Fda Intelligence Mcp

A production-ready Model Context Protocol (MCP) server that gives AI agents and LLM applications direct access to the FDA's public drug database. Built for pharma competitive intelligence teams, biotech analysts, medical affairs professionals, and investment researchers.

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Overview

FDA Intelligence MCP wraps the OpenFDA public API into four semantically-named tools following the fda_{action}_{resource} convention. Deployed as an Apify Actor using Streamable HTTP transport with pay-per-event billing.

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Available Tools

Tool	Purpose	Key Parameters
fda_get_drug_approvals	Search FDA drug approval records (CDER)	drug_name, applicant, application_type, date_from, date_to
fda_get_safety_alerts	Retrieve recalls, warnings, and market withdrawals	drug_name, recall_class, date_from, date_to
fda_get_drug_label	Fetch full FDA-approved prescribing information	drug_name, label_type
fda_get_pipeline_activity	Analyze pre-approval competitive pipeline activity	applicant, drug_class, application_type, date_from

All tools return structured JSON with calls_remaining, total_results, returned_count, has_more, and structured error dicts on failure.

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Quick Start

Local Development

git clone https://github.com/MCPPro/fda-intelligence-mcp.git
cd fda-intelligence-mcp

python -m venv .venv
source .venv/bin/activate  # Windows: .venv\Scripts\activate

pip install -r requirements.txt

cp .env.example .env
# Optionally add your OPENFDA_API_KEY

cd src && python server.py

Docker

docker build -t fda-intelligence-mcp .
docker run -p 8000:8000 -e OPENFDA_API_KEY=your_key fda-intelligence-mcp

Run Tests

$pytest tests/test_server.py -v

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Authentication

Mode	Rate Limit
No API key	40 requests/min, 1,000/day
With API key	240 requests/min, 120,000/day

Get a free key at open.fda.gov/apis/authentication.

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Example Queries

1. Which GLP-1 drugs did Novo Nordisk get approved in 2022–2023?

{ "tool": "fda_get_drug_approvals", "params": { "applicant": "Novo Nordisk", "application_type": "NDA", "date_from": "2022-01-01", "date_to": "2023-12-31" } }

2. Are there any Class I recalls for metformin?

{ "tool": "fda_get_safety_alerts", "params": { "drug_name": "metformin", "recall_class": "I", "date_from": "2022-01-01" } }

3. What are the approved indications and warnings for Keytruda?

{ "tool": "fda_get_drug_label", "params": { "drug_name": "keytruda", "label_type": "prescription" } }

4. What BLA submissions has AstraZeneca filed since 2023?

{ "tool": "fda_get_pipeline_activity", "params": { "applicant": "AstraZeneca", "application_type": "BLA", "date_from": "2023-01-01" } }

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Rate Limits and Pricing

The server implements a 1 request/second rate limiter and 1-hour TTL cache. Apify billing is $0.01 per tool call via Actor.charge(event_name='tool-call').

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Data Source

All data from the OpenFDA public database (U.S. FDA). Public domain data per U.S. government policy.

• Drug Approvals: /drug/drugsfda.json
• Safety Alerts: /drug/enforcement.json
• Drug Labels: /drug/label.json