generic drugsAlmost everyone knows that generic drugs are cheaper than brand name drugs – and the difference in price can be as much as 80 percent. Whether the money comes from your pocket (after all, a large percentage of the population has no health insurance) or you pay for a part of it as co-pay or you pay nothing at all because your insurance company pays for it all, would you consider taking generics instead of branded drugs? You would save a great deal of money after all. In 10 years it is estimated that more than a trillion dollars have been saved thanks to generic drugs. In 2012 the generic drugs saved $192 billion according to the Generic Pharmaceutical Association.

But is this the whole picture? Is it all about money, after all?

The fact of the matter is the branded drugs are expensive for a reason. The pharmaceutical companies spend a great deal of money on research and development of new drugs and as also time and money on all kinds of trials including human trials and studies. It is only after a lot of hard work do they get FDA approval. In return, they get patent protection, which enables them to sell the drug at a high price to recover their costs and make profits. The patents usually last around 20 years, sometimes more.

When the drug goes off-patent, other companies can manufacture it. Since they already have the composition in hand or rather they know the main chemical ingredients of the product, they only have to tweak it a bit and sell it at a much lower price, still making handsome profits because the original brand already has its customers who will switch to cheaper generics and all this without having to go through the lengthy process of research, development and trials.

Is the generic the same as the branded?

In chemical terms, yes. The FDA ensures strict compliance with safety and efficacy of the medicine, whether generic or branded before it reaches the consumer. They have to meet the same standard and cannot be made in substandard manufacturing facilities. Their dosage, active ingredients, packaging and life also has to be the same as that of the branded version.

However, pharmaceutical companies manufacturing generics may use different inert ingredients, flavorings and additives or even change the size, shape and color of the product and package it somewhat differently. After all, product differentiation is also a marketing ploy and trademark rules do not allow different generic version to be exactly the same as the original brand name drugs.

Is that the whole story?

Sadly no. While it is true that generic and brand name drugs have the same chemical formula and the cheaper versions usually work the same way as their expensive counterparts, there are occasional instances where they don’t work as they should for unknown reasons. Research conducted by the FDA between 1996 and 2007 showed that there is supposedly only a 3.5 percent difference between generic and brand name drugs absorption and effects, a difference that is deemed to be acceptable and may even occur in different batches of the same branded drug, made at different times.

In reality, thanks to insert ingredients a generic drug may be as much 45 percent different (below 20 percent or above 25 percent) from the brand name drug. Additionally the supposedly inactive ingredients may cause the drug not to act properly or the way it should. FDA standards also do not specify in how much time a generic drug version reaches peak levels in the blood. This again can have a negative impact on its efficacy, especially in drugs that are in time release forms.

FDA actually withdrew its approval for Teva’s version of Wellbutrin (an anti-depressant) called Budeprion XL after FDA tests (conducted under pressure from patient advocates) revealed that Budeprion XL was only between 45 and 85 percent as effective as Wellbutrin, so it did not do the work it was supposed to do. In other cases where there is a very narrow therapeutic range for the drugs to work, often generic drugs are not as effective as brand name drugs or cause reactions that can often be serious.

Many doctors, however, routinely prescribe branded drugs because they have been used to doing so for years when the drug has been under patent. Sometimes they may not even be aware of the names under which many generics are available. At other times, doctors may prescribe generics instead of branded versions. Then there are times when patients themselves opt for generics either as a cost cutting measure or because the branded drug may not be immediately available in some situations or any other reason.

So should you take the generic or the branded version?

Rarely does it happen that the generic version contains some inert ingredients that may have unwanted side effects. Or because of its inactive ingredients it either does not work as well as it should or works faster, thus either not having the desired effect or causing complications. This is what happened to Karen L. Bartlett. In 2004 she took a generic drug, Sulindac (Clinoril) for shoulder pain according to her doctor’s prescription for three weeks.

She developed a rare skin problem called Stevens-Johnson Syndrome resulting in toxic epidermal necrolysis. Her skin started deteriorating and she suffered burn-like lesions all over her body, became nearly blind and disfigured. Sulindac’s label did not having any warning against this kind of reaction.

She sued the company and was awarded a whopping $21 million as damages in a law suit filed under state law. However, the U.S. Supreme Court recently overturned the damages on a technicality, while sympathizing with her plight. In 2011 the Supreme Court had ruled that companies making generic drugs were not liable for damages due to inadequate labeling, but pharmaceutical companies making branded drugs were liable. Taking this prior ruling into account and going by legal niceties, the court ruled that Mutual Pharmaceutical Company, the manufacturer, was not liable for damages, since it made the generic version of the drug. The generic drug manufacturers are now legally protected under Federal law which may be different from state law, but takes precedence over it.

In effect this means that if you take a generic version of a drug, and suffer from any problems or reactions, you cannot sue the company. If the same happens with a brand name drug, you can.

Does that mean that generic versions of branded drugs are inferior or substandard?

There are many anecdotal and personal experience cases found on the internet regarding problems with generic versions of medicines. Unfortunately, the FDA usually does not conduct its own tests. The companies manufacturing brand name drugs guard their formulae and do their own research and testing. The generic brand companies only have access to the information of the active ingredient in the brand name drug and add their own inactive ingredients – no tests are conducted about the efficacy of the new formulae of the drugs.

Another problem with generic drugs exists – often generic drugs are manufactured in countries other than the US and the facilities may not have the same high manufacturing standards as required in the US. This can lead to compromised quality.

The future

Congress has now passed a Generic Drug User Fee Amendments of 2012 act by which the generic drug industry will pay FDA $229 million a year for five years to review and approve generic drug applications and also conduct check in manufacturing facilities aboard. Hopefully this will bring more transparency to the generic drug market and ensure patient safety as well.

Meanwhile, if you need medicines for any ailment, minor or serious, do consult with your doctor and seek his or her advice on whether to opt for brand names or generics. If you have a history of allergic reactions, do not take generics. On the whole, though generics are safe and do save a lot of money, remember that you will not have a case if you suffer any problems if you take generic medicines. For that matter, even doctors cannot be sure whether or not you will suffer from any reactions or side effects if you take any medicines, so the principle of caveat emptor applies. After all, Karen only took a simple non steroid anti inflammatory drug on doctor’s prescription and still suffered. If you do have to take generic medicines, take those made by a reputed pharmaceutical company in the very least.

Sources:
Reuters
Fortune
Harvard Medical School

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