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									Certain conditions exist which may allow the distribution of information con
cerning off-label uses of drugs.

For drug approval; the Food and Drug Administration Modernization Act (F
DAMA section 401) has to have information for a drug or device that has
been approved by the FDA. However according the new 2009 Guidance, the s
tatus of the drug-approval is not mentioned.

For the filing of a supplemental New Drug Application, the FDAMA requires
 that the manufacturer submit a supplemental New Drug Application for a n
ew use or studies. In the new guidance, nothing is mentioned, but compani
es are encouraged to seek approval for new uses or indications.

In the advance provision to the FDA, the company must submit all informati
on concerning efficacy and safety of the drug 60 days before dissemination
. In the new guidance, it is not mentioned.

For the source of underlying clinical data, it has to be accurate resulting
from serious well controlled clinical studies and trials according to the FD
AMA and the new guidance of 2009.

Concerning the subject of accuracy, the FDAMA requires that the informatio
n must be accurate, true, and not misleading, conclusions must be appropri
ate and the information must not pose a threat to public safety. Other saf
ety and efficacy information can be required from the manufacturer. The sa
me applies to the new guidance of 2009.

For the provision of countervailing scientific findings, the information mus
t be provided with approved labeling and a complete bibliography of publicat
ions concerning the off-label uses (including unfavorable studies) and other
 information concerning risks of this new use. The new guidance requires the
 same comprehensive bibliography of publications related to the off-label us
e, and also other publications concerning this use that are opposite or diff
erent.

The required disclosures must state that the off-label use is not FDA -appr
oved and must identify other products that are FDA-approved for that same u
se. The new guidance disclosure's statement identifies study sponsors, fina
ncial interests, and should mention any known risks not discussed in the pu
blication.

The presentation of journal article includes the unabridged article or sect
ion of reference publication. Company representatives may not verbally prom
ote the new use, and no promotional materials should be included in the pub
lication. The new guidance adds that the publication unabridged should not
be highlighted, summarized or differentiate in any way.

The journal requirements, the information should be published in peer-revi
ewed scientific or medical journals (listed in Index Medicus). Also unabri
dged reference texts can be distributed without highlighting the off-label
 unapproved use. No company supplement should be used. According to the ne
w guidance, the information should be published by organizations with peer
-review procedures and a panel of experts. And the new information cannot
appear in company funded supplement or publication.

The distribution must be restricted to health care practitioners, pharmacy
managers, health insurers, group health plans and federal and state agencie
s. The distribution to consumers is not allowed. The new guidance adds that
 information should be provided separately from promotional information and
 the distribution should be restricted to the same as above mentioned.

For the other avenues of dissemination, the company can give information a
bout off-label uses in response to special requests from healthcare practi
tioners. The new guidance agrees with the FDAMA.

								
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