We have serious drug problems in this country. I am not talking about illicit drug use. We have problems with drugs that are FDA approved and the problems are not related to dependence or addiction to mind altering FDA approved drugs. The problems to which I am referring are much more insidious than addiction or dependence. The problems are inherent in the FDA approval process; after drugs are FDA approved, the problems remain prevelant, due to FDA regulatory failure.

Most adverse events related to FDA approved drugs, including fatalities, result from known effects of the drugs, (known to the FDA and to the manufacturers) These known adverse effects are hidden from the public by manufacturers; even more alarming, these known adverse effects are hidden from the public by the FDA. How can it be that this federal regulatory agency does not require full disclosure of known risks from the manufacturers for the drugs marketed to the American people? This failure makes the FDA complicit in fraud being committed by drug makers. In fact, the FDA aids and abets the drug companies in committing this fraud; the FDA then claims it does not have a duty to warn the American people about known adverse effects of drugs that the FDA approves. Once a drug is approved for any population or condition, it can be prescribed for all populations. Medical professionals call this "off-label" prescription use; the FDA calls it "experimental" use.

The FDA's primary mission is supposed to be to protect the American people; the FDA fails it's primary mission when it purposely does not inform the public about what the known risks are for FDA approved drugs. The FDA fails to collect after-market safety and risk data from drug makers, on drugs approved in the expedited approval process, known as PDUFA. The FDA fails to inform the public about known risks of drugs it does approve; including risks of fatality. The FDA fails to regulate direct-to-consumer advertising, and drug advertisements are not subject to the Consumer Protection Act. The FDA continues to allow the most egregious Conflicts of Interest to to go uncorrected in the approval process. In a nutshell, the FDA is a regulatory agency without any ethical integrity evident in the way it conducts business; consequently, the FDA does not protect the American people.

The FDA does not want to be accountable for the decisions made by the FDA which place the American people at risk. Incredibly, the FDA in spite of it's regulatory failures; or perhaps because of these failures, has attempted multiple times to secure the right to fail it's mission to protect the American people with impunity. The FDA has sought to protect the FDA from being held accountable for it's regulatory failures, by seeking protection from failure to warn damage claims. The FDA, in effect, seeks to protect itself from ever being held accountable for failing to protect the American people. The FDA seeks to protect itself for the way it is aiding and abetting the drug industry, while failing to protect the people who take FDA approved drugs.

Incredibly, the FDA fails to regulate the safety and efficacy of drugs after FDA approval; and fails to hold drug companies accountable for performing post-marketing studies required when drugs are approved through the expedited PDUFA process. The FDA reportedly fosters a culture of fear; encouraging scientists to suppress data relating to drug safety and efficacy. Who is being protected by the FDA? Medical professionals are not required to report adverse events, including death, caused by FDA approved drugs. Who is the FDA protecting?

It is plain the FDA is protecting the FDA

AN ESSAY PUBLISHED IN 2007 titled, "A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims" by David A. Kessler University of California San Francisco School of Medicine and David C. Vladeck Georgetown University Law Center reports:

"The past few years have witnessed a seismic shift in FDA policy. The agency now maintains that state-law failure-to-warn cases threaten its ability to protect the public health. According to the agency, a determination in civil litigation that an FDA-approved label fails adequately to warn of risks may force manufacturers to add warnings that are not approved by the FDA, thus rendering the product “misbranded.” Even worse, the FDA says, adverse rulings could force manufacturers to add warnings that the FDA considered and rejected — thus placing manufacturers in the untenable position of having to violate federal law to avoid state damages judgments. For these reasons, the FDA now argues that the federal Food, Drug and Cosmetic Act (FDCA) impliedly preempts many failure-to-warn claims based on product labeling approved by the FDA. The FDA first announced this position in 2002, by filing amici briefs asking courts to dismiss failure-to-warn cases. More recently, the agency formalized this position in the preamble to a 2006 rule that revises requirements for drug labeling."

"Rather, this essay highlights what we believe are two of the most problematic aspects of the FDA’s pro-preemption position — one legal, the other practical — that do not stand out in more comprehensive treatments of the issue. The first point we make is that the FDA’s propreemption arguments are based on a reading of the FDCA that, in our view, undermine the incentives drug manufacturers have to change labeling unilaterally to respond to newly discovered risks, or to seek labeling changes from the FDA. In fact, drug manufacturers have significant authority — and indeed a responsibility — to modify labeling when hazards emerge and may do so without securing the FDA’s prior approval. The background possibility of failure to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate and up-to-date safety information.

"Our second concern is that the FDA’s pro-preemption arguments are based on what we see as an unrealistic assessment of the agency’s practical ability, once it has approved the marketing of a drug, to detect unforeseen adverse effects of the drug and to take prompt and effective remedial action." Read online or download a pdf of the essay for free.

This from Tom Lamb, at Drug Injury Watch:

2008 Emory Law Journal Article Presents Ketek As A Case Study In FDA Regulatory Failure

Discusses The Dire Consequences Of Fraudulent Science, Federal Preemption, And Corporate Deregulation

an excerpt:

"Why does Ketek matter? Because FDA broke its own rules and allowed Ketek on the market; because dozens of patients have died or suffered needlessly; because FDA allowed Ketek’s maker to experiment with it on children over reviewers’ protests; because FDA ignored warnings about fraud; and because FDA used data it knew was false to reassure the public about Ketek’s safety."

Ketek, according to the article, "is in a class of drugs called ketolide antibiotics and is to be prescribed only for community-acquired pneumonia. Ketek has been associated with adverse side effects such as liver damage, liver disease, liver failure, and hepatitis." read the article here.