Congressman Brian Bilbray introduces bill to provide patients fighting life threatening diseases greater access to treatment

Washington, D.C. – Congressman Brian Bilbray (CA-50) today introduced H.R. 6288, the Patient Choice Act of 2012, a bill to speed up the approval process of drugs used in therapies and treatments of patients fighting life threatening diseases.

“It is inexcusable that patients have to travel overseas to receive the treatment they need,” stated Bilbray.  “While we continue to streamline the approval process at home, we should recognize the advances made in patient care in other countries that have rigorous approval standards similar to our FDA.”

The Patient Choice Act fast tracks the approval process by instituting the following policies and procedures:

• Grants the Secretary of Health and Human Services (HHS) the discretion to administratively determine what drugs can be approved for fast track status
• Once fast tracked, provisional approval can be given to begin treating patients
• States that if a drug has been approved for use in countries recognized by the Federal Food, Drug and Cosmetic Act, then the HHS Secretary must make a decision on a drug’s provisional status

The use of a drug with “provisional approval” requires full disclosure and informed consent of the patient.  The Food and Drug Administration maintains full control and can withdraw provisional approval of a drug if the data shows that a product is not safe. 

Bilbray added that, “The goal of this bill is to keep the decision of care between the patient and their physician.  Government should not force patients with life threatening diseases overseas to receive care.  Patients should be allowed to receive the treatment of their choice in the comfort of their own community.”