PRE-PEN® receives waiver

Earlier this year, the College and Advocacy Council met with the manufacturer of PRE-PEN® and offered guidance for ways of approaching the FDA to reduce some of the barriers they previously encountered. The College wrote a letter to the FDA in support of PRE-PEN® and penicillin testing as a public health need. Recently, in an unusual move by the FDA, PRE-PEN® received a waiver – under the public health and barrier-to-innovation waiver provision.

“FDA has determined that, given the nature of the PRE-PEN® product, and its potential role in facilitating good antibiotic stewardship of existing antibiotics, it is appropriate to depart from the standard analysis recommended in the Waiver Guidance regarding whether a waiver is necessary to protect the public health. …FDA finds that a waiver is necessary to protect the public health because it helps assure that this important diagnostic drug is available as one tool to help combat antimicrobial resistance.”

We will keep membership informed as we learn more. Also, check out the College’s Penicillin Toolkit, filled with free resources to help you conduct penicillin testing.