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Saturday, January 18, 2014

GENERIC DRUGS HARM W/ NO MEANS OF VINDICATION



Today I writing about something that I recently discovered and am personally outraged about as it affects my family personally. 8 out of 10 prescription filled are generic drugs. This saves money for everyone, which is great.  A few years ago, a family member had some side effects resulting from a generic medication.  Fortunately, it was discovered before it became more severe.  My children were affected.  I will explain about it in more detail later.

Generic medication is produced for all types and classes of medication.

So how do generic drugs save money? The generic manufacturers do not perform research studies. They simply prove that their drug comprises a satisfactory amount of the active ingredient contained in the brand name drug.


This seems ok, right?? WRONG! Here's why......

Let me give you a little background......


According to Wikipedia, "prior to 1962, drugs were approved for efficacy only. In 1962, in the aftermath of the discovery that the use of a drug called thalidomide by pregnant women (mostly in Europe) had caused severe birth defects, Congress added a requirement - the Hatch-Waxman Act - that drug manufacturers also prove the safety of the products before FDA could approve them for marketing. Thus, under these amendments to the Federal Food, Drug, and Cosmetic Act, new drugs had to be proven safe and effective before they could be legally marketed. It is also important to note that for drugs approved prior to 1962, generic versions could be approved with a “paper” new drug application (NDA). The NDA was based solely on published scientific or medical literature. Therefore, a generic manufacturer could get its drug approved by presenting academic articles about the chemical demonstrating that it was safe. Despite this fact, it was found that in the years after 1962 there were 150 drugs that were off-patent, but for which there were no generics because generic companies simply would not spend the time and money doing the clinical trials to get to market, and that there were only fifteen “paper NDAs,” for post-1962 generics.[2]"

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"The Hatch-Waxman Act had a significant impact on the U.S. healthcare system in many respects. The primary being the robust generic drug industry that only began to flourish as a result of the policies enacted through the Act, and the patent term extensions or restorations that make up a very important part of the research based pharmaceutical industry. However, the act makes many assumptions that since being proved invalid or inappropriate have caused the act to come under scrutiny.



  • A major assumption within the Hatch-Waxman Act concerns the sameness of a generic drug to the pioneer. Currently the FDA’s method of determining similarity between drugs is through a comparison of the bioavailability, the amount of active ingredient in the blood over a period of time. The FDA holds that if the proposed generic comes within plus-or-minus twenty percent of the bioavailability of the pioneer drug, then the drugs are sufficiently similar. Similarly many medical professionals believe twenty percent is a fairly good margin in many cases, however, there are instances with drugs where there is a very narrow therapeutic band where plus-or-minus twenty percent may not be appropriate and in fact dangerous. The FDA has not altered this particular aspect of the regulation, despite the advances in modern pharmaceutics which would allow these standards to be tightened.


  • A second assumption was that establishing similarity, as described above, is an effective substitute for the previous safety and efficacy requirements. Therefore, the ANDA drug does not have to undergo the same extensive testing as the pioneer drug.



  • Another assumption was that drugs that were under FDA review during the time the Act was passed would be approved shortly after the Act’s enactment, and that two-year extensions were adequate. However this was not the case, in fact there was one famous case where the drug was not approved for eight years. In addition to making this it was also assumed that five years of extension and fourteen years of market exclusivity were sufficient to stimulate research and development within the research based drug industry.


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    So amendments keep being made to improve the FDA guidelines, but patients are still being hurt.......HOW????? What about the percentages that are dangerous and the PUBLIC does not know. The drug classifications seems ok, but THEY ARE NOT, NOR is there a requirement to report cases where HARM has been done to patients......LABELING for generic medications only have to match that of the BRAND drug........

    BOTTOMLINE - PEOPLE ARE BEING HARMED EVERYDAY BY GENERIC DRUGS AND THERE ARE NO REPORTS unless a lawsuit is filed. BETTER YET - You can file a lawsuit, but the BRAND is not responsible and the GENERICS are not responsible because they are within federal guidelines. Ok so let's change the laws, we tried and we were overruled by the Supreme Court 5-4 to change the labeling to protect the consumer back in November of 2013. So, we can't protect the consumer.... can we get retribution ... THE ANSWER IS NO.....Can't sue the BRAND, it is NOT their drug ingested by the patient..... it is the GENERIC.....

