Brand-Name Drugs or Generics?
There’s been a lot of debate about the use of generic drugs over brand-names. But if you’ve filled a prescription recently, in all likelihood you’re taking a generic drug.
According to the FDA, 8 in 10 prescriptions filled in the U.S. today are for generic drugs.1 What’s more, generic use is expected to increase over the next few years as the patents for a number of popular brand-name products expired in 2015.
It makes sense. On average, the cost of a generic drug is 80-85% lower than the brand-name product. But are we sacrificing our health to save money?
Some people might think so. After all, an original Prada bag is a much higher quality product than a copy. But in the pharmaceutical industry, that’s not quite the case. The cost is low because someone else has done all the work. In this case, the original pharmaceutical companies.
According to Tufts Center for the Study of Drug Development, the cost to develop and win marketing approval for a new drug is $2.6 billion.2 This also pays for research and development for medications that failed in trials and can’t be brought to market. The original company shoulders the responsibility for these costs.
This is partly the reason the price for brand-name drugs are so high. The pharmaceutical companies are trying to recover their investment. To balance their right to do so with the rights of patients to have access to lower cost generic drugs, the FDA allows new brand-name drugs to have patent protection. That protection spans 20 years beginning when the drug is invented. By the time it goes through testing and whatever else is necessary to get approval from the FDA, the drug company is usually left with about 12 years of exclusivity before generic brands hit the market.
Once a patent expires, the FDA allows one generic to be the first on the market. That generic is then given about six months before any other generics are released. And because the product was already developed and tested by the original pharmaceutical company, production costs are relatively low. That means lower prices to the pharmacies, and ultimately to us. Prices drop even lower once other companies get the go-ahead to release their own generic version of the drug.
This isn’t to say generic prices are immune to economic highs and lows. A report released in December 2015 by the Department of Health and Human Services indicates prices for 22% of the top generic drugs reviewed between 2005 and 2014 rose faster than inflation. But when compared to the cost for brand-name drugs, generics are still quite the bargain.
Consider, for example, antidepressants. Most drugs in this class are now available as generics and cost under $20 for 30 pills at Costco. By comparison, Cymbalta – ranked as the most prescribed antidepressant in 2014 by Mental Health Daily 3 – costs close to $250 for 30 capsules.4 The generic version, duloxetine, was just over $30.
The savings associated with generic drugs is undeniable. Yet some still feel generics are simply not as good as brand-name drugs. Dr. Dawn Davis, an assistant professor in Family and Community Medicine at Saint Louis University and a SLUCare family physician, said the reason may be because the drug companies have done a good job with marketing their products. But that hasn’t stopped her from recommending generics to her patients.
“I generally recommend generics because prescription drugs are prohibitively expensive, and I have a number of patients with limited resources. But if a patient is reluctant to take generics, I explain that they do meet the same FDA standards as the name-brand medications. So for all intents and purposes they are an equivalent drug. I also let them know that I personally use generics and that seems to help too.”
The FDA says it requires generic drugs to be “identical” to brand-name drugs to be approved for the marketplace. By law they must:
- Contain the same active ingredients as the brand-name drug
- Be identical in strength, dosage form (pill, inhaler, or liquid), and administration
- Work the same way in the body (be bioequivalent)
- Meet the same standards for identity, strength, purity, and quality
- Be made by the same rules the FDA has set for the brand-name drug.
Some will point to the word “identical” and say it’s misleading. The truth is there are some differences between brand-name and generic drugs. For instance, trademark laws in the United States don’t allow generic drugs to look exactly like the brand-name medications. As a result, a generic’s shape, color, packaging, and to a certain extent labeling may be different.
The FDA also allows a different combination of inactive ingredients as long as they’re safe. These include such things as binding materials, dyes, preservatives and flavoring agents; none of which, they say, alters the effectiveness of the active ingredient. But they can influence how a drug affects some patients.
For example, a patient may have an allergic reaction to an inactive ingredient such as a dye used in a generic drug. Pat Berry, executive director retail pharmacy services for Mercy Hospital St. Louis, said simply switching to another generic may solve the problem because another manufacturer might use something completely different. So it doesn’t mean the generic is substandard.
“When things are FDA approved as a qualified generic, then it’s no different from the brand-name product. Of course it might look different or taste different, but the active ingredient has to be the same as the brand-name. I think some patients just get a bit confused when you go from one generic to another, so they believe there’s a problem. But by and large they’re the same drugs.”
There is some controversy, however, over the use of generics in place of brand-name drugs with a “narrow therapeutic index” (NTI). NTIs are effective and safe only within a small dosing range. In other words, too little active ingredient and the drug doesn’t work; too much and it becomes toxic. Antiseizure medications for treating epilepsy, blood-thinning drugs like warfarin, antiarrhythmics for controlling irregular heartbeats, and drugs that help prevent the rejection of a transplanted organ all are NTIs.
“You do have to be careful with some NTI drugs,” Berry said. “Although I’d say 99% of the time the generic versions are not a problem. But if you’re going to use one of these generic drugs, I really recommend that you stick with the same manufacturer.”
Depending on who has the best price, a pharmacy could potentially change suppliers from month to month. So for instance, if you’re taking the generic thyroid medication levothyroxine manufactured by Company A, then later receive levothyroxine manufactured by Company B, Berry said there’s a chance you might “see a difference and could potentially end up with hypothyroidism.”
The potential for problems has prompted several states to restrict generic substitutions of NTI drugs and require additional monitoring if they are used. The FDA is also working toward establishing new standards to assess the bioequivalence of both generic and brand-name NTIs. Berry said this may make people some rethink using generic NTI drugs, but he still advocates their use.
“There’s a big cost difference between the generic and brand-name. As long as you stick with the same manufacturer of a generic NTI drug, it really shouldn’t be an issue. Just talk with your pharmacist if you have concerns.”
And that’s what it really comes down to — cost. A 2015 survey by the Kaiser Family Foundation found that a quarter of U.S. prescription-drug users said it was difficult to afford their medications. 5 That number rises to 43% for individuals in fair or poor health.
In another survey published in the journal Lancet Haematology, 10% of insured U.S. patients with the blood cancer multiple myeloma said they had stopped taking a cancer drug because of its cost.6
The bottom line is if generic drugs are similar to brand-name drugs, are as safe and effective, and cost 80-85% less, then using them isn’t sacrificing your health to save money. But do your homework. Make sure whatever you take is right for you. Here are some tips to help you:
- Investigate your medications. Don’t assume just because it’s a generic it’s not as good. Check it out. Then assess each medication based what you learn and your own experience.
- Ask your doctor if there is a generic version of your medication that is as safe and effective, but less expensive than your name-brand drug. If your drug doesn’t have a generic yet, ask if an older generic version in the same class would work just as well.
- Ask your pharmacist to verify the ingredients in your prescription for you, especially if you’re allergic or sensitive to lactose and gluten. These items are sometimes used as a binding material.
- Ask your pharmacist how to use products such as inhalers. The generic product may look and operate a little differently than the brand-name.
- Monitor your symptoms. If you’ve changed your medication for an enlarged prostate yet you’re visiting the bathroom twice as much at night, it’s not working.
- Learn the generic and brand-names of your medication to avoid taking multiple versions of the same drug.
If you follow these suggestions and talk with your doctor or pharmacist, you’ll not only save money, but you’ll be doing what’s best for your health.