Last week I wrote about how the era of Complete Response Letters (CRLs) with which CDER has replaced "Approvable Letters and "Not Approvable" Letters opens up some new communications challenges for those working in or on behalf of a company that receives a CRL.
To that end, BioDelivery Sciences provides a very good example of a skillfully crafted press release that communicates the terms of the letter to provide some comfort to investors and analysts about the contents, without reprinting the letter.
BioDelivery Sciences had submitted an NDA for the approval of BEMA™ Fentanyl, which will be marketed in the United States as ONSOLIS™ (fentanyl buccal soluble film). The FDA issued a CRL and on August 28 the company announced the receipt of it.
The headline of the press release is very bold and does not even mention the CRL –
BioDelivery Sciences Anticipates First Half 2009 Approval of BEMA(TM) Fentanyl (ONSOLIS(TM))
which is an interesting move to make. When I went to look for the press release about the CRL, it did not immediately occur to me that the press release was even about the letter. Then immediately after the opening sentence announcing receipt of the CRL, the company said:
"The FDA has requested that the Company make modifications to the submitted risk management program. All aspects of the review were complete and no deficiencies were noted in chemistry, manufacturing and controls, nonclinical, or clinical efficacy/safety. The Company will submit the requested information and anticipates a first half 2009 approval."
Thus in the first paragraph, the company sounded an optimistic note and conveyed that there were no issues of safety or efficacy and no deficiencies in manufacturing and controls. That sends a signal that the FDA has bothered to cover that ground and has approved a brand name – why would the FDA bother to inspect and allow a brand name if it weren’t anticipating eventual approval?
The next paragraph of the press release explains that the FDA has requested that the risk management program (RiskMap) be converted into a Risk Evaluation and Management program (REM) and then states that the company had anticipated this and proactively began working on the conversion.
It was a well-done release and provides a good basis for further learning and insights into responding to CRLs.
Last week I wrote about how the era of Complete Response Letters (CRLs) with which CDER has replaced "Approvable Letters and "Not Approvable" Letters opens up some new communications challenges for those working in or on behalf of a company that receives a CRL. 