Generic Drug Problems
The FDA assures us that generic drugs are just as safe and effective as their costlier brand name counterparts. Why, then, do prescription forms allow doctors to indicate "no substitution", meaning that the name brand drug must be used? Are generic drugs always exactly the same as the name brands?
I have personally been given prescriptions for which my doctor mandated "no substitution". A cynic might say that my doctor was being paid by the manufacturer to push the more expensive drug. After doing a little research and discussing it with my doctor, however, I don't think so. Generic drugs are a great way to lower health care costs, and, in most instances, they'll do the job just fine. In order to make an informed decision, however, there are potential problems - both medical and legal - that you should be aware of.
New Drugs: Patent Protection
Developing a new drug involves years of research, development and testing. The average cost of developing a new drug is over $800 million.[1] Patent protection gives the original manufacturer a chance to recover those costs.
What are Generic Drugs?
Generic drugs contain the same active ingredient, at the same strength and dosage, as a brand-name drug, but at a lower cost to the consumer. Not every drug is available in generic form. Generic versions of a drug cannot be manufactured until the original patent on the drug, which gives the pharmaceutical company that developed the drug the exclusive rights to sell it, expires.
Why Do Generic Drugs Cost Less?
In the case of generic drugs, lower cost does not mean lower quality. The FDA requires that they be manufactured according to stringent guidelines, in safe facilities. They can be sold at a lower price because the producer of the generic drug has little or no R&D cost to recoup. If there is high enough demand, competition may drive prices even lower. The name brand manufacturer usually continues to spend much more on marketing, which is reflected in their higher prices.
Are Generics the Same as Name Brand Drugs?
The FDA requires a generic drug to be bioequivalent with the brand name drug, meaning that it delivers the same amount of the active ingredient to the bloodstream. They do state, however, that there is always "a slight, but not medically important, level of natural variability".[2]
In the vast majority of cases, the variability is not significant, but for some drugs even a slight difference may have serious consequences. Studies have shown that switching from a brand name to a generic drug resulted in more seizures for epilepsy patients, for example. For this reason, the American Academy of Neurology advises against the use of generic drugs for the treatment of epileptic seizures. Cardiologists have also expressed concern about drugs such as blood thinners, where the difference between a helpful dose and a harmful one is very small.[3]
NBC News: Are generic drugs as good as brand names?
Generic Drugs - Inactive Ingredients
There are no regulations regarding the inactive ingredients contained in generic drugs. Dyes, coatings, binders (which hold the tablet together) and other inactive ingredients may all be different. These can affect how some individuals metabolize the drug, resulting in different reactions to generic vs brand name drugs.[4] In rare instances, a person may even have an allergic reaction to one of the inactive ingredients.[5]
These differences in inactive ingredients, as well as variations in level of active ingredients, exist not just between the name brand and a generic, but between different brands of generics, as well. If you've been taking a prescription medication and you notice a change in your symptoms, one thing to check is whether your pharmacist has substituted a generic for the name brand you had been taking, or changed from one brand of generic to another.
Difference Between Generic and Brand Name Drugs:
My intention is not to scare you off of using generic drugs. In fact, my own decision has been to use generics except in those instances where my doctor explicitly advises against it, in which case I'll pay extra for the name brand. I believe my doctor has sufficient knowledge and experience to make the right call.
Some people (including some doctors, as the video to the right shows) insist on always using only name brand drugs, however. It's a personal decision that needs to be made between you and your doctor.
Generic Drugs and Legal Liability
There are some legal issues related to generic drugs that are quite troubling. In 2011 the US Supreme Court ruled that generic drug companies, unlike the manufacturer of the brand name, cannot be sued for failing to provide adequate warnings about potential side effects on a drug's label.[6]
Generic manufacturers are required by federal law to use the same labeling as the name brand drug. As they have no control over what goes on the label, they can't be held liable if the labeling is inadequate. In other words, if you use a generic drug, you give up your right to sue the manufacturer over inadequate labeling.
Legally, the decision may be correct, but its effect on the safety and legal rights of the consumer is unacceptable. The law needs to be changed, and bills have been introduced in both the House and the Senate to address this situation.[6] If you are concerned about this issue, I suggest you make your voice heard by writing to your Senator and Representative.
