The GDUFA II Program Fee Estimates – Gulp!

Today, FDA announced the current data they are collecting from which the “Program Fee” will ultimately be calculated for the three tiers of approved application holders.  And while it is really not much of a surprise, based on some back of the envelope calculations we have done in the past, it may be a bit of a shock to some in the medium and highest tiers. 

OGD Approvals Look About the Same

According to our tracking of OGD approvals for March 2017 through the daily listings of approvals on Drugs@FDA: FDA Approved Drug Products (which was fairly close to the final numbers last month), there appears likely to be 59 full ANDA approvals and 16 tentative approvals reported when OGD issues final numbers in its Activities Report of the Generic Drug Program in a few days.

First Time ANDA Approvals Announced for 2017

FDA announced (here) that, so far this CALENDAR year through March 24th,  the Office of Generic Drugs has approved 11 first-time generics. That appears to be a good start for the first three months of the year.  All the first-time approvals can be viewed at the link above.

Remember that not all first approvals will immediately be available in the marketplace. 

This Could Make Your Head Spin

Seems like almost every day a new Federal or State law is proposed to deal with drug pricing for both brand and generic pharmaceuticals. .  The latest entries that appear to be making progress through the legislative process are from the states of Washington and Nevada. One can just imagine that there are specific differences in all the state and federal bills floating around,

Paul F. Vogel retires as Chairman of the Board, Richard S. Bowles, III, Ph.D. assumes the role

Paul F. Vogel has announced his retirement as Chairman of the Board of Lachman Consultants, effective March 31, 2017. Paul plans to spend more time with family and his many personal interests, following a 44-year career that included 21 years at the U.S. Food and Drug Administration followed by 23 years at Lachman Consultants. Richard S.

Hey, Wait a Minute Here! Are the UFAs in Danger?

Just as the various User Fee Acts (UFA) go to congress for mark-up and reauthorization, a proposed administration budget contains a suggested doubling of fees charged for medical product reviews.  Am I seeing this correctly?  Industry and FDA have worked tirelessly over the last year and a half to get the various User Fee programs negotiated for reauthorization and at the 11th hour,

BE Recommendation Revision Again Demonstrates OGD Recognition of Q1 and Q2 Value

OGD has revised its bioequivalence (BE) recommendation for rifaximin 200 mg and 550 mg tablets. Quite interestingly, the requirements for products that are qualitatively and quantitatively (Q1 & Q2) the same as the reference listed drug (RLD) will have a reduced burden and may eliminate conducting bioequivalence studies with clinical endpoints (albeit pharmacokinetic [PK] studies and in vitro testing will still be needed).

Abuse Deterrent Products – The Debate Continues


We don’t like to mention specific products in this blog, so let’s just say an FDA panel yesterday gave a less-than-stellar review of the benefits of an abuse deterrent product by stating that the benefits of a firms’ long-acting opioid pain reliever no longer outweighed its risk. A crushing blow to the product for certain.