Generic Prescriptions – Money Saver or Safety Hazard?

“While the FDA regulates the safety of generic drugs, they do not regulate the dosage as closely as they regulate name-brand drugs” is a oft-repeated line used by brand name drug reps. However, I am a pharmacist and I have never seen anything in FDA regulations to support such a claim. Does anyone actually believe that Brand name companies spend more money on quality control at their drug factories compared to cheaper generics? They spend their money on direct-to-consumer marketing and research and generics don’t. Generic manufacturers have just as much or more at stake than brand name manufacturers do to make sure they get a quality product to the market. The last thing a company wants to do is a massive recall, it obliterates their market share.

Regarding narrow therapeutic drugs (like thyroid hormone) most experts maintain that it’s important to stay consistently on one manufacturer of the drug and not bounce from brand to generic, to another generic, and back to brand, etc. If there was actual evidence that Synthroid was a more accurate or stable treatment for hypothyroidism, I’m sure Abbott’s drug reps would canvas the world with the data.

And the idea that drugs may be cheaper if you DON’T use your insurance is very, very unlikely. Virtually all insurance companies’ computer systems automatically reduce your co-pay to the lower cash price that the pharmacy submitted. The best way to get the best price is to call around to different pharmacies and get price quotes, there is often a wide range of pricing. And don’t hesitate to ask your pharmacist for cheaper alternatives do expensive drugs that your doctor prescibe. Apparently doctors write for whatever drug is in their head at that moment (which often is the drug that they were just detailed on by a rep during a lunch break). Doctors assume that if you have insurance, brand name drugs aren’t that expensive, but we all know how high co-pays can be.

Just my two cents.

I am mortified by this blog! It sounds to me like you have very little knowledge of the brand vs. generic industry. First, similar to generics, brand name drugs have inactive ingredients that can illicit an allergic reaction. In fact, a person just might be allergic to the inactive ingredients in the brand name drug but would tolerate a generic version just fine.

Second, your statement, “while the FDA regulates the safety of generic drugs, they do not regulate the dosage as closely as they regulate name-brand drugs.” is ridiculous. On the FDA’s website, you can research the drug manufacturing process. Before a generic manufacuture’s application is approved a generic drug must be determined to be equivalent (by FDA’s standards) to the brand name. This was found on their website as part of that definition: “Pharmaceutical Equivalents. Drug products are considered pharmaceutical equivalents if they contain the same active ingredient(s), are of the same dosage form, route of administration and are identical in strength or concentration (e.g., chlordiazepoxide hydrochloride, 5mg capsules). Pharmaceutically equivalent drug products are formulated to contain the same amount of active ingredient in the same dosage form and to meet the same or compendial or other applicable standards (i.e., strength, quality, purity, and identity), but they may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration time, and, within certain limits, labeling.”

They also must be determined to be therapeutically equivalent, which is defined on the FDA’s website as: “Therapeutic Equivalents. Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.”

Next, regarding drugs with a narrow therapeutic index (i.e. Thyroid meds, Warfarin), these patients have frequent lab tests to ensure that the dose of medication is correct. If a patient goes in for blood work and their “thyroid hormone” is too low they will increase the dose until the their TSH level returns to normal. You should not however, jump back and forth between brand name and generic because this makes the monitoring and interpreting of the lab tests difficult if not impossible. Start with one or the other and get your lab work done.

Also, it is illegal for an insurance company to charge more than the cash price. If the cash price is lower than your copay, you will only be charged the cash price. That’s just the way it works.

Most often, you will find that generic drugs are going to be as clinically effective and definitely most cost-effective. Companies cant “decide” not to offer a generic. They have patents and exclusivity rights to fund the approximate ten to fifteen years worth of research they spent in developing the drug. When the patent expires, there will be a generic. That is the law, also found on the FDA Website.

As a healthcare professional, I am insulted by this article. Did the author even attempt research? The best advice for anyone with health related questions is not to try and find answers in articles such as this on the web or in newspapers, unless they come from credible sources such as the FDA or CDC. Ask your local pharmacist or family doctor. They will be your best source of information.

Everyone has to watch out for themselves. No-one else is going to take care of you. Even folks with insurance should pay attention. If you've got a $10 co-pay on a generic ask what the cash price is because it might be less than $10!! I found a prescription discount card to help with my meds. It's at http://www.rxdrugcard.com. They tell you right there on the website what you'll be paying if you use their card. And the membership fee is only $4.95 a month for the whole family. Don't pay more than you need to. Do some research. It's YOUR money.