Jhe firestorm over infant formula shortages presents the Food and Drug Administration with an opportunity to address a larger, more fundamental problem: the potential for similar circumstances across the agency’s regulatory portfolio. .
More than a decade ago, the FDA faced an equally intense storm over drug shortages, with clear calls to address the issue from Congress, the media, health care providers and the wider regulatory ecosystem. In 2010, 77% of drugs in short supply were sterile injectable products, essential for acute care. Media coverage has highlighted the plight of patients and doctors facing shortages of cancer drugs, anesthetic agents and critical care drugs. Backlogs of drug orders have resulted in patients receiving substitution therapies that have added expense to patient care. Unsurprisingly, the reasons for these shortages were almost identical to the current formula imbroglio: manufacturing issues.
Supply chain issues are not new. Even before Covid-19, the FDA had identified product shortages caused by delays in receiving raw materials and components from foreign and domestic suppliers.
During a recent congressional hearing, FDA Commissioner Robert Califf spoke about the agency’s lack of regulatory authority to demand information from food manufacturers. This is a crucial question, but not a new one. In 2010, 178 drug shortages were reported to the FDA. The question at the time was whether that was a reliable number, because regulations didn’t require companies to notify the FDA of shortages. The only requirement was that companies notify the FDA six months in advance of stopping single-source medically necessary drugs. (In 2010, for example, 38 shortages were averted by companies voluntarily notifying the FDA of potential issues that could lead to shortages, and the FDA was able to work with the company to avert a shortage.)
There are many lessons to be learned from the way the medical products side of the agency has tackled the problem of shortages, especially of products that, like infant formula, are only made by 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 respond to potential or actual drug shortages 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 components of the FDA to manage product shortages.
For example, when the drug shortage is for a generic product (as is often the case), the FDA works with other companies making the drug to help them scale up production if they wish. They often need approval for new production lines or new sources of raw materials to help increase supplies. The FDA can and is accelerating the review of these to help address shortages of medically necessary drugs.
In addition to direct communications with industry, the Drug Shortage Program also receives reports from healthcare professionals, patients and professional organizations. As I learned in interviews with FDA officials, the program currently has 14 full-time staff, shortages have diminished, and those that do occur are well managed.
There is no similar program on the food side of the FDA. It is time for that to change.
To the agency’s credit, once the Abbott baby formula recall decision was made, the FDA notified a large number of people and entities, including the American Academy of Pediatrics; the people in the Department of Agriculture in charge of the Special Supplemental Nutrition Program for Women, Infants and Children (which supports about half of all infant formula); and the media. One of the problems faced by the FDA was the lack of clear data on total supply. As Califf told the House and Senate subcommittees, the lack of authority to have regular access to this information and the information technology infrastructure to analyze it quickly and correctly have severely limited the FDA’s ability to understand and maintain control of the situation.
The drug shortage problems of a decade ago are very similar to the current infant formula crisis. According to a 2010 survey of 1,800 healthcare professionals, more than half of respondents said they frequently or always encounter difficulties associated with drug shortages. The top three issues fall squarely within the FDA’s area of proper attention and action:
- Little or no information available on the duration of a drug shortage (85%)
- Lack of advance warning from manufacturers or the FDA to alert practitioners to impending drug shortages and suggested alternatives (84%)
- Little or no information on the cause of the drug shortage (83%)
Survey respondents felt “unsupported by the FDA” and said they were perplexed as to why the United States was experiencing drug shortages of an “epic proportion often associated with countries in the world.” Third World”. Deja vu parallels the current infant formula crisis, and the perceived lack of communication from the FDA to pediatricians and parents is instructive. A key lesson from Covid-19 is that when the agency is proactive and transparent on important issues, its various constituencies are grateful – even if they don’t like what they’re hearing. The result is a more informed public with greater trust and respect for the FDA.
The shortage of infant formula is a swipe at the front of the FDA. The agency should not allow the following title to be “Who Lost Food Security?” Here are six potential proactive steps I think he should take now:
- Create an intercentric working group within the FDA to collect and share best practices for avoiding and addressing shortages.
- Identify products in the agency’s regulatory portfolio (such as infant formula, IV tubing, and sterile injectables) that have only a few major manufacturers.
- Develop specific legislative demands for more robust authorities to require information from manufacturers.
- Reach out to affected groups for more regular communications about situations that may cause or worsen shortages.
- Request funding for one or more Center for Food Security and Applied Nutrition staff to be specifically assigned to address shortages.
- Recognize that part of resolving the issue is through early, broad, and strong communications. Establish an inter-centre communications team (coordinated by the Senior Deputy Commissioner) dedicated to rapid and proactive measures in the event of a shortage situation. Accurate and regular communication about the process and progress is crucial.
Knowledge is power, but siled and unshared knowledge is a missed opportunity. The product shortage ecosystem is built on more than legally mandated notification requirements – it’s built on trust. The shortage of infant formula is a wake-up call for the FDA to move forward in its mission to promote not only the safety, efficacy, quality, but also the availability of the products it regulates.
Peter J. Pitts is President of the Center for Public Interest Medicine, Visiting Professor at the Faculty of Medicine of the University of Paris and former Associate Commissioner of the FDA.