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Regulatory Compliance/FDA Why Regulatory Intelligence Is More Important Than Ever W By Cathy Yarbrough, contributing editor hen FDA official Robert Temple, M.D., speaks at the agencyÕs opento-the-public workshops and other meetings, Gary Buehler, VP of global regulatory intelligence and policy at Teva Pharmaceuticals, listens. ÒRemember the old TV commercial about the stock brokerage company, ÔWhen E. F. Hutton talks, people listen?ÕÓ Buehler asks. Dr. Temple, deputy center director for clinical science at CDER (Center for Drug Evaluation and Research), is an FDA Òthought leader,Ó to whom regulatory intelligence officials should listen during public meetings, Buehler said. ÒDr. TempleÕs comments often provide insight about how FDA officials are thinking, what they are planning to do, and what is on the horizon regarding new policies, regulations, and guidelines,Ó he said. ÒI take that information and assess how it applies to Teva,Ó added Buehler, who formerly headed the FDAÕs office of generic drugs. He joined the company in 2010 after 24 years at the agency. Regulatory intelligence (RI), which made its first appearance about 15 years ago at the large biopharmaceutical companies, is a relatively new arm of global regulatory affairs (RA) at Teva, Buehler said. RI typically is part of a biopharmaceutical companyÕs RA department and broadens the traditional regulatory affairs function beyond preparing and submitting applications to the FDA and the regulatory agencies of Europe and Asia. RI officials keep the companyÕs leadership up-to-date about current regulations affecting the development, approval, and maintenance of products, as well any changes to the regulations and/or regulatory landscape 52 LifeScienceLeader.com that may impact their efforts. ÒRI focuses on the regulatory pathways associated with the drug development and approval process, often using historic decisions of regulatory agencies as a lens for potential future decisions,Ó he said. According to Buehler, RI contributes to every biopharmaceutical companyÕs bottom line by helping the RA teams provide the highest quality submissions to agencies. If the FDA or EMEA (European Medicines Agency) delays approval of a regulatory submission because of a flaw in the application, the long-term sales of the new compound could be significantly affected, particularly if the company aims to be firstto-market in a specific drug class. ÒGlobal regulatory drug development is more complex than ever before,Ó because of the globalization of the life sciences industry, Buehler noted. ÒTodayÕs regulatory professionals must understand not only the regulatory guidances for each geographical market in the world, but also the hot button issues that affect the review of new drug applications in these regions. ThatÕs because those issues also may influence the FDAÕs evaluation of the compounds,Ó he said. RI AND THE REGULATORS TodayÕs RI professionals also must shape the global regulatory landscape. ÒBy proactively participating in the drafting of legislation and guidance documents and providApril 2013 ing input to questions regulatory agencies have in formulating their perspectives we are ultimately helping the regulatory agencies have the information they need to review and approve medicines,Ó he said. By submitting comments about the FDAÕs draft proposals, the companyÕs RI staff can influence whether the proposed regulation or guidance will be adopted entirely, in part, or at all. In assessing a regulatory agencyÕs guidance documents and other statements, Buehler said that RI officials Òoften have to read between the lines,Ó because the agencyÕs expectations and requirements are not always clear. For example, the FDA has issued three draft guidance documents on biosimilar product development, in response to the 2010 Patient Protection and Affordable Care Act that amended the Public Health Service Act to create an abbreviated approval pathway for biosimilar products. Despite these guidance documents, the FDA is being Òcoy,Ó Buehler said. ÒThe FDA has stated that the process for approving certain follow-on protein products is likely to be complex. There are a number of factors that will influence development and eventual approval, and the FDA would like to comment on them in the early stages. For this reason, the agency is advising manufacturers to meet with the agency to present their