Business analysis, calculation of the budget in the design of information related to business

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,

Balancing Spheres

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).

Man collapsed after a overdose of drugs, Tablet drugs. In-hand with a syringe

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. 

A Glowing Luminescent  Arrow Standing Out.

Cost and Approvals – A Give and Take

Almost every health-related headline today mentions costs.  Whether it be cost of health insurance, cost of hospital stays, doctor’s charges, and (of course) cost of drugs.  While there are some shockers out there for drug costs, most are in line with expectations.  One of the big problems is that even moderately priced drugs are most expensive if they are not taken,

Business partnership meeting. Picture businessmans handshake. Successful businessmen handshaking after good deal. Horizontal, blurred

Backlog vs. Workload – Why All the Ruckus

Irritation has been building between the Office of Generic Drugs (OGD) and industry over the use of the terms backlog vs. workload, particularly over the last few months.  At the recent Annual Meeting of the Association for Accessible Medicines (AAM), formerly the Generic Pharmaceutical Association (GPhA), the semantics pot almost boiled over.  So why the big debate over the term describing the number of ANDAs OGD has in its court,

Crossroad signpost saying this way and that way concept for lost, confusion or decisions

Good Review Practices MaPP Recertification

The FDA published a recertification of its Manual of Policy and Procedure (MaPP) titled, “Good Review Practices”, MaPP 6025.1 yesterday.  The first iteration of this document was issued in 2006.  This is its second recertification.  In reviewing the document, I was reminded of several calls and discussions I have recently had with my industry colleagues regarding lack of consistency in the ANDA review process.


Cook Serves Up Numbers and Observations

Dr. Kathleen “Cook” Uhl, Director, Office of Generic Drugs told the story of the past, present, and future of GDUFA and how the industry and OGD are doing.  Interestingly, she noted this was the first meeting she had attended where she heard that industry members said they are happy!  Then she noted “you are not really happy,


Association for Accessible Medicines –  What is This?

Today, at the Generic Pharmaceutical Association (GPhA) Annual Meeting, Chip Davis, the CEO of the “former” GPhA announced the rebranding of the association to its new name, the Association for Accessible Medicines (aam).  The change is designed to further the work of the industry group to provide more affordable medicines in both the generic and biosimilars space.


OMB Clarifies Hiring Freeze for FDA

A memo and its attachments was issued on February 6, 2017 to give various position classes, including pharmacist, consumer safety officers, microbiologists, chemists, medical officers, etc., which cover many of the FDA position classifications. Also, there is no freeze of the hiring of Commissioned Corps Officers of the United States Public Health Service.


triple dollar sign - red stencil text on a paper price tag against rustic wood

States Getting into Pricing Issues – Look Out Below!

Seems like every day we see new proposed legislation being introduced into another state’s legislature.  Each one seems to have a somewhat different methodology or focus for controlling and reporting on drug prices.  Let’s think about this.  Everyone wants to strive for lower drug prices.  Remember, in the early 1980’s, the entire nation was focused on reducing health care costs and the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman Act) came along to address drug prices and associated health care costs while providing additional protections for band name drug products.