#!/usr/bin/env node
import { McpServer } from '@modelcontextprotocol/sdk/server/mcp.js';
import { StdioServerTransport } from '@modelcontextprotocol/sdk/server/stdio.js';
import {
ListPromptsRequestSchema,
GetPromptRequestSchema
} from '@modelcontextprotocol/sdk/types.js';
import { z } from 'zod';
import { lookupDrug, lookupDevice } from './fda-search.js';
const server = new McpServer(
{
name: 'fda-mcp-server',
version: '1.0.0',
},
{
capabilities: {
tools: {
"listChanged": true
},
prompts: {
"listChanged": true
},
},
}
);
// Register the FDA info tool
server.tool('fda_info', 'Unified tool for FDA drug and medical device information lookup. Access drug labels, adverse events, regulatory information, recalls, shortages, and device registration data from the openFDA database.', {
method: z.enum(['lookup_drug', 'lookup_device']).describe('The operation to perform: lookup_drug (search across multiple relevant fields, or search a specific field if field parameter is provided), lookup_device (search device registration and listing data)'),
search_term: z.string().describe('Search term to look for in the FDA database. Can be a drug name (generic or brand), manufacturer name, dosage form, marketing status, or any other searchable value. Supports wildcards (*), phrase matches ("term"), boolean operators (AND, OR), field combinations, date ranges, and special modifiers (_missing_, _exists_). Examples: Simple: "aspirin", "PFIZER"; Field searches: "sponsor_name:PFIZER", "products.brand_name:VISTARIL"; Complex: "sponsor_name:\\"PFIZER\\"+AND+products.dosage_form:\\"CAPSULE\\"", "(products.dosage_form:\\"TABLET\\"+OR+products.dosage_form:\\"CAPSULE\\")+AND+sponsor_name:\\"PFIZER\\"; Date ranges: "receivedate:[20240101+TO+20241231]", "receivedate:[20240815+TO+20240915]+AND+patient.drug.medicinalproduct:semaglutide"'),
search_type: z.enum(['general', 'label', 'adverse_events', 'recalls', 'shortages', 'device_registration', 'device_pma', 'device_510k', 'device_udi', 'device_recalls', 'device_adverse_events', 'device_classification']).default('general').describe('Type of information to retrieve. For drugs: "general" for comprehensive search, "label" for prescribing information, "adverse_events" for safety data, "recalls" for drug recalls, "shortages" for supply shortages. For devices: "device_registration" for medical device registration and listing data, "device_pma" for Pre-Market Approval (PMA) decisions and submissions, "device_510k" for 510(k) premarket notification clearances, "device_udi" for Unique Device Identifier (UDI) database information, "device_recalls" for device recalls and enforcement reports, "device_adverse_events" for medical device adverse event reports, "device_classification" for device classification and regulatory information'),
fields_for_general: z.string().optional().describe('Optional field to search within general drug data'),
fields_for_adverse_events: z.string().optional().describe('Optional field to search within adverse events data'),
fields_for_label: z.string().optional().describe('Optional field to search within drug labels'),
fields_for_recalls: z.string().optional().describe('Optional field to search within drug recalls and enforcement reports'),
fields_for_shortages: z.string().optional().describe('Optional field to search within drug shortages data'),
fields_for_device_registration: z.string().optional().describe('Optional field to search within device registration and listing data'),
fields_for_device_pma: z.string().optional().describe('Optional field to search within device PMA (Pre-Market Approval) data'),
fields_for_device_510k: z.string().optional().describe('Optional field to search within device 510(k) clearance data'),
fields_for_device_udi: z.string().optional().describe('Optional field to search within device UDI (Unique Device Identifier) data'),
fields_for_device_recalls: z.string().optional().describe('Optional field to search within device enforcement (recall) data'),
fields_for_device_adverse_events: z.string().optional().describe('Optional field to search within device adverse event data'),
fields_for_device_classification: z.string().optional().describe('Optional field to search within device classification data'),
count: z.string().optional().describe('Field to count/aggregate results by'),
pharm_class: z.string().optional().describe('Search by pharmacological class (drug class)'),
field_exists: z.string().optional().describe('Filter records to only those that contain a specific field, regardless of field contents'),
limit: z.number().min(1).max(100).default(10).describe('Maximum number of records to return (default: 10, max: 100)')
}, async (args) => {
try {
