Beyond baby formula: advancing best practices in FDA’s efforts to prevent shortages

The firestorm over baby formula shortages offers an opportunity for the Food and Drug Administration to address a bigger and more fundamental issue: the potential for similar circumstances across the agency’s entire regulatory portfolio.

More than a decade ago, the FDA was in the midst of addressing a similarly intense tempest over drug shortages, with clarion calls to fix the problem from Congress, the media, health care providers, and the broader regulatory ecosystem. In 2010, 77% of drugs in short supply were sterile injectable products, critical in the acute care setting. Media coverage highlighted the plight of patients and physicians faced with shortages for cancer drugs, anesthetic agents, and critical care medications. Drug back orders caused patients to receive substitute therapies that added expense to patient care. Not surprisingly, the reasons for these shortages were almost identical to the current baby formula imbroglio: manufacturing issues.

Supply-chain issues aren’t new. Even before Covid-19, the FDA had identified product shortages caused by delays in receiving raw materials and components from suppliers both foreign and domestic.

At a recent congressional hearing, FDA Commissioner Robert Califf discussed the agency’s lack of regulatory authority to demand information from food manufacturers. This is a crucial issue, but not a new one. In 2010, 178 drug shortages were reported to the FDA. At the time, the question was whether that was a reliable number because regulations did not require companies to notify FDA of shortages. The only requirement was that companies inform FDA six months in advance for discontinuations of sole-source medically necessary drugs. (In 2010, for example, 38 shortages were prevented by companies notifying FDA voluntarily of potential issues that could lead to shortages, and FDA was able to work with the company to avoid a shortage.)

There are many lessons to be learned from how the medical products side of the agency addressed the shortage issue, particularly from products that — similar to baby formula — are manufactured by only a few large companies.

The FDA’s Drug Shortage Program (DSP) resides in the Center for Drug Evaluation and Research. This program was established to address potential or actual shortages of drugs that have a significant impact on public health. Through communication, facilitation, and negotiation, the Drug Shortage program works with pharmaceutical manufacturers, review divisions, compliance, and other FDA components to manage product shortages.

For example, when the drug shortage is for a generic product (as it often is), the FDA works with other firms making the drug to help them ramp up production if they are willing to do so. They often need approval for new production lines or new raw material sources to help increase supplies. The FDA can and does expedite review of these to help resolve shortages of medically necessary drugs.

In addition to direct communication with industry, the Drug Shortage Program also gets reports from health care professionals, patients and professional organizations. As I learned from interviews with FDA officials, the program currently has 14 full-time employees, shortages have decreased, and those that happen are well managed.

There is no similar program on the food side of the FDA. It’s time for that to change.

To the agency’s credit, once the Abbott baby formula recall decision was made, the FDA notified huge numbers of people and entities, including the American Academy of Pediatrics; people at the Department of Agriculture in charge of the Special Supplemental Nutrition Program for Women, Infants, and Children program (that supports about half of all formula); and the media. One problem the FDA faced was lack of clear data on total supply. As Califf told subcommittees of both the House and Senate, the lack of authority to have regular access to this information and the information technology infrastructure to quickly and properly analyze it severely limited the FDA’s ability to understand and maintain control over the situation.

The problems of drug shortages from a decade ago are very similar to today’s baby formula crisis. According to a 2010 survey of 1,800 health care practitioners, more than half of respondents said they frequently or always encountered difficulties associated with drug shortages. The top three problems fall squarely within the zone of appropriate FDA attention and action:

• Little or no information available about the duration of a drug shortage (85%)
• Lack of advance warning from manufacturers or FDA to alert practitioners to an impending drug shortage and suggested alternatives (84%)
• Little or no information about the cause of the drug shortage (83%)

Survey respondents felt “unsupported by the FDA” and said they were perplexed about why the U.S. was experiencing drug shortages of “epic proportion that are often associated with third-world countries.” The déjà vu parallels to today’s baby formula crisis, and the perceived lack of FDA communication to pediatricians and parents is instructive. A key lesson from Covid-19 is that when the agency is proactive and transparent about important issues, its various constituencies are grateful — even if they don’t like what they hear. The result is a more informed public with greater trust and respect for the FDA.

The baby formula shortage is a shot across the bow of the FDA. The agency mustn’t allow the next headline to be “Who lost food safety?” Here are six potential proactive steps I believe it should take now:

• Create a cross-center working group inside the FDA to collect and share best practices in avoiding and addressing shortages.
• Identify products across the agency’s regulatory portfolio (such as baby formula, IV tubing, and sterile injectables) that have only a few large manufacturers.
• Develop specific legislative requests for more robust authorities to demand information from manufacturers.
• Reach out to relevant constituencies for more regular communications on situations that might cause or heighten shortages.
• Request funding for one or more staff members in the Center for Food Safety and Applied Nutrition to be specifically tasked to address shortages.
• Recognize that part of solving the problem is early, broad, and robust communications. Establish a cross-center communications team (coordinated by the principal deputy commissioner) dedicated to speedy and proactive measures when a shortage situation arises. Accurate and regular communications on both process and progress is crucial.

Knowledge is power, but knowledge siloed and unshared is a missed opportunity. The product shortage ecosystem relies on more than just legislatively mandated notification requirements — it’s built on trust. The baby formula shortage is a wakeup call for the FDA to move forward in its mission to drive not only safety, effectiveness, quality, but also the availability of the products it regulates.

Peter J. Pitts is the president of the Center for Medicine in the Public Interest, a visiting professor at the University of Paris School of Medicine, and a former FDA associate commissioner.