FDA To Devise New Guidelines For Drug Cocktails
10 CommentsBy Ed Silverman // March 18th, 2010 // 6:10 am
The move is designed to jumpstart testing and approval of new regimens for so-called drug cocktails to combat tuberculosis, AIDS and cancer. The guidelines would apply only to drugs for life-threatening illnesses for which options don’t already exist, and that drug cocktails are believed necessary.
Among those involved: the Critical Path to TB Regimens, which includes Pfizer, Sanofi-Aventis, AstraZeneca, GlaxoSmithKline and a unit of Johnson & Johnson; Global Alliance for TB Drug Development, the Critical Path Institute and Treatment Action Group, as well as the Bill & Melinda Gates Foundation. The companies have agreed to share data and test combo treatments.
“This represents a bigger issue - the strengthening of regulatory science” to encompass scientific advances, FDA commish Margaret Hamburg, tells The Wall Street Journal. She’ll announce further details today at the National Press Club in Washington, D.C. (background here and here).
JaT
So basically they aren’t developing anything new and want to re-patent their drugs.
Condor
Ding.
Spot on, JaT.
In this way, a 17 year long monopoly-at-law (via patent statute), may become up to a 32 year long monopoly, via creative ledger-domain (this is the case with Temodar).
Namaste
Condor
Think also of Vytorin (Merck’s Zocor plus Zetia), of Tri-Cor (Abbott) — and dozens of others, here.
JaT
Aggrenox
pharmavet
Condor, I believe that new formulations only carry three years of additional exclusivity for each drug.
A CMl Patient
I am not opposed to this.
Just recently it was announced that a combination of Peg Interferon (or Intron A for that matter) with a TKI like Gleevec or Sprycel or Tasigna could cure CML patients. Roche and or schering could partner with these other companies and sponsor trials.
They could if seeking a cure was really the goal…
What do you think?
Condor
Well, pharmavet — there is a shorter period of exclusivity (at FDA, via ORange book pubication), but it is longer than three years, at the US PTO — the patent office.
Each of these turns on various distinct factors, including how much time is left on the applicable patent(s) in the non-combined form. There is no hard and fast rule, here, that applies to all combo drugs.
For example, Merck’s Zocor was coming off patent in 2006 — and now, combined with what was Schering-Plough’s (now Merck’s) Zetia, and called Vytorin, it boasts patent exclusivity until 2017. That’s a lot longer than three years, at least. . . .
In theory, anyway.
In fact, though, Teva has already declared its intention to make a generic version of the Vytorin cholesterol combo-pill, and Merck has sued Teva, alleging patent infringement, as of March 2, 2010.
That may result in a “paid delay” by Teva, or it may result in generic Vytorin by the end of 2010. Who knows?
Namaste
JaT
In combining drugs- if you have a problem with either of the medications then one dosage cannot be adjusted while maintaining the other.
patrons99
This pharma-driven approach to dis-ease may be completely wrong. Pasteur’s Germ Theory and Koch’s Postulates may be wrong. Bacteria, bacteriophages, and viruses are virtually certain to win this battle. Should we ask whether multi-drug cocktails will not promote the world-wide development of multi-drug resistant infections and zoonoses? Would our resources not be better spent on trying to lessen the conditions in which diseases thrive: for example, with better hygiene, less crowding, pure drinking water? As long as the soil is fertile for microbes, they will “set up shop”. Germs are opportunists. The multi-drug cocktail approach to treating disease, just happens to make society ever more dependent on pharma and their Johnny-on-the-spot remedies. Probiotics and measures to strengthen our natural immunity may be a safer and more effective approach. Perhaps, this is where the research should be directed. Our natural immunity has been increasingly battered by indiscriminate antibiotic use and the stupendous vaccine schedules, from cradle to grave.
G
This is will be of major benefit to patients. Finally, the FDA has done something helpful for drug discovery. This is not a ploy to create super viagra. There are many complex diseases for which no single entity has worked or, indeed, may ever work. If new drugs for these indications that might be useful in combination need to show individual efficacy to reach the clinic there is no chance for them. What are the patients supposed to do, wait for the impossible? As a scientist specialing in severe diseases with unmet need, I say thank you FDA!