const { method, search_term, search_type = 'general', fields_for_general, fields_for_adverse_events, fields_for_label, fields_for_recalls, fields_for_shortages, fields_for_device_registration, fields_for_device_pma, fields_for_device_510k, fields_for_device_udi, fields_for_device_recalls, fields_for_device_adverse_events, fields_for_device_classification, count, pharm_class, field_exists, limit = 10 } = args;
if (!search_term) {
throw new Error('search_term parameter is required');
}
switch (method) {
case 'lookup_drug': {
// Determine which field parameter to use based on search_type
let field = null;
if (search_type === 'adverse_events' && fields_for_adverse_events) {
field = fields_for_adverse_events;
} else if (search_type === 'label' && fields_for_label) {
field = fields_for_label;
} else if (search_type === 'recalls' && fields_for_recalls) {
field = fields_for_recalls;
} else if (search_type === 'shortages' && fields_for_shortages) {
field = fields_for_shortages;
} else if (search_type === 'general' && fields_for_general) {
field = fields_for_general;
}
const results = await lookupDrug(search_term, search_type, limit, field, count, pharm_class, field_exists);
return {
content: [
{
type: 'text',
text: JSON.stringify(results, null, 2)
}
]
};
}
case 'lookup_device': {
// Determine which field parameter to use based on search_type
let field = null;
if (search_type === 'device_registration' && fields_for_device_registration) {
field = fields_for_device_registration;
} else if (search_type === 'device_pma' && fields_for_device_pma) {
field = fields_for_device_pma;
} else if (search_type === 'device_510k' && fields_for_device_510k) {
field = fields_for_device_510k;
} else if (search_type === 'device_udi' && fields_for_device_udi) {
field = fields_for_device_udi;
} else if (search_type === 'device_recalls' && fields_for_device_recalls) {
field = fields_for_device_recalls;
} else if (search_type === 'device_adverse_events' && fields_for_device_adverse_events) {
field = fields_for_device_adverse_events;
} else if (search_type === 'device_classification' && fields_for_device_classification) {
field = fields_for_device_classification;
}
const results = await lookupDevice(search_term, search_type, limit, field);
return {
content: [
{
type: 'text',
text: JSON.stringify(results, null, 2)
}
]
};
}
default:
throw new Error(`Unknown method: ${method}`);
}
} catch (error) {
const errorMessage = error instanceof Error ? error.message : String(error);
return {
content: [
{
type: 'text',
text: JSON.stringify({
error: errorMessage,
success: false
}, null, 2)
}
]
};
}
});
// Register all 7 prompts
server.registerPrompt('drug_safety_analysis', {
description: 'Comprehensive drug safety analysis using FDA adverse events data (FAERS database). Analyzes safety profile with total reports, top reactions, serious events by demographics, and age patterns for deaths.',
argsSchema: {
drug_name: z.string().describe('Name of the drug to analyze (generic or brand name)')
}
}, async (args) => {
const { drug_name } = args;
const prompt = `Analyze the safety profile for ${drug_name} using FDA adverse events data with these optimized queries:
1. Total reports with reaction data:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drug_name}\\"",
"search_type": "adverse_events",
"field_exists": "patient.reaction.reactionmeddrapt",
"limit": 1
}
2. Top adverse reactions (count statistics):
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drug_name}\\"",
"search_type": "adverse_events",
"count": "patient.reaction.reactionmeddrapt.exact",
"limit": 10
}
3. Gender distribution of serious events:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drug_name}\\" AND serious:1",
"search_type": "adverse_events",
"count": "patient.patientsex",
"limit": 5
}
4. Age patterns in death outcomes:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drug_name}\\" AND patient.reaction.reactionoutcome:5",
"search_type": "adverse_events",
"field_exists": "patient.patientonsetage",
"limit": 20
}
5. Recent serious events (last 2 years):
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drug_name}\\" AND serious:1 AND receivedate:[20220101+TO+*]",
"search_type": "adverse_events",
"limit": 15
}
Execute each query sequentially and provide a comprehensive safety analysis covering:
- Overall safety profile with total adverse event reports
- Most frequently reported adverse reactions and their significance
- Demographic patterns in serious adverse events
- Age-related patterns in fatal outcomes
- Recent trends in serious adverse events
Present findings with clinical context and statistical interpretation for pharmaceutical safety assessment.`;
return {
description: `Drug safety analysis for ${drug_name}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
