Still, companies are supposed to tell the FDA about potential shortages and discontinuations ahead of time so it can minimize the impact on public health. It can help a firm resolve a manufacturing issue, decide whether it’s safe to extend an expiration date or help a company making an alternative product to ramp up production.
“The FDA expects that manufacturers will notify the agency before a meaningful disruption in their own supply occurs,” FDA spokesperson Jeremy Kahn wrote in an email. “When the FDA does not receive timely, informative notifications, the agency’s ability to respond appropriately is limited.”
But the rules are somewhat flexible. A company is required to notify the FDA of an upcoming drug supply disruption six months before it affects consumers or “as soon as practicable” after that. But their true deadline is five business days after manufacturing stops, according to the FDA website.
“They’re supposed to tell the FDA, but even if they don’t, there’s no penalty,” Fox said. “There’s no teeth in that law. … Their name can go on the FDA naughty list. That’s pretty much it.”
In rare cases, the FDA will send a noncompliance letter to the drugmaker and require it to explain itself. This has happened only five times since 2015. There is no such letter about Vantas, suggesting that Endo met the FDA’s requirements for notification.
Concerned about potential drug shortages caused by COVID-19 in March 2020, a bipartisan group of legislators introduced the Preventing Drug Shortages Act, which aimed to increase transparency around shortages. But the legislation gained no traction.
As a result of limited FDA power, the intricacies of drug shortages remain opaque, Fox said. Companies don’t have to make the reasons for shortages public. That sets the Vantas shortage and discontinuation apart from many others. The company is saying more about what happened than most do.
“Many companies will actually just put drugs on temporarily unavailable or long-term backorder, and sometimes that can last years before the company finally makes a decision” on whether to discontinue a product, she said. “It can take a long time, and so it can be frustrating to not know — or to kind of stake your hopes on a product coming back to the market once it’s been in shortage for so long.”
It’s hard to know exactly how many children will be affected by the Vantas discontinuation because data about off-label use is hard to come by.
Dr. Erica Eugster, a professor of pediatrics at the Indiana University School of Medicine, said central precocious puberty patients weren’t her first thought when she learned of the Vantas discontinuation.
“I immediately thought about our our transgender population,” she said. “They’re the ones that are really going to suffer from this.”
No medications have been FDA-approved to treat patients with gender dysphoria, the medical term for when the sex assigned at birth doesn’t match someone’s gender identity, causing them psychological distress. As a result, any drug to stop puberty in this population would be off-label, making it difficult for families to get health insurance coverage. Vantas had been a lower-cost option.
The number of transgender patients receiving histrelin implants rose significantly from 2004 to 2016, according to a study published in the Journal of Pediatric Endocrinology and Metabolism.
Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!
-----©2021 Kaiser Health News. Distributed by Tribune Content Agency, LLC.