So Much Confusion Over Generics

In reading the article about generic drugs and the subsequent comments, I am amazed at how much mis-information and confusion exists.

Let’s start with a few facts:

  • Generics are approved by the FDA and have to have the same manufacturing standards.
  • Generics receive a rating (e.g., A-B) and are chemically equivalent to the brand drug upon whose patent they are based.
  • Chemically equivalent drugs have the same active ingredients but different inactive ingredients.
  • Generics cost less since there is no research and no sales and marketing activity to support.
  • A high percentage of generic drugs are made by the brand drug manufacturers.
  • Consumers save money on generics.  Pharmacies and PBMs make money on generics.  Plan sponsors (i.e., employers) save money on generics.  Everybody wins!
  • The variance in active ingredients is no different on generics than it is on brands.

There is definitely plenty of misinformation out there.  I would suggest sticking with sites like the FDA’s site on what’s real.

As the study by Prescription Solutions (United Healthcare) shows, there is confusion in the market.

  • Nearly 1/3rd of Americans don’t know or believe that generics are identical to brand drugs.  (They’re not identical, but the active ingredients are.  I would have asked the question differently.)
  • 2/3rds of respondents didn’t know that generics typically cost 50-70% less than brands.  (That surprises me.)

Jacqueline Kosecoff, Ph.D., chief executive officer of Prescription Solutions, said, “Using generics helps make health care more affordable without compromising results. Many Americans erroneously believe that the most expensive drug is always the most effective drug, so by helping to change perceptions, we can help people save money and still get the best treatment available.”

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2 Responses to “So Much Confusion Over Generics”

  1. [George comments – I’m posting since I think this is a general perception, but I’m calling it BS. I’ve researched this multiple times and while the myth is out there, I’ve never found anything from a reputable source to support it. Pharma reps tell MDs this and they willingly accept it. A 40% swing is ridiculous. A 20% swing is unlikely. Read the research not some blog.]

    “The variance in active ingredients is no different on generics than it is on brands.”

    True, however what you’re not seeing is what the pharmacy does to it, and the amount of active ingredients actually get into ones blood stream.

    The rules for generics are: they have to be exactly the same chemical, and they can only have a 20% variance in the amount of active medicine getting into the blood stream.

    Pharmacies can change generics: If they do choose to change the generics, there could be a change of a stunning, maximum 40% of active ingredients getting into the blood stream.

    Source: http://www.addadhdblog.com/adhd-medication-are-generics-the-same/

    I currently take Adderall XR every morning for attention issues. I started this last year, and it was helping a lot better then, than now. I think the reason for this is my pharmacy changing the variance of the active ingredient that actually hits my blood stream. I am soon going to switch to brand name Adderall and see if that helps.

    Keep in mind I’m not doubting what you say, I’m just using the information I’ve been handed to suggest more information

  2. Often when one goes to seek medical attention from a health care provider, that provider usually writes a prescription for that patient for medication to either treat the symptoms of the disease that may be present.

    Or, the health care provider may actually cure the disease, as with the case regarding antibiotics.

    Also, the provider may prescribe medications to delay the progression of a disease that may exist with their patient.

    The actual cost of that medication the patient receives from a pharmacy can vary greatly, and here is why:

    More now than in the past, generic medications have been encouraged and selected by prescribers at a much higher rate.

    Health care providers are aware that generic drugs are less expensive than branded drugs that are equivalent to the generic drug prescribed as far as safety and efficacy are concerned.

    Nearly two thirds of all medications prescribed to patients in the United States are now for generic medications.

    Generic medications are bioequivelant copies of branded medications that previously existed, yet no longer have a patent on these medications, which allows generic drug companies to produce these formally expensive drugs and a much lower cost.

    Why aren’t generic medications prescribed all the time, then?

    The branded drugs have their company sales representatives who leave samples of these branded medications with the health care provider, with the intention and belief that this provider will select this branded drug as a result.

    Generic medications, while much less expensive than branded medications, do not have samples of these drugs to be left with health care providers.

    Around 4 billion prescriptions filled every year, so cost savings is rather important.

    Generic medications are about two thirds of this total pharmaceutical market with the drugs included in this market.

    However, while most prescriptions are for generic medications, this still is less than 15 percent of the total money spent on prescription drugs.

    With branded medications, about 75 percent of these newly approved drugs by the FDA are similar in efficacy as drugs that already exist in this market, so there is no benefit with many of these expensive branded drugs.

