Not All Generics Are Created Equal
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The generic drug industry didn’t exist until the passage of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). This piece of legislation, better known in the pharmaceutical industry as the Hatch-Waxman Act, was proposed and adopted by the US Congress because of the escalating costs of brand name drugs manufactured by large pharmaceutical companies (sound familiar?). The act provided the US Food and Drug Administration (FDA) with a regulatory pathway to approve and bring to market “generic” versions of branded drugs that lost patent protection. During the debate over the amendment, and for many years thereafter, branded pharmaceutical manufacturers tried to stifle the growth of the generic drug industry by suggesting that generic versions of their branded medications were unreliable and unsafe. This tactic was partly responsible for the stinted growth of the generic pharmaceutical industry until the mid 1990s when the price of branded pharmaceutical drugs began to skyrocket and insurance companies began to realize that something had to be done to manage rising drug reimbursement costs. To that end, insurers and third party payors began requiring patients to use generics (when available) instead of branded products to cap rising prescription drug costs. Because of this, the generic industry has grown by leaps and bound over the past decade and now threatens the stability of the branded pharmaceutical industry!
Unfortunately, while increased generic drug use may be good for generic drug manufacturers and insurance companies, it isn’t always in the best interests of patients who use prescription medications. For example, there are a growing number of stories and complaints from patients who were forced to switch from a brand name drug to a generic one and had side effects, or found that their symptoms returned or may have been worse than before. In fact, this happened to my mother who was switched from a brand name pain reliever that worked to a generic version that no longer controlled her symptoms and induced some untoward side effects. Scientifically, there ought to be little difference in the efficacy, safety or tolerability profiles of a branded drug and its generic equivalent. This is because both medications contain the same active pharmaceutical ingredient. However, differences in the formulation of the branded and generic versions of the drugs may be responsible for reduced efficacy or safety and tolerability issues.
While clinical studies conducted by the insurance industry suggest there are no safety or tolerability differences between brand name and generic drugs and the American Medical Association’s assertion that, as a whole, generic drugs do work as well as branded drug, there is some evidence to suggest that some generic drugs may not be interchangeable or substitutable for certain branded medications. This appears to be the case for certain drugs that are used to treat neurological conditions and mental health diseases like seizures, depression and bipolar disease. Lesley Alderman, in an article she wrote in today’s New York Time business sections provides excellent examples of this.
The problems with some generic drugs may arise as a result of the approval process for this class of drugs. According to provisions outlined in the Hatch Waxman Act which stipulate that a generic version must have the same active ingredient, strength and dosage form as the brand name drug or reference product. The generic version must also be demonstrated to be “bioequivalent” to the brand name drug. This means that the generic product must be shown to reach blood levels (drug concentration) that are very similar to the brand name product. This is usually determined by administering the generic and brand name drugs to a relatively small number (24 to 36) of healthy human volunteers. Generally speaking, once bioequivalence is established it paves the way for regulatory approval of the product. Typically, once approved, many generics receive what is known as an AB rating. Generics that are AB-rated can freely be substituted (by a licensed pharmacist) for a brand name product even though the physician may have written the prescription for the branded product.
In the past, patients were usually given a choice between a generic and a brand name drug —a decision that was largely based on the percentage of the cost of drug that would be covered by insurance. These days, patients no longer have a choice and are generally forced to use generic drugs rather than brand name products based on formulary lists compiled by insurance companies. While I am not practically or philosophically opposed to using generic drugs, there is a growing body of evidence which suggests that not all patients respond the same way to branded and for that matter generic drugs. Therefore, I contend that allowances ought to be made for these differences and patients who don’t respond to (or experience side effects) after taking generics shouldn't’t be denied access to the branded product that, in most cases, was originally prescribed by that patient’s physician. It is one thing to cut costs; it is another to increase a patients suffering or anxiety. If you are concerned about switching from a branded medication to a generic, please read this for some helpful tips and guidance.
Until next time...
Good Luck and Good Job Hunting!!!!!!!!
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A much-anticipated .jpg)
As many of you may know, Ranbaxy was involved in a bitter patent dispute with Pfizer over Lipitor, Pfizer’s blockbuster multibillion, dollar anti LDL-cholesterol drug. Ranbaxy was challenging the validity of Pfizer’s intellectual property estate for Lipitor which would have extended patent protection for the drug until 2013 or longer. The patent dispute began after Ranbaxy filled an ANDA with the US Food and Drug Administration to sell generic Lipitor after uncontested Lipitor patents expire in early 2010. 