    Generic Manufacturers are protected because the government does not require studies to be conducted on generic drugs. This is what keeps the generic drug cost down. GUESS WHO is the MAJOR PURCHASER of generic drugs - THE GOVERNMENT. And, the final nail in the coffin comes from the insurance companies who require us to purchase the generic drugs. There are commercials everyday detailing the harmful effects of these drugs and the potential lawsuits. One might not even realize that these lawsuits do not include generic medications. All of the available loopholes make it easy for lawsuits to be denied. 



    DENIALS:
    http://www.nytimes.com/2011/06/24/business/24bizcourt.html?hp=&adxnnl=1&adxnnlx=1390071818-0DvAcx1eVGWSO9V0ABoaxw

    http://www.nytimes.com/2013/06/25/business/justices-rule-generic-makers-not-liable-for-drugs-design.html?_r=0

    In 2009,  guest bloggers of  http://druganddevicelaw.blogspot.com/2009/11/scorecard-non-manufacturer-name-brand.html said,

    "  For those keeping score, this makes 31 courts in 19 states that have refused to impose liability on a brand name drug manufacturer for injuries caused by its competitors’ generic drugs." 

    WHYYYYY? They misinformed the public and relayed the same information to the generic companies who are forced to provide the same labeling (information, i.e. side effects) by the FDA.  The truth is it is the fault of the Brand Manufacturer.  Is it a coincidence that the cases about "undue harm" against the drug creators relate to the same damages as the generic drugs?




    CASES THAT THE PLAINTIFF WON!

    In a recent NY Times article, a man was awarded the opportunity to sue the  original brand manufacturer.....http://www.nytimes.com/2013/01/12/business/court-says-pfizer-can-be-sued-by-man-who-took-generic.html

     "In the Alabama case, the plaintiff, Danny Weeks, claimed that he had developed a movement disorder known as tardive dyskinesia after taking generic versions of Reglan to treat his acid reflux. Mr. Weeks sued Actavis and Teva, the generic companies that made the drugs he took, as well as Wyeth, which developed the drug, for failing to adequately warn about Reglan’s risks........

    .......The court ruled that Mr. Weeks could go ahead with his lawsuit based on what Mr. Newsom described as a “unique wrinkle” in Alabama state law: that third parties like Wyeth can be held liable for a person’s injury if that third party provided false or misleading information that led to the injury. Mr. Weeks is arguing that Wyeth misinformed his doctor, not Mr. Weeks himself.........

    .....Chris Hood, a lawyer for Mr. Weeks, said, “When someone’s hurt by a generic tablet and that injury can be laid at the feet of misinformation about the drug, then there’s only one party who can be held responsible,” he said, “the branded company.” Let's all hope that each state has a "wrinkle in the law" that allows Big Pharma to be held accountable. 

    Two of my children have been affected by two different generic anti-depressants.  One son was born with multiple birth defects and has undergone numerous surgeries and will have a few more in the future.  My other son is autistic as a result.  Why should my children struggle and suffer and no one be held accountable?  

    In my quest for justice, I found out that it is difficult to hold the generic manufacturer liable for the harm that these drugs do to unknowing patients.  When I found out I was pregnant, I stopped taking any medication.  But at 10 weeks gestation, it was too late.  I asked my doctor to check the medication and tell me if it was safe to take during pregnancy.  Based on the classification at the time, both drugs were safe,  but they were not.  A letter was sent to doctors after my son was born warning of the side effects.  The classifications have since changed to protect patients.   Now patients can be better informed prior to taking the medications.   


    Generic drug manufacturer employee blows the whistle on FDA requirements that were skipped....... November 2013



    But what happens to all of the children born with disabilities as a result?  Who pays for the therapies and medication?  It should be Big Pharma!








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