});
server.registerPrompt('pharmaceutical_competitive_intelligence', {
description: 'Comprehensive pharmaceutical competitive intelligence analysis for company positioning, market share, portfolio strength, and strategic assessment using FDA regulatory data.',
argsSchema: {
company_name: z.string().describe('Name of the pharmaceutical company to analyze (sponsor name in FDA database)')
}
}, async (args) => {
const { company_name } = args;
const prompt = `Conduct comprehensive pharmaceutical competitive intelligence analysis for ${company_name} using FDA regulatory data:
1. Company drug portfolio overview:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${company_name}",
"search_type": "general",
"fields_for_general": "sponsor_name",
"limit": 50
}
2. Recent regulatory approvals and submissions:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${company_name}\\" AND submissions.submission_status:AP",
"search_type": "general",
"limit": 25
}
3. Safety profile across company portfolio:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.openfda.manufacturer_name:\\"${company_name}\\"",
"search_type": "adverse_events",
"count": "serious",
"limit": 10
}
4. Product recalls and enforcement actions:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${company_name}",
"search_type": "recalls",
"fields_for_recalls": "recalling_firm",
"limit": 20
}
5. Supply chain vulnerabilities:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${company_name}",
"search_type": "shortages",
"fields_for_shortages": "company_name",
"limit": 15
}
Analyze and present:
- Portfolio breadth and therapeutic focus areas
- Regulatory performance and approval success rates
- Safety profile compared to industry standards
- Supply chain reliability and risk factors
- Strategic positioning and competitive advantages`;
return {
description: `Pharmaceutical competitive intelligence for ${company_name}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
});
server.registerPrompt('generic_competition_assessment', {
description: 'Comprehensive generic competition assessment for Orange Book FDA analysis. Evaluates market entry patterns, competitive landscape, reference vs generic drug distinction, and market maturity indicators.',
argsSchema: {
brand_drug: z.string().optional().describe('Brand name of the drug to analyze for generic competition (provide either brand_drug or generic_name)'),
generic_name: z.string().optional().describe('Generic name of the drug to analyze for generic competition (provide either brand_drug or generic_name)')
}
}, async (args) => {
const { brand_drug, generic_name } = args;
const searchTerm = brand_drug || generic_name;
const fieldType = brand_drug ? 'openfda.brand_name' : 'openfda.generic_name';
const prompt = `Conduct comprehensive generic competition assessment for ${searchTerm}:
1. Reference vs Generic drug landscape:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "general",
"fields_for_general": "${fieldType}",
"count": "products.reference_drug",
"limit": 25
}
2. Market maturity and competition level:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "general",
"fields_for_general": "${fieldType}",
"count": "sponsor_name",
"limit": 20
}
3. Dosage forms and strength variations:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "general",
"fields_for_general": "${fieldType}",
"count": "products.dosage_form",
"limit": 15
}
4. Marketing status distribution:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "general",
"fields_for_general": "${fieldType}",
"count": "products.marketing_status",
"limit": 10
}
Analyze and present:
- Number of generic competitors in the market
- Market concentration and competitive intensity
- Available dosage forms and therapeutic options
- Patent protection status and generic entry patterns
- Market maturity indicators and future competition outlook`;
return {
description: `Generic competition assessment for ${searchTerm}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
});
server.registerPrompt('supply_chain_intelligence', {
description: 'Comprehensive supply chain risk assessment for drug manufacturing and availability. Analyzes current shortages, therapeutic vulnerability patterns, supplier concentration risks, and manufacturing resilience.',
argsSchema: {
drug_name: z.string().optional().describe('Specific drug name (generic) to analyze for supply chain risks (provide either drug_name or therapeutic_area)'),
therapeutic_area: z.string().optional().describe('Therapeutic area to analyze (e.g., "Oncology", "Cardiovascular", "Pediatric") (provide either drug_name or therapeutic_area)')
}
}, async (args) => {
const { drug_name, therapeutic_area } = args;
const searchTerm = drug_name || therapeutic_area;
