The healthcare industry is one of the most highly regulated out there — and for good reason. When it comes to developing and then getting life-saving medications to patients, there is little room for error. Regardless of where you fall on the healthcare continuum (manufacturing, transporting, storing, or dispensing drugs), staying on top of the various and ever-changing quality and regulatory requirements will set you and your customers up for success long-term. 

Trends in FDA Approvals

As the FDA continues to approve more drugs each year, the list of requirements continues to grow as well. In fact, a study of FDA drug approvals by the NIH’s National Center for Biotechnology Information found that from 2000-2008, the FDA approved an average of 23.3 new drugs per year while from 2018-2021, this grew to 52.5 per year- a whopping increase of 125%. Additionally, many of these new drugs also require special storage and handling instructions which must be followed to stay in compliance with both state and federal regulations. 

While the FDA is busy approving more drugs, they have also been busy giving out more and more FDA Form 483 Inspectional Observations. A Form 483 is given after an inspection of a drug manufacturer or compounding pharmacy if the inspector finds any regulatory violations. A study of 483s trends by Barbara Unger shows that the number given by the FDA increased each year from 2014-2019 (the number dropped drastically in 2020 and 2021 as COVID-19 limited the ability to have on-site inspections). If a firm receives a 483, they have 15 business days to respond. As with many government processes, there are unwritten rules and conventions which when followed increase the likelihood and the response being received favorably. 

These trends demonstrate the importance of having a trusted quality and regulatory partner on your side. Experience in the inspection process (which can help prevent the 483 in the first place) and expert knowledge in regulations for both new and legacy drugs can help ensure your procedures, lab controls, operations and training, and other processes are in line with everything an FDA inspector will be looking for when they arrive. Inevitably, there will be 483s, but a partner with knowledge of the best practices of writing and delivering an FDA response that will be well received can be invaluable and a huge stress reliever.

Industry Regulatory Trends

And now there may be new scrutiny coming to the industry. In June of 2022 the FTC voted to begin a study of pharmacy benefit managers and how their business practices may impact both drug prices and the access to drugs for certain patients. While the FTC is currently only looking at a specific role in the industry, this analysis by the law firm Epstein Becker & Green and published by JD Supra believes it opens the door to broader implications for pharmaceutical manufacturers and pharmacies.

At the same time, the Health Insurance Portability and Accountability Act (HIPAA) and patient privacy in general is getting a fresh look from Congress and tech companies as the use of technology in healthcare, including apps, is blurring the lines of private and shared PII data.

As the landscape continues to grow and change, the importance of a trusted partner with experience in quality and regulatory requirements becomes even more vital to help you avoid roadblocks which can delay products going to market and other setbacks.

Identifying the Right Partner

While healthcare regulations continue to change, the best practices to ensure you’re in compliance remain the same. 

1. Quality Management: Validate your current systems, policies, training, qualifications, and procedures. If changes are needed, implement a well-documented change control and change management oversight. When ready, have an expert take you through a compliance and quality data review to see how prepared you truly are.
2. Auditing and Deviation Management: Are you prepared for an outside audit for the FDA? Do you know everything an inspector might be looking for when they show up? The most important step to being ready for any audit is to always be “audit-ready.” Have a partner or internal expert perform an audit to assess preparedness. Evaluate any non-conforming products and conduct a root cause analysis so they can be brought into compliance. For more information about preparing for an audit, please check out our blog Three Steps to Prepare for an FDA Inspection. 
3. Regulatory Requirements: Stay up-to-date on all licensing for products and facilities. Know and meet all regulations, standards, GxP requirements, privacy and HIPAA regulations. It’s critical to ensure you are following all safety laws and OSHA guidelines.
4. Relationship Management: Always be ready to host an external inspection by working from the start to ensure all suppliers have qualifications, meet any licensing or regulatory guidelines, and have quality agreements in place.

In Summary: Don’t Wait for Quality & Regulatory to Become a Problem

As tempting as it may be to push quality and regulatory to the backburner until an issue or audit arises, doing so will ensure that more time and resources will need to go towards addressing them once they inevitably happen (which they will). By doing your diligence on the front end, you can make things much easier on everyone in your organization once it is time for an inspection or an issue has arisen. If you are harder on your own organization than a regulatory body might be, then there is nothing to worry about. 

It’s also understandable that at times, it may be incredibly challenging to stay on top of all things quality and regulatory. Not all companies are large enough to have expertise in each of these areas, especially considering how many moving parts there are in today’s requirements in healthcare. For this reason, don’t be afraid to enlist a partner to help guide you through these processes. It can help your organization focus on your areas of expertise and can save you much needed time and money through efficiencies and avoiding potential roadblocks.

About QRCare

QRCare is a quality and regulatory consultancy service that provides organizations with the support needed to develop and maintain strategic quality and regulatory efforts. Whether they are establishing a system from the ground up, preparing for a supply chain inspection or implementing change control, QRCare offers assistance to customers throughout their quality and regulatory journeys. For more information about partnering with QRCare, please visit here.