What Experts in Law and Medicine Have to Say About the Cost of Drugs image

The Health Care Blog, February 2, 2017
Andy Oram, on PFC's 5th Annual Health Law Year in P/Review Conference


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From the article;

Pharmaceutical drug costs impinge heavily on consumers’ consciousness, often on a monthly basis, and have become such a stress on the public that they came up repeatedly among both major parties during the U.S. presidential campaign–and remain a bipartisan rallying cry. A good deal of the recent conference named Health Law Year in P/Review, at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, covered issues with a bearing on drug costs. It’s interesting to take the academic expertise from that conference–and combine it with a bit of common sense–to see which narratives about drug costs hold up.

The Industry Narrative

In defending the ever-growing cost of drugs, the pharmaceutical industry can’t roll out a single, intuitive explanation. Rather, their justification breaks down into many independent but interacting parts. We have to tease these apart before examining their validity.

Rising complexity of clinical trials

Over the years, the experiments required to prove the efficacy and safety of medicines have become longer in length and more complicated. The FDA has imposed new requirements in the wake of embarrassing failures like the fatalities ascribed to Vioxx. All this improves safety, but raises costs–and also ensures that fewer drugs will make it through the every-tightening gauntlet of tests.

Constricted time for exclusivity

The 20-year period during which U.S. patents allow drug companies to have exclusive rights to sell their drugs seems generous (and is longer than the period for other machines and processes). But a patent has to be filed near the beginning of the research process, and more than half the alloted period may elapse before the company can find a compound that works, make sure they can deliver it to the body, test it, and put it through the FDA approval procedure. [...]

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bioethics biotechnology fda health care reform health law policy holly fernandez lynch human subjects research i. glenn cohen pharmaceuticals public health regulation research