The Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted on July 9, 2012. Title X of FDASIA, which addresses drug shortages, took effect on the date of enactment and, among other things, amended the Federal Food, Drug, and Cosmetic Act by adding section 506C-1, which requires the Food and Drug Administration to file an annual report to Congress on drug shortages.

This Tenth Annual Report to Congress published by the FDA on June 7, 2023 summarizes the major actions taken by the U.S. Food and Drug Administration during calendar year 2022 to prevent or mitigate drug shortages in the United States. As a result of presidential, congressional, and Agency actions, manufacturers are notifying FDA earlier than in the past about certain manufacturing interruptions and discontinuances that can lead to shortages.

The FDA reports that at the height of the drug shortage crisis, the number of new drug shortages tracked by Center for Drug Evaluation and Research (CDER) quadrupled, from approximately 61 shortages in 2005 to more than 250 in 2011. “The number of new drug shortages per calendar year has declined from a high of 250 in 2011 to 49 in 2022”.

Although the number of new drug shortages has declined since 2011, the FDA in general terms cautions that “shortages continue to pose a real challenge to public health, particularly when the shortage has involved a critical drug to treat cancer, to provide parenteral nutrition, or to address another serious medical condition, such as a shortage of antibiotics.”

The FDA report is very general and does not specifically point out a supply crisis on the immediate horizon. But a new report just published by Kaiser Health News does not depict a good picture for shortages, especially in the generic drug marketplace.

KHN reports that Cisplatin and carboplatin are among scores of drugs in shortage, including 12 other cancer drugs, attention-deficit/hyperactivity disorder pills, blood thinners, and antibiotics.

It claims that “Covid-hangover supply chain issues and limited FDA oversight are part of the problem, but the main cause, experts agree, is the underlying weakness of the generic drug industry. Made mostly overseas, these old but crucial drugs are often sold at a loss or for little profit. Domestic manufacturers have little interest in making them, setting their sights instead on high-priced drugs with plump profit margins.”

“The 10 cancer clinicians KFF Health News interviewed for this story said that, given current shortages, they prioritize patients who can be cured over later-stage patients, in whom the drugs generally can only slow the disease, and for whom alternatives – though sometimes less effective and often with more side effects – are available. But some doctors are even rationing doses intended to cure.”

The causes of shortages are well established. The average net price of generic drugs fell by more than half between 2016 and 2022, according to research by Anthony Sardella, a business professor at Washington University in St. Louis.

And some generic manufacturers are going out of business. Akorn, which made 75 common generics, went bankrupt and closed in February. Israeli generics giant Teva, which has a portfolio of 3,600 medicines, announced May 18 it was shifting to brand-name drugs and “high-value generics.” Lannett Co., with about 120 generics, announced a Chapter 11 reorganization amid declining revenue. Other companies are in trouble too, said David Gaugh, interim CEO of the Association for Accessible Medicines, the leading generics trade group.

The generics industry used to lose money on about a third of the drugs it produced, but now it’s more like half, Gaugh said. So when a company stops making a drug, others do not necessarily step up, he said. Officials at Fresenius Kabi and Pfizer said they have increased their carboplatin production since March, but not enough to end the shortage.

On June 2, FDA Commissioner Robert Califf announced the agency had given emergency authorization for Chinese-made cisplatin to enter the U.S. market, but the impact of the move wasn’t immediately clear.

So KHN concludes by saying “Despite a drug shortage task force and numerous congressional hearings, progress has been slow at best. The 2020 CARES Act gave the FDA the power to require companies to have contingency plans enabling them to respond to shortages, but the agency has not yet implemented guidance to enforce the provisions.”