const fieldType = drug_name ? 'generic_name' : 'therapeutic_category';
const prompt = `Conduct comprehensive supply chain intelligence analysis for ${searchTerm}:
1. Current shortage status:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "shortages",
"fields_for_shortages": "${fieldType}",
"limit": 25
}
2. Historical shortage patterns:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "shortages",
"count": "status",
"limit": 10
}
3. Supplier concentration risk:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "general",
"fields_for_general": "${drug_name ? 'openfda.generic_name' : 'sponsor_name'}",
"count": "sponsor_name",
"limit": 20
}
4. Therapeutic area vulnerability:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "shortages",
"count": "therapeutic_category",
"limit": 15
}
5. Manufacturing quality issues:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "recalls",
"count": "reason_for_recall",
"limit": 15
}
Analyze and present:
- Current availability and shortage risks
- Supplier concentration and single-source dependencies
- Historical shortage frequency and duration patterns
- Manufacturing quality and recall patterns
- Supply chain resilience recommendations`;
return {
description: `Supply chain intelligence for ${searchTerm}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
});
server.registerPrompt('fda_regulatory_intelligence', {
description: 'Comprehensive FDA regulatory intelligence analysis combining approval timeline, safety surveillance, recent regulatory activity, and supply chain status for drugs or companies.',
argsSchema: {
drug_name: z.string().optional().describe('Drug name (brand or generic) to analyze for regulatory intelligence (provide either drug_name or company_name)'),
company_name: z.string().optional().describe('Pharmaceutical company name to analyze for regulatory intelligence (provide either drug_name or company_name)')
}
}, async (args) => {
const { drug_name, company_name } = args;
const searchTerm = drug_name || company_name;
const isCompany = !!company_name;
const prompt = `Conduct comprehensive FDA regulatory intelligence analysis for ${searchTerm}:
1. Regulatory approval status and history:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "general",
"fields_for_general": "${isCompany ? 'sponsor_name' : 'openfda.generic_name'}",
"count": "submissions.submission_status",
"limit": 20
}
2. Recent submission activity:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${isCompany ? 'sponsor_name' : 'openfda.generic_name'}:\\"${searchTerm}\\" AND submissions.submission_status_date:[20230101+TO+*]",
"search_type": "general",
"limit": 25
}
3. Safety surveillance signals:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${isCompany ? 'patient.drug.openfda.manufacturer_name' : 'patient.drug.medicinalproduct'}:\\"${searchTerm}\\" AND serious:1 AND receivedate:[20230101+TO+*]",
"search_type": "adverse_events",
"count": "patient.reaction.reactionmeddrapt.exact",
"limit": 15
}
4. Enforcement and compliance actions:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "recalls",
"fields_for_recalls": "${isCompany ? 'recalling_firm' : 'product_description'}",
"limit": 20
}
5. Supply chain status:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "shortages",
"fields_for_shortages": "${isCompany ? 'company_name' : 'generic_name'}",
"limit": 15
}
Analyze and present:
- Regulatory approval timeline and success rates
- Recent FDA submission activity and priorities
- Safety profile and emerging surveillance signals
- Compliance history and enforcement actions
- Supply chain reliability and risk factors`;
return {
description: `FDA regulatory intelligence for ${searchTerm}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
});
server.registerPrompt('weekly_regulatory_monitoring', {
description: 'Automated weekly pharmaceutical regulatory intelligence report with surveillance queries for monitoring regulatory activity, safety signals, and supply chain intelligence.',
argsSchema: {
target_entity: z.string().describe('Company name, drug name, or therapeutic area to monitor (e.g., "Pfizer", "metformin", "Oncology")'),
current_date: z.string().describe('Current date in YYYY-MM-DD format for date range calculations (e.g., "2024-09-17")')
}
}, async (args) => {
const { target_entity, current_date } = args;
const weekAgo = new Date(new Date(current_date).getTime() - 7 * 24 * 60 * 60 * 1000).toISOString().split('T')[0].replace(/-/g, '');
const currentDateFormatted = current_date.replace(/-/g, '');
const prompt = `Weekly regulatory monitoring report for ${target_entity} (${current_date}):
1. Recent adverse events (last 7 days):
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${target_entity}\\" AND receivedate:[${weekAgo}+TO+${currentDateFormatted}]",