References
- [1] Scientific American. What's the difference between brand-name and generic prescription drugs? http://www.scientificamerican.com/article.cfm?id=whats-the-difference-betw-2004-12-13
- [2] U.S. Food and Drug Administration. Facts About Generic Drugs. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm
- [3] New York Times. Not All Drugs Are the Same After All. http://www.nytimes.com/2009/12/19/health/19patient.html?_r=3&pagewanted=1&ref=health
- [4] Los Angeles Times. FDA Standards Are Questioned. http://articles.latimes.com/2008/mar/17/health/he-genericside17
- [5] Kids With Food Allergies Foundation. Ingredient Differences Between Generic and Brand Name Drugs. http://www.kidswithfoodallergies.org/resourcespre.php?id=74&
- [6] New York Times. Bill Seeks to Change Rule on Generic Drug Labeling. http://www.nytimes.com/2012/04/19/health/bills-seek-to-change-rule-on-generic-drug-label.html?_r=1
Comments
We had trouble with a time-release medication that a family member was taking; one of the generic versions turned out to be faulty in the release, so that the blood concentration for active ingredient was too high in the a.m. and then dropped off too early & too suddenly in the p.m. Luckily the FDA got on top of it and recalled that particular brand. But I think it's wise to check with the pharmacy on which co. manufactures the generic that they're currently dispensing for a given med. & dosage (and pharmacies change this up pretty regularly - just to keep us on our toes lol), then google it for any problems before you purchase. Takes an extra few minutes, but if you're a worrier like me vis a vis medications, it's worth it.
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LisaKoski, it's a subject people know surprising little about, considering how many of us it potentially affects, especially if you include OTC drugs. I guess we tend to assume that the doctor, or the pharmacist, or the FDA will make sure nothing goes wrong. And for the most part they do, but it still pays to be informed. Thanks for the comments.
This is a really fascinating read. I work at a drug store and sometimes I get stuck back in the pharmacy where it's not uncommon for a customer to request a generic for a drug just because of the price difference. It's good to know that there's more than just a difference in cost for generic versus name brand drugs.
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nifwlseirff, it can be frustrating. It's hard to know ahead of time if the generic will be ok. And it's different for everyone, so even when someone you know has no problem with a generic, it's still possible that you will. Thanks for commenting.
I did find that generic anti-epileptics (gabapentin) were less effective for me than the original name brand at double the price. I've also had some bad effects from certain fillers (non-active ingredients) in generic pain killers.
One the other hand, I've never had any problems with most generic antibiotics. It's very hard to tell which medications will be ok if you take the generic.
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Thanks alissa. It's something I'd never considered either until my doctor mandated no substitution on one of my prescriptions. On OTC drugs I still go with the cheaper generic. If the generic doesn't seem to have the desired effect, or seems to have side effects, then I'll try the name brand and see if there's a difference.
Job well done on this very useful and well researched hub on generic drugs! I have never thought to consider that there may be problems associated with the generic form of a drug. I just always go with what is cheaper because of our stict budget. Might have to change my way of thinking. Thanks for the great info - voted up!
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Thanks for the information, TDAPharm. This is an important and sometimes confusing subject that a lot of people seem to be interested in, so it's good to get clarification from a pharmacist. I've been reading your hubs on drug-related issues - they're very informative and well-written.
I've noticed the confusion on the instances where generic drugs look similar to their brand name original. Some reasons for this is that when a drug goes generic, usually only one company has rights to produce the generic for a set amount of time (6 months normally). What sometimes occurs is that the original brand name manufacturer will simply sell the manufactured drug to the generic company to repackage. This still ensures a profit for the brand company, and profit for the generic company, and maintains a reasonably high-price market on the drug during this time frame. This is often why when a drug goes generic, the price doesn't just bottom out overnight.
However, after a few months time, and when all other generic companies gain the right to make the drug, then the prices start to drop and the medication becomes visibly different. That being said, there are times when the drug may look very similar to the brand drug if the process of the medication is specially formulated and has very little room in design. Perhaps the only noticeable difference will be the markings differentiating them by producers. I hope this helps, let me know if you would like anything else clarified.
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That's a good question, Robin. As a DzyMsLizzy pointed out, sometimes the generic is actually the same exact medication from the same exact manufacturing plant - but I don't know how to find out if that's the case. I guess a close examination of the ingredients may be the best we can do.
I also had never thought about the inactive ingredients and the slight, minute variations that may occur in the generic drugs. I'm wondering if the case is the same with medications like Robitussin vs. Waltussin (which is Walgreen's generic version).
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It sounds like "big Pharma", like many large corporations, is guilty of some shady practices. The idea that a corporation, or any organization for that matter, including labor unions, can make political contributions is crazy! Only entities that actualy have the right to vote - i.e., individuals (PEOPLE) - should have the right to make political contributions. A corporation can't cast a vote in an election - meaning that they aren't supposed to have a voice in the political process. To give them political influence by allowing them to make political contributions is just wrong. But that may be the subject for another hub.
Ok, I see what you mean. But you know what? My husband looked up some info, and found that in MANY cases, the generic is made by the very same company as the name brand medication, and most often in the very same facility. Now THAT is troubling, indeed...if that is the case, then they are triple-dipping!
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DzyMsLizzy, thanks for the comments and the info. You may be right about the R&D costs, and if so it is indeed troubling, but the more important point is simply that generics aren't always identical to the brand names, regardless of cost (your point about the pharmacists having more up-to-date info is a good one).