    Roughly half of all newly approved prescription drugs have had serious side effects soon after they have been approved, so newer is clearly not always better, of course, as it relates to safety for the patient taking the drug.

    Most recently, certain managed health and prescription providers have been actually paying doctors to initiate if not switch their patients from branded medications they may be taking to generic medications, if possible.

    This may be due to a reaction caused by branded pharmaceutical companies offering similar inducements to health care providers to select their promoted medications.

    Both financial inducements that occur are remarkably legal, overall. Yet I find financial inducements in health care inappropriate and unethical when a health care provider treats a patient with prescribing medications for them.

    Not long ago, generic drugs were not prescribed that often, or produced to a great degree, because of the cost of bringing such a med to the market, which at the time required the same clinical trial protocols as branded meds.

    Fast forward to 1984, as this is when the Hatch-Waxman Act was introduced.

    This Act only required generic meds to demonstrate bioequivalence to the branded med that they desire to reverse engineer.

    So nothing else was now required in the approval process that is mandated by branded medications to be completely developed and approved by the FDA.

    This reduced cost of generic manufacturing and approval allowed for more of these meds to saturate the pharmaceutical market, and doctors started prescribing more generic meds as a result.

    Branded pharmaceutical companies were not pleased in large part with this new act.

    So some drug companies devised schemes to extent the patents of their branded meds through such tactics as altering their existing branded medication by combining it with another generic drug from another class of medications.

    This tactic is referred to as evergreening, and the tactic extends the patent life of their branded drug of concern.

    Additional branded drug company tactics include frivolous patent infringement lawsuits, which delays generic availability for a longer period because of these lawsuits.

    Also, branded pharmaceutical companies have been known to actually pay generic manufacturers to not release the equivalent of a branded medication they wish to continue to promote.

    The pharmacies that fill the prescriptions for the patients written by the health care providers support generic use, as pharmacies make more money off of generic prescriptions they fill for others compared with branded drugs.

    Generics seem to remain a concern to branded companies in spite of their efforts of avoiding their access into a market they believe to own.

    Recently, branded pharmaceutical companies have either purchased smaller generic drug companies, or have started to produce generic medications on their own.

    This is due to the progressive impact generic drugs are having on the business of branded drug companies.

    Also, other reasons for increased generic prescribing may be due to the awareness and clinical experience of the previous branded med that has now been replicated by the generic medication.

    Again, newer drugs at times are not a desirable choice of treatment for patients because of understandable concerns by the prescriber.

    One particular concern is safety that has not fully established with a new medication.

    The familiarity of the generic drug accessible to them after the patent expiration of a branded medication the prescriber has utilized often in the past with treatment success for their patients allows the prescriber to utilize the generic equivalent not that it is available often.

    Many clinical studies have proven that generics are as effective compared with branded medications for particular disease states.

    The cardiovascular disease trial called the ALLHAT trial showed this. In this trial, with surprise to many, the old class of drugs called diuretics showed equivalence if not superiority over the branded medication utilized in this trial.

    This comparative effectiveness trial lasted over four years, and was funded mostly by the NIH.

    Most encouraging for even greater use of generic meds is that at least one company has created vending devices for doctor’s offices for dispensing both generic and over the counter drugs.

    This may discourage the use of branded equivalent drugs at a greater amount with generic samples available with this method.

    In addition, and in some cases, doctors can order generic samples from the manufacturers directly.

    Both mechanisms for obtaining samples of generic drugs by a health care provider remain quite rare, however.

    Then there are some health care providers who insist that you get what you pay for, so they are convinced that branded drugs are always more efficacious and tolerable than generic medications.

    This misconception is largely a fallacy, as both are determined to be bioequivalent, since the generic drug has to show this in order for the drug to be authorized for use by prescribers.

    Efficacy differences may exist, but are thought to be minimal.

    I’m sure it’s possible others have encouraged such doctors to take such a stance that is absent of evidence.

    In the U.S. Health Care System, cost is a rather large concern for members of the public health, and those who attempt to restore their health as it needs to be at times.

    Generic medications provide financial relief for patients in need of drugs to improve their health.

    And both the health care provider as well as the patient can be assured that a generic drug prescribed to, and taken by, a patient will provide the efficacy needed to address the medical problems of the patient.

    More importantly, the patient saves money, without compromising their safety,

    Dan Abshear

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