Approvable Letter Update

J0385349While it seems that the rate for approvable letters has slowed down over last year, it is nevertheless brisk and I’ve been a bit remiss on keeping up to date.  As noted recently, the FDA has acknowledged that it will be slowing down approvals and it probably isn’t prudent to expect this trend to end during 2008. 

In addition to approvable letters issued, Labopharm has heard an outcome to the company’s curious and determined appeals to an FDA earlier decision to issue an approvable letter for its application for Tramadol.  As one might expect, the appeal was not granted.   According to the company’s statement in their press release – "Procedurally, Dr. Douglas Throckmorton, M.D., the FDA’s Deputy Director, Center for Drug Evaluation and Research, agreed with Dr. Jenkins, M.D., Director for the Office of New Drugs, Center for Drug Evaluation and Research and denied the appeal. However, he suggested a regulatory path forward. Dr. Throckmorton has suggested that the Company submit the analysis put forward by Dr. Jenkins in his letter of earlier this year."  The company now plans to respond by the end of the week. 

Now we know where the appeal process can get you.  In the meantime:

  • Merck & Co., Inc Receives Complete Response Letter from the Food and Drug Administration for Use of GARDASIL® in Women Ages 27 through 45 – The company announced on June 25 that a CRL (also known as an "approvable letter") that stated "there are issues that preclude approval of the supplement within the expected review timeframe."   The response also referred to the sBLA for the use of compound against non-vaccine types (cross protection) and stated that "the data submitted do not support extending the indication for GARDASIL to include non-vaccine HPV types."  The company did not say what obstacles stood in the way of the approval of use in older women and that they would be submitting a response in July. 
  • Indevus Receives Approvable LetterThe company announced on June 30 that it had received an approvable letter for  NEBIDO(R) is a long-acting depot preparation of testosterone undecanoate under development for the treatment of male hypogonadism.  The press release stated that the FDA was asking the company to respond to "clinical deficiencies" related to the product – which is vague to say the least.  Specifically, the release said, that the agency has requested the FDA has requested follow-up data from on-going U.S. and European studies in which patients are being treated with NEBIDO on an extended basis and most of which will be completed within a year.
  • Akorn Gets Approvable Letter on June 6 for Akton Opththalmic Gel – The company announced the receipt of an FDA approvable letter for Akten® Ophthalmic Gel 3.5%, an ocular topical anesthetic drug product that identified what were referred to as "several minor CMC deficiencies" and stated that a response will be submitted to the FDA within ten days and that no additional clinical data is required.  No further press release was issued to say that the company had submitted the response.


This entry was posted in Approvable Letters. Bookmark the permalink.

2 Responses to Approvable Letter Update

  1. Kerry Donahue says:

    CR letters, also know as approvable letters are denials.
    CR/aprovables give the applicants no greater rights than if their application was denied. Its an FDA joke.
    Following a CR or approvable letter the company has to file a new application for approval, same as if there was a denial.
    The use of CR/approvables is a sham. They are a mechanism created by the FDA themselves to limit or deny the applicants and the patients due process rights.
    The FDA rarely gives an outright denial because that would be considered a final decision (reviewable by Congres or the Courts). Reviewability means a more transparent and accountable FDA, which of course the FDA does not want.
    On July 29th the Federal Court three Judge panel in Cincy will hear arguments regarding this issue in the case of CareToLive vs. FDA and then decide whether this mechanism being used by the FDA can still be an effective FDA tool or not. They will decide the ripeness and finality issues as related to the Provenge decision.
    A ruling against the FDA will result in the FDA’s disontinued use of approvable letters as their reason for using them will no longer exist. It wil be back to approve, deny or conditional approval as the three choices.

  2. kyoto27 says:

    The other joke Kerry is that the FDA keeps no records of which individuals within the agency approve or disapprove a drug, and why?
    For example, if an FDA’s public Advisory Committee (AC) hearing recommends the approval of a new drug and the FDA later issues a Complete Response Letter is there public access or a public record kept at the FDA regarding the “non-public” closed door hearing (s) that resulted in the FDA overruling such a positive AC panel?
    As we all know billions of dollars –not to mention the lives of those living with advanced prostate cancer were at stake in the FDA’s decision to issue the CRL regarding Dendreon’s Provenge. If this was a Supreme Court decision we would at least know who voted; how they voted and a summary of the arguments for/against.
    I cannot believe there are no checks and balances within the FDA to prevent individuals from being bought. The thought of a paperless world within the FDA of ‘winks and nods’ to issue complete response letters, approve or disapprove drugs is more than alarming…
    And why is the FDA unwilling to even answer the simple question of whether there is a public record available (even if one is “unavailable” to the public now) of the non-public meeting? And if there is no public record, is the FDA telling Americans that it does not keep transcripts of all the arguments, notes and votes of those who attend the “non-public” meetings? And who would that benefit? It would also be nice to know who calls the non-public meeting(s) to order, and who decides who attends the “non-public” meeting(s)? And finally, is there even a meeting?
    Considering the FDA regards itself as a ‘science based agency,’ why is the FDA unwilling to have its science based arguments made public –along with their complete response letter. That, IMO, would be a complete response.
    As it is now, the public AC panel hearing is merely a sham and the “real meeting (s) ” occurs behind closed doors. And worse, there may not even be any meetings….
    So much for good science; so much for government transparency.
    Taking the “due” out of “due process” is not just a ‘deliberate wrongdoing’ by the FDA –it shreds the entire fabric of this Republic.

Comments are closed.