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Articles throughout December explored advertising, promotion and labeling in addition to the role of social media in regulatory communications. Leading experts in the profession shared valuable insight on a wide range of issues impacting APL professionals today, including optimizing ad/promo regulatory affairs communications, Facebook chat study results and the use of hashtags, social media influencers and considerations, price transparency and assessing risk and strategic business decision-making.

Regulatory professionals, DiDonato, Lee and Roychowdhury, discuss the emergence of social media for use in pharmaceutical advertising and promotion in The Brave new World of Social Media: Regulatory Perspective on Hashtags and Facebook Messenger. The authors cover what hashtags mean, how they function, their uses and potential misuses and provide results of their investigation into how pharmaceutical companies using the social media platform Facebook Messenger respond to consumer questions received through social media. They conclude that the pharmaceutical industry and regulatory professionals should use social media carefully and remain complaint with standard advertising and promotion regulations.

Over the past seven years, there has been a steady decline in the number of FDA enforcement letters pertaining to the advertising and promotion activities for prescription drug products. At the same time, the Office of Prescription Drug Promotion (OPDP) have issued guidance documents to provide a framework for industry to address the current issues facing todays regulatory professionals. Regulatory enthusiast, Jurcik, discusses how regulatory professionals can make benefit-risk decisions with limited agency guidance materials or enforcement examples in Assessing Risk and Strategic Business Decision-Making Without Consistent FDA Enforcement. She concludes that with a scarcity of enforcement letters from FDA in recent years, regulatory professionals must turn to other tools to understand FDA and other government agency issues related to drug promotional activities.

Advertising and promotional (Ad/Promo) review committees in the pharmaceutical industry serve an important role in helping to protect the company, its employees and, most importantly, the patients who take prescription medicines. Ad/Promo committees review and approve product advertising and promotional materials and other internal and external communications. In Optimizing the Review Process of Advertising and Promotional Communications, Gomba, Jameison and Sadowski discuss how medical, legal and regulatory review committee members can best function to provide efficient and effective communication as well as a productive environment aimed at yielding creative, yet compliant, materials. The experts make suggestions for optimizing communications as part of the internal review process by providing clear understanding of regulations and establishing clearly defined processes to foster compliance. They also touch on the importance of timelines and work prioritization, having a unified committee perspective and the need for respectful behavior in team meetings.Engaging social media influencers for prescription drug promotion can present a challenge for most pharmaceutical companies; however, by working with the right social media influencer and operating within standing regulations, companies can reach appropriate patients via social media. In Clarity in Chaos: Best Practice Tips for Engaging Influencers for Pharmaceutical Promotion, Blackmon and Williams demonstrate how one pharmaceutical company used social media to offer guidance to pharmaceutical companies considering using media influencers to promote their products. The experts cover internal collaboration and alignment, identification of creative guardrails for brand teams and regulatory requirements and recommendations.

Whether you are a patient, healthcare provider, industry professional or just have access to news, you have probably witnessed conversations regarding drug pricing transparency, an issue unfolding across America. In Drug Pricing Transparency: the Conversation is far From Over, Walker and Lem discuss the US governments attempts to require drug pricing transparency in advertising. The thought leaders explain the events following the Centers for Medicare and Medicaid Services (CMS) publication of a proposed rule for regulation to require drug pricing transparency. They outline recent initiatives by a number of other federal agencies to develop ways to inform the public about drug costs, efforts by the Pharmaceutical Research and Manufacturers of America (PhRMA) to add their voice to the issue, lawsuits filed by several pharmaceutical companies against federal agencies and subsequent court decisions and appeals.

Regulatory Intelligence

To support the release of the Q4 Regulatory Focus Article Series, Regulatory Intelligence and Policy: Shaping the Global Landscape, RAPS hosted a lively discussion on Regulatory Exchange with three regulatory intelligence experts, Meredith Brown-Tuttle, Matt Medlin and Kirsten Messmer. In Regulatory Intelligence and Policy, the experts, who were all authors in the series, offered their perspectives on the importance of regulatory intelligence and the integral role RI professionals play in defining strategy for companies in regard to development, approval and maintenance of products, as well any changes to regulations impacting the global regulatory landscape. This article presents the questions and answers from the 11 December online discussion.

What you Missed at Convergence

The following two articles were based on a presentations given at RAPS Regulatory Convergence, 21-24 September 2019, Philadelphia, PA.

Global Pediatric Drug Development addresses global pediatric drug development and compares strategies and regulations in the US and the European Union (EU). Regulatory experts, Georgopoulos and McBride, identify key regulations and resources to support pediatric drug development, describe some of the most important factors to consider when developing a global pediatric drug development strategy and point out some common pitfalls in the development of a global pediatric drug development strategy.

Form FDA 1572: Challenges and Opportunities discusses considerations for conducting global clinical trials under the US Food and Drug Administrations Form FDA 1572, an agreement signed by the Principal Investigator (PI) to provide certain information to the sponsor and ensuring the sponsor will comply with FDA regulations related to the conduct of the clinical investigation of drugs and biologics. Some national authorities will not allow their investigators to sign Form FDA 1572 as from their perspective it represents a foreign legal requirement. Regulatory expert, Pangu, discusses the challenges in not signing and recommends processes that sponsors of global clinical trials can adopt to overcome the challenges of signing or not signing Form FDA 1572.

Whats Coming in January

January feature articles will explore the vital role of regulatory within organizations and throughout the product lifecycle. We have brought together some of the leading experts in the profession 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, regulatorys role in business strategies and UDI and recall management. Other articles will cover REMS requirements for healthcare providers, independently unified drug development processes, a review and update of Chinas regulatory environment and the changing regulatory landscape for insulin. Look for these articles and more throughout January.

March Call for Articles

Regulatory Focus is looking for articles for the March 2020 topic covering regulatory ethics and history. Ethics is the assumed hallmark and unequivocal standard behind all elements of regulatory affairs and compliance. This issue seeks to examine various perspectives on this essential concept. Desired contributions will explore ethics and compliance with broad applicability to the field. Articles are sought evaluating:

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Advertising, Promotion, Labeling and the Role of Social Media in Regulatory Communications - Regulatory Focus