H. C. R. 18
(By Mr. Speaker, Mr. Chambers, and Ninety-four Members
of the House of Delegates)
[Introduced February 22, 1996; referred to the
Committee on Rules]
"Urging the Congress of the United States to amend the
Federal Food and Drug and Cosmetic Act and the Public Health
Service Act to facilitate the development and approval of new
drugs and biologics."
WHEREAS, Improving patient access to quality health care is
the number one national goal; and
WHEREAS, The key to improved health care, especially for
persons with serious unmet medical needs, is the rapid approval
of safe and effective new drugs, biological products and medical
devices; and
WHEREAS, Two thirds of all new drugs approved in the last
six years by the Food and Drug Administration were approved first
in other countries with approval of a new drug currently taking
14.8 years; and
WHEREAS, The United States has long led the world in
discovering new drugs, but too many new medicines first are
introduced in other countries, with forty drugs currently
approved in one or more foreign countries still in development in
the United States or awaiting FDA approval; and
WHEREAS, The patient is waiting for the industry to discover
and efficiently develop safe and effective new medicines and forthe FDA to facilitate the development and approval of safe
medicines sooner; and
WHEREAS, There is a broad bipartisan consensus that the FDA
must be re-engineered to meet the demands of the twenty-first
century; and
WHEREAS, The current rules and practices governing the
review of new drugs, biological products and medical devices by
the United States Food and Drug Administration can delay
approvals and are unnecessarily expensive; therefore, be it
Resolved by the Legislature of West Virginia:
That this Legislature respectfully urges the Congress of the
United States to address this important issue by enacting
comprehensive legislation to facilitate the rapid review and
approval of innovative new drugs, biological products and medical
devices, without compromising patient safety or product
effectiveness; and, be it
Further Resolved, That the Clerk of the House of Delegates
be hereby directed to transmit appropriate copies of this
resolution to the President of the United States, the Speaker of
the United States House of Representatives, the President of the
United States Senate, and to each member of the West Virginia
Delegation of the Congress.