HHE (Health Hazard Evaluation)

1. What is HHE 

HHE is a tool for classifying a voluntary recall by a pharmaceutical company. Pharma companies will perform this evaluation, which will be submitted to the FDA, to determine the risk to the public from the defective product and appropriate actions for the pharmaceutical company and the FDA to take to protect public health.

HRA is a tool for predicting possible harm from a defective or malfunctioning device. The assessment helps the FDA and the firm determine if any actions are necessary, such as recalling the devices or notifying the public about the risk.

2. When is HHE written 

HHE is written when there is a product quality issue or a formal request from the FDA.

 3. What are the components and steps of HHE?

Components for assessment for HHE

Qualitative and quantitative outputs from the safety database for the search terms related to the problem (AE-adverse event, PQC product quality complaint, LOE Lack of efficacy etc)

•        Support of internal and external data sources as but not limited to 

•        Literature

•        Competitors’ products

•        RA (Regulatory Authority) database

Steps in HHE: 

•        Collaboration and participation in risk mitigation measures for a recommendation for further steps

•        Plan for Submission to the regulatory agency

•        Implementation of risk minimization measures and additional risk minimization measures

•        Monitor and evaluate the comments from Regulatory if any

 4. Regulatory actions for HHE (High level)

1.      Once the MAH/Pharma submits the HHE data to the FDA

2.      FDA will have an internal team of physicians and engineers to evaluate the response and carry out the same exercise

3.      based on this determination, the Food and Drug Administration will assign the recall a classification

4.      Recall classification e.g. Class I, Class II, or Class III, to indicate the relative degree of the health hazard of the product being recalled or considered for recall.

 5.  Sections in HHE (MAH):

1.  MAH details

2. Product details

3. Device issues

4. Association of AE with this particular device issues

5. What is the impact of this AE in patients i.e. serious, reversible, preventable, treatable etc

6. Can this device issue be easily identified by the patient population?

7. Mechanism of action of this issue

8. Impact on the patient population 

9. Mitigation of this risk that can happen due to this device issue

Written by:

Dr.Shraddha Bhange.

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References:

Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs) | FDA 

Description of the Health Hazard Evaluation Program - The Health Hazard Evaluation Program at NIOSH - NCBI Bookshelf (nih.gov)