Generic Drugs - Are they really the same?

What is a generic drug?

When a brand-name drug’s patent protection expires, generic versions of the drug can be approved for sale. The generic drug should work like the brand-name drug.

♦ Most of the generic drugs consumed in the U.S. come from India, Israel and parts of Europe.

• China is the lead supplier of key starting materials used to mix drugs in labs in India that eventually get shipped to the U.S. either as finished product, or sent to U.S. subsidiaries and commercial partners who repackage the drugs, sometimes turning the ingredients into pills and tablets, for example.

• Many people view the word generic as something of lower quality. For the most part, this is not true.

The generic drug must provide the same active ingredient and performance as intended by the brand-name drug that it replaces. The generic must meet the same quality and safety standards as the brand-name drug or it cannot receive approval from the FDA.

♦ Generic drugs now account for 91 percent of prescriptions sold in the U.S.

Most insurance plans favor generic brands by requiring lower copays for generics and higher copays for brand drugs.

• Some insurance plans will not cover a brand drug when a generic is available.

It is becoming more comment for insurance plans to require you to first try a cheaper drug before they are willing to cover a more expensive brand drug.

• Not all brand drugs have a generic version.

What is the difference between generic and brand-name drugs?

Generic drugs have different names.

♦ The generic drug will cost a lot less than the brand-name drug. Sometime as much as 80% less.

The generic drug will look different. They could be a different size or color and have a different marking. Generic drugs look different because certain inactive ingredients, such as colors and flavorings, may be different.

They look different because trademark laws in the U.S. do not allow a generic drug to look exactly like other drugs already on the market.

♦ They will have the same active ingredients but they might have different inactive ingredients. The inactive ingredients may affect some people differently than the brand drug’s inactive ingredients.

There can be more than one generic drug for the same brand drug.

Generic alternative vs. Generic equivalent

This term is often confused when people refer to generic drugs in general. An alternative drug whether it is a brand or generic is just that, an alternative.

♦ A generic alternative is not the same as a generic equivalent because it does not use the same active ingredients as the brand-name drug that the generic equivalent is modeled after.

♦ A generic alternative is a drug approved by the FDA for the treatment of the same condition that a brand-name drug may have been approved for. The active ingredient may be similar but not the same.

The alternative may or may not be as effective as the brand-name drug. Your insurance company may cover an alternative drug because of lower cost and / or a longer history of use.

Your doctor would be to the best person to ask if a particular alternative drug would be a good option for you.

Preferred generic vs. Non-preferred generic

Preferred generic is a relatively new term. It has been rapidly picked up by almost all insurance plans.

It is a means for insurance companies to split the class of generic drugs into two levels much like they have traditionally done with brand-name drugs.

• In some cases, the difference in price between a preferred and non-preferred generic drug is a few dollars per prescription. In most cases, the difference in copay is $10, $20 or even more. It is not uncommon these days to pick up a generic prescription and be hit with sticker shock.

• There have already been a number of lawsuits filed against insurance companies for classifying some long standing generics for the treatment of H.I.V. as non-preferred thereby throwing them into a much higher costing tier for the patient.

• Many generics have risen in price due to demand and supply problems. This has put a squeeze on insurance companies’ profits.

To shift the cost more toward the patient, most insurance company are now classifying a much smaller number of generics at the lowest cost tier of preferred generic.

• Just because something is a generic do not assume your insurance plan will cover it. It might not be on their list “formulary” of approved generics. This is another trend that has both healthcare providers and patients crying foul.

Who makes generic drugs?

The same companies that make brand name drugs are responsible for manufacturing approximately 50 percent of generic drugs.

Are they made in America? Unfortunately, like brand-name drugs many are made overseas. Many of the active ingredients in both brand-name drugs and generics are also sourced from foreign countries.

Are generic drugs safe?

The FDA assures us that generic drugs are safe.

♦ But at the same time, countries like India and China have been cited by the FDA for falsifying data and test results and in some cases supplying ingredients containing contaminates.

This has been an issue not only for generic drugs but also brand-name drugs. While the number of incidents is quite low, many people are still concerned.

• India is the second-largest exporter of drugs to the U.S., and almost half of active pharmaceutical ingredients used in the U.S. come from India or China.

One of the problems with overseas manufacturing of drugs is that the FDA cannot inspect foreign facilities as often as it does domestic ones. The FDA Safety & Innovation Act of 2012 is supposed to provide additional resources for inspections of foreign manufacturing sites.

♦ Some medical experts believe that not all generics are the right way to go. The experts tend to cite studies comparing the safety of replacing a brand- name drug which might have a very narrow window of effectiveness or narrow window of safety.

• For example, too little of the active ingredient and it doesn’t work or too much and the drug does harm.

Some experts argue that generics that supply the active ingredient in a different dosage range may be too risky to use.

You really need to talk with your doctor and find out if the drug you are taking is safe to change to a generic. Contrary to what most people think, the majority of doctors will give you an honest reply.

Is there a generic equivalent for my brand-name drug?

Start by asking your doctor. Next try asking your pharmacist.

The FDA keeps an online list that is searchable. It is called the “Electronic Orange Book”. It is not easy for the average person to understand. Pharmacists will often look at this source.

You can learn from this site whether or not a generic exists. Unfortunately, there is a delay of about a month after a generic is approved and when it appears in the "Orange Book”. If nothing is found still speak with your doctor and even ask your pharmacist.

• To use the search functions for find a generic you must first know the active ingredient in the brand-name drug. You can find this information by first searching by the brand name. Select search field: Proprietary Name and enter the brand name and click submit.

Copy the name of the active ingredient and repeat the search but this time search using the active ingredient name.

When searching by the active ingredient, if more than the brand name’s manufacturer is listed then the other manufacturer(s) should be the generic drug’s manufacturer.