I’m sorry… I truly am. I had every intention of writing something uplifting to kick off Food Allergy Awareness Week, but I’m left with little more than anger and resentment at the failure of the institutions tasked with keeping our families safe.
As a community, we’re on the cusp of a national tragedy as the sources of the epinephrine auto-injectors we rely on dry up throughout the country. Why is it that two of the three manufacturers who market them can’t get their devices out the door? We don’t know. All we know is that Kaleo’s Auvi-Q is the only game in town now that Pfizer and Impax have imploded, unable to deliver the products they spend millions marketing to assure us are safe, reliable, and available to use.
Despite an e-mail campaign whereby 300+ of our readers so far have written to the company demanding answers, Pfizer continues to spew their tired company response:
We are currently shipping product; however, supplies may vary from pharmacy to pharmacy. The FDA has not announced a shortage in the US.
We understand how important this potentially life-saving product is to patients, and we are working closely with Mylan to monitor supply levels so patients have access to epinephrine auto injector products.
- Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21CFR211.192).
- Your firm failed to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product (21 CFR 211.198(a)).
- Failure to adequately analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems, as required by 21 CFR 820.100(a)(1).
- Failure to adequately establish and maintain procedures for verifying the device design, as required by 21 CFR 820.30(f). Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.
How are we as a community supposed to trust EpiPen once adequate supplies return to the shelves? Why isn’t Pfizer out in front of this problem, reassuring their customers by providing full transparency and a cogent strategy for addressing their manufacturing and procedural woes? WHAT IS GOING ON?
The FDA itself is by no means absolved from mishandling this shortage. While we were reporting empty shelves and consumers throughout the country were panicking because they couldn’t renew their prescriptions, the FDA dragged it’s feet, remaining silent until prodded by FARE to do or say something. Finally, the agency issued a proclamation that “spot shortages” were ongoing, of little consolation to the giant swaths of our nation where EpiPens and Adrenaclicks are increasingly unavailable.
And turning to the market where competition is supposed to quench demand, where is Symjepi? You know, that pre-filled epinephrine syringe that’s not quite a true auto-injector that was supposed to drive down prices by providing a low cost option to the myriad professionals who must be prepared to administer epinephrine in an emergency? As of this writing, the company STILL hasn’t found a partner to commercialize the product despite FDA approval. Way to run a company, Adamis!
While the advances in therapies and diagnostics we often report on bring families like yours and mine much needed optimism for a future devoid of fear of food allergies, I can’t help but look on in horror as our pharmaceutical industry and the agency charged with overseeing them are failing us today.
And I haven’t even mentioned a healthcare system that excludes many from affording epinephrine auto-injectors even when they’re available. Let that sink in: many are forgoing epinephrine in order to put food on the table and a roof over their heads.
During this week dedicated to fostering awareness of the unique problems facing our community, teal ribbons and proclamations are not enough. We need accountability from the very institutions that are supposed to ensure adequate availability of safe, effective, affordable, and reliable drugs to keep us alive until those therapies bear fruit.
I closing, I urge you to write to Pfizer! Call your representatives! Complain to anyone with the power to effect change! Let’s turn up the heat by turning Food Allergy Awareness Week into Food Allergy Action Week!