Problems with Generic Drugs

Some people have concerns about the safety and the effectiveness of Generic drugs. They do not go through the tough clinical trials that the original drug does.

The FDA says that the active ingredient has already been through clinical trials and would be no good to make the generic versions do the same thing because they are made from the same exact ingredients.

Bioequivalence tests are enough to make sure that the drug is effective and safe just like the original drug.

In most instances there is nothing to worry about because the generic drugs are regulated. Generic drugs are found to have the same problems as the originals just like the same side effects.

Some of the comparing studies say that there are generic drugs that are performed in the same way as the original but something different.

If you are moved from a brand name drug to the generic and you notice a change in the symptoms that you have especially if you get worse, you need to go to your GP and get some advice.

The research on drugs that you find out about has been well thought out. Researchers do their job and make sure that drugs are safe for the public to use first. Information about generic drugs will allow you to make a good decision about the medication that you use.

The Third World and Generics

The third world countries are sometimes in the most need of the new medicines that are being made by the generic name and this could be one way of getting them what they need.

To make a solution the World Trade Organization or WTO made a legislation in 2003 that could allow the third world countries to let them know which medications require and allow companies licenses to produce generic versions of patented drugs to fill this demand up.

Some may fear that the drugs be re imported and also back to the west where the seller would get a great profit rather than going to benefit those that are in need of strict regulation that the drug can be produced and imported for humanitarian reasons.

One other problem is to ensure that the prices remain low so that the developing countries can afford them. This will require a market that is big enough to attract large amounts of competition that will help to lower the prices.

There are some claims that the large Pharmaceutical companies are stopping efforts by countries like India to produce cheaper generic versions of their own drugs. Drugs that are made cheaper in these countries are usually important to the west rather than going to those that are in need of them.

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Facts about Generic Drugs

What is a generic drug?

A generic drug is made one the patent of a new drug has expired. It is the same as the original in just about every way.


How are generic drugs regulated?

Generic drugs are regulated by the FDA and must be tested and then approved by them before it goes into production.

Are your generic drugs made by the same company as the brand name version? It just may be about 50% of all generic drugs are made by the company that developed the original drug.

Are generic drugs made in the same standard facilities as the name brand ones?

Yes al facilities have to meet the FDA standards.

Why do all the brand name and generic drugs look different?

The trademark laws do not allow the generic versions to look just like the originals that are on the market. The coloring, size and shape might be different but they are still going to act the same way and do the same thing.

What is bioequivalaence?

If a generic drug is bioequivalent to the original it may mean that the generic drugs will work in the exact same way. It will release the same amount of the active ingredient in to the blood stream over the same amount of time.

Why are generic drugs so much cheaper?

Because of the increased competition between the pharmaceutical companies once a patent has been lifted on a patent has been lifted on a certain drug they will be cheaper in price.

Why are generic drugs made?

The same company produces Fifty percent of all the generic drugs. Some are made by the developing countries in cases where the drug is exempt in the country from an existing patent in the West.

What is GIVE

Generic Initiative for Value and Efficiency or GIVE is an initiative by the Food and Drug Association to bring in more generic drug products to the markets so that they can make cheaper drugs more wide spread to the public.

Its purpose is to get higher numbers of applicants and give priority drugs because there are fewer generics available.

In order to make this happen, the FDA needs to streamline the regulatory and approve the process in order to keep getting more applications and regulate pharmaceutical companies and more efficiently keep higher standards.

It is important because the increasing volume of applications and the expansion of the association and the workload that has picked up over the years due to the rate of the advanced medical science.

An interview with GIVE and their Direction of the Office of Generic Drugs Mr. Buehler, RPH, said that this was going to be achieved.

Q: How will the goals of GIVE happen?

A: GIVE will work by combining our offices different efforts into one harmonized activity to implement process improvements through the entire program. The initiative is to review oriented programs that are focused on three main ideas:

- Mobilizing staff effort to increase review productivity.

- Optimizing the capacity and capability of all assets within OGD and leveraging wherever possible resources from FDA components.

- Using every possible place to recruit and hire reviewers for the critical care needs of patients.