Dr. Gottlieb on the future of big pharma

ACSH friend and former FDA Assistant Commissioner Dr. Scott Gottlieb, a resident fellow at the American Enterprise Institute, writes about the trials and tribulations of current pharmaceutical R&D in a new op-ed for the Wall Street Journal.

Blockbuster drugs such as cholesterol-lowering Lipitor, says Dr. Gottlieb, are a thing of the past; drug research must now become a much more targeted endeavor that focuses on precision, as is the case with treatments for cancer and Alzheimer s disease. In addition to refining the model of drug discovery, government agencies need to become less risk-averse and diminish the number of regulatory requirements necessary for drug approval. As Dr. Gottlieb aptly points out:

There are ways to make the regulatory process more effective but also more efficient. Adaptive clinical trial designs, which allow drug makers to adjust a trial based on accruing results, can help drug companies learn more about the patients most likely to benefit from a new medicine.

Read more of Dr. Gottlieb s analysis of the current status of the pharmaceutical industry here.

ACSH s Dr. Josh Bloom points out, These are not new concepts, but they are well described by Dr. Gottlieb. He adds, There is absolutely no reason that the tools currently in use (including the high-throughput screening mentioned in Dr. Gottlieb s article) cannot be successful. What is really changing is the economics of the business. Companies are getting away from small molecule research (pills) that may sell for a few hundred dollars per month and are focusing on biologics instead, which sell for hundreds of thousands per year. I believe this trend is being driven by economics more than by science.