The Health and Human Services published its semiannual regulatory agenda and guess what popped up on review? The proposed date of finalization of the Rule on label changes that can be made by an ANDA holder relative to newly acquired safety information is listed as December 2014.
Looking more typical of a December number of ANDA submissions, the May 2014 number of 134 is just a blip before (what we believe will be) a very big June. Remember that firms will be hustling to get ANDAs in before the new stability requirements go into effect on June 20, 2014.
With the approval of only 20 ANDAs in May (information derived from the CDER application approvals report), a statistic that is sure to give CEOs heartburn, the industry may start to question the GDUFA goals, unless many more ANDAs are driven to approval. As I have written before, Complete Response Letters (CRL) are the measure of GDUFA success based on the GDUFA metrics, but you can’t market products that receive Complete Response Letters. If I am not mistaken, the 20 monthly approvals are perhaps the lowest since the generic drug scandal back in the late 1980s and early 1990s.
In the Federal Register (FR) Pre-Publication listing this morning, FDA is announcing the issuance of a Draft Guidance entitled, Abbreviated New Drug Applications: Content and Format of Abbreviated New Drug Applications. The FDA says in the FR notice that “[I]n an effort to increase the number of original ANDAs that the Agency can receive upon initial submission and to decrease the number of review cycles required to approve an application for marketing, FDA prepared this Guidance on improving the quality of original ANDA submissions. FDA is committed to providing comprehensive assistance in the early stages of the application process to ensure that an original ANDA contains all information necessary for FDA to complete its review in one review cycle.“
FDA issued a Draft Guidance, entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification which describes the proper means of notification of FDA by trading partners of the potential suspect products. The requirements under the Drug Supply Chain Security Act (DSCSA) will kick in on January 1, 2015 and also requires firms to identify other immediate trading partners of their suspicion. The Guidance defines trading partners as manufacturers, repackagers, wholesalers or dispensers and requires the notice to be given to FDA within 24 hours of identifying a suspect product.
In the first two years of GDUFA, the Office of Generic Drugs (OGD) DMF review team has been hard at work clearing up the backlog of DMF reviews and trying to figure out how to stay ahead of the game once the GDUFA metrics kick in in 2015. OGD did not want to penalize GDUFA submissions based on DMF submissions too severely because the DMF review process was so dramatically impacted and adjusted once GDUFA went into effect. So for years 1 and 2 of GDUFA, OGD exercised some regulatory flexibility in establishing a workable system. Now OGD has some advice for ANDA applicants that must be incorporated into your development and submission plans before your application is submitted.
The Office of Generic Drugs (OGD) is now receiving help from other CDER components in its battle to get the supplement backlog down. In May of 2013, OGD reported just fewer than 6000 supplements in its backlog. Today with a little help from their friends, the total supplemental backlog stands at less than 4000. What we don’t know is how many of the actions that took the supplements off of the OGD clock were Complete Response letters versus approvals.
FDA typically requires safety and efficacy to be demonstrated in humans, but there are times when exposure of humans to toxic therapeutic substances may be impractical and ethically impossible (e.g., antidote for nerve gas treatment, nuclear threat, biological, chemical or substance that would otherwise causea life-threating condition or poisoning [e.g., snake venom, virus, industrial chemicals]). The FDA has released a newly revised update to its previously issued 2009 Guidance on this topic.
Usually I concentrate on ANDAs received and the numbers approved as a measure of the Office of Generic Drugs’ (OGD) progress, but this month, let’s just mention that there were 41 full approvals and 7 tentative Approvals and, as the table below reveals, OGD received 74 ANDAs in April 2014. By the way, OGD reported issuing 100 Complete Response Letters in April 2014.
I have been getting lots of calls and questions on my blog post of May 15, 2014 on clarification of the stability guidance particularly on the issue of primary stability batch packaging. Apparently, the Office of Generic Drugs (OGD) has also received e-mails on this issue as well. So to clarify the clarification, here goes!