Regarding the labelling, the Supreme Court ruling applies specifically to instances where the manufacturer has become aware that the labelling does not adequately explain the risks, but does nothing about it. A brand-name manufacturer would be legally liable, and could be sued (and some have been successfully sued for damages in such cases), as they have input into the contents of the labelling. A generic manufacturer, on the other hand, is not liable, and cases against them are being dismissed even when they know the labelling is inadequate, because they can't legally alter the labelling. Sorry I wasn't more clear on that point.
Very interesting.
However, there is one misperception that is very common--and that is the R&D costs. The drug companies do not actually bear those costs--they are given huge government grants to do that research, which means that you and I, the taxpayers, have already paid for that, and are being raked over the coals by their so-called "recouping" of R&D costs. NO, what they are doing is called "double-dipping," and it is unconscionable.
As far as the difference in labeling, the FDA labels require such things as quantity, dosage, and warnings about food or drink combinations, or side effects such as drowsiness. That is going to be on all of them, generic or not, so the "labeling difference" is rather a moot point...there's really no need to try and sue.
As for passing any bills about drugs...probably not going to happen--Big Pharma is in bed with the politicians (and have been for decades); they contribute massive sums to campaigns, in order to get the laws the way THEY want them--and to garner those research grants.
In closing, doctors are overwhelmed with things to remember, and they are familiar with a certain, limited range of drugs off the tops of their heads. (And yes, kickbacks still exist--even if not as blatantly or frequently as in the past.)
Bottom line: if you really want the inside story about what the drug is, how it works, and comparisons between options--ask the pharmacist, not your doctor; they have better and more up-to-date information.
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Thanks, Simone. This was a good topic for the Weekly Topic Inspiration.
This was so interesting! I had never considered how inactive ingredients might come into play when considering generic vs. brand name drugs. Wow!
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Thanks, Express10. That was my hope in writing this - not to scare people away from generics, just to have them discuss options with their doctor. I appreciate your reading and commenting.
This is a very useful article about a subject that has been talked about in the healthcare world for a long time now. Hopefully your readers will be prompted to discuss their options more carefully with their Dr.
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MarleneB and PWalker, thanks for the comments. As noted, inactive ingredients almost never cause problems, but it has happened, so it's just something to bear in mind. Sometimes just switching to a different generic will help. I take several prescription drugs and have noticed changes in some cases when switching from one generic to another, but, as you say PWalker, this also applies to OTC drugs.
Good information to know about generic drugs, Doc. I'm not on any prescription meds, but I do take an antihistamine every now and then and always look for a generic. So I'll definitely keep in mind what you've said about inactive ingredients. Thanks for sharing. Voted up and useful.
This is excellent information about generic drugs. I had not even considered the effects of "inactive" ingredients.
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Docmo, you're right - it's worth repeating that generics are only problematic in a small minority of cases. It's just something people should be aware of. Thanks for the comments.
Good info. Generic drugs are so called because when the sole patent for manufacturing a drug expires ( usually 3-5 years or longer) anyone could manufacture a said drug. The companies try to make their profit when they are the sole manufacturers and when it expires cheaper alternatives appear in the market. Most generic drugs have the same benefits and risks without the brand identity. Some, as you say may have slight differences in colorants, additives and bioavailability that can affect a very small minority who may need the branded preparation. Well written hub- thanks for sharing.
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missolive, thank you for the feedback! I'm glad you found the hub useful.
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Teresa, ultimately it comes down to trusting your doctor. I try to do enough research so that I can converse at a reasonably informed level with my doctor, but she's the one with the medical degree. I'm glad she takes time to listen to my concerns, but if I didn't trust her to make the final call, I'd be looking for another doctor. Thanks for the comments.
Doc Sonic, this is very valuable information. I appreciate your research and explanation. Thanks for the heads up!
Excellent hub Glen. My parents are both on many medication being octogenarians and are on a number of medications. I'm sure interactions between medications must be taken into consideration when changing from a brand name to a generic. My father has had problems in this area when medications have been changed. It is a complicated issue but like you, I tend to trust my doctor when prescribing brand name or generic.
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Daisy, thanks for stopping by, and for taking the time to comment. I appreciate it!
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Thanks for the comments, TDAPharm. With your background, you obviously know what you're talking about. It is those drugs with a narrow therapeutic window that are of greatest concern.
Glen,
Thanks for publishing this well-researched informative Hub. You've done a great job explaining what generic drugs are.
Your formatting makes your article very easy to read.
Some drugs should not be changed between brand and generic without the prescriber being aware due to their narrow therapeutic spectrum, this includes levothyroxine and warfarin.
In addition, some generic medications are still made by the company that created it, and merely repackaged under a generic manufacturer. This still minimizes cost overall and creates a means of profit for the original brand company, however, this is more common when a drug first goes generic and there are limited manufacturers.
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