Fwd: FDA Steps Up Enforcement on Drug Imports

[Guest guest]

It is pretty obvious who there are protecting, if you look over the last 70

years or so and getting worse over time.. F.

 

luckypig <luckypig wrote: " @ TheMultiD "

" luckypig "

Tue, 30 Sep 2003 13:02:08 -0400

FDA Steps Up Enforcement on Drug Imports

 

Just who is the FDA protecting, it sure is not the consumer ....

-

 

> washingtonpost.com

>

> FDA Steps Up Enforcement on Drug Imports

> Safety Concerns Cited in Response to Governors Seeking Purchases in Canada

>

> By Ceci Connolly

> Washington Post Staff Writer

> Tuesday, September 30, 2003; Page A02

>

> As a growing number of governors say they intend to defy federal

regulators

> and purchase lower-cost prescription drugs from Canada, the Bush

> administration is pushing back, stepping up its enforcement actions

against

> what it describes as " illegal and potentially dangerous " shipments from

abroad.

>

> Officials from the Food and Drug Administration announced yesterday that a

> check of 1,153 mail parcels arriving from foreign countries showed that

> 1,019 contained medications that in some way violated U.S. drug safety

> laws. Many were of " unknown quality or origin, " the FDA said, or had been

> shipped with improper packaging or labeling. A majority of the drugs came

> from Third World countries, it said.

>

> In announcing the " blitz, " FDA officials reiterated warnings that anyone

> shopping for medicine outside the United States is taking a risk.

>

> " There is no evidence that unapproved imported drugs are becoming any

safer

> or more reliable, " FDA Commissioner Mark McClellan said in a press

release.

> " Given FDA's limited resources and authorities to detect and block

> potentially unsafe imports, we are concerned about any measures that would

> increase the flow of these unapproved drugs, or provide easier channels

for

> them to enter the United States. "

>

> Although the agency does not prosecute individuals who buy medicine from

> other countries, it has begun court action against Rx Depot, a chain of

> storefronts that facilitates drug purchases from Canada. The agency also

> has mounted a vigorous lobbying campaign against legislation that would

> legalize buying drugs from Canada and Europe.

>

> FDA Senior Associate Commissioner William Hubbard said in a telephone

> briefing that the legislation sponsored by Reps. Gil Gutknecht (R-Minn.)

> and Rahm Emanuel (D-Ill.) " would make things worse. " He said the

> anti-counterfeiting packaging envisioned in the bill does not exist and

> legalizing any type of drug importation would " open up the floodgates to

> many more of these drugs and encourage people to go buy drugs no one had

> any regulatory oversight over. "

>

> Gutknecht disputed the FDA's assertions, saying " the FDA's blind

refutation

> of fact and its duplicity in making safety claims are predictable and

> pathetic. " Rather than fight his legislation, he added, the agency ought

to

> focus on ensuring the quality of imported drugs.

>

> " Interpreting their actions regarding the outrageously high cost of

> prescription drugs for Americans, one might be led to think their mission

> is to protect the well-being of pharmaceutical manufacturers, " he said.

>

> Only a fraction of the drugs seized in the recent sweeps -- about 20

> percent -- would have been legal under the Gutknecht legislation, Hubbard

> acknowledged. The others would continue to be illegal and in fact,

> Gutknecht said, penalties for some of those violations would be harsher if

> his bill became law.

>

> Despite its assertions that the " shipments often contain dangerous

> unapproved or counterfeit drugs that pose potentially serious safety

> problems, " the FDA did not test the drug samples but relied on visual

> inspections to determine whether they met basic safety guidelines, Hubbard

> said.

>

> In some cases, the American recipients of the shipments had attempted to

> purchase controlled substances, such as narcotics, or drugs that are

> currently licensed for animal use but not human patients. In one instance,

> the drug dipyrone was shipped from Mexico even though it was withdrawn

from

> the U.S. market in 1977.

>

> The Gutknecht-Emanuel bill passed the House with overwhelming bipartisan

> support but faces some skepticism in the Senate. While Congress debates

the

> issue, sometimes called " reimportation " because some medicine purchased in

> Canada is manufactured in the United States, growing numbers of consumers

> are defying the FDA's warnings.

>

> Michael Albano, the mayor of Springfield, Mass., has enrolled more than

> 1,100 city employees and retirees in a low-cost Canadian drug plan, and

the

> governors of Illinois, Minnesota and Iowa are all pursuing similar plans.

>

> http://www.washingtonpost.com/wp-dyn/articles/A19769-2003Sep29.html

>

 

 

 

 

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