To say that globalization matters to pharmaceutical and medical device companies is an understatement. Labor, research, and payer coverage and reimbursement obstacles in North America and Europe, as well as increasing patent challenges, are forcing an intense focus on maximizing development activities and commercial opportunities around the world, including in jurisdictions that were barely on the radar screen in decades past. At the same time, speed to approval in developed markets remains critical, and a significant portion of the value proposition of research conducted in developing markets is often focused on support of approval applications in the US and EU, where the scrutiny of research and publication practices has steadily grown. Taken together, these trends require legal, regulatory, and compliance professionals to pay close attention to how clinical research activities are planned and executed.
Jennifer L. Mallory | Nelson Mullins & Scarborough LLP
Female libido drug candidate flibanserin has rekindled a debate about gender bias in the Food and Drug Administration’s drug approval process. The debate centers on that agency’s approval of 24 drugs to treat male sexual dysfunction and its failure to approve even one drug to treat female sexual dysfunction. While commentators and politicians debate alleged gender bias at a federal agency headed by a woman, the flibanserin story provides important lessons for pharmaceutical and biotech companies that run into obstacles along the path toward approval.
Joe Archer | MMS Holdings, Inc.
The Food and Drug Administration (FDA) is the primary enforcement agency of human subject protection in the United States. With its gatekeeping role over medical products and statutory authority with an established inspection force, the FDA is undeniably a powerful player in regulating clinical research. In September 2012, the US Department of Health & Human Services (HHS) transferred authority from HHS control to the FDA to oversee information that is filed to ClinicalsTrials.gov (“clinical trial registry data bank”), and seek out those who fail to file, or file misleading or false data, according to a statement in the Federal Register (Note: ClinicalTrials.gov is mandated under U.S. Public Law 110-85 (Food and Drug Administration Amendments Act “FDAAA” of 2007), Title VIII, Section 801).