Economics in Regulatory

This month's theme is economics and regulatory strategy. Although it is still common for many regulatory professionals to be concerned only with the pure scientific/regulatory side of their work, as the profession has evolved over the years, the ambit of advice they provide has expanded-and with it, their need for knowledge of the entire product lifecycle, from the glimmer in an inventor's eye, through research, trials, approval and even marketing. Many of these stages require an eye to the economics of product development, launch and even postmarket events.

To that end, we have gathered several lead articles this month to give you insight into various aspects of the dollar side of the regulatory business. Regular contributor Philipp Novales-Li gives us an excellent introduction to the whole topic of pharmacoeconmics, reminding us that the link between products and health outcomes can and usually should be quantified. Although no one wants to put a price on human health, reality demands that we measure the effectiveness of products and treatments.

Ray Huml gives us a detailed focus on "patient-centric services," the design of programs to increase effectiveness and lower costs. By taking this perspective, we are able to judge the differences between treatments and preventative steps (including inducing behavioral changes). The article discusses some sophisticated applications of IT technology to healthcare decision making.

Since costs are our focus, we also have an introduction to device clinical trial cost management by Jeffrey Zigler. Device IDE costs have been significantly affected by recent government initiatives and other factors. Zigler gives us the lowdown on the impact of Medicare contracting changes on IDE planning and makes some suggestions for controlling these complications and costs.

Finally, my colleague Thomas Wong and I revisit and debunk a recurring theme about the economics of drug marketing in Canada. Many American regulatory professionals of my acquaintance continue to assume that, because practitioner services are covered by governmental  programs in Canada, drugs are similarly "free." This is not the case, and what drugs will be covered by provincial governments in Canada-and to what degree-can have a critical impact on decisions as to whether a particular drug treatment will be made available there.

The most important economic factor to remember is that Regulatory Focus is free to you-a great member benefit of RAPS. Enjoy, with no opportunity cost or other economic consideration!