Why Generics Cost Less Than Their Brand Name Counterparts?

According to the FDA, generic drugs only become available after rigorous review and after a set time period that the brand-name version has been on the market exclusively. The FDA goes on to state that this is because new drugs are usually protected by patents that prohibit others from making/selling copies while drug manufacturers recoup the costs of bringing a new drug to the market (- as if they really need the financial support, right?) As per the FDA, generic drugs also tend to cost less than brand-name because generic drug applicants do not have to repeat clinical studies (both animal & human) that were "required" by brand-name drugs to demonstrate safety & efficacy. The FDA insinuates that because of this and the competition between brands + multiple generics are a large part of why generics cost less. "The reduction in upfront research costs means that, although generic medicines have the same therapeutic effect as their branded counterparts, they are typically sold at substantial discounts, an estimated 80 to 85% less, compared with the price of the brand-name medicine." Source: fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm#q4 Controversy surrounding generic efficacy vs brand: What the FDA doesn't discuss is that even though generics are boldly affirmed (by the FDA themselves) to provide the same therapeutic effect as brand names, is the difference in binders/fillers that affect bioavailability (absorption/metabolization) and therefore drug efficacy. Not to mention, the lack of FDA oversight in generics brings into question quality control (using inherently cheaper & different fillers), using the appropriate amount of active ingredients and assurance of following ethical & moral guidelines therein... The FDA should be held accountable for making such bold claims insinuating that there is no difference between generics and brands, when clearly they are not the ones taking these medications, nor are they overseeing their production.

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I have huge problems with certain generic medications that I've been sold over the years after taking the brand name previously. Some generics are so bad and low quality it's not even like it's the same medication. I've become sick of certain ones and others are just really underdosed. There are some companies that make decent generics and others that I've learned to always stay away from. There should be way more oversight on generics. People shouldn't have to take medication that is very low quality. I'm sick of certain people in the industry saying that they are all the same and even equivalent to the name brands... This is so not true. Sometimes a medication will discontinue a brand name so you're at the mercy of all generics and it's just figuring out with ones are ok and which ones to avoid and hopefully you don't get stuck with bad ones.

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There is an abundance of anecdotal evidence on this site alone to indicate that generics are often-times less efficacious, (often significantly less) than their name brand counterparts. Most worrying is that it would appear that the FDA appears almost unwilling to investigate such claims and both the FDA and manufacturers refuse to throw any light on the discrepancies.

If the discrepancy in effectiveness is indeed a result of using different binders and fillers I cannot understand why they wouldn’t use the same binders and fillers in the generic version. These are the least expensive components.

Compounding the issue is that generic manufacturers have multiple manufacturing facilities worldwide and production of any given medication is switched between them. There is, therefore no consistent link between raw product and the consumer.

I have personally experienced two issues with generic drugs.

I was originally prescribed Diovan for hypertension and it proved extremely effective in controlling my elevated blood pressure. For about 2 years my BP was consistently between 115/70 and 110/65. My insurer then insisted I switch to a generic version, Ibersatan, and my BP immediately rose and is now consistently between 120/75 and 125/80. Not tragic numbers I know but inferior to Diovan.

I am also diagnosed with ADD. (Too old to have the energy for the “H” part!!) my doctor titrated me to 30mg Adderall XR. I was quickly switched to the Actavis generic which, although a little less effective was fine with me. Seven years later, and with the first capsule of a new prescription Actavis generic was suddenly totally ineffective. Worse, it had no effect on my ADD and additionally made me drowsy. After stopping the meds for 6 months I tried again - same thing, useless. Since that time I’ve tried Concerta, (minimal effectiveness) and Vyvanse, (limited effectiveness, gives me palpitations and makes me tense, anxious and short tempered). I tried one month of name brand Adderall which worked. Unfortunately I can not afford the copay.

