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Most Frequently the Real Causes of Drug Product Shortages Can't Finger Point

May 10, 2011

Analysis of:Attention Disorder Drug Shortage Prompts Finger-Pointing | online.wsj.com

Both Shire and the DEA are blaming each other. The DEA points (no pun intended) out its readiness to approve quota increases and Shire, that the DEA takes too long. In most cases, the real cause of a shortage is due to an unanticipated and/or unknown change in the physical-chemical properties of the API or an excipient that effect the processing or the quality properties of the drug product. Unfortunately they are silent, often requiring investigation or additional development work to overcome.

First Generic in Class - Added Advantage in Sales

July 14, 2010

It is well known that the first approved generic for a drug product has the benefit of 6 months exclusivity which translates into a fantastic monetary reward. However, health insurance adds an additional advantage that is new.  The lower co-pays associated with the first in class generic are attractive incentives to switch to the newly available generic.

Outsourcing R&D: The other benefits

June 28, 2010

Contract Vendors specializing in R&D services can save sponsors more than money. Thy provide experience, expertise, space and equipment on an as needed basis. Charges accumulate only when the project is active, and these resources need not be mainained by the sponsor.

Topiramate generics - anaother view

April 9, 2009

Analysis of:Ranbaxy, Aurobindo get US FDA nod for epilepsy drug | economictimes.indiatimes.com

TOPAMAX(R) brand topiramate generated about $2.2 billion sales annually.  The emergence of generic topiramate while a temporary advantage for those who purchase it, takes away $2.2 billion in income from an innovator Pharma Company, Ortho-McNeil-Jansen (J&J), as well as a large number of talented R&D personell who previously worked for OMJ. 

A merger that makes sense.

March 3, 2008

Analysis of:CollaGenex Pharmaceuticals Agrees to $420M Galderma S.A. Takeover | www.fiercebiotech.com

CollaGenex is a smaller, virtual company with 3 marketed products and 1 in development.  Galderma is a larger company that markets 4 x as many products, has an international presence, R&D laboratories, and products in development.

FDA faults drug plants; AP faults the FDA; Identify the Root Cause(s) and Industry heal thyself.

February 14, 2008

Analysis of:AP IMPACT: FDA faults drug plants | seattlepi.nwsource.com

The Associated Press (AP) story regarding contamination (adulteration) blames the FDA for having too few inspectors to oversee the production of pharmaceutical in Puerto Rico.  The FDA response is that the problem is not different but proportionate to what occus in the US mainland.  (1) Is it really the fault of the FDA?   (2) Is the AP exaggerating a bit?  (3) Who or what is to blame?  (3) Find the Root Cause and fix the problem.

Let the People Decide

January 25, 2008

Analysis of:Upbeat diagnosis for clinics, Specialists in other states reject qualms about CVS units | www.boston.com

I offer my opinion as a part time pharmacist who works for CVS as well as an independent. The services offered by the mini-clinics include treatment for specific acute illnesses and physical examinations for participation in scholastic sports. Let's let the public decide. 

Johnson & Johnson Needs New Pharmaceutal Products (aka New Chemical Entities)

August 3, 2007

Analysis of:Johnson & Johnson Plans to Improve Overall Cost Structure, While Continuing to Invest in Opportunities for Sustained Profitable Growth | www.pipelinereview.com

The latest news from Johnson & Johnson is not related to the approval of a new pharmaceutical entity (NCE) but that they will decrease head count. The Cordis stent initiative has been disappointing because of studies showing no advantage resulting in decreased sales. As each Johnson & Johnson trademarked product goes off patent, there is nothing to replace it and replace its income.

Bureaucracy, More Fed, Less Fed or Just Fed-Up?

July 30, 2007

Analysis of:Fed Feels Pressure to Protect Consumers | online.wsj.com

Every time a Federal Bureau's responsibilities for monitoring and protecting the citizens of this country it becomes more than the original problem.

What are the Alternatives?

July 30, 2007

Analysis of:An Innovation in Health Care Opens at CVS/Pharmacy Stores in Knoxville and Chattanooga | money.cnn.com

CVS Style Nurse Practitioner Treatment Centers might be filling a real need.  Pharmacies sometimes function as a first triage center for medical products.

The Tooth Fairy - A Fairy Tale about a Tooth Filled Drug Delivery System

July 30, 2007

Analysis of:Engineers building drug filled tooth | news.yahoo.com

Those who might comtemplate resolving some problems related to drug delivery where the ability to swallow an oral dosage form or a lack of compliance exists fail to consider the practicallity of a tooth drug delivery system with regard to 1.  Strength and durability. 2.  Tooth volume, mode and frequency of filling. 3.  Drug-device compatability, and mode of refilling. 4.  Mechanism for controlled release.

Outsourcing is part of business dynamics

July 27, 2007

Analysis of:Going Away | www.cfoasia.com

Those who view outsourcing as a dying business assume the absence of business dynamics.  They ignore the possibilities of change and specialization.  If something works it can get better.  If something does not work well, it gets improved or discontinued, and another source is identified.

How generics divert income from innovators

July 24, 2007

Analysis of:Pfizer Signals More Cuts as Net Falls; Abbott Profit Rises 62% on Humira | online.wsj.com

Before generic substitution was mandated, generics provided a substantial income to the innovator companies which helped to support development of new pharmaceuticals.  Income now comes only from innovative products and casues promotion and marketing directed to the newer patent protected products.

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