FDA

[Guest guest]

This may help explain the recent actions of the FDA:

 

From NYT 1/24/04

 

F.D.A. Begins Push to End Drug Imports

By GARDINER HARRIS and MONICA DAVEY

 

Published: January 24, 2004

 

 

second " blitz " inspection by federal drug and customs

officials of medicines imported from Canada has found

that nearly all of the almost 2,000 packages opened

contained foreign versions of American pharmaceuticals

that officials said might not be safe.

 

Five of the packages contained Serevent, an asthma

medicine made by GlaxoSmithKline that had been

recalled in Canada because of a manufacturing defect.

People in the United States who ordered the drug from

Canada " probably got that defective product and

weren't notified, " said Tom McGinnis, the Food and

Drug Administration's chief pharmacist.

 

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The inspections, whose results are to be formally

announced next week, form part of a coordinated push

by the Bush administration to stop drug imports and

defuse a budding confrontation between Washington and

the states.

 

The city governments of Springfield, Mass., and

Montgomery, Ala., are already helping buy drugs from

Canada to save money for themselves and their

employees. And officials in more than a dozen states

and scores of towns, cities and counties have said

that they may do the same.

 

The F.D.A. commissioner, Mark McClellan, said in an

interview that the results of the inspections, which

took place in November, demonstrate that drugs ordered

from Canada are often manufactured in distant corners

of the world. After an earlier survey, the agency

announced in September that most of the imported drugs

it inspected were counterfeit knockoffs. Neither round

of inspections included any chemical tests on the

drugs.

 

Asked if the pills reviewed in the latest survey were

unsafe, Dr. McClellan answered, " We just don't know,

because it's so hard to tell. "

 

Governors and mayors leading the charge for Canadian

drugs flatly dismiss Dr. McClellan's safety concerns.

Many point out that even though the value of drug

imports from Canada probably topped $700 million last

year, the F.D.A. has yet to identify a single patient

harmed by the trade. And they say that Health Canada,

which regulates drugs in Canada, is just as rigorous

as the F.D.A.

 

" This has little to do with health and safety and

everything to do with the pharmaceutical industry, "

said Peter A. Clavelle, mayor of Burlington, Vt., who

said he intended to have a Canadian drug purchase

program up and running for city employees and their

families by March 1.

 

The Bush administration is hoping to use a combination

of aggressive inspections and pointed political advice

to persuade local officials to back away from the

border drug trade. " Our first preference is to work

with them to help them lower costs, " Dr. McClellan

said. " But we're definitely not ruling out taking

legal action against cities and states. "

 

Some state officials say a showdown is inevitable.

 

" This is all going to come to a head in 2004, " said

Gov. Tim Pawlenty of Minnesota, a Republican. " Either

the F.D.A. will sue somebody or throw someone in jail

over this, or the pharmaceutical companies choke off

supply, or the F.D.A. comes to their senses. "

 

The pharmaceutical industry, which gets most of its

worldwide profits in the United States because of

higher prices here, had hoped that the issue died last

year, when its allies in Congress fought off a bill

that would have legalized imports from 25 countries,

including Canada.

 

Instead, Congress included a provision in the Medicare

drug legislation passed in November that allows

imports only if the administration deems them safe,

something it has steadfastly refused to do. The

industry also hoped that the bill's promise of a drug

benefit for the elderly beginning in 2006 would reduce

pressure for drug price cuts.

 

" We need more and better coverage, and Congress began

the process of resolving the situation when it passed

the Medicare law, " said Jeff Trewhitt, a spokesman for

the Pharmaceutical Research and Manufacturers of

America, the industry's trade group.

 

But even those with health insurance are being forced

by insurers to bear an increasing share of drug

expenses, making many Americans increasingly sensitive

to those costs.

 

 

 

 

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[Guest guest]

On Feb 20, 2004, at 1:39 AM, wrote:

 

> 3. Argue that most if not all the " documented " adverse effects of

> CHMs / Chinese supplements were because of OTC (non-

> professionally prescribed) use, and that the effects in most cases

 

True.

 

> involved INTERACTION with other (allopathic) drugs in patients with

> already compromised LV, KI or HT function.

>

 

Hold your horses, there. This is where we need to be really careful, if

we don't want to end up having to get pharmacology degrees / be under

the supervision of pharmacists / etc.

 

Who holds the keys to herb-drug interactions, anyway? Certainly not

licensed acupuncturists. I'm not so sure anyone does, at least not

outside of China and the Chinese diaspora. FDA could destroy us just as

effectively with the interaction question. We say, " we know what we're

doing. " FDA then says, " Okay, prove it. " How do we do that? Just as

important, how do we afford to do it?

 

-Jeffrey