Consistent with the FDA's mission to protect the public's health, the agency has regulatory authority over the advertising and promotion of prescription drugs (Fig. 7.25). The intent is to ensure that promotions of drug and biologic products to prescribers and/or consumers are truthful, do not exaggerate the benefits, and fairly present the risks of the products. There are written regulations on what can and cannot be presented in advertising materials. It is a regulatory requirement that sponsors submit all their promotional materials to the FDA for review at the time of dissemination or publication.

Promotional material must not be false or misleading. The claims in advertising must fairly reflect the information in the package insert or additional scientifically defensible information. Examples of false and misleading claims are false statements regarding a competitor's product, a claim of unsurpassed safety not substantiated by data, or a claim of unsurpassed efficacy. The material also must contain "fair balance" of the benefits and the risks. The same scope, depth of detail, and prominence need to be presented for both in the form of words used and even type styles and sizes and colors. Because initial impressions are so critical to the lasting image of a product, it is incumbent on the sponsor to have the FDA pre-clear advertising materials used in the initial launch of a new product to ensure that the sponsor's advertising is compliant with the regulations. Negotiating this advertising copy with the agency can lead to intense interactions between the sponsor and the FDA. Educational materials used by the sponsor (e.g., publications, monographs, and symposia) must also comply with regulatory guidances, be within labeling claims, and are subject to FDA review.

Although there are countless exchanges between the sponsor and the FDA during the typical review process, there are certain critical milestone communications that transpire during the product review (Fig. 7.26). As mentioned earlier, once an application is submitted, the agency has 60 days to determine if it is substantially complete and be can officially filed. If it is complete, the sponsor will receive a letter stating the submission is filed and FDA will proceed with its complete review process. If a priority review has been requested by the sponsor, the review team at the agency will decide to grant the priority review or not and inform the sponsor accordingly. If a NDA/BLA application is not sufficiently complete, the applicant is sent a refuse-to-file (RTF) letter with the deficiencies outlined. Examples of deficiencies include an incomplete application form, inadequate English translations, inadequate organization of the NDA, or failure to submit sufficient information to evaluate safety and efficacy. Minor deficiencies that can be addressed and likely fixed during the review and interaction with the company will not lead to a RTF letter.

Abbreviated NDAs are handled slightly differently. If the ANDA for a generic product is complete, it is "received" and the applicant will be notified in writing. If it is not complete, it is not received and the applicant is usually notified by telephone.

When FDA finishes reviewing the application, they will issue either an approval letter or a complete response letter, the latter of which outlines the deficiencies in the submission. If the sponsor receives an approval letter, they are free to introduce the product into commerce in the United States, under the conditions outlined in the approval letter. If a complete response letter is sent to the sponsor, it will indicate whether there are major or minor deficiencies with the application. Minor deficiencies require a class I resubmission.

r Initial NDA, BLA, ANDA application: o Complete application o Refuse to File letter r Action letters after application review: o Complete Response letter o Approval letter c Information Request letter r Complete response to an action letter: o Class 1 resubmission - minor updates to the application i.e. draft labeling, stability data updates, minor reanalysis of data o Class 2 resubmission - major update, i.e. warrant presentation to an Advisory Committee

Fig. 7.26. FDA Communication During Product Review

Examples of a class 1 resubmission include certain safety updates, product stability updates, phase IV commitments and proposals, assay validation data, or minor reanalysis of data. These submissions are to be reviewed by the FDA within 2 months of their receipt. Major deficiencies require a class 2 resubmission. Examples of a class 2 resubmission include data from additional clinical trials or preclinical studies. These submissions are to be reviewed by the FDA within 6 months of their receipt.

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