Detailed Instructions: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
Q: 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 of the diseases or disease subtypes that are
targeted by new therapies.
(7) Access to external experts provides valuable advice
about rare diseases or disease subtypes, disease severity, and
unmet medical needs.

SEC. 3. CONSULTATION WITH EXTERNAL EXPERTS.

Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the
following:

''SEC. 568. CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES,
TARGETED THERAPIES, AND GENETIC TARGETING OF TREATMENTS.

''(a) In General.--
''(1) Opportunities for consultation.--The Secretary shall
ensure that opportunities exist, at a time the Secretary
determines appropriate, for consultation with external experts
on the topics described in subsection (c), for the purpose of
promoting the efficiency of and informing the review by the
Food and Drug Administration of drugs and biologic products for
rare diseases and drugs and biologic products that are
genetically targeted.
''(2) Consultation.--The Center for Drug Evaluation and
Research and the Center for Biologics Evaluation and Research
shall, when appropriate, seek the opinion of external experts
on any topic, including the topics described in subsection (c),
by initiating contact with such experts. External experts may
also request the opportunity to meet with a review division
regarding any topic described in subsection (c).
''(b) External Experts.--The external experts under subsection (a)
may include--
''(1) representatives of patient, consumer, research, and
health professional organizations with expertise relevant to
the review of rare disease products;
''(2) experts on rare diseases, rare subtypes of rare and
other diseases, and genetic targeting of treatments, including
experts from academia; and
''(3) experts in innovative clinical trial designs for
small target populations.
''(c) Topics for Consultation.--Topics for consultation may
include--
''(1) rare diseases;
''(2) the severity of rare diseases;
''(3) the unmet medical need associated with rare diseases;
''(4) the willingness and ability of individuals with a
rare disease to participate in clinical trials;
''(5) an assessment of the benefits and risks, including
side effects, of current and investigational therapies;
''(6) the design of clinical trials for rare disease
populations and subpopulations, including regulatory and
scientific policies affecting the design of such trials; and
''(7) demographics and the clinical description of patient
populations.
''(d) Classification as Special Government Employees.--The external
experts who are consulted under this section may be considered special
government employees, as defined under section 202 of title 18, United
States Code.
''(e) Proprietary Information.--Nothing in this section shall be
construed to create a right for any external expert, as described in
subsection (b), to obtain access to proprietary information of a
sponsor without the permission of such sponsor.
''(f) No Right or Obligation.--Nothing in this section shall be
construed to create a legal right for a consultation on any matter or
require the Secretary to meet with any particular expert.''.
A:
Expanding and Promoting Expertise in Rare Treatments Act of 2012 or EXPERT Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to ensure that opportunities exist for consultation with external experts to promote the efficiency of and inform the review by the Food and Drug Administration (FDA) of drugs and biologic products for rare diseases and drugs and biologic products that are genetically targeted.

Requires the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research to seek the opinion of external experts on topics that may include: (1) rare diseases; (2) the severity of rare diseases; (3) the unmet medical need associated with rare diseases; (4) the willingness and ability of individuals with a rare disease to participate in clinical trials; (5) an assessment of the benefits and risks, including side effects, of current and investigational therapies; (6) the design of clinical trials for rare disease populations and subpopulations; and (7) demographics and the clinical description of patient populations. Authorizes: (1) external experts to request the opportunity to meet with a review division regarding any such topic, and (2) external experts who are consulted to be considered special government employees.

Declares that nothing in this Act shall be construed to: (1) create a right for any external expert to obtain access to proprietary information of a sponsor without that sponsor's permission or a legal right for a consultation on any matter, or (2) require the Secretary to meet with any particular expert.