So, the generic drugs may, or may not work. Even the same brand of generic can change effectiveness. To my mind generic drugs are an ongoing crap shoot. The FDA is continually underfunded and cannot, or will not, fulfill the role expected of it, and the pharma lobby is clearly more powerful than the NRA.

It’s little wonder that US life expectancy is one of the lowest in the industrialized world.

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I have communicated with a number of Congressmen, Congresswomen, Senators and Governors to ask, “How do you plan on controlling pharmaceutical prices?”. Do they really expect pharmaceutical companies to lower their profit margins? That will not happen. The problem is the Congress’s action to not fund the FDA with tax dollars but to authorize the FDA to charge fees.

In 2012 the FDA needed $300 million to support the disposition of the backlog of Generic submissions. The Congress unanimously passed the 2012 FDA Innovation and Safety Act, which authorized the Office of Generic Drugs (OGD) to fund the backlog by charging each manufacturer of a generic drug an annual fee. The problem is the calculation.

Consider that FDA requires each generic drug manufacturer to register (self-identify). When all have registered, FDA adds up the number of self-identifiers and divides that number into $300,000,000.00. That quotient is the fee.

In 2012 the fee was $74,000. Today the fee is $248,000. The Federal Register reported that the fee increase was due to the reduction in the number of self-identifiers by 65 self-identifiers. The denominator got smaller.

If a self-identifier manufactures one (1) generic drug the fee is $248,000. If the self-identifier manufactures one-thousand (1000) generic drugs, the fee is $248,000.

Clearly the calculation should be amended to divide $300,000,000 by the number of generic drugs OGD administers. That provides a dollar factor quotient. When a company self-identifies they then multiply that dollar factor by the number of generic drugs that self-identifier manufactures. That is their fee. That levels the playing field for the small manufacturer. $248,000 to a small manufacturer means middle class jobs. $248,000 to Teva is a rounding error.

Companies that leave the field increase the potential for monopoly. Monopolies erode competition and prices rise. Last year’s House Oversight Committee, heard the Eppy pen issue and closed stating that the answer to the problem is competition.

Generic drug prices have increased 10%-20% since the enactment of the Act.

The Act, has eliminated middle class jobs, increases the cost of generic drugs and reduces competition.

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I couldn't agree more. I can't tell you how many generics I've had lately that paled in comparison to their brand-name counterparts. The frustrating thing is that both the pharmacist, & the doctor will look at you like you've completely lost your mind if you mention it to either one of them...

They are both so "programmed" in medical school by Big Pharma, that "generics are exactly the same". It's pretty ridiculous, TBH...

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Generics are garbage!! They dont work!! I have found this out through experience. I always have a negative reaction.

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THANKYOU SO MUCH for these facts validating mine & so many other Chronic Pain patients suffering from horrific side effects of generic PERCOCET (oxycodone/aceteminaphen 10/325) suddenly occuring approx a year ago & getting worse! After 15+ yrs of managed comfortable use I know the formula/fillers have changed. They pass it off as a body tolerance issue...NOT!! I feel as if I’m being poisoned.

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I am a registered nurse, retired three years and have given many drugs both genetic and brand names. What I’ve found since retirement and on Medicare with HMO/medicine coverage that generic drugs like clonidine tts transdermal patch and nifedipine which are very old drugs cost way more than they should. And when you question the cost, they want to know why you can’t take a different generic. Classifying these drugs as preferred generics are a way to charge the elderly more money. I’ve been hypertensive since age 21 and have been on a myriad of drugs over the years and currently take the 2 generics mentioned plus Losartan/Hctz and Bystolic. I was placed on the Clonidine patch to cover morning blood pressure surges and it has worked beautifully. I’m now challenging the insurance company to allow a tier reduction to help decrease cost. If there was another patch in the same class as Clonidine and cheaper, I would gladly try it because this drug has a lot of nasty side effects and I sure don’t want to have a stroke, etc. Hope my tier reduction is granted

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There there is a big difference in generic and brand. Definitely should be held accountable. I cannot take generic drugs and always have to switch back to the brand.

