Changing Regulatory Landscape, Strategy and Global Policy

January feature articles explored the vital role of regulatory within organizations and throughout the product lifecycle. Some of the leading experts in the profession have come together to share their valuable experience on a wide range of issues impacting regulatory professionals today, including regulatory leadership for a culture of quality, how to successfully hire and engage consultants, regulatory’s role in business strategies and UDI and recall management. Other articles will cover REMS requirements for health care providers, independently unified drug development processes, a review and update of China’s regulatory environment and the changing regulatory landscape for insulin.
 
Changing Regulatory Landscape
 
Diabetes affects more than 30 million Americans, approximately 7.4 million of whom use one or more formulations of insulin to achieve glycemic control. Regulatory scientists, Duran and Candando, tackle the insulin issue in The Changing Regulatory Landscape for Insulin where they discuss the rising price of insulin, review and analyze legislative efforts to keep prices reasonable for patients and present the various barriers to making insulin less expensive. The authors explore the potential effects of regulatory changes by FDA to transition insulin from regulation under the Federal Food, Drug and Cosmetic Act (FD&C Act) to the Public Health Service Act (PHS Act) and suggest that insulin deserves special regulatory consideration.
 
The development of biologics is a complex, multi-faceted process. In recent decades, the process of developing biologics has become more efficient through scientific and technological advances and stringent regulations to ensure biologics are of high quality, safety and efficacy for their proposed indication. In Drug Development Process for Biologics: Regulatory Expectations, regulatory specialist, Chughtai, presents various elements involved in “upstream” and “downstream” manufacturing processes for biologic drug development and the importance of their unification. The author elaborates on the complexity and sensitivities inherent in biologics and emphasizes safety considerations and highlights European regulatory expectations for biologics development.
 
For drugs with known or potential serious risks (adverse events), FDA requires sponsors to develop a Risk Evaluation and Mitigation Strategy (REMS) to ensure the benefits of a drug outweigh its risks. In How FDA Makes Decisions About REMS Requirements for Healthcare Providers, regulatory expert, Kashoki, discusses how companies can scrutinize regulatory precedent to best ensure health care providers fully understand risks associated with drugs and can safely administer them. The author covers FDA’s requirement that companies develop a Risk Evaluation and Mitigation Strategy (REMS), but highlights the lack of REMs specifics, especially where health care provider education and/or training is concerned. She emphasizes where companies should be proactive in determining and communicating risk for their drug products during drug development.
 
Regulatory Strategy
 
FDA’s “Case for Quality Initiative” sought to shift the mindset of medical device manufacturers from mere regulatory compliance to true product quality. Quality assurance and regulatory expert, Ajamil, tackles the issue and outlines the critical attributes of a culture of quality. Her article, Regulatory Leadership for a Culture of Quality in the US Medical Device Industry, explains how such a culture can be built, the benefits it offers and touches on the roles played by regulatory and quality professionals in leading the effort to build quality.
 
In today’s business climate, choosing the right consultants for the right reasons can make the difference between positioning the company for success or setting the company up to spend a great deal of money to the frustration of everyone. Regulatory authority, Husman, discusses the reasons consultants are engaged and how companies can ensure success in executing the relationship in How to Hire and Engage Consultants for Success. The author outlines points such as hiring the right consultant for a specific task, onboarding a consultant, clarifying and communicating expectations regarding specific projects, getting updates from consultants and having a structured project ending to ensure all deliverables have been received.
 
Global Regulations and Policy
 
China’s drug and medical device regulatory environment has changed dramatically in the last four years, with various reforms initiated since August 2015 when China’s central government issued its notification to eliminate the backlog of drug applications, upgrade the quality of generic drugs, encourage new drug R&D in line with global development and improve the quality and transparency of the review and approval process. Regulatory affairs experts, Davidson, Liu and Wang, provide an overview of the clinical trial Investigational New Drug (IND) approvals and New Drug Application (NDA) approvals in China for locally developed and foreign-developed new drugs, based on information from the database and annual report of China’s National Medical Products Administration (NMPA). In China’s Evolving Regulatory Environment: Special Report, the authors assess how the clinical trial market has responded, analyze the future of the China market and review key considerations for new drug investigation on urgent/unmet medical needs.
 
Today, millions of patients rely on medical devices for their care, including life-saving implanted devices such as pacemakers and hip and knee replacements. The introduction of UDIs on medical devices means the devices are beginning to be recorded in inventory systems, health records and registries. Regulatory policy authority, Reed, offers a case example to demonstrate the importance of having UDIs included in a patients’ medical records and requiring manufacturers to include the UDI in product information. Her article, Unique Device Identification and Recall Management: Starting with the Patient in Mind, provides an overview of FDA’s medical device Unique Device Identification System Final Rule and explains why including UDIs in health information and in device recalls can improve patient safety.
 
What you Missed at Convergence
 
The following articles were based on presentations at RAPS Regulatory Convergence, 21-24 September 2019, Philadelphia, PA.
 
Legal expert, Friedman, provides an overview of FDA’s authority, regulations and policies regarding promotion of medical devices through websites and social media in Applying FDA’s Rules in the new World of Online Marketing and Crowdfunding. The author discusses internet and social media marketing and online preapproval communications, specifically addressing “crowdfunding” and where FDA may focus its enforcement activity in this newer context.
 
The advent of today’s smaller, virtual, venture-backed start-up companies has created an environment where lean staffing has become the norm rather than the exception. As a result, many companies are opting to have a single, individual regulatory and/or quality compliance person who must be a “Jack-of-all-trades.” Regulatory experts, Knapp and Verderame, explore the issue in Regulatory Affairs Consultants: Who Needs Them and Why. The authors discuss employing regulatory affairs consultants and offer advice on who needs consultants and why, the “dos and don’ts” of finding, managing and maintaining consultants, how to choose the right consultant with the right background and expertise for the needed tasks and consultant service and pricing models.
 
What’s Coming in February
 
Regulatory Focus has lined up a well versed group of authors to tackle today’s most pressing issues for regulatory professionals on communication methods to employ with various stakeholders about why regulatory is important. Experts will share their experiences and provide insight on the importance of regulatory affairs to key company decision makers including what regulatory can do for all stakeholders, demonstrating regulatory value and writing informed consent documents. Other key focus areas will be on the evolving role of regulatory operations professionals and building interorganizational relationships. Look for these and other topics throughout February.
 
Regulatory Focus Call for Articles
Regulatory Focus is looking for subject matter experts to contribute articles to the Q2 2020 topic “shifting global regulatory landscape.” See below the monthly themes and deadlines for April, May, June and the Q2 Series.
 
April: MDR/IVDR Implementation and Acceptance
Submission Deadline: 2 March
Articles posted throughout the month of April
 
May: Risk Management and Mitigation, Dealing With Contractors and Vendors (CMOs, CROs)
Submission Deadline: 6 April
Articles posted throughout the month of May
 
June: Nutrition in Health and Disease Management
Submission Deadline: 4 May
Articles posted throughout the month of June.
 
Q2 RF Article Series: Shifting Global Regulatory Landscape
Submission Deadline: 1 April      
Release date: Monday, 1 June   
Ask Me Anything: Wednesday, 17 June 

If you are interested in writing on any of the above topics or have a recommendation, email Gloria Hall at ghall@raps.org. Author guidelines are available.