FDA Topic...

[drugdoc]

Hello all,

I have to do a paper on a recent (since 2003), newsworthy event dealing with either drugs or food. So far I've come up with not so interesting ones such as....E.coli problems, abx resistance, labeling of peanut items, etc. Boring. Can you give me some ideas??? Anything that has been in the news in the past 5 years. We are currently reading a book about the FDA, and this paper coincides with it.

Thanks!

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[WVUPharm2007]

Vioxx is an easy one...

 

[labrat024]

How about the counterfeit pill problem due partly to a large increase of pharmaceutical agent purchasing from countries like China and India that have different quality standards. The ingredients also get passed through many hands before they reach the final destination which allows for "watering down" of the active agents. It is very difficult for pharmacists to discern between true pills and these so called counterfeits.

 

[Farmercyst]

How about selective publication of studies to reveal only positive info about new drugs.

 

[Hels2007]

Are you kidding? Did you look beyond Google, in any pharmacy publication (Pharmacy Times, Drug Topics, Pharmacy Today, etc.)? Just in the last 12 months:
- Avandia (a big safety issue)
- Enhance (a big efficacy issue)
- FDA trying out the "early safety warning system" with Nexium/Prilosec
- FDA calling up the Behind-the-counter meds discussion
- Toddler cough/cold medications being removed off the market
- FDA cracking on non-approved medications (grandfathered cough syrup containing Hydrocodone, for example)
- The lowest number of new drugs being approved in 2007 since 199-something, and mutual finger-pointing (FDA: not our fault, we have fewer submissions! Pharma: FDA's fault, they are afraid to approve anything after Vioxx & Avandia)
- The new FDAAA act just passed by congress (aka PDUFA IV) including review of DTC ads

These are things that I can think off the top of my head.

 

[ForcedEntry]

Dextromethorphan is only good for robo-trips. Honey is better at treating a cough.

 

[drugdoc]

Are you kidding? Did you look beyond Google, in any pharmacy publication (Pharmacy Times, Drug Topics, Pharmacy Today, etc.)? Just in the last 12 months:
- Avandia (a big safety issue)
- Enhance (a big efficacy issue)
- FDA trying out the "early safety warning system" with Nexium/Prilosec
- FDA calling up the Behind-the-counter meds discussion
- Toddler cough/cold medications being removed off the market
- FDA cracking on non-approved medications (grandfathered cough syrup containing Hydrocodone, for example)
- The lowest number of new drugs being approved in 2007 since 199-something, and mutual finger-pointing (FDA: not our fault, we have fewer submissions! Pharma: FDA's fault, they are afraid to approve anything after Vioxx & Avandia)
- The new FDAAA act just passed by congress (aka PDUFA IV) including review of DTC ads

These are things that I can think off the top of my head.

Aside from the saracism, thank you for your insight. Your suggestions were appreciated.

 

[Hels2007]

Aside from the saracism, thank you for your insight. Your suggestions were appreciated.

You are welcome. Don't mind sarcasm, I like being snarky in this incarnation (don't you see my status (I bite). It's a nerve survival test for the tender new pharmacy students - it's a brutal world out there.