FDA Proposes to Remove Mycoplasma Test Method

The US Food and Drug Administration (FDA) issued a proposed rule on Monday to remove the required testing method to detect the presence of Mycoplasma because FDA said the regulation is restrictive in that it identifies only one test method to be used even though other methods may be appropriate.

The proposed rule seeks to remove the testing method for Mycoplasma detection in virus harvest pools and control fluid pools of live and inactivated virus vaccines produced from in vitro living cell cultures, as currently required by 21 CFR 610.30. The removal is part of FDA’s implementation of the Trump Administration’s “two out, one in” executive order to reduce regulatory burden and provide additional flexibility.

“Removal of this regulation would allow manufacturers of live virus vaccines produced from in vitro living cell cultures and inactivated virus vaccines produced from such living cell cultures to select the most scientifically appropriate Mycoplasma testing method to assure the safety, purity, and potency of their vaccines,” FDA said.

The proposal comes as resistance to antibiotics that treat the respiratory infections caused by the bacteria has grown in recent years, according to the Centers for Disease Control and Prevention.

FDA noted the action is needed since “it has become increasingly clear that the test for Mycoplasma requirements is too restrictive…. because they specify particular methodologies when alternatives may be available that provide the same or greater level of assurance of safety.”

But removing this regulation would not remove Mycoplasma testing requirements specified in biologics license applications (BLAs).

“A manufacturer of a live virus vaccine produced from in vitro living cell cultures and inactivated virus vaccines produced from such living cell cultures would continue to be required to follow the Mycoplasma test requirements specified in its BLA, unless the BLA were revised to modify or replace the test through a supplement,” the proposal says.

Medical technology company Hologic snagged FDA marketing authorization earlier this year for a test indicated to aid in the diagnosis of the sexually-transmitted infection known as Mycoplasma genitalium.

Proposed rule