FDA drug laboratories

Federal Drug Administration ^

[Princeton_University]

Does the FDA have its own independent laboratories or does it farm out the lab testing of drugs to the pharmaceutical companies themselves? I have been unable to find out this information. In other words, does the FDA approval process rely upon completely independent governmentally operated labs? Or does the FDA depend upon test results provided by the pharmaceutical companies themselves?

SANDY KRAMER, Ph.D.

[Princeton_University]

http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm279676.htm

Does the FDA have its own independent laboratories or does it farm out the lab testing of drugs to the pharmaceutical companies themselves? I have been unable to find out this information. In other words, does the FDA approval process rely upon completely independent governmentally operated labs? Or does the FDA depend upon test results provided by the pharmaceutical companies themselves?

SANDY KRAMER, Ph.D.

"Q: Does FDA test drugs?... A: No. It is the responsibility of the company seeking approval to market a drug to conduct laboratory and animal tests on the safety and effectiveness of a proposed new drug and then to submit that information to FDA for review by CDER physicians, statisticians, chemists, pharmacologists, and other scientist (sic)."

http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm279676.htm

Does not this represent the sine qua non of conflict of interest? Why hasn't Congress done something to address this issue? Why has this issue not aroused more outrage?

[RetiredTexasVet]

I don’t know about the FDA but Chicago has contracted theirs out to the Sinaloa Cartel.

[Missouri gal]

All FDA-approved testing is strictly monitored by a huge array of interested parties, including monitors hired by the companies, Internal Review Boards paid by the hospital or medical facility in which the testing is done, and state and federal officials. All is reviewed out the wazoo. All paperwork is submitted digitally and paper copies kept at the site. US has the most stringent standards of any country. It's so over-monitored that most pharma companies have ditched us and gone elsewhere, most of them while Clinton was wrecking our economy, and it has only gotten worse.

[huldah1776]

Some still get through by lying and cheating...plus some used in Europe for decades are still not approved.

Seems wacky to me. All the hoopla and drugs still hurt or kill people. The bottom line is the money. Ahhh, capitalism.

One example discussed yesterday...

http://freerepublic.com/focus/f-chat/3216998/posts

[GotMojo]

Pharma Co’s test own products....all labs and methods reviewed, approved and routinely inspected by FDA. Also, FDA will routinely, or for cause, take samples for testing within FDA labs. This is true in Europe and emerging market health authorities are starting to follow same level of oversight. One production lot of drugs distributed globally could easily be tested by 5 separate labs.....

[Agamemnon]

Does not this represent the sine qua non of conflict of interest? Why hasn't Congress done something to address this issue? Why has this issue not aroused more outrage?

Manufacturers use analytical methods to evaluate products against product release specs and for long term storage stability. FDA has laboratories for evaluating validity of analytical methods furnished to FDA by manufacturers. It is part of the approval process for medical product marketing.

FDA field laboratories will also test products for which complaints have been lodged with FDA. The laboratories are in most cases associated with FDA's inspection offices located throughout the US and in recent years throughout the world - particularly in places like India and China.

Companies are routinely inspected for compliance with current good manufacturing practices (i.e., "cGMP") regulations by FDA as specified in 21 CFR 210, 211 for pharmaceuticals; devices specified in 21 CFR 820, combination drug/device products specified in 21 CFR 3, nutraceuticals specified in 21 CFR 110, 111, etc. Companies which fail inspections may be slapped with Warning Letters and in more extreme instances with Consent Decrees whereby products may be impounded and fines levied.

The regulation of pharma-device-biologic-diagnostic products manufacturing industries in the US is intended to assure that the US applies the highest quality standards to marketed products, which assure their safety, potency, purity, in order to thereby assure the labeled therapeutic efficacy claims of those same products.

There is no conflict of interest. In fact pharma firms dare not be found out of compliance with cGMP when inspectors arrive because it can be a very costly thing for them to remediate, if they fail inspections.

FReegards!

[Mastador1]

I don’t know about the FDA but Chicago has contracted theirs out to the Sinaloa Cartel.

Yeah but that's for production not testing.