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College members meet with the Center for Drug Evaluation and Research of the FDA

December 9, 2019

College members meet with the Center for Drug Evaluation and Research of the FDA

On Dec. 2, representatives of the College met with Janet Woodcock, MD, Director, and other representatives of the FDA Center for Drug Evaluation and Research (CDER) to support the need for penicillin skin testing materials in diagnosing IgE-mediated allergy to penicillin in our patient population. Representing the College were James Sublett, MD, FACAAI executive director advocacy and governmental affairs of the Advocacy Council; Michael Blaiss, MD, FACAAI, executive medical director of the College; Niraj Patel, MD, MS, associate professor of pediatric infectious disease and immunology, Levine Children’s Hospital, Charlotte, North Carolina; and Rebecca Burke, JD, the Advocacy Council’s legal counsel.

Use of penicilloyl polylysine (PrePen) and off-label Penicillin G for skin testing leaves a substantial number of patients with penicillin allergy undetected, requiring an additional oral challenge to confirm the patient is not allergic. The College representatives stressed to CDER officials that there is a public health need for better diagnostics for detecting penicillin allergy quickly and safely. The vast majority of people who carry the label of “penicillin allergic” do not, in fact, have the condition.

In the name of antibiotic stewardship, it is essential to accurately diagnose penicillin allergy. In doing so, the use of broad-spectrum antibiotics can be decreased, patient health outcomes improved, resistance to antibiotics reduced, and an overall reduction in costs will be achieved.

Niraj Patel, MD; Rebecca Burke, JD; Michael Blaiss, MD; and James Sublett , MD, attend a meeting with CDER representatives.

The College representatives responded to questions from CDER. The agency official inquired about how allergists and other physicians use the approved penicillin testing materials now; why having better skin test reagents – with all the major and minor determinants of penicillin and amoxicillin – would improve the accuracy of the testing; and how this improved testing reagent could lead to more patients having the penicillin-allergic label removed from their charts.

CDER officials expressed appreciation to the College representatives for coming to their Silver Spring, Maryland office and providing them with the perspective of the practicing allergist on this important public health issue.

We are pleased with the outcomes of the meeting and hope it will bring approval of better allergy skin test materials to the allergist for our patients in the near future.

The Advocacy Council – we have you covered.

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