To provide for the withdrawal of the drug OxyContin from the commercial market.

May 5, 2005

Mr. LYNCH introduced the following bill; which was referred to the Committee on Energy and Commerce

To provide for the withdrawal of the drug OxyContin from the commercial market.

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 `Act to Ban OxyContin'.

SEC. 2. FINDINGS.

The Congress finds as follows:

(1) The drug OxyContin has proven to be highly addictive.

(2) The use of over-the-counter narcotics such as OxyContin has risen to as much as 9 percent among students in middle schools and high schools.

(3) Overdoses of OxyContin have increased by 450 percent in recent years.

(4) The abuse of the drug, which is prevalent in economically depressed areas, has been strongly linked to criminal activity and has in some cases overwhelmed local law enforcement.

(5) Over 1.5 million tablets of the drug were stolen from pharmacies between 2001 and 2003.

(6) The active ingredient of OxyContin, oxycodone, is twice as strong as morphine.

(7) OxyContin's time-released effect, an important element of its pharmaceutical use, is easily negated by abusers to achieve a heroin-like effect.

(8) The manufacturer of the drug has been cited twice for using negligent and inappropriate advertising, downplaying the potentially fatal risks of abuse.

(9) OxyContin is the first brand-name product targeted for monitoring by the Drug Enforcement Administration.

(10) Health care professionals, such as pharmacists and physicians, have been among those arrested and indicted for distributing the drug in a nonofficial capacity.

(11) The burdens of this drug to the public health outweigh its potential therapeutic benefits, and given that alternative pain medicines and methods are widely available, OxyContin should be banned.

SEC. 3. WITHDRAWAL OF DRUG OXYCONTIN FROM COMMERCIAL MARKET.

Effective upon the expiration of 45 days after the date of the enactment of this Act, the approved application under section 505(b) of the Federal Food, Drug, and Cosmetic Act for controlled-release oxycodone hydrochloride, which drug is marketed as OxyContin, is deemed to have been withdrawn under section 505(e) of such Act.

END