PHARMA: Understanding Pharmaceutical Issues
October 11th, 2006
by
Rob Cunningham
|
Two respected and influential public brain trusts have weighed in recently on major issues in the pharmaceutical arena, leaving us all better informed but probably no closer to consensus on the challenges of balancing quality against cost and market forces against government regulation. In “Research and Development in the Pharmaceutical Industry,” the Congressional Budget Office finds justification for a widely discussed and controversial estimate of the average cost of new drug development at about $800 million. For the industry, this estimate represents a rationale for current pricing and patent policies. To critics, it is a smokescreen for extortionate profits.
Meanwhile, the Institute of Medicine has posted prepublication proofs of “The Future of Drug Safety,” which calls for a sweeping overhaul of the Food and Drug Administration’s procedures for monitoring and enforcing drug safety policies. The New England Journal of Medicine endorsed the recommendations today. In addition to raising a politically contentious argument for stronger FDA regulation, the report calls for expanded clinical research efforts with inescapable cost implications, while speaking to widely shared, bipartisan concerns about safety prompted by the Vioxx controversy and other recent drug and device misadventures.
What are policymakers and the public to make of these imponderable issues, and the surfeit of intelligence that continues to pour forth about them? Health Affairs operates on the assumption that there are no easy answers and that our readers want the problems broken down and explained by the best minds in the policy sphere so they can draw their own conclusions. Over the past five years, since our special issue on “The Value of Innovation” appeared in September 2001, the volume and quality of manuscript submissions on the pharmaceutical industry that the journal has received and published has grown dramatically, spurred by rapid increases in drug spending and debate on the Medicare Modernization Act. A second special issue on pharma appeared in January 2004, and the biopharmaceutical industry is the focus of our current issue. [For the recent journal issues, abstracts are free access and most full-text articles require a subscription. For the earlier 2001 issue, all articles are free.]
Many aspects of the subjects addressed in the recent CBO and IOM reports also have been discussed elsewhere in the journal and in electronically published papers. A critique of drug development cost estimates [2 weeks free access], for example, appeared in our March/April 2006 issue. An analysis of postapproval drug safety monitoring [2 weeks free access], the focus of the IOM report, ran in that same issue. A package of Web-published papers in April 2005, took stock of drug coverage for seniors [2 weeks free access] as implementation of Medicare Part D began. Readers may search the journal’s archives by author or subject to dig deeper. We hope that these resources will inform ongoing dialogue on pharmaceutical policy and that readers will use this new Health Affairs blog to make their own contributions to the debate. And watch this space for posts on pricing of biopharmaceuticals later this month.
