Generic Drug User Fee Act (GDUFA) - What will be the implications for the consumer & for the generic API manufacturers based outside NA & EU

20 August, 2011

Posted in Linkedin Answers by Murali Apparaju

For those who remember SOCMA & EFCG making a fervent pitch in 2006 for a level playing field for domestic (read: NA/ EU) and foreign (read India, China) API manufacturers, this is an announcement of their first success & how.....

Two days ago, GPhA, EFCG & SOCMA reached an agreement with US FDA on the proposed final form of the Generic Drug User Fee Act (GDUFA).

While at the conceptual level this act is for higher patient safety through a tighter regulation of Ingredient manufacturer, this also appears to be an apparent back-door strategy to wall-out "old-technology" (read: "No QbD/ PAT" also read: "Cheap") Indian & Chinese API manufacturers in favor of the more-regulated, domestic, safe & costlier? local manufacturers.

(the NY times brief in the above link is titled "A deal to get Cheaper & Safer drugs" - wonder how exactly was this deduced?!)

What do you think GDUFA will eventually achieve/ cause & do you think consumer is the real beneficiary?

Hoping to see some comments here.

Cheers,

Murali Apparaju

NRAchists in gun-afflicted america....

December 2012

My comment on a LinkedIn article on need for Gun Control in USA, I only see the comments now, no article!!, still an interesting read...

http://www.linkedin.com/today/social/comments?articleId=5686805067156422750&offset=15&limit=365&trk=tod2-all-comments

As per the chart, USA has ~90 guns for every 100 people. Despite this startling fact, I still see many below demanding a more scientific & non-discriminatory analysis rather than brooding over the above fact. - know what, to hell with more stats.... it is probability! - the probability of a gun being used is directly proportional to the number of guns that are available for use........ stop kidding yourselves gents & ladies, face it instead & save the kids.

Caste, gender & slur - Quite an explosive cocktail!! :-)

01 March 2009

Wow, this repro' is a dinosaur, way back from 2009!!! - my comment below was on a real flamer of a topic that was originally posted in November 2007 & still going strong with 983 comments amounting to terabytes of sane words & insane rhetoric. I don't want to be another blogger to do the same mistake & hence have disabled comments on this - If you have a compulsive impulse to add to Uday's woes, post your comments on the original site below - cheers, V 

http://udayms.wordpress.com/2007/11/16/brahmin-guys-are-not-lovemarriage-material-says-brahmin-girl/

My observations on the original post (rather on the content of Brahmin Ponnu’s statements) – to keep it simple, I will assume she’s indeed a brahmin ponnu & the feelings indeed are true…

I)

“Familiarity breeds contempt – Over exposure to a certain kind makes one nauseated – the insider knowledge causing prejudice”

•  Doesn’t this happen in your company, aren’t the insiders the last choice for the new post created & don’t outsiders look eminently more attractive than insiders to the management – this is a similar syndrome.

II)

“Choice of mate instincts keeps changing with age..”

•  At college I’m sure the lure is of big talking, macho & adventurous guys – which an average brahmin male may not demonstrate owing to upbringing.. PHYSICAL & SOCIAL QUALITIES COUNT WHEN ONE IS LOOKING FOR A PRINCE ON THE WHITE HORSE TO TAKE YOU ON A DATE – SWEEP YOU AWAY?….FOREVER?….. THINK AGAIN…
• 5 years down the line, I’m sure ponnu would settle for a Bay area techie in favour of the college stud who may not have settled as well & earning that well – MONEY COUNTS WHEN YOU ARE LOOKING TO MARRY

III)

“The lady’s comments are possibly reflecting the general liberation of minds in either sexes in this modern age…”

•  Perhaps an indication of a growing & general reluctance to accept limitations in partners & aversion to compromise.
• May be polygamy/ multiple partners is making a come-back… (check out the Axe Deo ad where mixing makes babes better….:-))
• Perhaps, the ever increasing domination of “I” over anything else

IV)

“Brahmin men caught in a time-warp? – starting to live the stereotypes showcased by society, films??

• Someone said this before, buck-up guys, change, work-out, change your attitude to looks, you have the basics in place, all you need to do is polish the stuff..
• Forget about the simplicity your grandfather so believed in — he was in a different era… re-package your body, spirit, get attractive to the opposite sex…
• I’m sure those who have done/ doing this already see the results, non-brahmin girls falling for them & yearning for them… (all the above applies still to these wide-eyed wonders, grass is greener on the other side of the fence)
• finally it’s an appraisal, part-true, part-crap —- well…take some good out of it…. emerge better… don’t justify & get labelled more harshly…

all the best…

3200% premium for innovation!!

