The Damage of Drugs:Generic or Brand-Name?

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 Last week, New York Times writer Katie Thomas published an article “Generic Drugs Prove Resistant to Damage Claims,” exploring the effects that the establishment of the 1984 Hatch-Waxman Act has on patients in care and in need of medical drug assistance. Thomas surveys 3 well-related cases, all of which are firmly expressed examples of patients in medical care, receiving needed drug assistance, and finding themselves severely harmed and left in compromising positions due to the drug and/or the procedure needed to supply the drug to an individual; said examples were strongly advised to use the drugs in question. The Hatch-Waxman Act, more formally addressed as the Drug Price Competition and Patent Term Restoration Act, was approved by congress in 1984 and ultimately allows drug companies to produce generic versions of brand-name drugs in a much more fast paced fashion and significantly, conveniently at a fraction of the cost. As long as these companies can effectively prove that their drug is of the same uniformity as the brand-name drugs their obligation to provide any warning or education of the drug other than what can be read on the label (labels are produced solely by the brand-name drug company,) is lifted. In other words, if patients who use a generic drug incur negative side effects, (such as the development of gangrene to a stage which forces the amputation of a body part, as Ms. Schork experienced according to Author Katie Thomas,) they are in no position to neither sue the drug company nor receive any form of reimbursement or assistance.

 By encouraging drug companies to recreate brand-name drugs and produce less-costly generic forms, individuals all across the globe are more or less granted their use; though the Hatch-Waxman Act quite obviously encourages the prior, they informally produce a double standard when the producers of generic drugs have no legal responsibilities intact when drug use has unsettling results, furthering the infringement of those individuals who are unable to obtain the use of brand-name drugs.

 At no point in Thomas’ article are references made to, what I presume as being plausible, the liability of hospitals and/or health care providers in any of the three cases publicized. Numerous times have I personally been under care when my provider didn’t even bother to check my allergies prior to prescribing drugs, let alone ask whether I cared for a brand-name drug or a generic version; with this in mind I am at a loss of where I find the error – who ought to be blamed? It seems to me that the Hatch-Waxman Act was not passed to further inhibit individuals in need of medical and drug assistance, rather the opposite, as assistance for those. Yet, plenty instances of uneasiness arise throughout the cases which Thomas presents in her Times’ article, leaving the begging of the question: who needs to be held responsible?

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1 comment
  1. jaredb said:

    This is a very interesting and thought provoking post. I am personally surprised by the lack of liability for producers of generic drugs. I wonder if/how this will work its way into the pricing structure of brand name drugs. Brand name producers can very easily claim that they have the consumers best interest in mind, and they back it up with settlements when an unfortunate reaction to a drug does occur.

    The question of responsibility is hard to answer, and likely context specific. If an adverse reaction is the result of negligence, then the provider or institution should bear the responsibility. The question of a settlement/assistance for unforeseeable drug reactions is a murky one for me, my general view is that if there is a party to be held responsible it should be the specific manufacturer, and that fact that a product is generic should not protect companies from accepting responsibility.

    I can envision the development of a No-Fault Pharmaceutical Insurance program that manufacturers pay into, and all claims are then handled by the insurer. http://en.wikipedia.org/wiki/No-fault_insurance

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