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dobbs (# 4) --

My wonderful Pain Mgmt Dr 3 mos ago understood my symtoms, agreed w/me & confirmed that YES; ingredients to PERCOCET GENERICS & all oxycodone meds have been altered (fillers, etc) due to opiod crisis abuse. He now writes “medically necessary, BRAND ONLY” on my percocet mthly scripts. My insurance company approved as well. Problem is, NO PHARMACY I’ve approached will carry nor order for me the Percocet brand name & only will offer generic. Why?...Well, a pharmacist told me the BRAND costs them $1,800 per 100 pills to order & their reimbursement from ins. companies is less than HALF; ie; $900 & under. So here we are; chronic pain LEGITIMATE GOOD PATIENTS totally thrown under the bus.

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Re: MeJane (# 9)

I have never heard anything like that in my life. If your insurance company has approved for you to get the brand I don't see how a pharmacy cannot accept that.

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Re: MeJane (# 9)

Just looked up Walgreens pharmacy and there is an online form you can fill out to complain about your situation. Apparently they have been doing this but fill out the complaint and I believe it's sent to AMA. GOOD LUCK.

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Re: dobbs (# 11)

Thank you for the info! It's good to know. But I'll contact the FDA first so it gets to them faster.

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Re: MeJane (# 9)

I hate what big pharma is doing to us legit pain suffers!! We need to find a good attorney who can take care of us!! I am not an abuser!! I don't buy my drugs off the street!! I DO NOT like being put in the same category as those abusers!! This lack of quality medicine should be illegal!! I have years of documented pain and injuries to show I'm legit!! There needs to be someone who will stick up for us and change this nasty underhanded crap that is being done to lower the effectiveness of medicine!!

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Re: MeJane (# 9)

Have you tried the Endo Brand generics? They are yellow & have "E712" on one side & "10/325" on the other. They are actually made by Endo who makes the brand name Percocet. They aren't as strong as they used to be unfortunately, but compared to the rest of the garbage available today they are a Godsend for chronic pain sufferers. Just asking...

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Re: KDubya (# 14)

Thank you! Hope my pharmacy has them or order them for me. This site a Godsend to me & to us all I’m sure as a TEAM re-assuring us our sudden horrible side effects we share are real; we are not losing our minds Amen. It’s scary living in fear day-to-day praying we don’t lose our life-line. Somehow we must take a stand to bring awareness to the FDA, our Dr’s, our gov’t that us long-term Chronic Pain patients should be categorized as basically terminally ill as we were put on this med percocet/oxycodone because we’ve exhausted every other treatment(s) to live a somewhat “normal” tolerable, functional life. Chronic pain can eat you from outside-in & inside-out.

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Re: dobbs (# 10)

It’s mindblowing to me too & that's why I wrote about it. Every pharmacy so far has said brand Percocet is not available to them to order! Even Publix, Target, WalMart ALL OF THEM! For what reason & why?...who knows; then some of the smaller pharmacies have told me it’s too expensive to order for them to carry at $1800 per 100 &/or they say their wholesaler doesn't & wont offer them brand Percocet! Its a no-win situation for us.

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Re: MeJane (# 15)

If you're dealing with a large chain or grocery store pharmacy, they are usually contracted to buy certain types of generic brands. However smaller independently owned pharmacies usually have far less red tape. They should be able to order them for you. They are more expensive than other generics though. The Endo Brand generics can cost anywhere from $1-2 per pill. They do work though, so there's that...

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Re: KDubya (# 17)

Thankyou KDunya! I’ve been approved for ENDOCET by my ins. co. as previously a few months ago I tried it, it agreed w/me. However the follwing month my phcy no longer had it avail?!? My Dr told me it was ok to switch/look for any phmcy that carried/or would offer it. Not one phmcy would/could get it for me. I’ll keep trying ! So unfair we should be put through this!

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