Good News on Supplement Backlog Outlined at GPhA/FDA CMC Workshop

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.

Use of Animal Rule Discussed in Revised FDA Guidance

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.

April OGD Statistics Just Published – Let’s Look at the Numbers a Bit Differently

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.

Buyer Beware! That Legitimate Looking Prescription Site May Cost You Your Health

In a coordinated enforcement action involving the FDA, US Customs and Border Patrol, along with international agencies like Interpol and enforcement and regulatory bodies from 111 countries, action was taken against web sites that “sell unapproved prescription drugs to US consumers.” This is part of an ongoing effort of a program termed Operation Pangea.

Salonpas Pain Relief Patch Petition Does Not Provide Full Relief Sought by Petitioner

In a petition response issued on May 23, 2014to Hisamitsu Pharmaceutical Company, the FDA partially approved, but mostly denied the requests of the NDA holder for Salonpas (menthol and methyl salicylate 3%, 10%) Patch in a petition submitted on January 6, 2010. While the response did not come as much of a surprise relative to the NDA holders asks, the fact that the petition was submitted in 2010 and is just now being responded to is somewhat a matter of conjecture.

FDA to Give Industry Heads Up on Finalizing Q&A Guidance on Stability Testing for ANDAs

With about one month to go before the Office of Generic Drugs (OGD) new stability requirements go into effect, a one hour briefing by invitation will be held on May 15, 2014 to discuss the new requirements. It will likely touch on the Draft Questions and Answers Guidance ANDA: Stability of Drug Substance and Drug Products, with (hopefully) an emphasis on any clarifications or revisions that have been made to the final guidance (to be published soon).

Revised Q&A on Stability Issued – Clarity Provided on Some Issues But Questions Still Remain

The Revised Q&A Guidance on stability for ANDA drug products and drug substances was posted on the CDER web page today (here). While the Agency did a good job in terms of some of the clarifications requested by questions submitted in response to the initial document, there are still some unanswered questions that may require clarification to the clarifications!

FDA Acts to Prevent a Shortage Situation for an Emergency Drug

On May 13, 2014, the FDA took the third in an unusual series of evaluations to extend the expiration date of certain lots of the drug DuoDote Autoinjectors (atropine and pralidoxine chloride), a drug indicated for the initial treatment of poisoning by organophosphorous nerve agents and insecticides. The manufacturer of the drug product notified FDA of problems relative to under-dosing or failure to activate associated with a small number of its autoinjectors. The FDA responded with a letter (here) indicating that the Agency would exercise enforcement discretion and would, based on information provided by the firm, extend the expiration date for one year beyond the current established expiration date. FDA also noted that the firm would not need to revise the expiration date on the actual packaging.

Confused About the Force of FDA Draft Guidance? You Are in Good Company!

The issue of when to apply FDA Draft Guidance has always been a bit confusing and sometimes an amusing subject. FDA Guidance (whether in draft or final form) is supposed to represent the FDA’s current thinking on a specific matter. If the Draft Guidance is newly issued and is still within a reasonable comment period, then it may be best to contact FDA to see if the Guidance is likely to change. Sometimes you can look at the comments submitted to the appropriate Docket to see if there appears to be controversial issues raised by the industry or other government components. The real problem comes when a Draft Guidance is issued and the comment period has passed and months or years go by where the Guidance just sits there in limbo before being finalized.

Agency Rules Final Approval Date Starts NCE Exclusivity, Even if Firm Can’t Go To Market

In a (not unexpected) petition denial, the FDA confirmed the statutory requirement that the 5 year New Chemical Entity (NCE) starts on the date of the letter approving the NDA. While this has long been the standard, this case does have a wrinkle that at least two firms, Eisai and UBC, argued in almost identical petition requests. The products in question were substances with abuse potential and also clearly qualified as first time approvals of the drug entity that guaranteed them 5 year NCE. However, because they were controlled substances, there was a need for the Drug Enforcement Administration to formally schedule the product prior to the firms actually being able to market them, even though the firms had final FDA approval in hand.

Patent Reissue- How Does it Impact 180-day Exclusivity 30-Month Stays? FDA Split the Baby

In a letter issued April 24, 2014 to ANDA applicants for Celecoxib, the FDA explained its rather complicated view of how to treat reissue patents as they relate to 180-day exclusivity and 30-month stays. And, in this case, the FDA did not provide a decision on 180-day exclusivity for any Celecoxib applicant because exclusivity determinations are not made until an ANDA that may be subject to either 180-day exclusivity or may be blocked by such are approved. In the former case, FDA would indicate the eligibility for the 180-day exclusivity, and, in the latter, would issue a Tentative Approval letter indicating that the application (while meeting all other approval requirements) cannot receive final approval due to another applicant being eligible for 180-day exclusivity. As things stand today, there are three firms that have tentative approval letters (Mylan, Teva, and Watson).