House Committee Asks Industry For Input On FDA Approval Process Of Follow-On Biologics
The questions were sent by Pallone and Deal to more than 30 trade associations, big businesses, major biotechnology companies, unions and other organizations, including the Generic Pharmaceutical Association and the Biotechnology Industry Organization. The questions also were sent to FDA, the Federal Trade Commission and CMS. The questions focused on potential safety issues, market exclusivity, mandated clinical trials, interchangeability at pharmacies, patent protection and possible savings generated by follow-ons.
The lawmakers wrote, "Members of the Subcommittee on Health are committed to this issue and several have introduced legislation to establish an abbreviated approval process," adding, "We have found it challenging, however, to reach consensus on a single bill that would accomplish this goal." According to the lawmakers, "In order for the subcommittee to better evaluate the merits, benefits and costs of a biosimilars bill, we wish to understand more fully the range of perspectives, concerns and objectives that might be addressed in such a legislative proposal." They added, "We are also interested as to where consensus exists within the biotechnology community and among other stakeholders." Pallone and Deal have requested responses to the questions by April 22 (Edney, CongressDaily, 4/9). Competition Can Lower Costs, Opinion Piece Says
The cost of biologics can be "expected to remain high for the majority of patients who need them," unless "Congress allows monopoly-busting competition by creating a regulatory pathway for generic versions of these medicines from other manufacturers," Insmed CEO Geoffrey Allan writes in a Richmond Times-Dispatch opinion piece. According to Allan, biologics "can cost 20 times more than traditional drugs." He adds that the costs "reflect the high expenditures for research and development that go into creating these medicines, the complexity of their manufacture, the enormous patient benefit and the need for innovators to make a reasonable profit," as well as the fact that they "are sold under monopoly conditions that permit prices to remain high."
According to Allan, more than $10 billion of biologics will lose their patents by 2011 with an additional $9 billion to $10 billion losing patent protection between 2012 and 2015. He continues, "The stakes for patients and their caregivers are significant." Allan writes, "Bringing competition to the current de facto monopoly will not only lower costs, but also bring competition and advancement to one of our most innovative industries" (Allan, Richmond Times-Dispatch, 4/6).
Reprinted with kind 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.
Casa de Comitetul solicitã industriei de intrare Pe FDA Aprobarea procesului de urmãrire Pe Biologics - House Committee Asks Industry For Input On FDA Approval Process Of Follow-On Biologics - articole medicale engleza - startsanatate