President’s Budget Has a Hidden Change to Hatch-Waxman — Watch Out.

There is a proposed change to 180-day exclusivity which is awarded to the first -to-file (FTF) applicant with a paragraph IV certification.  The proposal would trigger the 180-day exclusivity period if a subsequent applicant obtains tentative approval prior to the FTF applicant gaining final approval.  While this on its face may in some instances appear to permit a generic applicant to enter the market faster,

OGD Busy on the Bioequivalence Guidance Front

In the newest posting of bioequivalence (BE) guidance documents (here),  the Office of Generic Drugs has issued 35 new guidance documents and revised 22 previously issued guidances.

We have previously posted about the impact of revised BE guidances and now there are 22 more that firms must review to see if any of the changes recommended will mean more work or repeat studies.

Ah Ha!  Guidance from FDA on Elemental Impurities Issues

It looks like our guess was correct, and it also looks like OGD either liked our suggestion or, on its own initiative, decided to provide guidance to ANDA applicants concerning the best way to handle the submission of documentation on meeting the elemental impurities issue!

The one pager (here) discusses the fact that submission of the information as an unsolicited amendment as soon as possible,

FAQ on Patents and Exclusivity – A Primer for Newbies and More

The FDA published a Frequently Asked Question (FAQ) on Patents and Exclusivity on Friday (here).  Turns out it is a very nice primer for those new to the generics or 505(b)(2) game or those that need a refresher in the ins-and-outs of two of the most contentious and confusing issues associated with the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman Act).

OGD Updates December 2017 Statistical Report

I must honestly say that there is not a lot that stands out in this update for the December ”Activities Report of the Generic Drug Program Monthly Performance” that we have not either already commented on, or where there appears to be a significant trend, albeit there are a couple of issues that we point out for further scrutiny when more data for this FY is available.

Is There a New Tactic for Generic Manufacturers to Use to Hit a Bullseye?

We have long heard arguments that traditional and Outsourcing compounding entities represent unfair competition to the generic drug industry and that they frequently circumvent the Federal Food, Drug and Cosmetic Act (especially the 2013 Drug Quality and Security Act, DQSA).

A new tactic that has been recently used by a generic firm to protect its approved product was to sue FDA on the grounds that the FDA Interim Policy on compounding using bulk drug substances (APIs) under section 503B of DQSA is contrary to law. 

Thought FDA Was Tempering Back Its Oversight and Enforcement of Compounding Operations? Think Again!

Commissioner Dr. Scott Gottlieb shared FDA’s 2018 Compounding Policy Priority Plan (here) providing an overview of the Agency’s key priorities to implement (and enforce) the federal law on compounding (Drug Quality and Security Act [DQSA], signed into law November 2013). He also states that this plan advances FDA’s mission to protect the health and safety of the public.

Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2018

FDA listed 106, either new or draft and/or revised draft guidances that it plans to issue in CY 2018.  This is quite an ambitious agenda!  This is a yearly exercise that FDA does and they have a tendency to come close to meeting their projections; be sure to review the entire list (here) to see if some of your interests will be met or augmented by some additional Agency guidance.

Elemental Elements Appear to Sink January Approvals

On January 11, 2018, we went out on a limb prognosticating that the very low numbers of ANDA approvals in January might be linked to a new USP requirement on documentation of elemental impurities that went into effect January 1st (see post here).  Since that time, the number of approvals has jumped from 2 to 4 (as posted on the FDA All Approvals site [here] through January 16th) but,