Understanding Specialized Health and Medical Products

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts. However, before a generic drug is approved, it must go through a rigorous testing process and because it is a known bioequivalent of the original drug, it is not necessary that all of the tests be repeated. The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made it easier for generic drugs to come to market. Very simply, under Hatch-Waxman, a generic company can produce a drug and sell it if it is the same as the brand-name drug – except that the generic drug is always cheaper. This is because brand-name drugs are typically given patent protection for 20 years from the date of filing. This means that only the company that filed the drug can produce it and sell it – this is what gives brand-name drugs their original monopoly. After the patent expires, other manufacturers are free to make their own version of the drug. Due to the fact that the generic company does not have nearly the same cost as the original manufacturer to discover the drug, it can sell the drug for a substantially lower cost, while making a tidy profit.

The term "generic" has also come to be used as a reference to things that are sold under a less-expensive unbranded label. By this definition, a generic drug does not have to be bioequivalent to a brand-name drug, as the term is used to define that drug with a simpler name that is not protected by a trademark. However, the FDA only approves drugs as generics if they are bioequivalent to the original.

In general, the average patient does not realize the cost differences between the brand-name drug and generic drug outside of acute medications (ex: antibiotic, pain relievers). Patients who have chronic medical conditions that require taking medication on a daily basis might end up spending hundreds to thousands of dollars per year on medications. In situations like these, if the patient can purchase the generic drug, there are often times significant cost savings. These cost savings can lead to a patient being able to afford other necessities, adhere to his/her medication regimen, and avoid being forced to take cheaper, less effective medications. Given the current economic climate and impending healthcare bill, using generic drugs may be a viable option for cost containment.

Brand-name drug: What is an ANDA? (new article) on the off-patent drug. The drug does not need to go through the research stages so this makes it significantly less costly. The drug company is able to sell the drug at a lower price than the brand-name drug due to not having development costs, being able to pass this undoubtedly cheaper production cost to the consumers. Brand-name drug companies argue that generic drugs are cheaper than their drug for the reason that it lures people away from the brand-name drug, relying on the fact that patients who see their doctor would be more inclined to prescribe the drug they are more familiar with (the brand-name drug). This is, in fact, true.

Generic drugs are significantly cheaper than brand-name drugs but are similar in quality. According to the FDA (Food and Drug Administration), a generic medication is the same as a brand-name drug in dosage, safety, strength, route of administration, quality, performance characteristics, and intended use. Though it is important to note that the generic drug has to contain the same active ingredient. The inactive ingredients such as color, shape, or taste may be different but this does not affect the quality of the generic drug. In most cases, when comparing a generic to a brand-name drug, they are exactly the same. But generic drugs are much less costly, mainly due to the cost of research and development. In order to make a generic drug, the company just needs to go through an abbreviated new drug application (ANDA).

Yes. An FDA approval is mandatory for any generic drug to confirm it meets the rigid requirements of identity, strength, purity, and quality. All generic medications obtain FDA approval. For many years, the FDA has also conducted over 3000 inspections a year of manufacturing plants to make sure their standards follow those of the brand-name drug. In fact, 50% of generic drug production is by brand-name companies. The theory that name-brand drugs are of superior quality is a misconception.

Another misconception is based on the invariance in the physical appearance of drugs. Even though some differences are allowed, the FDA has stated that generic drugs, their brand-name counterparts, and innovator drugs are all the same in terms of performance, quality, and intended use. This should answer any questions about the effectiveness of generic medication. The national surveys state that 72% of consumers know that generic drugs have the same quality and are bought at a higher rate due to this. So, considering the money spent on brand-name drugs and the general trend of the pharmaceutical market, generic drugs are the most cost-effective and efficient medications available.

If a generic equivalent is not available, you may want to request your physician to prescribe a therapeutic alternative that may be available in generic form. Be sure to check with your physician to see if such a choice is appropriate for your condition.

Another easy way to find out if a generic is available is to ask your pharmacist whether a generic version is on the market. If one is available, be sure to ask if the generic medication is right for you. In some cases, pills are scored to make cutting them in half easier and cheaper; if you need a full-strength pill, a scored tablet may not be the best choice in a generic.

