Comments on: The US Pays Millions For Unapproved Drugs http://www.pharmalot.com/2008/11/the-us-pays-millions-for-unapproved-drugs/ News, Comment and Conversation Fri, 10 Feb 2012 21:29:37 +0000 http://wordpress.org/?v=2.6.2 By: Compliance Analyst http://www.pharmalot.com/2008/11/the-us-pays-millions-for-unapproved-drugs/#comment-383030 Compliance Analyst Wed, 26 Nov 2008 13:01:45 +0000 http://www.pharmalot.com/?p=17958#comment-383030 They are perfectly aware. You have to also remember that "grandfather drugs" are also considered unapproved drugs (drugs like cocaine, morphine, and codeine). I know my company still has pending approvals, because the FDA started coming down on companies and making them put in applications for the GF drugs. It still takes a long time to review these products though, even though yuo have a ton of historical knowledge. They are perfectly aware. You have to also remember that “grandfather drugs” are also considered unapproved drugs (drugs like cocaine, morphine, and codeine). I know my company still has pending approvals, because the FDA started coming down on companies and making them put in applications for the GF drugs. It still takes a long time to review these products though, even though yuo have a ton of historical knowledge.

]]> By: Jaynesday http://www.pharmalot.com/2008/11/the-us-pays-millions-for-unapproved-drugs/#comment-382935 Jaynesday Wed, 26 Nov 2008 00:09:33 +0000 http://www.pharmalot.com/?p=17958#comment-382935 Here's some related information I just stumbled upon from the FDA Docket. Titled: FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH MARKETED UNAPPROVED DRUGS WORKSHOP Tuesday, January 9, 2007 8:30 a.m. Universities at Shady Grove Conference Center 9640 Gudelsky Drive Auditorium Building 1 Rockville, Maryland http://www.fda.gov/ohrms/dockets/dockets/03d0478/03d-0478-tr00001.pdf Sounds like the FDA is well aware of unapproved drug marketing. I haven't read it myself but if you're so inclined... Here’s some related information I just stumbled upon from the FDA Docket. Titled:
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
MARKETED UNAPPROVED DRUGS WORKSHOP
Tuesday, January 9, 2007
8:30 a.m.
Universities at Shady Grove Conference Center
9640 Gudelsky Drive
Auditorium
Building 1
Rockville, Maryland

http://www.fda.gov/ohrms/dockets/dockets/03d0478/03d-0478-tr00001.pdf

Sounds like the FDA is well aware of unapproved drug marketing.
I haven’t read it myself but if you’re so inclined…

]]> By: The Caped Crusader http://www.pharmalot.com/2008/11/the-us-pays-millions-for-unapproved-drugs/#comment-382818 The Caped Crusader Tue, 25 Nov 2008 03:47:36 +0000 http://www.pharmalot.com/?p=17958#comment-382818 These unapproved drugs are subverting the FDA and CMS. The companies producing them have intentionally misled the state and federal authorities and gone around the rules to make millions in profits illegally. What is worse, is these crooks do so marketing dangerous addicting drugs into pediatric populations, they sell medical combinations that are untested for safety or efficacy in the areas they market too. It is absurd that they are allowed to bilk the federal and state coffers in such a blatant fashion. The presciption narcotics they sell are dangerous to children, especially in today's turn key society. Something needs to be done. How do these outfits stay around? Is anyone going to mind the store? Let's hope they do something this time. It may be time to come to roost! All of us can only hope. These unapproved drugs are subverting the FDA and CMS. The companies producing them have intentionally misled the state and federal authorities and gone around the rules to make millions in profits illegally. What is worse, is these crooks do so marketing dangerous addicting drugs into pediatric populations, they sell medical combinations that are untested for safety or efficacy in the areas they market too.

It is absurd that they are allowed to bilk the federal and state coffers in such a blatant fashion. The presciption narcotics they sell are dangerous to children, especially in today’s turn key society.

Something needs to be done. How do these outfits stay around? Is anyone going to mind the store? Let’s hope they do something this time. It may be time to come to roost!

All of us can only hope.

]]> By: Meg http://www.pharmalot.com/2008/11/the-us-pays-millions-for-unapproved-drugs/#comment-382794 Meg Tue, 25 Nov 2008 00:44:10 +0000 http://www.pharmalot.com/?p=17958#comment-382794 As Lilli has also stated, FDA approval quite often means squat. There is no follow up when people die of a drug. The psychiatrist who urged "safe" Zyprexa on my son left town when he died, and the state medical society refused to take any action. I was the one who forwarded the information the Medwatch, and despite testifying a year ago June, the FDA still has no medguides for Zyprexa or the other atypicals. So who really cares about unapproved drugs. It's all like the wild, wild West. As Lilli has also stated, FDA approval quite often means squat. There is no follow up when people die of a drug. The psychiatrist who urged “safe” Zyprexa on my son left town when he died, and the state medical society refused to take any action. I was the one who forwarded the information the Medwatch, and despite testifying a year ago June, the FDA still has no medguides for Zyprexa or the other atypicals.

So who really cares about unapproved drugs. It’s all like the wild, wild West.

]]> By: LILLI http://www.pharmalot.com/2008/11/the-us-pays-millions-for-unapproved-drugs/#comment-382763 LILLI Mon, 24 Nov 2008 18:56:31 +0000 http://www.pharmalot.com/?p=17958#comment-382763 Just because a medication is approved by FDA does not make it safe for everyone. Thast why the doctor questions if you are allergic to any medications. At this time it urgent that Congress, the medical profession and the pharmaceutical companies aupervise medications with the general public's welfare and not the greed of our Culture and Society. Doctors are avoiding and not reporting serious adverse side effects that are causing unnecessary deaths, reporting fatalies as natural causes. UNETHICAL ELECTED AND APPOINTED OFFICALS SHOULD BE DISCIPLINED. Sen. Chuck Grassley constantly writes letters, investigates----but nothing is changed---it just continues. He is joined by the rest of congress. Just because a medication is approved by FDA does not make it safe for everyone. Thast why the doctor questions if you are allergic to any medications.

At this time it urgent that Congress, the medical profession and the pharmaceutical companies aupervise medications with the general public’s welfare and not the greed of our Culture and Society.

Doctors are avoiding and not reporting serious adverse side effects that are causing unnecessary deaths, reporting fatalies as natural causes. UNETHICAL ELECTED AND APPOINTED OFFICALS SHOULD BE DISCIPLINED.
Sen. Chuck Grassley constantly writes letters, investigates—-but nothing is changed—it just continues. He is joined by the rest of congress.

]]> By: Dan A. http://www.pharmalot.com/2008/11/the-us-pays-millions-for-unapproved-drugs/#comment-382743 Dan A. Mon, 24 Nov 2008 15:35:11 +0000 http://www.pharmalot.com/?p=17958#comment-382743 I was a rep for a company who did this- promote drugs not approved by the FDA. The CEO was a former FDA lawyer. Uh, that's scary.... I was a rep for a company who did this- promote drugs not approved by the FDA. The CEO was a former FDA lawyer.

Uh, that’s scary….

]]>