Rise and shine, everyone. Another day is on the way. What will this one hold in store? Certainly, those meetings and deadlines are looming. To prepare, we are quaffing the mandatory cup of stimulation. Feel free to grab a cup yourself. By the way, we are hosing a webinar on Drug Safety on Nov. 16 (see here), so please join us. Meanwhile, here are a few tidbits. Hope your day goes well...
Amlyn Can Withstand Diabetes Setback, CEO Says (Dow Jones)
Novartis' Onbrez Better Than Pfizer COPD Drug In Study (Reuters)
Breakthrough Could Lead To Cure For Common Cold (BBC)
Big Pharma Avoids Diet Drugs (Dow Jones)
Lilly Loses Bid For Gemzar Patent Rehearing (Indianapolis Business Journal)
FDA Needs More Time To Review Bristol Melanoma Drug (Dow Jones)
1 Comment
Just a heads up as you might walk a mile in my shoes.
Big Pharma Embraces Branded Generics http://seekingalpha.com/article/233592-big-pharma-embraces-branded-generics?source=yahoo
While not all generics are the same - the approval process is. I find it difficult to believe a company can legally promise better quality without comparative studies, and to charge more because their name is on a bottle. But I guess if people want to buy that idea it's their right to do so. Many people did not find Pfizer's Branded Generic, "New Look" Dilantin, to be safer or more effective than it's other generic counterparts. And many of us moved to other generics as a result of this Branded Generic.
I wanted to give people a heads-up because the generics that have existed for a long time already have it down (such as they are). New ANDAs mean new guinae pigs to prove changes in quality and production.
If innovative companies decide to take their products generic after patent expiration, be prepared for a loss of the tighter in-house-protocol and a potential difference in efficacy. _____________________
This is what Janet Woodcock recently said about generic drugs, and it puzzles me - the position she is taking.
"The absorption problems aren’t necessarily harmful, Woodcock said."
"The standards assure the generic is absorbed at the same rate and extent as the brand-name version." "FDA permits generic drugs to absorb at a 25 percent different rate and extent than the originals they copy." (the same but up to 25% different - got it)
"Woodcock also urged generic-drug makers to put more emphasis on “product presentation.” “Manufacturers need to think beyond therapeutic equivalence,” Woodcock told the industry group." "She urged generic drugmakers to aim to make their pills look more like the original versions." http://www.bloomberg.com/news/2010-10-20/fda-says-it-may-tighten-standards-for-generic-drugs-update2-.html
The last paragraph of quotes makes me wonder, if for the same reason drugs are carefully named to avoid confusion, would making them look the same make people think these products are not now generics? Wouldn't it be better if a consumer knows that the medication (s)he is swallowing might act differently? ____________________
One example of Branded Generics - as I know them: http://www.pharmalot.com/2008/05/a-new-version-of-dilantin-is-giving-pfizer-fits/ http://www.pharmalot.com/2010/09/family-charges-a-pfizer-drug-switch-killed-their-son/ ___________________
Trying my best to keep from being sarcastic or pissy - this is far from my other attempts on the subject. I sincerely hope your experience goes better than ours did.