Guidance Documents

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Chapter: Pharmacovigilance: Legal Basis - United States

Over the last decade, FDA has published a series of guidance documents that further articulate its views about how IND sponsors and NDA or Biologics License Application (BLA) applicants can comply with the regulations and statutes governing adverse event review and reporting.


GUIDANCE DOCUMENTS

Over the last decade, FDA has published a series of guidance documents that further articulate its views about how IND sponsors and NDA or Biologics License Application (BLA) applicants can comply with the regulations and statutes governing adverse event review and reporting. Many of these guidance documents address or incorporate by refer-ence the applicable international standards.

In June 2002, the United States Congress re-authorized the Prescription Drug User Fee Act III (PDUFA III) for the second time. In the context of the PDUFA re-authorization, the FDA agreed to satisfy certain performance goals, including producing guid-ance for industry on risk-management activities for drug and biological products.

Unlike statutes and regulations, however, agency guidance documents do not have the force and effect of law; instead, they represent the agency’s current thinking and recommendations on particular topics. Thus, if a company does not comply with the conduct described in a guidance document, then the company’s behaviour is not automatically unlawful and subject to penalties. Conduct that is contrary to an FDA guidance presents a risk, however, that the FDA will consider such conduct a violation of law and will attempt to bring an enforcement action. It is important, therefore, for companies to understand these guidance docu-ments and to make carefully informed judgments, so that any action that does not comply with policies expressed in a guidance document will nonetheless meet the requirements of applicable law and regula-tions. In any event, guidance documents do provide IND sponsors and NDA applicants with a clear idea of what FDA considers to be lawful conduct, and there-fore, familiarity with them is critical. Current FDA guidance documents can be found on the agency’s website at http://www.fda.gov.

RISK MANAGEMENT – PRE- AND POST-MARKET

To fulfil its commitment to produce guidance for industry on risk management, and in response to increasing concerns about drug safety, in 2004, the FDA initiated a public process to develop the follow-ing final guidance documents. Each of the three docu-ments focuses on one aspect of risk management:

·    CDER/CBER, Guidance on Premarketing Risk Assessment (March 2005).

·    CDER/CBER, Guidance on Good Pharma-covigilance Practices and Pharmacoepidemiologic Assessment (March 2005).

·    CDER/CBER, Guidance on the Development and Use of Risk Minimization Action Plans (RiskMAP) (March 2005).

The first two guidance documents address pre- and post-marketing risk assessment, respectively, provid-ing information on the data and systems that are necessary or advisable for reporting adverse events to FDA. The guidance on risk minimization discusses the development of objective plans to utilize specific tools to minimize a known risk associated with the use of a particular product (i.e. education/outreach or registered access programmes to minimize in utero exposure to teratogenic drugs). The agency notes that a RiskMAP could also be considered as a selectively used type of Safety Action Plan as defined in the ‘International Conference on Harmonization (ICH) guidance E2E: Pharmacovigilance Planning’.

Food and Drug Administration has also issued a guidance document explaining the agency’s new Drug Watch system [CDER Guidance on FDA’s ‘Drug Watch’ for Emerging Drug Safety Information (May 2005)]. The agency plans to make information avail-able on its website to consumers and healthcare professionals about drugs for which the agency is actively evaluating early safety signals.

INTERNATIONAL CONFERENCE ON HARMONIZATION

In recent years, FDA has been supportive of interna-tional efforts to harmonize reporting requirements and standards. In general, FDA’s policy on international standards states that

[w]here a relevant international standard exists or completion is imminent, it will generally be used in preference to a domestic standard, except when the international standard would be, in FDA’s judgment, insufficiently protective, ineffective, or otherwise inappropriate (60 Fed. Reg. 53077, 53084 (1995)).

To that end, the FDA has issued many ICH or ICH-influenced documents as guidance for industry, including the following:

·     CDER/CBER, Guidance on E2B(M): Data Elements for Transmission of Individual Case Safety Report, ICH Revision 2 (March 2005).

·        CDER/CBER, Guideline for Industry-E2A Clini-cal Safety Data Management: Definitions and Stan-dards for Expedited Reporting (1995).

·        CDER/CBER, Guidance on E2E Pharmacovigi-lance Planning (April 2005).

·    CDER/CBER, Guidance for Industry-Post-Marketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (1997).

·    CDER/CBER, Guidance for Industry-E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (1997).

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