OREGON PASSES LANDMARK DRUG LAW

The Oregon state legislature passed the nation's strictest
anti-methamphetamine measure to date, requiring prescriptions for many
over-the-counter cold medications. The law, passed 57-2 by the Oregon House
of Representatives and previously passed by the state Senate, would mark
the first time a state has required prescriptions for over-the-counter
drugs, and poses a challenge to the Food and Drug Administration's
pre-eminence in regulating medicines.

The bill requires that by July 1, Oregon patients will need prescriptions
from a doctor to buy cold treatments containing pseudoephedrine, or PSE, a
key ingredient in making the illegal stimulant methamphetamine. The law
goes much further than other state laws that move PSE-containing products
"behind the counter" -- that is, out of easy reach but still obtainable
without a prescription.

Supporters hailed the bill as a blow to the spreading abuse of
methamphetamine. "This is a great day for Oregon," said Craig Prins,
executive director of the state's Criminal Justice Commission.

PSE is a decongestant in several over-the-counter medications, including
Schering-Plough Corp.'s Claritin-D and Johnson & Johnson's Tylenol Cold &
Sinus.

Drug industry lobbyists for nearly two decades have resisted federal and
state efforts to restrict or ban sales of cold medicines containing PSE.
Sales of PSE products have been hurt by the recent state behind-the-counter
laws.

Now, some drug makers are bringing PSE alternatives to market, and
positions have shifted. In January Pfizer Inc. introduced Sudafed PE in the
U.S.; it contains phenylephrine, an ingredient that can't be used to make
methamphetamine. Once a strong opponent of behind-the-counter PSE laws,
Pfizer now supports them. Leiner Health Products Inc., maker of store-brand
over-the-counter drugs, has introduced similar alternative products.

If other states follow Oregon's lead, it will be a further blow to the $1.4
billion market for PSE-containing products. For large pharmaceutical
companies, cold remedies represent a much smaller portion of sales and
profits than do prescription medicines.

Under the Food, Drug and Cosmetic Act, the FDA rules pre-empt state laws on
over-the-counter drug regulation. The FDA says it isn't aware of any other
instance where a state has passed such a bill. The FDA would have to weigh
whether to fight the Oregon law in court, or watch as other states
potentially follow suit. The agency could support any lawsuits filed by
companies making PSE-containing cold remedies.

The Consumer Healthcare Products Association, the trade association for
makers of over-the-counter medications, didn't have an immediate comment on
the legislation.

Gov. Ted Kulongoski is expected to sign the legislation in the next five to
10 days, according to senior policy adviser Craig Campbell. An FDA
spokeswoman said, "We don't comment on pending legislation."

Some lawyers say it is in the FDA's best interest to challenge Oregon's
proposal. "It's contrary to the legal regime FDA has set out," says Daniel
Troy, who was chief counsel at the FDA from Aug. 2001 to Nov. 2004. "One
would hope the FDA would stand up and say this goes too far; this harms the
public's health." Mr. Troy, now a partner at Sidley Austin Brown & Wood in
Washington, D.C., says he doesn't work with industry clients on the PSE
issue. Some critics of the Oregon bill say it will place a greater burden
and cost on the health-care system if patients need a doctor to get these
medications.

But lawmakers in Oregon and elsewhere are getting desperate in the face of
the methamphetamine scourge. Last year the state's narcotics division shut
down an average of 40 clandestine methamphetamine labs a month, according
to Rob Bovett, legal counsel for the Oregon Narcotics Enforcement
Association. Mr. Bovett says that 95% of terminations of parental-rights
cases in Oregon last year stemmed from meth-addicted parents. Oregon lab
seizures were cut in half following a "behind-the-counter" state law passed
last November. The new bill will seek to prevent what is known as "group
smurfing," or groups of methamphetamine addicts purchasing legal limits of
PSE products from multiple pharmacies. Mr. Bovett said he and other Oregon
law-enforcement agents are consulting with several other states that have
expressed interest in passing laws similar to Oregon's.

A federal anti-methamphetamine bill is pending in Congress. The
Talent-Feinstein Bill cleared the Senate Judiciary Committee last week with
an amendment that removed federal pre-emption on anti-methamphetamine
legislation, keeping the door open for stronger state laws.