. It is used primarily in the elderly, whose immune response to flu vaccines typically is poor. Fluad had been used in Italy since 1997 and approved in more than three dozen countries. The 18‐year delay in availability in the U.S. undoubtedly resulted in many avoidable hospitalizations and deaths.
The stage is set for reciprocity of approvals. The U.S. has participated in international deliberations that have led to harmonized standards among the FDA and its foreign counterparts. Many countries now have a standardized dossier for seeking approval of new drugs, the U.S. accepts research conducted in other countries to support drug and medical device approvals, and the FDA has established Current Good Manufacturing Practices for foreign production facilities.
In addition, there is a new International Recognition Procedure introduced at the start of the year that allows U.K. drug regulators to exchange information with their counterparts in the EU, U.S., Japan, Australia, Canada, Switzerland, and Singapore. In February, the U.K. cleared in just 30 days a new formulation of a cancer drug, Xgeva, based on a European approval.
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In a statement, the U.K. said that because of the IRP, “medicines that have been approved in other countries with stringent regulators will get to UK patients without delay, resulting in a more rapid, efficient, and cost-effective process for life sciences companies.” We could, and should, do the same.
Americans need to be assured of the availability of pharmaceuticals in the marketplace so that healthcare providers have more reliable inventory, experience fewer shortages, and have more choices when shortages arise. Reciprocity of drug regulatory decisions would help to achieve that, and the White House and Congress should implement it without delay.
Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger distinguished fellow at the American Council on Science and Health. He was the founding director of the FDA’s Office of Biotechnology.
