4 Reasons the FDA is Creating New Regulations for Life Sciences

August 16, 2017

By Tom Middleton


How Regulators Are Addressing Ongoing Issues in Life Sciences

Compliance is king. At least it has been for decades as far as quality teams at pharmaceutical and medical device companies are concerned. And now, FDA, is taking an emboldened step with another autocratic change. 

The FDA and other regulatory bodies are driving drug and device manufactures to go beyond compliance and focus on product quality, operational efficiency, and patient safety. Regulators want manufactures to prove their commitment to instilling quality into every aspect of operations—from design and manufacturing, all the way through to patient outcomes.

The Agency realizes that in the past, the focus of the relationship between FDA and industry may have been on managing compliance rather than on a shared goal for continuously improving quality.” 
- Jeff Shuren, M.D., Director of the FDA’s Center for Devices and Radiological Health (CDRH)*

Let's first explore the impetus behind moving beyond compliance and then evaluate how quality teams at life sciences companies will need to respond.

Four Drivers for New Life Sciences Regulations

The driving force for this change has been building for many years. On the medical device side, the FDA issued its 2011 report Understanding Barriers to Medical Device Quality, which analyzed[1]:

  1. Product Recalls: More than half of all product recalls were caused by failures in product design and manufacturing process control.

  2. Adverse Events: Serious adverse event reports related to medical device use have outpaced industry growth by 8% per annum since 2001.

    With regard to pharmaceutical manufacturing and regulations, FDA data uncovered the following problems:

  3. Product Defects: Product recall and defect reporting data demonstrate unacceptably high occurrences of problems attributed to inherent defects in product and process design; these data further indicate failures in the implementation of manufacturing process scale-up as well as routine production.

  4. Drug Shortages: There have been alarming shortages of critical drugs over the past few years. Many of these shortages were caused by the use of outdated equipment, reliance on aging facilities operating at maximum production capacity, and lack of effective quality management systems.

New and Emerging Quality Regulations

The life sciences industry is undergoing a fundamental shift. Regulators have enacted new regulations and guidance aimed at prompting manufacturers to instill a culture of quality by establishing the systems and processes needed to proactively identify and prevent issues.

Manufacturers are being asked to provide greater visibility into operations and quality processes. Many of the regulatory changes require that manufacturers make meaningful changes to their quality systems, data management and submission processes, including:

  • Digital/Electronic Submissions: Transition from paper to electronic regulatory submissions.

  • Data Management: Provide in-depth data and documentation, including evidence of quality system effectiveness.

  • Supplier Quality: Provide greater visibility into supplier quality operations.

Most enterprise life sciences companies will be able to adapt to these changes as they have been building out their quality systems for years. On the other hand, these changes could have a profound and perhaps even disproportionate impact on mid-sized and emerging companies as they have typically done the minimum with regards to updating their systems—often using manual and paper-based quality management systems.

Next Steps

For more information about regulatory changes, how they will impact the industry and how quality teams can prepare—Download “How Evolving Regulatory Pressure Will Impact Emerging Life Science Companies” white paper. 

[1] https://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM277323.pdf

[2] https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM442666.pdf


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