Monday, April 11, 2011

Vol. 1, No. 7: Should Congress Amend FDCA To Create Earlier Patient Access to New Treatments for Serious and Life-Threatening Conditions?

Should Congress Amend FDCA To Create Earlier Patient Access to New Treatments for Serious and Life-Threatening Conditions?

Steven T. Walker, Co-Founder, Abigail Alliance for Better Access to Developmental Drugs

Walker explains that “timely approval and access to investigational drugs has been strictly limited by FDA, rendering the agency a powerful protector of the 50-year-old clinical trials system—a system now broadly perceived as failing and obsolete.” He suggests an updated clinical trial system that will allow patients safe and quick access to new drugs.

The author specifically recommends that Congress should:
·         Create the statutory flexibility needed for establishing new medical treatment development concepts and approval standards that are better aligned with advancing scientific knowledge and medical innovation by updating the approval standards set forth in the Federal Food, Drug and Cosmetic Act.
·         Establish a transparent congressional annual review process to assess the state of FDA’s scientific performance, with the goal of ensuring that its regulatory science catches up and keeps pace with advancing biomedical science.
·         Create a new drug approval pathway and improve investigational drug access mechanisms to complement FDA’s efforts to characterize the safety, efficacy and targeting of new treatments while simultaneously addressing the unmet needs of patients.

This article is available for download at http://fdli.org/pubs/policyforum/ now. All issues of FDLI's Food and Drug Policy Forum are free to FDLI members and can be purchased by non-members.

If you have any difficulty posting your comment, please contact Sarah Sansolo at sks@fdli.org.

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