"search_type": "adverse_events",
"count": "serious",
"limit": 20
}
2. New regulatory submissions (last 7 days):
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${target_entity}\\" AND submissions.submission_status_date:[${weekAgo}+TO+${currentDateFormatted}]",
"search_type": "general",
"limit": 15
}
3. Recent recalls or enforcement actions:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "recalling_firm:\\"${target_entity}\\" AND report_date:[${current_date.substring(0,4)}-01-01+TO+${current_date}]",
"search_type": "recalls",
"limit": 10
}
4. Supply chain updates:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${target_entity}",
"search_type": "shortages",
"fields_for_shortages": "company_name",
"limit": 10
}
5. Competitive landscape changes:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${target_entity}",
"search_type": "general",
"count": "submissions.submission_status",
"limit": 10
}
Generate a structured weekly report including:
- Executive summary of key developments
- Safety signal alerts and trending adverse events
- Regulatory milestone updates and approvals
- Supply chain risk assessments
- Competitive intelligence insights
- Recommended follow-up actions`;
return {
description: `Weekly regulatory monitoring for ${target_entity}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
});
server.registerPrompt('fda_market_intelligence', {
description: 'FDA-focused market intelligence analysis including patent protection timelines, generic competition risks, and regulatory pathway impacts on market access for investment decision-making.',
argsSchema: {
drug_name: z.string().optional().describe('Drug name (brand or generic) for market intelligence analysis (provide either drug_name or company_name)'),
company_name: z.string().optional().describe('Pharmaceutical company name for market intelligence analysis (provide either drug_name or company_name)')
}
}, async (args) => {
const { drug_name, company_name } = args;
const searchTerm = drug_name || company_name;
const isCompany = !!company_name;
const prompt = `Conduct FDA-focused market intelligence analysis for ${searchTerm}:
1. Market exclusivity and competition landscape:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "general",
"fields_for_general": "${isCompany ? 'sponsor_name' : 'openfda.brand_name'}",
"count": "products.reference_drug",
"limit": 25
}
2. Generic competition timeline:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "general",
"fields_for_general": "${isCompany ? 'sponsor_name' : 'openfda.generic_name'}",
"count": "sponsor_name",
"limit": 20
}
3. Regulatory pathway advantages:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "general",
"fields_for_general": "${isCompany ? 'sponsor_name' : 'openfda.generic_name'}",
"count": "submissions.review_priority",
"limit": 15
}
4. Safety liability assessment:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${isCompany ? 'patient.drug.openfda.manufacturer_name' : 'patient.drug.medicinalproduct'}:\\"${searchTerm}\\"",
"search_type": "adverse_events",
"count": "serious",
"limit": 10
}
5. Supply chain risk factors:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${searchTerm}",
"search_type": "shortages",
"fields_for_shortages": "${isCompany ? 'company_name' : 'generic_name'}",
"count": "status",
"limit": 10
}
Generate investment-focused analysis including:
- Market exclusivity protection and erosion timeline
- Generic competition risk assessment and timing
- Regulatory advantages and approval pathway benefits
- Safety liability profile and litigation risks
- Supply chain stability and manufacturing resilience
- Revenue protection strategies and market access implications`;
return {
description: `FDA market intelligence for ${searchTerm}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
});
// Legacy prompt handlers for Claude Code compatibility
const legacyPrompts = [
{
name: "drug_safety_analysis",
description: "Comprehensive drug safety analysis using FDA adverse events data (FAERS database). Analyzes safety profile with total reports, top reactions, serious events by demographics, and age patterns for deaths.",
arguments: [
{
name: "drug_name",
description: "Name of the drug to analyze (generic or brand name)",
required: true
}
]
},
{
name: "pharmaceutical_competitive_intelligence",
description: "Comprehensive pharmaceutical competitive intelligence analysis for company positioning, market share, portfolio strength, and strategic assessment using FDA regulatory data.",
arguments: [
{
name: "company_name",
description: "Name of the pharmaceutical company to analyze (sponsor name in FDA database)",
required: true
}
]
},
{
name: "generic_competition_assessment",
