On June 15-18, 2015 the Drug Information Association (DIA) held its 51st Annual Meeting in Washington, D.C. This is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines each June all with a common goal: to foster innovation that will lead to the development of safe and effective medical products and therapies to patients. The Annual Meeting features hundreds of programs. Below is a sampling of some of the programs I attended this year.
On the first day, a program, “REMS Integration into the Health Care System: Three Perspectives in an Evolving Environment”, one perspective included an announcement from Theresa Toigo, Associate Director for Drug Safety Operations, Center for Drug Evaluation and Research, FDA, of FDA’s new page for Risk Evaluation and Mitigation Strategies (REMS) called REMS@FDA. The revamped website features a new look with a more-easily-searchable table of REMS programs, a listing of requirements for various health care providers (e.g., pharmacists, physicians) and patients, links to relevant data, and downloadable files. Toigo outlined how FDA has been meeting its commitments to improve REMS, including various stakeholder meetings and engagement. One initiative FDA has underway it a program to integrate continuing education into REMS with the communication plan, but there are many other initiatives underway as part of FDA’s REM’s standardizations initiatives. Some suggestions that came out from other presenters and questions from the audience included the need for designing programs for successful outcomes in real-world conditions by engaging the healthcare community in developing REMS, not just a conversation between FDA and a manufacturer/sponsor , as well as a diverse representation of patients, not just a vocal minority.
On the second day, I attended several presentations on combination products and pharmacovigilance, an enforcement panel for advertising and promotion, and a Center for Devices and Radiological Health (CDRH) Town Hall. From those presentations, it appears clear that combination products pose an issue for transparency between the combined regulatory requirements involving multiple centers. Michelle McMurry-Heath, Vice President, Worldwide Regulatory Affairs, Johnson & Johnson, who moderated a panel, “Regulation of Combination Products in the 21st Century” had an excellent “wish”: she thought reviewers who encounter combination products should have rotations in other centers, to understand the different perspectives in the approval process. Robert Califf, Deputy Commissioner, Office of Medical Products and Tobacco, FDA, from the same panel, thought there could be better discussion about combination products and transparency concerning their regulatory issues, if the names of the products were de-identified, where both manufacturers and practitioners could demand higher quality data for better alignment. And Patricia Love, M.D., M.B.A., Deputy Director, Office of Combination Products, FDA, drove the point home well in several related sessions that combination products need to meet the requirements for all of their indicated centers, the lead which is driven by the intended use and primary mode of action of the combination product.
Along the lines of pharmacovigilance, there are old and new issues cropping up, especially thinking globally and about biosimilars, which are an entirely new industry that has not begun marketing its first approved product. FDA’s CDER, CDRH, and Center for Biologics Evaluation and Research (CBER) cited common themes for advertising and promotion violations that include omission and minimization of risk information, unsubstantiated superiority claims, overstatement of efficacy claims, and unapproved (off-label) communications, including complicated issues surrounding practitioner promotion of products for these uses with insufficient patient disclosures.
And then Jeffrey Shuren, Director, CDRH, delivered a very comprehensive view and vision of CDRH in the CDRH Town Hall, where he explained CDRH’s flexible data approach, where the Center strikes a balance, depending on indication, between premarket and postmarket data to provide a reasonable assurance of safety and efficacy, while delivering excellent customer service. Shuren reported that new policies on investigational device exemptions (IDEs) were coming out along with a revised benefit/risk framework. CDRH has a lot on its plate with retroactive device reclassifications, expedited reviews for devices for unmet needs, enhanced surveillance with unique device identifiers, next generation genomic tests providing the possibility for additional treatment insights, and a new laboratory developed test framework in development. And linking to the earlier topic of combination products, Shuren proposed that a new paradigm of shared user fees and performance goals should be developed for combination products, to help provide better alignment for the combined review standards. He added, “If you want to see rapid changes help us help you."