The United States, as in most countries in the developed world, does not have a central government agency entrusted with determining pharmaceutical policy and allocating funds to drug development and drug distribution. Most of the drugs that are prescribed in the United States, as well as in other countries, are developed by for-profit pharmaceutical companies that operate in response to market forces. However,
the marketplace in which those companies operate is an extraordinarily complex one, with substantial regulation and extraordinary information costs- the well-known high cost of the clinical trials for drug approval is just one example of the expense of generating essential high quality information about a drug. Pharmaceutical policy is the product of a number of areas of law and regulation that all have an effect on drug development and drug usage in the context of this complex market for drugs starting with the NIH’s role in basic research, and includes patents, FDA approval, our patchwork pharmaceutical benefit coverage, the First Amendment’s protection for pharmaceutical companies’ commercial speech, and product liability. The purpose of this blog is to discuss and examine developments in all the areas of law and regulation that impact drug development, access, and consumption.