April 2012

Discussion posted on Pharmaceutical Discussion Group on Linkedin

http://www.linkedin.com/groups/PhRMA-says-price-as-trigger-38263.S.105200659?qid=8b279aac-88f8-4538-b788-061d5b62bd1d&trk=group_search_item_list-0-b-cmr&goback=%2Egmr_38263

PhRMA says price as trigger for compulsory license is not provided for in TRIPS - wonder if TRIPS provides for 3200% premium for innovation?

Reference article:

PhRMA’s Special 301 Comments on Indian Compulsory Licensing...infojustice.org

PhRMA’s Special 301 comments to the U.S. Trade Representative include a section on the compulsory licensing provisions in India’s Patents Act.  PhRMA recommends that “India should ensure that the CL provisions comply with TRIPS...

Why won't Gates spend a few more cents (per dose) on non-mercury biocides & shut-up the vaccine detractors?

April 2012

Discussion posted on Pharmaceutical Discussion Group on LI - by Murali Apparaju

http://www.linkedin.com/groups/Why-wont-Gates-spend-few-38263.S.109547291?qid=8b279aac-88f8-4538-b788-061d5b62bd1d&trk=group_search_item_list-0-b-cmr&goback=%2Egmr_38263

I remember trying to promote ProClin (Supelco) as a viable safe non-mercury alternative to Thimerosal (Sigma), both Sigma-Aldrich products for the uninitiated - I've seen that despite obvious interest & some intention, vaccine manufacturers solely surviving from the bulk purchases by the likes of gates foundation continued to use Thimerosal owing to the cost-advantage it offers in a climate of 50% price fall each year… - 7 years hence, I’m wondering if all the noise on autism by Trump motivated Mr. Gates to at least encourage his supplier base to start looking at safer alternatives to Thimerosal albeit at a few cents higher per dose?... if not, why bill?

Reference video 

Why Bill Gates Is A Hero And Donald Trump Is A Zero - Forbes forbes.com

Donald Trump should stop creating fear about vaccines, which are safe.

Review of Mahendra Ramsinghani's "The Business of Venture Capital: Insights from Leading Practitioners on the Art of Raising a Fund, Deal Structuring, Value Creation, and Exit Strategies

21 Aug 2012

Review Posted on Amazon.com
http://www.amazon.com/review/R2Q6WI836ZOCJT/ref=cm_cr_pr_perm?ie=UTF8&ASIN=0470874449&linkCode=&nodeID=&tag=

A 'must' for all those who fancy the bucket & probably the ocean too!, August 21, 2012 By Vishrasayan As someone aiming to venture into VC, and moving quite laterally at that, I was on lookout for a book that not only strengthens my basics but would also help me develop my own perspective of how the ecosystem behaves & how I could synergize and coexist with the same - `The Business of Venture Capital..' by Mahendra Ramsinghani fit the bill perfectly. While essentially structured as a comprehensive guide to the VC process, the author took pains not to make the style pedagogic & peppered it liberally with quotes, case-studies and his own witty one-liners that helped the overall learning process while not getting your goat. Even as I persisted through all chapters, I did realize that the composition of each chapter allows one to skip a chapter or two & still make sense of the flow. The book ends with a quote by David Ogilvy "Don't bunt. Aim out of the ballpark. Aim for the company of immortals". Interestingly (for me at least...), the epilogue starts with the sentence, "At its core, VC is truly an apprenticeship business" - This seeming contradiction/ irony is what defines the approach taken by the author Mahendra Ramsinghani in establishing that a true venture professional is essentially a lifelong apprentice who nonetheless perpetually aims to challenge the boundaries of a conventional success. Highly recommended for aspiring & established VCs and anyone else who fancies the `bucket' in whichever way!

The clinical attrition of INX-189 post a 2.5 billion acquisition - are investors into life sciences really looking at where the buck is headed?

October 2012
Discussion initiated onGlobal Private Equity & Venture Capital group on Linkedin

http://www.linkedin.com/groupItem?view=&gid=48513&type=member&item=156370875&qid=b8ecfd7b-c40b-491c-9e3d-f3f42e0780e4&trk=group_search_item_list-0-b-ttl&goback=%2Egmr_48513

Agreed BMS is no VC & acquisition of Inhibitex at 2.5 billion was more a survival tactic, but probably the outcome could be such for many investments into the life science (drug discovery). I believe the investor due-diligence of the investee should go beyond market projections of the pipeline candidates & a rational assessment of the druggability & clinical longevity of the pipeline candidates is what should interest the investor the most – not sure if this happens to the extent required?

Would love to hear what the investor community feels about this.

----------------------------------

PS: My love went totally unrequitted :-)... zero response