Should I take generic drugs? Yes is the answer, generic drugs must show that they are bioequivalent to the original. They release just as much active ingredient in to the blood stream over exactly the same time period in other words they work exactly the same as the original in every way. The regulation and safety of generic drugs is just as rigorous as branded drugs and is just as tough. Generic drugs are manufactured in exactly the same way as the branded alternative and the facilities in which they are produced must adhere to exactly the same guidelines and regulations. In fact 50% of generic drugs are produced by companies, which also produce branded products. Generic drugs look different to branded versions because the look of the branded pill is often patented, so the generic version although containing exactly the same active ingredient differs in the non-active components to make the drug look different. The vast majority of drugs prescribed are generics. Talk to your Doctor about the medication you are prescribed if you have any concerns. They should be able to give you accurate advice of the drug, its effects and side effects; the important thing is to be informed. Generic drugs are cheaper than the original so reduce medical bills significantly. Sometimes especially if it is a new drug a generic version won’t be available.
GIVE Generic Initiative for Value and Efficiency or GIVE is an initiative by the Food and Drug Association to bring more generic drug products to the market in order to make safe cheap generic drugs more widely available to the public. Its aims are approve higher numbers of applications and give priority to drugs for which there are few generics available. In order to do this the FDA need to streamline the regulatory and approvals process in order to process more applications and regulate pharmaceutical companies more efficiently whilst still maintaining high standards. This is necessary due to the increasing volume of applications and consequent expansion of the association and its workload in recent years due to the rate of advancement in medical science. In an interview on GIVE the Director of the Office of Generic Drugs Mr Buehler, RPh., stated how this was to be achieved. Q: How will the goals of GIVE be accomplished? A: GIVE will work by combining our office's various efforts into one harmonized activity to implement process improvements throughout the entire program. The initiative is a review-oriented program that is focused on three main areas: - Mobilizing staff efforts to increase review productivity. - Optimizing the capacity and capability of all assets within OGD, and leveraging wherever possible resources from other FDA components. - Using every avenue possible to recruit, hire and train reviewers for our critical-need areas.
How Pharmaceutical Companies Prevent Generics Being Produced? Once a patent has expired there should be very little to stop companies producing generic versions of the original drug. However companies invest a lot in developing new drugs so try to extend their exclusivity as long as possible in a process known as evergreening. They can in some cases apply for a 5-year extension to their patent to cover the time they spent developing and testing the drug and not actually producing and selling it. They can also apply for 180 days exclusivity as the first one to apply and be accepted to produce a generic version of the original drug. As well as this there is aggressive litigation against those who try to produce generic versions in an attempt to dissuade them; this is costly but not as costly as the 80% or so price drop of their product caused by additional competition. The most common method of evergreening is updating patents claiming some change in the product and effectively resetting the clock. Drug companies also patent every possible thing about their drug from the colour, size, shape, taste production method and even the form of compounds used to make it in order to make it difficult for a company to produce a generic which does not infringe these trademarks and patents.
Generic Drug FAQ What is a generic Drug? A Generic drug is produced once the patent of a new drug has expired. It is the same as the original in virtually everyway. How are generic drugs regulated? Generic drugs are regulated by the FDA and must be tested and approved by them before production and afterwards. Is my generic drug made by the same company as the brand name version? Possibly 50% of all generics are made by the company which developed the original drug. Are Generic drugs made in the same standard facilities as brand drugs? Yes all facilities must meet FDA standards. Why do the branded and generic version of a drug look different? Trademark laws do not allow generic versions to look like other drugs on the market so coloring, size and shape etc may be different but they still act in the same way as the difference is in the inactive ingredients. What is bioequivalence? If a generic drug is bioequivalent to the original it means the generic drug works in exactly the same way. It releases the same amount of the same active ingredient in to the blood stream over the same time period as the original. Why are generic drugs cheaper? Due to increased competition between pharmaceutical companies once a patent has been lifted on a particular drug. Where are generic drugs produced? 50% of all generic drugs continue to be produced by the company, which held the original though at a lower price due to competition. Some are made by developing countries usually in cases where a drug is exempt in that country from an existing patent in the West.
Generics and the Third World Third world countries are often the most in need of new medicines but patents prevent the production of cheap generics, which could be one way of supplying this demand. As a solution the World Trade Organisation (WTO) introduced legislation in 2003 which would allow third world countries to let them know which medications they require and allow companies compulsory licences to produce generic versions of patented drugs to fill this demand, the patent would still hold elsewhere until expiration. Some fear the drugs may be re-imported and sold back to the west where seller would get a greater profit rather than going to benefit those in need but strict regulation that the drug be produced and imported for humanitarian reasons only. Another problem is ensuring prices remain low enough for developing countries to afford, this requires a market large enough to attract a large amount of competition that will keep prices down. There are many claims that large Pharmaceutical companies are blocking efforts by countries such as India to produce cheap generic versions of their drugs. Drugs that are produced cheaply in these countries are often imported to the west rather than going to those in need in the countries of origin. 1 in 4 aids suffers have access to the HIV drugs they need to stay alive and just 1 in 5 has access to basic prevention services. There are currently 33,000,000 people living with HIV and AIDS.
