Comments on: Congress Probes ‘Corrupted’ FDA Device Approvals

By: former fda reviewer

former fda reviewer — Wed, 04 Feb 2009 04:57:38 +0000

Correspondence between POGO and the Center for Devices and Radiological Health (CDRH) of the FDA

October 9, 2008

POGO is examining a long-standing regulation, the Good Laboratory Practice (GLP) regulation, 21 CFR Part 58, which is meant to ensure the safety of medical devices. Specifically, POGO is examining the apparent failure of a large subdivision of the FDA – the Center for Devices and Radiological Health (CDRH) – to enforce the regulation. POGO is preparing a report on the findings of this examination.

On April 30, 2008, POGO wrote CDRH Director Daniel Schultz asking a series of questions about the apparent decision not to enforce the GLP regulation. On May 13, 2008 POGO sent him a follow-up letter, and on May 27, 2008 POGO received a reply from the Associate Director of a unit within CDRH.

Founded in 1981, the Project On Government Oversight (POGO) is an independent nonprofit that investigates and exposes corruption and other misconduct in order to achieve a more effective, accountable, open, and honest federal government.

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By: RA professional

RA professional — Thu, 27 Nov 2008 14:17:07 +0000

All of you at FDA who care about the safety and effectiveness of drugs, devices and biologics PLEASE continue to speak out. Never let any product out to market that you DO NOT believe is safe or effective.

As the person who writes and submits PMAs and 510(k)s to CDRH and CBER, ask me lots of questions. If you DO NOT believe that the data shows to you that the product I am submitting is neither safe and/or effective, do not let me release the product to market!

By: OperationLegalize

OperationLegalize — Tue, 25 Nov 2008 18:23:20 +0000

this is nothing new, the FDA does a lot of good things but more and more people have been dying w/ their so called Approved pharmaceuticals. We need to step up and use Natural products as mother nature knows what our bodies need. That’s why not a single being has died using natural remedies. Did you know that The FDA will fire any medical doctor (MD) for using or recommending any natural product unless it’s for a side effect from a pharma product? That’s because if the people realized that they just should have used the natural product in the first place instead of the synthetic patented formula by the FDA, their multi-billion dollar profit would disappear. Not a single company or person can patent anything completely created by mother nature. It’s like patenting an orange and taking all profits and rights, it’s not possible thru the USPTO.GOV where companies register their products. The Green-Era’z Comin’ thru anyways so keep fuckin’ up FDA and proving our natural points.

By: Compliance Analyst

Compliance Analyst — Mon, 24 Nov 2008 20:20:55 +0000

They publish the audit reports….you just have to pay for them.

By: WARRIOR OF TRUTH

WARRIOR OF TRUTH — Mon, 24 Nov 2008 19:52:16 +0000

Anon,
Why are you surprise about retaliation? Have you read about all the whistle blower cases? Especially against giant Novartis? All that happens is aggressive, well coordinated retaliation. Numerous legal complaints from Class actions, regional director, global director,…{sexual harassment, fraud in clinical trials, whistle blowers etc.). Novartis is now a den of monster bullies with employees are kept under mute surveillance. You complain, you are out, and followed around by the Swiss Mafias!

FDA stings when it comes to ethics. The system is fractured and obsolete. They conduct meaningless audits and refuse to publish the reports. “User fees” speak louder than science and ethics. Hopefully, and soon Obama team will rescue the masses.

By: Lawyer for justice

Lawyer for justice — Thu, 20 Nov 2008 20:38:36 +0000

That would be very useful.

By: Jaynesday

Jaynesday — Thu, 20 Nov 2008 17:37:48 +0000

Isn’t this a funny environment we live in? The blogosphere allows voices from nowhere to be heard by many (I include myself of course). Names, backgrounds, motives and beliefs can be hidden or invented at will.
Just a crazy thought. I’ll go back to my real life now.

By: Anon.

Anon. — Thu, 20 Nov 2008 16:18:13 +0000

Lawyer for Justice.

I can contact the Congressional Committee who released the letter about retaliation against the CDRH reviewers. Will this be useful?

By: Lawyer for justice

Lawyer for justice — Thu, 20 Nov 2008 14:23:40 +0000

To Anon on Nov 18 at 11:13 am–

Very interesting about Mr. McConagha. Can you please provide more details? I think other persons at FDA need to know more about this. Thanks

By: Jaynesday

Jaynesday — Wed, 19 Nov 2008 23:36:50 +0000

Ed,
Sorry I didn’t see the story on the Congressional probe anywhere but here.
Good Job!