description: "Comprehensive generic competition assessment for Orange Book FDA analysis. Evaluates market entry patterns, competitive landscape, reference vs generic drug distinction, and market maturity indicators.",
arguments: [
{
name: "brand_drug",
description: "Brand name of the drug to analyze for generic competition (provide either brand_drug or generic_name)",
required: false
},
{
name: "generic_name",
description: "Generic name of the drug to analyze for generic competition (provide either brand_drug or generic_name)",
required: false
}
]
},
{
name: "supply_chain_intelligence",
description: "Comprehensive supply chain risk assessment for drug manufacturing and availability. Analyzes current shortages, therapeutic vulnerability patterns, supplier concentration risks, and manufacturing resilience.",
arguments: [
{
name: "drug_name",
description: "Specific drug name (generic) to analyze for supply chain risks (provide either drug_name or therapeutic_area)",
required: false
},
{
name: "therapeutic_area",
description: "Therapeutic area to analyze (e.g., \"Oncology\", \"Cardiovascular\", \"Pediatric\") (provide either drug_name or therapeutic_area)",
required: false
}
]
},
{
name: "fda_regulatory_intelligence",
description: "Comprehensive FDA regulatory intelligence analysis combining approval timeline, safety surveillance, recent regulatory activity, and supply chain status for drugs or companies.",
arguments: [
{
name: "drug_name",
description: "Drug name (brand or generic) to analyze for regulatory intelligence (provide either drug_name or company_name)",
required: false
},
{
name: "company_name",
description: "Pharmaceutical company name to analyze for regulatory intelligence (provide either drug_name or company_name)",
required: false
}
]
},
{
name: "weekly_regulatory_monitoring",
description: "Automated weekly pharmaceutical regulatory intelligence report with surveillance queries for monitoring regulatory activity, safety signals, and supply chain intelligence.",
arguments: [
{
name: "target_entity",
description: "Company name, drug name, or therapeutic area to monitor (e.g., \"Pfizer\", \"metformin\", \"Oncology\")",
required: true
},
{
name: "current_date",
description: "Current date in YYYY-MM-DD format for date range calculations (e.g., \"2024-09-17\")",
required: true
}
]
},
{
name: "fda_market_intelligence",
description: "FDA-focused market intelligence analysis including patent protection timelines, generic competition risks, and regulatory pathway impacts on market access for investment decision-making.",
arguments: [
{
name: "drug_name",
description: "Drug name (brand or generic) for market intelligence analysis (provide either drug_name or company_name)",
required: false
},
{
name: "company_name",
description: "Pharmaceutical company name for market intelligence analysis (provide either drug_name or company_name)",
required: false
}
]
}
];
const legacyPromptHandlers = {
"drug_safety_analysis": ({ drug_name }) => {
const prompt = `Analyze the safety profile for ${drug_name} using FDA adverse events data with these optimized queries:
1. Total reports with reaction data:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drug_name}\\"",
"search_type": "adverse_events",
"field_exists": "patient.reaction.reactionmeddrapt",
"limit": 1
}
2. Top adverse reactions (count statistics):
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drug_name}\\"",
"search_type": "adverse_events",
"count": "patient.reaction.reactionmeddrapt.exact",
"limit": 10
}
3. Gender distribution of serious events:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drug_name}\\" AND serious:1",
"search_type": "adverse_events",
"count": "patient.patientsex",
"limit": 5
}
4. Age patterns in death outcomes:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drug_name}\\" AND patient.reaction.reactionoutcome:5",
"search_type": "adverse_events",
"field_exists": "patient.patientonsetage",
"limit": 20
}
5. Recent serious events (last 2 years):
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drug_name}\\" AND serious:1 AND receivedate:[20220101+TO+*]",
"search_type": "adverse_events",
"limit": 15
}
Execute each query sequentially and provide a comprehensive safety analysis covering:
- Overall safety profile with total adverse event reports
- Most frequently reported adverse reactions and their significance
- Demographic patterns in serious adverse events
- Age-related patterns in fatal outcomes
- Recent trends in serious adverse events
Present findings with clinical context and statistical interpretation for pharmaceutical safety assessment.`;
return {
description: `Drug safety analysis for ${drug_name}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
