A gaggle of United States Senators are getting ready to introduce bills designed to change the way the FDA deals with drug safety. Can things be made better? Of course. But unless this is done carefully, there’s the real danger of turning the world’s gold standard into fools gold. A process that has evolved over time alongside important improvements in science and technology should not be subject to rash action or political maneuvering. Our system involves a careful balancing of drug benefits and risks based on the best possible scientific information that can be discovered about a drug’s safety profile. Reform? Certainly — but careful and considered reform that makes drugs safer — not hasty measures that grab headlines but do harm to the public health by slowing down the availability of new and better medicines.
The recent discussions about how to make our drug approval system better are important steps in the right direction. But we must be mindful of the fact that patients with life threatening diseases are given hope because of the advances of pharmaceutical discovery and development. Congress must support reform that makes drugs safer, but warn against those that might unintentionally slow down the flow of these new medicines, or worse, discourage the creation of some of them altogether.
Congress should embrace the following 5 key “Pillars of Safety” that are critical to reforms at the FDA:
1- Safety and Efficacy must continue to be the foundational elements of the FDA regulatory process. Safety cannot exist in a vacuum apart from efficacy.
2- Mechanisms to enhance existing structures and processes for post market safety monitoring and adverse event reporting must be explored.
3- Efforts to bring even greater efficiency and scientific expertise to the FDA’s review and monitoring processes must continue; such efforts must be done in a manner that empowers the Agency to keep pace with the rapid advancements now occurring in areas such as genomics, proteomics, and nanotechnology.
4- FDA must continue to work with industry, patient groups, physicians, hospitals, academia, and other government agencies to enhance the critical path.
5- The FDA must be sufficiently resourced in order to insure more effective pursuit of its existing mandates. Additional resources are even more essential if FDA is to successfully implement a comprehensive suite of reforms.
We should all be encouraged by FDA’s plan to allocate more than $70 million over five years to support enhanced monitoring and surveillance of risks that may be associated with drug products already on the market. However, no drug is without risk; and it always has been an unfortunate but unavoidable fact that some adverse effects may not become apparent until after a drug has been in wide or extended use. FDA must strive to minimize such adverse effects and enhance the agency’s capacity to report them, but we must also accept certain risks associated with beneficial drug products. Moreover, without new monies, every dollar the FDA shifts towards new regulations and infrastructure for safety is money taken away from programs that allow the agency to more effectively and efficiently evaluate risk and benefit together.
Finally, one of the keys to a stronger FDA and a more robust development pipeline is a clear plan for how the agency will work to modernize the medical product development process. Such a proposal has been presented in the report: “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.” This document details the agency’s plan to update the tools currently used to assess the safety and efficacy of new medical products. Congress should enthusiastically support the FDA’s willingness to reach out to numerous stakeholders in an effort, “to coordinate, develop, and/or disseminate solutions to scientific hurdles that are impairing the efficiency of product development industry-wide.”
