In the pharmaceutical industry, handling product complaints is a critical part of maintaining safety, quality, and customer trust. But in recent years, the time it takes to investigate and close these complaints has grown longer, and that’s causing serious concern.
Let’s explore the current timelines, the backlog problem, and what the data shows about delays in the complaint-handling process.
Why Complaint Investigations Matter
Pharmaceutical complaints are often related to product quality, packaging issues, labeling errors, or adverse reactions. Each complaint must be reviewed carefully. Delays in these investigations can:
- Put patients at risk
- Lead to regulatory non-compliance
- Damage a company’s reputation
- Cause drug recalls or enforcement actions
That’s why fast, thorough investigations are vital.
Growing Complaint Backlogs: A Global Issue
Across the pharmaceutical industry, complaint investigation times have grown significantly over the last 20 years. The data reveals a clear trend: the system is slowing down.
UK Case Backlog Trends
In the United Kingdom, the average time it takes to process a pharmaceutical complaint has almost tripled:
- In 2004, most complaints were processed in less than 3 months
- By 2021, the average had risen to over 8.5 months
- Some complaints now take more than a year to resolve
These delays are mostly due to:
- More complex product designs
- Higher complaint volumes
- Limited staff and resources
- Longer investigation and approval chains
As a result, industry bodies in the UK and beyond have flagged this issue as a growing concern.
What the Regulators Are Saying
Regulatory agencies like the FDA (U.S. Food and Drug Administration) and MHRA (UK Medicines and Healthcare products Regulatory Agency) have publicly acknowledged the rising backlogs.
In response:
- New policies have been introduced
- Filing fees have increased
- New policies have been introduced
- Agencies are pushing for more staffing and funding
But fixing these issues takes time, and meanwhile, complaints keep piling up.
FDA Investigation Timelines: Target vs. Reality
In the United States, the FDA sets internal targets for how quickly pharmaceutical complaints should be investigated and closed.
FDA’s Target Timelines:
- Standard complaints: Within 30 days
- Priority or serious cases (e.g., involving injury): Within 15–30 days
Industry Best Practice:
Most companies also aim for 30 calendar days to close an investigation. But that’s just a goal, and reality looks very different.
Real Investigation Timelines: Delays Are Widespread
Despite official targets, complaint investigations in the U.S. often take far longer to complete.
According to recent reports:
- The average time in investigation for pending FDA complaints was 210–256 days between 2021 and 2023
- That’s about 7 to 8.5 months, nearly seven times longer than the recommended 30-day goal
- Investigations that involve third-party manufacturers or cross-border issues tend to take the longest
These long delays make it harder for companies to fix product issues quickly and avoid further risk.
Why Are Complaints Taking So Long?
Several factors contribute to these growing backlogs in pharmaceutical complaint investigations:
1. Higher Complaint Volume
New technologies and global supply chains have increased the number of complaints filed each year.
2. Complex Investigations
Many complaints require lab testing, site inspections, or consultation with multiple departments, which takes time.
3. Limited Staff and Resources
Some companies and agencies do not have enough trained complaint-handling staff or tools to keep up with demand.
4. Involvement of External Partners
When third-party manufacturers are involved, it may take weeks just to gather necessary documents or test results.
5. Documentation and Approvals
Strict rules require complete documentation of all actions taken. These reviews often pass through multiple managers and quality teams.
Impact on Companies and Patients
Long complaint investigation times don’t just affect internal operations, they can also:
- Delay the release of safe products
- Lead to repeat quality issues
- Damage relationships with doctors, patients, and partners
- Increase the chance of regulatory fines or warning letters
In some cases, poor complaint handling has even triggered product recalls or forced temporary plant shutdowns.
How Are Companies Responding?
Faced with longer complaint timelines, many pharmaceutical companies are changing how they work. These steps may include:
- Hiring more quality and compliance staff
- Investing in complaint-tracking software
- Creating centralized teams to handle complaint investigations
- Improving communication with suppliers and third-party manufacturers
Still, even with better systems, solving the backlog is not easy, especially for large firms with hundreds or thousands of open complaints.
Are Delays the New Normal?
Industry experts warn that unless big changes are made, long complaint investigation times could become the norm.
A delay of 6 to 9 months may sound extreme, but based on current trends, it’s not unusual anymore. The average case is simply taking longer to close, and backlog is growing year by year.
What Can Be Done to Improve Timelines?
To reduce delays and build more trust, companies and regulators may need to:
- Set clearer triage priorities, focusing first on complaints that involve patient safety
- Add automation tools to speed up documentation and data entry
- Train more investigators, especially in complex product categories
- Audit backlogs regularly to avoid letting cases fall through the cracks
Some companies are even outsourcing investigation work to specialist firms when internal teams are overloaded.
Final Thoughts: Speed Matters
Slow complaint investigations can create serious risks, for companies, regulators, and especially patients.
The latest data shows that in both the U.S. and UK:
- Average investigation times now range from 7 to 9 months
- Backlogs are increasing, especially for complex complaints
- Efforts to fix delays are ongoing, but progress is slow
While timelines vary by company and region, one thing is clear: the industry needs faster, more effective complaint handling.
Until then, long wait times will continue to frustrate regulators and worry the public.
