WALDEN SEEKS FDA HELP ON METH

WASHINGTON -- U.S. Rep. Greg Walden, R-Ore., is pressing the U.S. Food and
Drug Administration for ways to promote development of cold medicines that
cannot be converted to methamphetamine.

Walden last week asked Patrick Ronan, an assistant FDA commissioner, to
examine how the federal government might encourage manufacturers to seek
FDA approval for such a product -- perhaps by offering expedited FDA review.

Walden told the FDA official that a meth-proof cold pill "could
dramatically reduce the availability of a key component of meth
production," according to his spokeswoman, Angela Wilhelms.

FDA spokeswoman Cindi Fitzpatrick confirmed that the meeting took place but
had no comment.

Walden's inquiry comes on the heels of The Oregonian's five-part series,
"Unnecessary Epidemic," which reported that Pfizer holds a patent on a form
of pseudoephedrine that is chemically impervious to being converted to the
street drug.

Pseudoephedrine is both an essential ingredient in methamphetamine and an
extremely popular decongestant among cold sufferers.

Pfizer officials say its new pseudoephedrine was shelved because it didn't
promise enough of an improvement on existing cold medicines, and FDA
approval would have required lengthy and expensive clinical trials.

Walden's meeting with the FDA is the latest sign of growing support in
Congress and the Bush administration for aggressive strategies to deprive
meth traffickers of their essential ingredients. The Oregonian
investigation, based on a statistical analysis of the meth market, showed
that such strategies could significantly disrupt the illicit trade.

In October, the White House drug czar's office released a comprehensive set
of proposals targeted at meth and other synthetic drugs, many of them
echoing the newspaper's findings. Ideas now circulating on Capitol Hill
range from tighter restrictions on retail sales of ephedrine and
pseudoephedrine to improved tracking of chemical sales overseas.

Walden, who represents rural Eastern and Southern Oregon, is the state's
only Republican in the House. He is a member of House Speaker Dennis
Hastert's task force on drugs. He also serves on the House subcommittee
that is investigating the FDA's oversight of antidepressant use in children.

In an interview, Walden said he plans in the next year to push for more DEA
help in rural areas such as Umatilla County, which he said have a
disproportionate share of the state's meth lab cleanups. He also wants to
hold a series of seven educational forums in communities across his district.

When asked about broader solutions to the problem, Walden called tighter
control over the trade in meth chemicals "about as close to a silver bullet
as I've seen."

Walden said support is growing in Congress for dealing with the problem. He
said efforts to regulate pseudoephedrine in the states -- such as
Oklahoma's recent law limiting cold pill sales to pharmacies -- are forcing
the issue.

"It becomes very difficult, when you look at the success in Oklahoma, what
they've done, to argue against a step that could have a tremendous impact,"
Walden said.

Pfizer's patented cold pill, meanwhile, could someday make controls over
retail sales unnecessary.

Known as "minus" pseudoephedrine, the product did well in animal tests
comparing its safety and effectiveness to the existing "plus" version on
the market. Meanwhile, attempting to cook meth with the new molecule
results in a benign drug with only minor stimulant effects, according to
the patent.

Chemical producers in India say they already have the technology to
manufacture the new version, if the U.S. market demanded it.

The invention differs from other innovations aimed at thwarting meth cooks,
such as additives that would make it harder for meth cooks to extract
pseudoephedrine from cold pills. Pfizer abandoned its quest to develop such
additives earlier this year, saying the technology was unworkable.

By contrast, "minus" pseudoephedrine has no known technical problems. The
main hurdle would be demonstrating the product's safety and effectiveness
to the FDA, a process the industry says can cost $800 million.

A Pfizer spokesman said in September that the company would be open to
discussing government incentives, if approached.

The concept has drawn interest from Oregon's Gov. Ted Kulongoski, a
Democrat, and Sen. Gordon Smith, a Republican. The White House meth
strategy also says the government should "encourage" manufacturers to
develop such products, but the document specifies no incentives.