Pubdate: Fri, 26 Nov 2004
Source: Oregonian, The (Portland, OR)
Copyright: 2004 The Oregonian
Contact:  http://www.oregonlive.com/oregonian/
Details: http://www.mapinc.org/media/324
Author: Steve Suo
Bookmark: http://www.mapinc.org/meth.htm (Methamphetamine)

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.
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