FDA Approves Some New Drugs Illegally
The Office of Inspector General has just released a sickening report on the FDA’s drug approval process; providing evidence the FDA has approved drugs without following required legal procedures. When is this madness going to stop?
The Office of Inspector General (OIG), as mandated by law, is the government agency responsible for making sure the FDA is abiding by Federal law, properly following procedure and protocol to assure the safety of human and animal foods and human and animal drugs. A new report from the OIG provides clear cut evidence the FDA is NOT doing their job; not following proper protocol required by Federal law.
The OIG investigated the FDA drug approval process; they discovered that in 2007, the FDA approved numerous new drugs without complete information; specifically conflict of financial interest information of clinical trial investigators.
The drug approval process is a lengthy and costly procedure. Millions of dollars are spent getting a new drug to market; many drugs fail the clinical process resulting in millions lost to the drug manufacturer. No refunds are provided to a drug company whose product fails clinical trials. In other words, the success of the clinical trial could mean the difference between a drug company making millions of dollars or losing millions of dollars.
The Federal government recognizes the importance a new drug clinical trial; the health and safety of future patients are at stake, and the government recognizes that the prospect of millions of dollars in profits can tend to make a company do bad things. As a result, Federal law requires that all investigators involved in clinical trials disclose any potential financial interests with the drug company. Law requires the FDA to review all clinical investigators financial information before a new drug is approved for sale, and should any conflict of interest be found, to closely re-examine the entire approval process.
Just to clarify the severity of the OIG findings, as example, XYZ Drug Company has applied for FDA approval of it’s new drug XYZ-E. Ten million dollars have been spent in the drug’s development, five million dollars to the FDA for approval; and the clinical trial begins. XYZ Drug Company REALLY needs this drug to be approved, so, the clinical investigators hired to manage the required clinical drug trials are provided stock in XYZ Drug Company as part of the compensation for their ‘work’. Any smart investigator realizes, if the clinical trial does well, so will I. The ‘smart investigator’ oversees the clinical trial making sure things go well, the new drug appears to be the next miracle drug, is approved and everyone gets healthy – wealthy.
You can see why government requires all clinical investigators involved in the process of testing a new drug, be required to provide the FDA any and all financial interest information of those involved in the clinical trial process. It doesn’t take a rocket scientist to figure out that a financial interest in the outcome of the clinical trial of those that run the clinical trial, could sway the results of the testing, putting countless humans and pets (depending on the drug) at great risk.
The Big problem is…for drugs approved in fiscal year 2007, the FDA did NOT review all the conflict of interest financial information, in fact they didn’t even collect this information on many new approved drugs.
The Inspector General’s findings:
• 23% of 2007’s approved drugs and approved medical devices were missing required attachments.
• 31% of the 2007 FDA approved drugs and approved medical devices showed the FDA did not document any financial information.
• 20% of the 2007 FDA approved drugs and approved medical devices showed the FDA did not take action to minimize potential bias of clinical trial investigators.
The FDA’s response to the OIG investigation and report, in typical form, was basically ‘it’s not our fault’. The FDA told the Inspector General, that the responsibility for collecting financial information regarding potential bias of clinical drug trial investigators was the responsibility of the drug companies. The OIG report stated “FDA asserted that this additional effort would not be worthwhile because financial interests are only one form of potential bias.”
The findings of the Inspector General prove the FDA cannot or will not, abide by Federal law, and furthermore, is not a Government Agency that has the best interest of U.S. citizens in mind. With pet food being at the very bottom of the FDA ‘to do’ list, just imagine what’s done and/or not done with regards to pet food safety.
Bailouts are the latest topic of discussion in Washington. Perhaps the law makers in Washington should take a closer look at the FDA’s misgivings, and consider an FDA bailout, of sorts. Not a financial bailout; a different kind…more like a ‘throw out’, a ‘throw out’ the front door every member of FDA administration. So long, good-bye, see ya, you are fired, don’t come back, don’t ask for a referral!
To read the full Inspector General report: http://www.oig.hhs.gov/oei/reports/oei-05-07-00730.pdf
Wishing you and your pet(s) the best,
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