Newspapers published an opinion piece and editorials examining a bill (S 623) being considered by the Senate Health, Education, Labor and Pensions Committee that would allow FDA to approve follow-on versions of biotechnology medications. Summaries of the pieces appear below.
- Una Ryan, Boston Globe: "As Congress presses forward, legislators and regulators must take the time to understand that biologics are very different from traditional chemical pharmaceuticals and that, unlike the process for producing generic version of chemical drugs, current scientific capabilities are not sufficient to produce generic biologics that are exact replicas of the original products," Ryan, president and CEO of AVANT Immunotherapeutics, writes in a Globe opinion piece. Ryan writes that "without the proper protections in place to ensure that" follow-on biologics "meet the highest clinical standards and protect the intellectual property of innovator companies, we could be threatening the future of" the biotechnology industry and "actually sacrific[ing] patient safety over the long term" (Ryan, Boston Globe, 6/11).
- Seattle Post-Intelligencer: "Our government allows drug companies to charge us whatever the market will bear, a situation that yields fat profits for the companies and tragic outcomes from consumers who simply can't afford prices that also burden Medicare," according to a Post-Intelligencer editorial. The editorial concludes, "The deadline for the committee vote" on the follow-on biologics measure "is June 20, and we can hardly wait to see what [lawmakers] will do. We're keeping our fingers crossed for 'the right thing'" (Seattle Post-Intelligencer, 6/11).
- Washington Post: "There should be a regulatory framework for the expedited approval of follow-on biopharmaceuticals -- as long as the FDA can ensure to a reasonable degree that the alternative treatments are safe and effective," a Post editorial states. FDA should be able to "design approval requirements on a case-by-case basis, which almost certainly would include clinical trials of various sizes," the editorial continues. This would be a "flexible approach that would ensure speedy approval when possible and that could adjust to changing science," according to the editorial (Washington Post, 6/15).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Publication Date: 2007-06-19 16:00
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