Information About Off-Label Uses of Drugs

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

For drug approval; the Food and Drug Administration Modernization Act (FDAMA 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 status 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 new use or studies. In the new guidance, nothing is mentioned, but companies are encouraged to seek approval for new uses or indications.

In the advance provision to the FDA, the company must submit all information 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 FDAMA and the new guidance of 2009.

Concerning the subject of accuracy, the FDAMA requires that the information must be accurate, true, and not misleading, conclusions must be appropriate and the information must not pose a threat to public safety. Other safety and efficacy information can be required from the manufacturer. The same applies to the new guidance of 2009.

For the provision of countervailing scientific findings, the information must be provided with approved labeling and a complete bibliography of publications 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 use, and also other publications concerning this use that are opposite or different.

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

The presentation of journal article includes the unabridged article or section of reference publication. Company representatives may not verbally promote the new use, and no promotional materials should be included in the publication. 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-reviewed scientific or medical journals (listed in Index Medicus). Also unabridged reference texts can be distributed without highlighting the off-label unapproved use. No company supplement should be used. According to the new 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 agencies. 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 about off-label uses in response to special requests from healthcare practitioners. The new guidance agrees with the FDAMA.