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.