To amend the Federal Food, Drug, and Cosmetic Act to strengthen the ability of the Food and Drug Administration to seek advice from external experts regarding rare diseases, the burden of rare diseases, and the unmet medical needs of individuals with rare diseases.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Expanding and Promoting Expertise in Rare Treatments Act of 2012'' or the ``ExPERT Act''.
SEC. 2. FINDINGS.
Congress finds as follows: (1) Biomedical research is yielding discoveries that are leading to the development of new therapies that hold great promise for treating disease. (2) Scientists are increasingly unlocking the potential for targeting treatments according to genetic defect. (3) Many of the new therapies that are under development in laboratories across the Nation are targeted to rare diseases, small subsets of diseases of significant incidence, or even small subsets of rare diseases. (4) Progress in the development of targeted therapies, while of great promise for those with disease or disability, requires the Food and Drug Administration to develop or obtain expertise in many diseases and disease subtypes. (5) In previous circumstances when the Food and Drug Administration has consulted with rare drug experts, the agency has been able to move new therapies to market with greater efficiency. (6) The Food and Drug Administration benefits from this type of consultation with external experts who have a deep understanding...