O/T FDA drug information that never reaches the clinician

[Guest guest]

FDA drug information that never reaches the clinician

Aspergillus Newsletter

Important information regarding the benefits and harms of FDA approved

prescription drugs, does not make its way into the hands of the clinician -

writes Schwartz in the New England Journal of Medicine. The FDA is the

American drug regulatory body. Drug labels (package inserts) are the direct way

of communicating prescribing information to physicians- but they are written by

the drug companies and then negotiated or approved by the FDA. Drug approval

requires that preclinical studies and the results of at least two phase 3

studies in patients - are submitted to highly qualifed FDA experts which may

take a year to evaluate. The FDA produce review documents recording the

reasoning behind approval. These are lengthy and can be complex - the problem

seems to be that important information is getting lost - and never makes it onto

a drug label. The authors report a number of possible harms - which fail to make

it onto the drug labels, but also efficacy data that can be useful, but again is

lost from the final drug sheets.

The FDA has recognised some problems with drug labels and in 2006 introduced a

highlights section to emphasize drug warnings and indications. It has also

issued guidance about reporting trial results in labels - but in at least 2

drugs studied, labels remained unimproved.

It seems that a better way of communicating information that is already known,

but not passed into the clinicians hands must be expedited.