Tuesday, March 16, 2010

Generic vs. Brand Medication

What is a generic drug? A generic drug is a drug product that has the same active ingredients, strength and dosage form as the brand-name counterpart.  It is sold under the chemical or scientific name for the drug instead of the manufacturer's brand name.  Brand name drugs have a twenty-year patent life.  Once that patent expires, other manufacturers are free to make the drug in a generic form.  The cost of a  drug drops between 30-80% once it becomes available as a generic.

Are there differences between a brand-name drug and its generic alternative? Yes.
Generic drugs marketed in the U.S. may differ from their brand-name counterparts in such things as shape, packaging fillers (including colors, flavors, preservatives), expiration time, and, within certain limits, labeling.  However, the federal Food and Drug Administration (FDA) requires that all drugs, both brand-name and generic drugs marketed in the United States, meet the same requirements for quality, strength, purity and potency.  The FDA will only approve generic drugs that have the same active ingredients and works the same in the body as the brand-name counterparts.

Are generics available for all brand-name drugs? No, only after a brand-name drug loses it's patent can other manufactures produce the generic form.  Keep in mind that even after a patent expires, some drugs may not be available in generic form, if no manufacturer makes them.  Today about 1/2 or 8730 of the 11,487 drugs listed in the FDA's Orange Book have generic counterparts. (source FDA, MedAd news)

Do generic drugs take longer to work? No, when a manufacturer wants to produce a drug generically, that manufacturer must provide evidence to the FDA that it works in the body just like the brand-name drug and within the same amount of time as the brand-name drug. 

Are generic drugs as safe as the brand-name drugs? Yes. All medications have risk. The manufacturer of the generic drug must prove to the FDA that the generic drug is as safe as the brand-name drug.  Only a consumer in consultation with their physician can determine if those risks outweigh the benefits in their specific situation. 

Are generic drugs made in the same type of facilities as the brand-name drugs? Yes. Generic manufacturers must meet the same exact standards as brand-name manufacturers. Brand-name manufacturers account for an estimated 50% of generic drug production.  They frequently make copies of their own or other brand-name drugs but sell them without the brand-name designation.  The FDA makes over 3,500 inspections a year to ensure the these standards are met in both brand-name and generic manufacturing facilities. 

Why should I use a generic drug? Generic drugs represent real value.  Generic drugs usually cost from 30-80% less than their brand-name counterparts and, since the FDA is very strict about approving generics, you can be assured that the generic drug you receive is a safe and effective alternative to the brand-name drug.  

Let me give you an example of the savings and power of generics.  Let's say a member's prescription drug plan has copays of $10, $35 & $50 depending on the classification (tier) of the drug as determined by the insurance carrier.  One member of a health insurance plan pays a $35 copayment a month for a 30 day supply of brand name Zocor. Other members use the generic version, simvastatin and pays a $10 copay. Over a full year, that amounts to a $300 savings, just by switching one prescription. 

Also, premiums for an insurance policy are determined based on the dollar amount of claims submitted to your insurance company.  Although your copay is only $35, the drug may cost say $180, so the additional $145 is billed to your insurance provider.  If all members of the plan make similar choices (insisting on a brand-name vs. generic), just think of the true cost to the insurance carrier.  

How do I get a generic drug? Start with your doctor or pharmacist. Questions you should ask include: 
  • is there a generic version of my drug available?
  • are generics right for me? 
  • are there any risks I should know about before I change to a generic?
  • how much will I save if I change to a generic?

According to the FDA, generic drugs approved by the FDA are biologically and therapeutically equivalent to their brand-name counterparts.....and people can use them with confidence!

Next blog: HSA, HRA, and FSA explained

Reference:  www.fda.gov/buyonlineguide/generics_q&a.htm, www.fda.gov/cder/ogd, www.fda.gov/buyonlineguide/generic_equivalence.htm, www.gphonline.org/content/navigationmenu/aboutgenerics/statistics/default.htm

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