FDA to allow importation of syphilis drug amid ongoing shortages

By CNN Newsource

Published January 10, 2024 4:50 PM

By Katherine Dillinger, CNN

(CNN) — The US Food and Drug Administration is working with a French drugmaker to temporarily allow imports of a medication that treats syphilis amid an ongoing shortage of the front-line treatment.

French drugmaker Laboratoires Delbert says in a letter that it’s working with the FDA to temporarily import 3.5 million units of Extencilline, which is not approved in the US. The move was approved Wednesday, according to an update on the agency’s website.

It’s similar to Bicillin, a long-acting injectable form of the antibiotic penicillin made by Pfizer that has been in short supply since the middle of last year. It’s the recommended treatment for syphilis in adults and one of a range of options to use against the infection in children. However, it’s the only recommended treatment for pregnant women, and it can prevent congenital syphilis, in which the infection passes from mother to newborn.

Pfizer said in June that it was prioritizing the manufacture of the formulation for adults but that it couldn’t ramp up production as quickly as it would like because of how tightly the manufacture of antibiotics is regulated and how complicated the products are to make.

In October, dozens of public health groups urged the White House to take action on the shortage amid a rise in syphilis cases across the country. The FDA’s drug shortages database says the supply problem is expected to be resolved in the second quarter of this year.

From 2017 to 2021, reported cases of syphilis in the US jumped about 74%, and cases of congenital syphilis increased more than 203%, according to data from the US Centers for Disease Control and Prevention. More than 3,700 babies were born with syphilis in the US in 2022, a rise of more than 1,000% from 2012 and the highest numbers in more than 30 years.

Syphilis in infants can be severe, disabling and even life-threatening. Congenital syphilis is considered a “never event” – a tragic outcome that should never happen – because it’s nearly always preventable. A single course of penicillin at least a month before delivery nearly always prevents infected mothers from passing the bacteria to their babies.

The National Coalition of STD Directors, one of the groups that signed the October letter to the White House, applauded the FDA’s move Wednesday.

“The delays in treatment that women have faced because of the shortage has placed them and their families at grave risk during the nation’s syphilis crisis,” executive director David Harvey said in a statement. “Today, the administration took meaningful action on our ongoing ask they do anything and everything in their power to address the Bicillin L-A shortage and to provide communities with the resources they need to treat patients and solve this public health crisis. We hope this is the first step toward seeing a resolution to this shortage, and that HHS and FDA will continue to take steps to ensure that communities never experience a syphilis treatment shortage again.”

CNN’s Brenda Goodman and Meg Tirrell contributed to this report.