Approval And Regulation Of Generic Drugs The process of approving a generic drug was simplified by the introduction of the Drug Price and Patent Term Restoration Act of 1984 more commonly known as the Hatch-Watchman Act after its main sponsors. Generic Drugs are approved, as with all drugs in America by the FDA or Food and Drug Administration. Innovator Drugs undergo lengthy clinical testing to ensure they are safe and do the job they claim. Generic Drugs are tested differently, as the clinical trial information already exists for the original drug; all the generic version has to prove is that it contains safe ingredients and is bioequivalent (works in the same way) as the original drug. Bioequivalence is stated by the FDA to be: "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study." (FDA, 2003)". This means it releases the same amount of the same active ingredient over the same time scale as he original drug. Once an existing patent has run out the applicant submits an ANDA or Abbreviated New Drug Application and bioequivalence tests are carried out. Once approved the new Drug is added to the Approved Drug Products List along with its bio equivalence standards.
Why Are Generic Drugs Cheaper? Generic drugs are cheaper for a number of reasons. The expiry of a patent allows free competition, which immediately lowers the price. Many different companies can now produce the drug and compete to sell it, so they want to get the production costs and profit margins down as low as possible whilst still retaining profitability in order to undercut their rivals. Patent holders on the other hand have huge expenses in developing a new drug so often place huge profit margins in order to make this money back before the patent runs out, they don’t need to lower the price of their product as there is no competition as they are the only ones allowed to produce the drug. There are often lower costs in developing and testing the drug for manufacture of generics as most of the hard work has already been done by the original developer and the company just has to prove to regulators their drug is bioequivalent and contains no harmful substances rather than go though lengthy clinical trials. They also receive benefits of the previous patent holders marketing and often the drug is already well known by the medical profession making it easier to sell. The lower price may also open up new markets who were priced out before. Cheaper does not mean lower in quality as generic drugs are just as tightly regulated as branded alternatives.
Concerns Over Generic Drugs Many people have concerns over the safety and effectiveness of Generic drugs as they don’t have to go through as rigorous or as lengthy clinical trials as the innovator drug. The FDA say that the active ingredient has already been though clinical trials and it would be pointless to make generic versions do the same as they are made from the same active ingredients. Bioequivalence tests are enough to ensure the drug is as effective and safe as the original as they differ so little. In most cases there is nothing to worry about as generics are tightly regulated. Generic drugs have been found to have many of the problems of the original, for example the same side effects. But some comparison studies have shown that whilst quite a number of generic drugs performed the same as the original, some differed substantially. If you are switched from a branded version of a drug to a generic and notice a change in your symptoms, especially for the worse, go to your GP who will be able to help and advise you. Research the particular drug you are on particularly any scientific studies which have been conducted and talk to others to find out what their experiences with the drug have been. Information like this will allow you to make an informed decision about your medication.
Why Are There Ggeneric Drugs Why are there generic drugs, surely all drugs are patented by those who develop them? Patents for drugs generally last for 20 years however they are taken out early in the development process and with lengthy animal then human clinical trials it can take a decade or more from getting the patent to going into production. Other companies may challenge patents or get around them by producing drugs which are do the same job but different enough not to be affected by existing patents. Companies may also produce generic versions of a patented drug in countries not covered by the patent. Companies can apply for a 5-year extension to their patent to make up for the time they were going through the approval process. They cannot however patent the active ingredient for more than the length of the patent or renew patents that have expired, though they can patent the inactive ingredients and specific forms of compounds used. Companies protect their product by patenting aspects of their drug such as the size shape and colour of the pill as well as the brand name, these patents do not run out. There is also what is known as a research exemption to these patents, other companies can research and develop their own generic versions of the drug whilst the patent protection is still in place and so can move fast to get their product onto the market once the patent expires. The first company to file an accepted abbreviated new drug application (for a generic) can also gain a 180 day exclusivity to produce a sell their generic version, this can be applied for by the original innovator company as a way of prolonging their exclusivity, though not using the original drug as there have to be some differences to make it a generic.
Is there a difference between generic and branded drugs? Generic drugs do not differ greatly from their branded equivalents. All drugs are carefully regulated in exactly the same way to ensure they contain the correct amount of active ingredient as well as suitable inactive ingredients and are produced and manufactured in a similar way. The generic drug must be shown to be bioequivalent to the branded alternative i. e. releases exactly the same amount of active ingredient over the same time scale. The differences often lie mostly in the presentation of the drug for example a branded drug may produce pills which have a nice colouring and flavour, whereas the generic version will generally contain little more than the active ingredient. There should therefore be very little difference to the patient between branded and generic drugs and both have to go through the same regulators. Generics have a few advantages however over the branded alternatives. The branded drug is often the first of it’s type to be developed and so the company spends a lot of money on developing, testing and patenting it’s new drug and consequently they are more expensive. Generic Drugs appear once a patent has expired or in rare cases are different enough from the original to get around the patent whilst still doing the same job. Generic drug with just smaller development and manufacture costs are often a lot cheaper and so are far more likely to be prescribed. This affordability also means increased availability especially to those in poorer countries.