Since the start of the pandemic, there's been a lot of focus on U.S. Food and Drug Administration approval. Many were eager for the approval of the first COVID-19 vaccine. We've also been dealing with many shortages.
Critics say there's a lot of red tape to the FDA approval process. However, when there are shortages for medications and other health products, that process looks a little different.
Grocery store aisles that normally carry formula were empty in May of this year, but the Biden administration and FDA quickly took action calling on foreign companies. Blake Waltrip is the U.S. CEO of a2 Milk Company, a company that started in Auckland, New Zealand. He says the shortage was a result of one the main U.S. formula producers temporarily shutting down.
"There were some bacterial infections that happened as a result of infant formula," Waltrip said. "Ultimately, that that company made the decision to close down that facility. When they did that, it created a domino effect of no product availability in the U.S."
As of early November, a2 Milk Company's formula has been approved by the FDA to be put on shelves in the U.S.
"So what the FDA created in conjunction with the administration was the opportunity to have something called enforcement discretion," Waltrip said. "And what that did was allow the ability for foreign brands to bring their products in."
Waltrip says it was a very lengthy process.
"We had to change our packaging to make sure it was U.S. standard," Waltrip said. "You know, instead of milliliters, it was in fluid ounces. Make sure that our serving size was appropriate for the U.S. consumer."
However, he says it was still quicker than the process of getting long-term approval. Whether it's infant formula or a medication, FDA has a system in place to handle shortages. Erin Fox at the University of Utah Health is an expert in how the FDA handles pharmaceutical shortages.
"They can ask manufacturers to ramp up their supply," Fox said. "They can ask the drug companies to increase production when they get new applications. So, let's say that there is a shortage and a new company wants to make a new drug, they can prioritize that application and they can put it at the head of the line. If a company needs an inspection or maybe a new raw material, FDA can also prioritize and really fast track those inspections as well."
Jonathan Darrow who has published many papers about FDA approval and pharmaceuticals says enforcement discretion is used with drugs too.
"There's also a program called expanded access that can be used to allow importation of a drug from abroad," Darrow said. "And this would be a case perhaps, where a drug in the United States is similar, but not identical to a drug that's available abroad."
As challenging as shortages can be, the FDA says it often leads to a more diverse market which gives people more to choose from down the line.
"The winners of more choice are always consumers," Waltrip said.