},
"pharmaceutical_competitive_intelligence": ({ company_name }) => {
const prompt = `Conduct comprehensive pharmaceutical competitive intelligence analysis for ${company_name} using FDA regulatory data:
1. Company drug portfolio overview:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${company_name}",
"search_type": "general",
"fields_for_general": "sponsor_name",
"limit": 50
}
2. Recent regulatory approvals and submissions:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${company_name}\\" AND submissions.submission_status:AP",
"search_type": "general",
"limit": 25
}
3. Safety profile across company portfolio:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.openfda.manufacturer_name:\\"${company_name}\\"",
"search_type": "adverse_events",
"count": "serious",
"limit": 10
}
4. Product recalls and enforcement actions:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${company_name}",
"search_type": "recalls",
"fields_for_recalls": "recalling_firm",
"limit": 20
}
5. Supply chain vulnerabilities:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${company_name}",
"search_type": "shortages",
"fields_for_shortages": "company_name",
"limit": 15
}
Analyze and present:
- Portfolio breadth and therapeutic focus areas
- Regulatory performance and approval success rates
- Safety profile compared to industry standards
- Supply chain reliability and risk factors
- Strategic positioning and competitive advantages`;
return {
description: `Pharmaceutical competitive intelligence for ${company_name}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
},
// Add handlers for other prompts with simplified implementations
"generic_competition_assessment": (args) => {
const searchTerm = args.brand_drug || args.generic_name;
return {
description: `Generic competition assessment for ${searchTerm}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: `Conduct comprehensive generic competition assessment for ${searchTerm} using FDA data to analyze market entry patterns, competitive landscape, and market maturity indicators.`
}
}
]
};
},
"supply_chain_intelligence": (args) => {
const searchTerm = args.drug_name || args.therapeutic_area;
return {
description: `Supply chain intelligence for ${searchTerm}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: `Conduct comprehensive supply chain intelligence analysis for ${searchTerm} focusing on current shortages, vulnerability patterns, and manufacturing resilience.`
}
}
]
};
},
"fda_regulatory_intelligence": (args) => {
const searchTerm = args.drug_name || args.company_name;
return {
description: `FDA regulatory intelligence for ${searchTerm}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: `Conduct comprehensive FDA regulatory intelligence analysis for ${searchTerm} combining approval timeline, safety surveillance, and recent regulatory activity.`
}
}
]
};
},
"weekly_regulatory_monitoring": ({ target_entity, current_date }) => {
return {
description: `Weekly regulatory monitoring for ${target_entity}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: `Generate weekly regulatory monitoring report for ${target_entity} as of ${current_date}, including safety signals, regulatory updates, and competitive intelligence.`
}
}
]
};
},
"fda_market_intelligence": (args) => {
const searchTerm = args.drug_name || args.company_name;
return {
description: `FDA market intelligence for ${searchTerm}`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: `Conduct FDA-focused market intelligence analysis for ${searchTerm} including patent protection timelines, generic competition risks, and regulatory pathway impacts.`
}
}
]
};
}
};
// Add legacy prompt handlers for Claude Code compatibility
// Note: McpServer doesn't expose setRequestHandler, so we need to access the underlying server
const underlyingServer = server._server || server.server || server;
if (underlyingServer && underlyingServer.setRequestHandler) {
underlyingServer.setRequestHandler(ListPromptsRequestSchema, () => ({
prompts: legacyPrompts
}));
underlyingServer.setRequestHandler(GetPromptRequestSchema, (request) => {
const { name, arguments: args } = request.params;
const promptHandler = legacyPromptHandlers[name];
if (promptHandler) {
return promptHandler(args || {});
}
throw new Error(`Prompt not found: ${name}`);
});
} else {
console.error('Unable to access underlying server for legacy prompt handlers');
}
// Start the server
async function main() {
const transport = new StdioServerTransport();
await server.connect(transport);
// Log to stderr so it doesn't interfere with JSON-RPC
process.stderr.write('FDA MCP server running on stdio\n');
}
main().catch((error) => {
process.stderr.write(`Server error: ${error}\n`);
process.exit(1);
});
