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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID
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To: Maurice Winn who wrote (1421)1/15/1998 3:59:00 PM
From: Pseudo Biologist  Read Replies (2) of 1762
 
Maurice, I think your interpretation of Scott's post is correct. Off-label use of approved drugs in the US at least is very flexibly dependent on the attending physician's judgement. What is regulated is the promotion of such use by the manufacturers/marketers. Even that is changing with the recent FDA reforms. In the near future it will be possible for companies to use peer-reviewed material (scientific, medical papers) to promote off-label use of approved drugs.

The concern I raised before is that of how the pay-ors (HMOs and insurance companies, for example) are likely to handle this. The trend seems to be that, in general, it will be difficult to get them to pay for off-label use. Input from practicing MDs, particulary oncologists, would be welcome here.

PB
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