In today’s healthcare system, many plans require generic medications rather than brand name products. Patients become concerned because generics are substantially less expensive than their brand name counterparts. They question if the quality and effectiveness have been compromised.

In truth, the FDA (Food and Drug Administration) requires that generic drugs be as safe and effective as brand name versions.They must contain the same amount of active ingredient.

So why the disparity in the cost of brand vs. generic?

When a brand product is brought to market, the initial manufacturer has spent money on research, development, marketing and promotion of the drug ($2.6 billion) . For this investment, the FDA grants a patent that allows this company exclusive rights to sell the medication until the patent expires. Patents usually last anywhere between 17-20 years. If the drug is successful, the company easily makes back its investment, and garners huge profits.

As the patent nears expiration, other manufacturers may apply to the FDA for permission to make and sell a generic version of the drug. A less expensive price ensues because this second manufacturer does not have startup, development and promotional costs as the original. If multiple companies wish to sell the same medication, competition at this level will may even drive the price lower for the consumer.

What about the quality of the product?

There is no truth in the myth that generic drugs are produced in poorer-quality facilities or are inferior in quality to the brand. The FDA applies the same standards for all drug manufacturing facilities. In fact, many brand companies, in order to secure their place in the market, produce both brand name and generic drugs. FDA estimates indicate that as much as 50% of generic drug production is by brand name companies.

Do generic products take longer to work?

Again, the FDA mandates that generic products work as fast and effectively as the original brand name entity. Sometimes, generic versions have different colors, flavors, or combinations of inactive ingredients than the original medications. However, the active ingredients must be the same in both products, which ensures that both have the same medicinal effects.

Is this true for over the counter (OTC) as well as prescription medications?

YES…..The FDA applies similar strict criteria so store OTC products must achieve similar blood concentrations as the brand. Most people don’t notice a difference.

Will you always get the same effect with a generic as with a brand name?

There is wide diversity among people who use medications. Every administration of a medication to a patient is a unique experience. The responses to each dose could be different for every patient and from refill to refill.

When monitoring therapy by using drug concentrations in the blood, since the inactive ingredients and the manufacturing process may be different, the same blood concentrations may not be achieved by everyone. Some patients may break down the drug faster or slower, or absorb the drug at different rates This can effect the active amount of the medication in the system. Some patients are just more sensitive to concentration changes and they will notice a difference.

Are there instances when you should opt for a brand name?

Some medications have what is known as a narrow therapeutic index (NTI). This means that the blood concentrations to achieve a therapeutic dose and those that will cause more serious harm are very close together. Small changes may lead to ineffective or toxic responses. Examples what these medications are used for:
• Seizures
• Heart arrhythmias
• Thyroid disease
• Warfarin (Blood thinners)
• Lithium salts

For these drugs talk to your physician specifically about using generic medications before making any changes in your therapy.

Is it dangerous to your health to switch back and forth?

In most cases, patients would not notice a perceptible difference in the effectiveness or safety if moving between brand and generics, or from one generic to another. If you experience mild symptoms, chances are good that these will resolve while you continue with the therapy. If these issues become more than a mild convenience, contact your provider as soon as possible.

Quick FDA Facts About Generic Drugs;

• 8 in 10 prescriptions filled in the U.S. are generic drugs

• Generic drugs have the same QUALITY AND PERFORMANCE as brands

• All manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs

• Many generic drugs are made in the same manufacturing plants as are brand name drugs

• Average cost of generic vs brand name counterpart: 80-85% LESS

• Savings to healthcare weekly: $3 Billion

Final Thoughts:

• Most patients appear comfortable using store brand generic medications without significant concerns.

• Most health plans require generic products be used to save their costs, I might suggest you start out on a generic, or switch when they are available. They almost always work as well…..Why use a high cost brand when the generic will give you what you need at a fraction of the cost?

• If you believe you will ultimately prefer the brand product, try 1 or 2 generic versions of the product before moving back and having to pay the higher brand copay. You may discover that one of those choices may give you the desired result and negate the need for the brand change.

• If you are taking a medication with a narrow therapeutic index, before making any changes to a generic, discuss the risks and ramifications in detail with your physician so you will be comfortable with your decision.

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