Guideline on Advertising Disclosure for Drugs with “Notice of Compliance with Conditions” (NOC/C)

Guideline on Advertising Disclosure for Drugs with “Notice of Compliance with Conditions” (NOC/C)

Introduction:

The Therapeutic Products Programme on May 28 1998 released its “Notice of Compliance with Conditions (NOC/C) Policy”¹ to speed access to potential breakthroughs in serious, life threatening or debilitating diseases such as AIDS, ALS and some cancers. Products accepted with a conditional NOC have shown promising clinical benefit, shown often as effect on surrogate markers such as decreases in helper T cell counts in AIDS. Sponsors have made written undertakings to carry out studies to confirm the clinical benefit in a timely fashion, and these conditions are to be clearly reflected and highlighted in the Product Monograph.

Since the clinical benefits of these drugs have not been confirmed, it is important that advertising for these products clearly and prominently disclose to health professionals the conditional nature of the marketing authorization.

Guideline Text:

Details of the conditions are reflected in the Product Monograph, and advertising for all products in the scope of the PAAB Code of Advertising Acceptance must be within the limitations of HPB-accepted monograph or labeling (Section 3.1).

To clarify how PAAB reviewing practice will apply to a NOC/C product:

1. The display portion of advertising must contain a prominent disclosure of the conditional nature of the market authorization and the need to conduct studies to verify its clinical benefit.

2. The display portion of advertising must be consistent with the specific restrictions or conditions specified in the monograph, which inter alia will require clear disclosure of any statements in the monograph or labeling that the indication is based on surrogate endpoints and that clinical benefit has not been demonstrated.

3. In addition, the accompanying prescribing information must contain the full text of the restrictions and conditions, even if the product qualifies for Condensed Disclosure prescribing information (Code Section 7.5) after two years after introduction.

Example:

The upper right hand corner of a letter or journal ad or detail aid contains a boxed statement:

In the example, there is also legible disclosure in an appropriate location in the body copy, quoted from the Indications section of the Product Monograph, of the surrogate endpoint where effect was shown, and furthermore that clinical benefit from survival or other clinical endpoints has not been demonstrated.

Guideline Status and Implementation:

The Guideline is designed to help clarify how the Commissioner and review staff interpret the PAAB Code of Advertising Acceptance. It has the same status as Explanatory Notes on the ‘right side’ of the Code booklet, and will have formal effect on December 1 1998.