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.

Is There a Difference Between Generic and the Name Brand Drug

Generic drugs are not much different from their name brand successor. The drugs are carefully regulated in exactly the same way so that they can contain the same amount of active ingredient as well as be suitable in the way they are produced. They need to be just like the original.

The generic drug must be proven to be bioequivalent to the branded alternative i.e. releases the same amount of active ingredient over the same amount of time.

The differences are going to be in the presentation of the drug like a brand name drug may produce pills that have a nicer color or taste. However the generic version will usually contain a little more of the active ingredient.

There is little difference to the patient between the name brand and the generic. Both have to get through the same regulators and pass the same tests. Generics have a few advantages over the name brand pricier drugs.

The name brand is often the first of it’s type to be made and this is why the company spends a lot of money on making, testing and patenting the new drug and this is why they are more costly.

Generic drugs will have a patent once that has expired or in some cases are different enough from the original but still do the same type of job.

Generic drugs have a smaller manufacture and costs are usually less expensive so that we are able to afford them easier. This means that they are going to be more available to those in other countries.

Why Generic Drugs Are Made

You may wander why generic drugs are made. The patents for drugs usually last for twenty years however they are taken away early in the event of a process and with a long animal then human clinical trials it can take a decade or more from getting the patent to go into production.

Some companies may make a challenge for patents or get around them by making drugs that are going to do the same job but just a little bit different so that they are not affected by the existing patents.

Companies may also produce generic types of a patented drug in countries that are not covered by a patent.

Some companies can apply for a five-year extension to their patent to make up for the time that they are going through the approval period.

They cannot patent the active ingredient for more than the length of the paten or renew the paten that has already expired. They can however patent the inactive ingredients and different forms of compounds that are used.

Companies can protect their product by patenting the drug like the shape, size and taste of the brand name. These patents do not ever run out.

They may also do what is known as a research exemption to their patents. Other companies can do the research and make their own genetic versions of the drug while the patent protection is still available and can move fast to get their product onto the market once the patent expires.

The first company to file an accepted new drug application for a generic drug can also gain a 180-day exclusive to the produce and sell their generic version. This can be applied to the original innovator company as a way of prolonging their exclusive rights. However they are not using the original drug, as there has to be some differences to make it a generic brand.

Why is Generic Drugs Less Expensive

Generic drugs are cheaper for a few reasons. The expiration of a patent will help free up competition, which will immediately lower the price.

Many different companies will produce the drug and compete to sell it. This will help to get the production and costs down as low as possible so that they can turn a profit.

The patent holders on the other side have a lot of expense that goes into making new drugs. This means that the huge profit margins are replaced in order to make this money back before the patent runs out. They do not need to lower the price of the produce because they do not have any competition due to the fact that they are the only ones allowed to make the drug.

Usually there are lower costs in making and testing the drug for manufacture of generics because of all the hard work that has been done by the original company.

They will also get many benefits from the last patent holders marketing and often times the drug is already well known by the medical profession making it so much easier to sell it. The lower price may also open up new markets that were priced out in the past.

The cheaper cost does not mean that the lower the quality in generic drugs. It just means that they are tightly regulated as name brand competitors.

Can I Take Generic Drugs

The answer to this question is most likely, yes. They are bioequivalent to the original type.

They will release the same amount of active ingredient to the blood stream over the same amount of time. So this means that they will work exactly the same way.

The regulation and safety of the generic drugs is just as tough as the name brand goes through.

Generic drugs are made in exactly the same way as the name brand and the facilities that they are made in have to listen to the same rules and guidelines.

Companies that also produce the name brand ones produce Fifty percent of generic drugs.

Generic drugs look different to the name brand because the look of the name brand pill is often going to be patented. This means that the generic version ahs to look different in some way but the active ingredients are always the same.

Most drugs are prescribed as generics.

You should talk to your doctor about the medication that you are prescribed if you have any concerns or questions. They should be able to give you an accurate description of the drug. They will tell you the side effects and anything that is important.

Generic drugs are cheaper than the original so they can reduce the medical bills better. They will sometimes be available when the name brand is not so easy to find.

How Pharmaceutical Companies Stop Generics Being Made

After a patent has expired there should be very little a company can do to stop other companies from producing generic types of the same drug.

Companies however can invest a lot in developing new drugs to try and extend their exclusivity as long as they can in a process called ever greening.

They can in some instances, apply for a five year extension to their patent to cover the time they spend on developing and testing the drug and not actually producing and then selling it.

They may also apply for one hundred days exclusivity as the first company to apply and then be accepted in to produce a generic version of the original type drug.

There is an aggressive litigation against anyone that tries to produce a generic version in an attempt to dissuade him or her. This is very expensive but not as costly as the 80% or more price dip of their products that were caused by the other competition.

The most important method of ever greening is updating patents that claim some change in the product and successfully resetting the amount of time they have.

Drug companies also patent any thing possible about their drug like the color, size and shape. They even patent the form of compounds used to make it in order to make it hard for other companies to produce a generic drug like it.

The Regulations of Generic Drugs

The way of approving a generic drug was made easier by the Drug Price and Patent Term Restoration Act of 1984 that was introduced and more well known as Hatch-Watchman Act named from its main sponsors.

The FDA otherwise known as the Food and Drug Administration approves generic drugs just like all types of drugs in the United States.

The Inventor Drugs under went a long clinical testing time to make sure that everything was safe so that they could do the claim.

All Generic Drugs are tested differently. They go through a clinical trial and the information will already exist for the original drug. All generic versions have to prove that they are safe and have good ingredients in them that work just like the original drugs do.

Bioequivalence is stated by the FDA to be the absence of a big difference in the rate and extent to how the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives are available at the place of the drug action when it is given at the same molar dose under the conditions in an appropriate study.

This actually means that it releases the same amount of the same active ingredient over the same scale as the original drug.

After an existing patent has ran out the applicant can then submit an ANDA or Abbreviated New Drug Application and bioequivalence tests are carried out. Once approved the new Drugs is added to the Approved Drug Products List along with its bio equivalence standards.