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Federal Agents Seize More Than $24 Million In Unapproved New Drugs

Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

"American consumers are entitled to have safe and effective drugs," said Hanaway.

The seizure followed an inspection of several of the company's plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.

"The FDA is committed to taking enforcement action against firms that circumvent the drug approval process," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER). "Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace."

In a routine inspection of KV Pharmaceutical's facilities in early 2008, the FDA found the company was violating its May 29, 2007, notice (72 FR 29517) requiring companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs. FDA took the action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled. For products in timed-release form, FDA approval is also necessary to make sure that the product releases its active ingredients at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective.

The FDA required companies to stop manufacturing the affected products before August 27, 2007, and to stop shipping the products before November 26, 2007. KV Pharmaceutical continued to manufacture and ship these unapproved new drugs after the cessation dates.

The inspection also exposed the company's manufacturing and distribution of other unapproved drug products. Today's action addresses numerous unapproved drug products manufactured and distributed by the company.

The following drug products were seized and will be destroyed:

- PhenaVent Capsules
- PhenaVent LA Capsules
- PhenaVent PED Capsules
- Ethezyme Papain-Urea Ointment
- Ethezyme 650 Papain-Urea Ointment
- Ethezyme 830 Papain-Urea Ointment
- Hista-Vent DA Tablets
- Meperidine/Promethazine Capsules
- Pseudovent Capsules
- Pseudovent 400 Capsules
- Pseudovent PED Capsules
- Tri-Vent DM Syrup
- Tri-Vent DPC Syrup
- Hydro-Tussin DM Liquid
- Hydro-Tussin CBX Syrup
- Hydro-Tussin DHC Syrup
- Hydro- Tussin EXP Syrup
- Hydro-Tussin HD Syrup
- Hyoscyamine Sulfate Sublingual Tablets
- Hydroquinone 4% Cream
- Hydroquinone 4% Cream with Sunscreen
- Bromfenex Extended Release Capsules
- Bromfenex PD Extended Release Capsules

The seized drugs had been held under embargo by the state of Missouri. Since the time of the embargo, KV Pharmaceutical has been cooperating with FDA officials.

"The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date," said Deborah M. Autor, director of the FDA's Office of Compliance within CDER. "When a company does not heed a cessation date relating to a specific product, the FDA will take enforcement action relating to the company's other unapproved drugs."

In June 2006, the FDA issued a guidance document titled, "Marketed Unapproved Drugs-Compliance Policy Guide (CPG)." This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective.

The FDA encourages consumers who may have these products to contact their health care professional about FDA-approved treatments and discard these products.

Obama Campaign Launches LowRoadExpress.com

New Website will Fact check and Correct McCain Campaign's False Attacks

CHICAGO, IL - The Obama campaign launched a new website, LowRoadExpress.com, to answer the barrage of false, negative attacks launched by the McCain campaign. "The Low Road Express" is a new website that will document and fact check the McCain campaign's misleading and increasingly negative ads. At LowRoadExpress.com the Obama campaign will correct the record and fact check the barrage of false attacks the McCain campaign continues to launch.

In a March strategy memo from John McCain's campaign manager Rick Davis, McCain pledged to run a "respectful campaign focused on issues". In the past John McCain touted his "straight talk" and "civil" campaigning, but there are no signs of that McCain in this campaign.

With fewer than 100 days before Election Day, Senator McCain and his campaign have increasingly resorted to the low road. The tone of the McCain campaign has drawn criticism and disappointment even from loyal McCain supporters. John Weaver, McCain's former top aide told ABC News that the celebrity ad is "childish," adding that "The new negative strategy reduces McCain."

The media has taken notice that McCain, who started off talking about running an honorable campaign, has fallen back into negative attacks and false statements.

The New York Times says that McCain's campaign is turning into the "Low Road Express," saying that "the candidate who started out talking about high-minded, civil debate has wholeheartedly adopted Mr. Rove's low-minded and uncivil playbook."

In Florida, the St. Petersburg Times says, "The Straight Talk Express has taken a nasty turn into the gutter," and that McCain has gone "from 'straight talk' to a smear campaign.""

The Cincinnati Enquirer, in cooperation with The Canton Repository, The Plain Dealer, The Columbus Dispatch and Dayton Daily News denounced the new McCain ad comparing Obama to celebrities as "dubious" and rated it a zero out of 10 with zero being misleading and 10 being truthful.

"With fewer than 100 days before Election Day, Senator McCain and his campaign have increasingly resorted to the low road," said Obama campaign manager David Plouffe. "Given our enormous challenges from energy and healthcare to our economic and foreign policy challenges, the American people deserve a serious debate. Instead all we've been getting from the McCain campaign are misleading attacks and Paris Hilton and Britney Spears. All of the time the McCain campaign spends attacking Barack Obama is time they are not focusing on helping American families meet the challenges of the 21st century."

