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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?


To: Mudcat who wrote (27987)2/7/1999 5:28:00 PM
From: Andrew Cooke  Read Replies (2) | Respond to of 32384
 
Most medical professional liability insurers' policies would cover off label prescribing; my firm (which does a great deal of med mal defense) is currently defending providers in Diet Drug Litigation (coverage provided by med mal insurers). However, your question is a good one - as it does not seem unreasonable that policy language may change more now to exclude some off-label prescribing. I am not involved in the DDL, but do defend manufacturers in product liability matters. The interesting thing about the DDL in my state is that both manufacturers and docs have been sued - the docs on both product liability and med mal grounds. With respect to Phen Phen and Redux, it was probably $$$ and patient wants that most encouraged off-label prescribing - for those docs who prescribed the combo frequently, they did not apparently anticipate any legal ramifications from off-label prescribing.



To: Mudcat who wrote (27987)2/7/1999 10:45:00 PM
From: Cacaito  Respond to of 32384
 
Pediatricians are off label users, since few drugs are actually "approved" for children.

Check most package insert and almost every drug has a "not being tested in children under 2 years of age " or 7 years, or 16 years. It is almost a joke. Check a "PDR" in a local library one sees the same.

I work with newborn babies, Neonatologists are the last ones to use any drug and besides survanta, synagis and vaccines few has being formally tested for babies.

No problem getting insurance.

There are now some extra advantages to companies to research in pediatric patients like tax advantages, grant money and 6 months of extra patent for all uses. Did anybody noticed the Prozac research in Children? Lilly is after 6 months extra of a $2.6 billion dollars a year. If they expend $10 million for the studies they will get back $1.3 billion dollars ! not a bad return.

Panretin is already in research for some Pediatric Cancers, another 6 months of patent.