The Food and Drug Administration (FDA) has released an updated draft for the life science industry regarding communicating directly with health care professionals. This FDA guidance draft will go to industry for comment and feedback with the long term goal of streamlining the FDA regulatory process.
A specific use case mentioned in the FDA guidance is how HCPs use scientific information about unapproved uses (SIUU) for approved/cleared medical products. From the pharmaceutical or medical device perspective, are life science companies providing this scientific information in the context of clinical decision making? For example, are there off label uses of the FDA approved treatment for patients that may be going under investigated for both efficacy or compliance?
Scientific Information on Unapproved Uses (SIUU)
Particularly, this FDA guidance targets life science firms and how companies are sharing specific approval drug communications for medical products. Further, the following types of communications with HCPs were specifically mentioned by the Food and Drug Administration:
- Published scientific or medical journal articles (reprints)
- Published clinical reference resources:
- Clinical practice guidelines (CPGs)
- Scientific or medical reference texts (reference texts)
- Materials from independent clinical practice resources
- Firm-generated presentations of scientific information from an accompanying published reprint
Clinical Drug Trials
The FDA guidance speaks consistently to the delivery and context of medical trials data. Further, scientific information from clinical trials for approved products should be truthful, non-misleading, factual, and unbiased. The clinical research center should be in good standing from an FDA compliance perspective as well.
Finally, there is a legal responsibility for industry employees to communicate information that is generally regarded as safe. Those who communicate unapproved indications or create medical labeling should not be associated with different types of unresearched clinical outcomes.
Medical Manufacturers
The FDA guidance makes it a point to note the types of life science firms and industry employees who can be held legally responsible. Medical labeling and the labeling of medical products can include:
- Applicants
- Sponsors
- Requestors
- Manufacturers
- Packers
- Distributors
- Licensees
- Any person communicating on behalf of these entities.
Clinical Evaluation
There has been some clinical research concerns across the healthcare industry about data integrity and organizations or publications that have issued clinical studies. The FDA guidance describes what it considers a source publication for legitimacy as:
- The clinical problem is scientifically sound
- The clinical study provides relevant information
- Clinical data is relevant to HCPs who make clinical decisions
- Clinical treatment must be relevant to the the care of a patient
The FDA guidance is written so industry employees focus towards:
- Interpreting strengths and weaknesses of clinical research
- Interpreting validity and utility of the therapeutic information
Healthcare Providers (HCPs)
The FDA guidance goes on to elaborate about professionals who are engaged with clinical decision making during patient treatment. Additionally, special focus is given to individuals licensed or authorized by law to prescribe, order, administer, or use medical products during their daily job.
Regulatory Compliance
The FDA goes on to comment that medical product regulation has progressed over time and is shaped via real world clinical evidence. Additionally, there can be significant hazards to society when uses of medical products do not follow the clinical process for regulatory approval.
FDA’s premarket review process decides if a medical product is safe and effective for the specified use(s) in an recognized patient profile. Yet, after the premarket review process is complete and a product is approved/cleared, questions may arise.
Intended Use
These questions can be investigated during clinical use of the medical product for the intended patient. Specifically, FDA premarket review for medical products includes:
- Safety and effectiveness for each intended use needs to be appropriately studied by firms
- Independently evaluated by FDA before a medical product is introduced into interstate commerce
- Evidence that demonstrates effectiveness and safety for one product does not guarantee the clinical effectiveness or safety for additional uses
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About Regulatory Compliance Associates
Regulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:
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The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
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