* For a full account of the circumstances surrounding this serious event;
* What are the implications for patients who use or have used the product;
* How the companies plan to ensure patient safety going forward; and
* How the companies explain their delay in notifying
As we've previously reported, HFA and NHF convened a Safety Summit six months ago to address community concerns relating to a series of drug safety reports that emerged over the course of 2019. The Safety Summit's mission was to "articulate expectations for monitoring, informing, educating, and communicating issues related to product safety," with attention to the role of each stakeholder in the process. Eighty-five stakeholders, including CSL Behring, participated in the summit. It is disappointing that the bleeding disorders community finds itself once again facing some of the very gaps in safety notification standards that were comprehensively considered at the Safety Summit.
HFA and NHF will keep the bleeding disorders community informed as further information is gathered about the Stimate recall.
The HEALS Act does include a second round of Economic Impact Payments (akin to the
* HFA staff participated in the
* * *
Re: Pharmacy-Level Recall of desmopressin nasal spray (Stimate)
Dear Mr. Puglisi and
The National Hemophilia Foundation (NHF) and
We are writing concerning the announced recall of desmopressin nasal spray (Stimate) manufactured by
With this letter, NHF and HFA are initiating an ongoing dialogue so that our organizations can inform the patients we represent about the reasons for the recall, your proposed strategy for handling the recall, and implications for patients who use the product now and in the future. We have some immediate questions for CSL Behring and Ferring and ask that you respond to these questions in writing as quickly as possible.
1. Please describe the specific nature of the product deviation. If only certain lots were affected, please specify which lots, quantify how many vials were affected, and describe how many affected vials were distributed in the
2. What is the basis for Ferring's preparation of a Health Hazard Safety Evaluation and its warning that "there is a reasonable probability that the use of, or exposure to, certain defective units of this product could pose a significant hazard and may cause adverse health consequences due to increased concentrations of desmopressin"?
3. Have Ferring and/or CSL Behring received notice of any adverse events affecting patients who used the product, either in the
4. Please describe, specifically and in chronological order, how and when the product deviation was discovered, and what steps are being taken to correct the deviation and prevent it from recurring.
a. During what time period were the affected products manufactured?
b. Please provide a detailed timeline with dates of
i. Ferring's discovery of the product deviation
ii. Ferring's notification of CSL Behring that there was a problem with the product
iii. Ferring's notification of the
iv. Ferring's and/or CSL Behring's notification of
5. Has Ferring halted production of the product?
a. If yes, do you expect that production will resume? When?
i. When would
b. Has Ferring and/or CSL Behring notified the FDA of possible shortages of the product?
6. What actions are Ferring and/or CSL Behring taking to accomplish the recall as well as ensure that patients in the
a. Please explain why CSL Behring and/or Ferring determined that a pharmacy-level recall would be the appropriate level of recall in this instance.
b. Does a pharmacy level recall mean that Ferring and/or CSL Behring will take no steps to identify and/or notify affected patients?
c. How and to whom should patients return the product? Have pharmacies been provided with instructions on how and where to return affected product?
d. Has Ferring and/or CSL Behring submitted notice of the recall to the Patient Notification System (PNS)? If so, when will the PNS notification be distributed? If Ferring and/or CSL Behring do not plan to activate the PNS, why not?
e. Please describe how Ferring and/or CSL Behring are announcing the recall and explain your reasons for using different modalities (e.g. email vs. FedEx) to contact different groups of stakeholders.
7. What, if any, medical guidance is Ferring and/or CSL Behring providing to
a. Are you recommending any specific laboratory testing?
b. Are you recommending that patients transition to another treatment?
8. Based on available website information, recalls were announced in other countries as early as
We look forward to your prompt response with answers to these questions. We hope to keep open lines of communication as this situation develops. Please contact