The Low Road Express is a new website that will document the McCain campaign's false statements and negative attacks. At LowRoadExpress.com the Obama campaign will correct the record and fact check the barrage of false attacks the McCain campaign continues to launch.

We may all think people are smart enough to know the truth, but I may be wrong. McCain/Bush admnistration knows there are people who buy the bushit they are puting out. There are people accross United States, still believe Obama is a muslim. Even if facts states he is a christian.

So actually McCain/Bush knows that American people are dumb enough to buy their lies. I hope people can open their eyes and focus on the candidate that is addressing real issues, like the economy.

What explaination can McCain/Bush give on the US oil companies making Billions of Dollars in profit, when Bush/Cheney/McCain are interested parties? Are American that naive that they can not see all this Crap?

Full story here

http://www.huffingtonpost.com/2008/07/31/mccain-camp-obama-playing_n_116081.html

Talk about a rock and a hard place! (or a limp place!) On both sides. The denial, the arrogance, the hubris of the ol' phallic presence rearing up its increasingly (less able to think clearly) head.

There is a great article over at SFGate on all of this. I wouldn't expect any Democratic Women to fall in line over in the PUMAcamp. We represent that HUGE group of highly educated, working women -- and so many of us have been practicing feminism since our teens when it was taught to us, if not by our mothers, then their friends...

Clues for you! (in maleville) about how you really screwed up this election, bigtime. And there isn't an effing thing you can do about it, now, because it is too late!

An excerpt from SFGate's piece by Robin Lakoff:

"...So many women feel that the election was somehow stolen, and by their own party, to boot. They thus feel much the way many Democrats feel about the 2000 election: bitter. When one side feels that they lost an election fairly, any bitterness recedes early on (think of the 2004 election, by comparison). But when the adjective "stolen" leaps to mind, bitterness is apt to prevail, vanquishing any desire for reconciliation and cooperation. That is what many former Clinton supporters are feeling now..."

You'll love the last few lines, and the reference to Lolita. Don't miss that read...

The feminist vote is quite enraged at present. Mostly because of what the patriarchs have tried to do. We can all admit, I hope, by now, that sex happens among heterosexuals. We can all admit by now that most people work, and many women are not "stay at home" 1950's style moms. Can't we?

It makes sense not to call "birth control" methods "abortion," doesn't it?

So, why the big hush, hush and the big SEXUAL denial. Check this out!

But see, to us of the feminine clan, it might not just be a male's prerogative to do this. We do it too!

Can you believe it?

And all men are not created equal in the talent department, sexually. Isn't that sad?

Then, we get stories to read like this!

Or how about this!

We feel sorry for the wives in question...

What do you want to bet that the pumaclan is made up of very experienced women, in terms of their multiple relationships with men? You see, unlike what some men think, feminists aren't lesbians, in toto! Some of them might be, but not all! Some women (as we all grew up after the sexual revolution happened) have had the multiple relationships to prove that we are like you men!

Exactly like you!

So, why would you try and take away birth control, when in a tanking economy nobody is going to be able to get a job in the first place to take care of a child? Things are not like the 50's. Even though you would love to believe it...especially on the Republican side.

Marriages? They fall apart. Affairs? They happen. It's life, even among the most religiously devout of you, no? So? Why act dumb? Or play dumb right now? We women of the pumaclan see through it. We chose Hillary Clinton for a lot of things, but as women, what she went through in her own marriage resonates for all of us. Collectively. All of our lives we've seen stories like the above. But to think that this is a male's prerogative only in 2008? Not in our clan...

It's ironic that her marriage made it, but it did. Any of us who are married know that it isn't exactly a contract for sexiness, is it? It's a social contract people make in heterosexual circles.

It looks like the boys better grow up a little in this election. On both the Republican and Democratic sides, no?

I can tell you one thing though. Misogyny runs rampant over in camp d'O.

No pumafemme I know will ever vote for that nightmare, now.

Giving Hillary Clinton the finger was the capper for us. So expect the finger back. From your peers, no less!

McCain? He's had a lot of experience himself in life so far. I think he can make the right choices for the women's vote. It's not hard to take a pro-life stance, but still provide birth control especially in an economy like this one. And if he doesn't? I'm sure those pro-choice Republican Senate women will have a thing to say to him...

Why would any candidate right now want to create women who as my mother used to say are "barefoot, pregnant and under the table" -- when there are so few examples of decent men left on our planet?

To be fathers...