Bliley Queries FDA Role In Facilitating Access To INDs

US House Commerce Committee Chairman Thomas Bliley has written to Healthand Human Services Secretary Donna Shalala asking for information on the adequacy of the Food and Drug Administration's mechanism for facilitating patient access to unapproved therapies, such as compassionate-use Investigational New Drug approvals and treatment INDs.

To assist with the investigation into the process, Secretary Shalala was asked to provide the following information to the Committee by August 5:

- names of drugs and sponsors and dates of approval for all approvals under Hearing Procedures for new drugs (21CFR 314 regulation subpart E) or Accelerated Approval for New Drugs for Serious or Life-threatening Illness (subpart H) for drugs to treat diseases other than AIDS or cancer;