Interesting Change Coming to the FDA

If there is one thing the pharmaceutical industry has always been known for it’s this: resistance to change. This inertia is common. It begins in pharmacy school, gains traction through industry, and then peaks at the FDA and its international counterparts. From one point of view, such aversion to change supports consistency of product production. From the other, as many suppose, it’s due to expansive profit margins that insulate the industry from certain commercial and competitive realities. In the case of the FDA, resistance to change is symptomatic of an under-funded and under-staffed agency. Like many of my colleagues, I’ve grown to accept the status quo, so imagine my surprise when I heard about a massive FDA reorganization. My first thought was that any reorganization must be cosmetic, but my presupposition fell apart after reading a recently released FDA memo (italics mine):“In order for FDA to best adapt to the ongoing rapid changes in the regulatory environment, driven by scientific innovation, globalization, the increasing complexity of regulated products, new legal authorities and additional user fee programs, the Commissioner has formed a Program Alignment Group (PAG). … the PAG is charged with identifying and developing plans to modify FDA’s functions, processes and possibly its structure in order to address these matters and best achieve mission-critical Agency objectives … This initiative will provide an opportunity for CDER to continue modernization of operations in order to address the challenges noted above and to implement our new legislative responsibilities, including those imposed by the FDA Safety and Innovation Act and the Generic Drug User Fee Amendments of 2012 (GDUFA). … Most of you are aware of the proposed elevation of the Office of Generic Drugs to a super office, and the concomitant efforts to establish a new Office of Pharmaceutical Quality (OPQ). The work to establish OPQ will need to be closely coordinated with the Office of Regulatory Affairs (ORA).”