Drug shortages have rarely been so severe. In recent months, thousands of patients have had to delay treatments for cancer and other life-threatening diseases. Others are rationing their medicines. Shortages have hit more common drugs, too, including ADHD treatments, asthma inhalers and children’s Tylenol.
One of the Food and Drug Administration’s jobs is to foresee and avoid such shortages. It says it prevented more than 200 such incidents last year. For lifesaving medications, zero shortages should be the goal – and the agency could do more to make that happen.
Shortages have myriad causes. Most occur when regulators identify quality problems at manufacturing sites, which halts production of potentially harmful medications. Some shortages – most recently, of ADHD stimulants and weight-loss drugs – are partly the result of surging demand. Others are caused by natural disasters.
While the FDA can’t force a company to make a drug or boost production, it can help businesses resume operations. For example, it can expedite reviews of new production lines or help drugmakers find alternate sources of key ingredients. It can also establish workarounds by extending expiration dates when appropriate or allowing imports of medicines that aren’t approved in the U.S. but meet relevant safety standards.
Better oversight of the product pipeline would help, too. Traditionally, the FDA has relied on reports from pharmacies and voluntary disclosures from manufacturers to monitor shortages. In recent years, Congress established new mandatory reporting requirements for drugmakers, which were expanded during the pandemic. As a result, the agency has copious data that could help signal looming shortages. But it isn’t using that information well. A recent congressional report flagged complaints about data management and analysis. One large buyer of prescription drugs said the agency was “data rich, but information poor.” The FDA conceded that much of its information is “unstructured” and “buried in PDFs.”
Other federal agencies are working to map the drug supply chain. The Department of Homeland Security, for instance, has partnered with the private sector to monitor vulnerabilities using artificial intelligence. The FDA should do more to coordinate this work.
Some lawmakers want to mandate more reporting from drug companies, including demand spikes, the volume of ingredients purchased from suppliers and details about intermediaries involved with production. This would be useful, but only if the FDA deployed the necessary staff and technology to improve its analytics and predictive modeling.
With or without the FDA, don’t companies have every incentive to keep shortages to an unavoidable minimum? Evidently no – least of all in the market for generics, where shortages tend to be concentrated. Fierce competition on price alone means thin margins. Manufacturers often cut corners to lower costs, which leads to quality problems and makes supplies especially vulnerable to disruption. In many cases, producers can’t easily track the fluctuating conditions affecting their suppliers and intermediaries. Again, the FDA could help fill that gap with information already at its disposal.
Shortages can’t be eliminated, but they can and should be kept to a minimum. Don’t forget: Lives are at stake.
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