Your pharmacist can be an invaluable resource in helping you determine whether a generic equivalent of your brand-name medication is available. Asking your physician is another good strategy. Many doctors now automatically write prescriptions that will allow substitution of a generic equivalent. Your pharmacist, however, should always check with your physician before substituting a generic medication for a brand-name product if you and your doctor have not specifically discussed a change.

The cost issue is self-explanatory and if the generic medication is available, your doctor should understand that by changing to a generic medication, ultimately you are going to cut costs for yourself, or your healthcare provider depending upon who pays for your medications. In the long term, you should not find yourself in financial strife due to medication costs. If the cost of the medication is going to lead to difficulty paying for essential items such as food, shelter, and other bills, then you should seriously consider asking your doctor whether there is a generic version of your medication. This is primarily directed towards those who are unemployed, those who are on a disability support pension, and those who are single parents. A matter of a few dollars difference per medication can mean a great deal.

Can I ask my doctor to prescribe a generic medication? Asking your doctor for a generic medication has been searched on several occasions all over the world. This is because the generic medications are relatively cheaper and one might think that the generic medicines may work for them even if the branded one has not. It is very unlikely that a doctor will refuse your request to change to a generic medication or to prescribe a generic medication, however, it is important that both you and your doctor understand why you want to change to a generic medication. Reasons for changing to a generic medication often include cost and bad experiences with the branded medication.

Switching to a bioequivalent version from one that is not is estimated to save $964 million per annum for Medicaid. High-priced medications can be cost-prohibitive for some patients, resulting in a battalion off medication. Therefore, generic medicines can vastly improve the quality of life, allowing greater numbers of people access to the medications that they need.

Research has shown that costs of generic medicines are nearly 30% lower than the costs of brand name drugs, and in some cases, prices are 80% less at the time for trial being to affordable medication for other countries included. The prices come down because companies do not have the expense of creating a new drug and conducting tests to prove its efficacy and safety. Marketing costs are lower, thus reducing the retail price, and wholesale price continues to drop due to gigantic competition. As a result, patients receive more affordable medication and can allocate funds to other essential needs. 80% of all prescriptions in the United States are for common chronic diseases, and there are still further cost savings in using generic medications.

The cost of medicine is the amount of the rest of the public health hierarchy, which is in the cut lifetime cheap mainly due to hard competition in the pharmaceutical industry. The patent protection act permits pharmaceutical companies to develop generic medications. Such medications are the same as the brand name counterpart as active ingredient, form, treatment, and clinical uses, and prove to work similarly. Bioavailability studies conducted by FDA show that generic drugs are the same as the brand name drugs in their research.

Yes. In the past, when a prescription contained the name of a branded medication, pharmacists in some states were prohibited from substituting a generic medication without checking with the doctor. Now, in almost all states, laws allow pharmacists to dispense a generic medication as long as the prescription does not include a 'no substitution' directive from the doctor. If you have any doubts, you can ask the pharmacist to substitute a generic medication when it is available. Be sure the pharmacist makes the switch and you are not charged the brand medication price.

If it is an over-the-counter medication in Australia, New Zealand and other countries, you may purchase the generic medication without a prescription. In the US, where the situation is more complex, there are still fewer generic medication choices in the OTC market. This is largely due to the fact that to obtain FDA approval, a generic prescription medication must be pharmacologically equivalent to the brand name medication. On the other hand, demonstrating pharmaceutical equivalence for an OTC medication, which may have been on the market for only a few years, is not an easy task. Because of this and various market factors, OTC generic medications are often slow to emerge. For specific cases, it may be best to ask your doctor if an OTC generic medication is available.

Many people question the quality of generics in relation to brand-name drugs. They fear that generics are not as potent as brand-name medications or have a higher risk of side effects. The quality of generic medications is addressed in questions 3.1 through 3.4. United States generic drug resources are world leaders in assuring that generic drugs are safe and effective. The FDA has assured that the same standards are used when testing all drugs, regardless of whether they are generic or brand name. The same rules of bioequivalence are used for generic and brand-name drugs. The FDA is a Public Health Service federal agency and is responsible for assuring the safety, efficacy, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices.

The FDA is also responsible for assuring the safety and security of America's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. This is done through a system of regulations and inspections that guarantee that all pharmaceutical production is done in safe and clean conditions. All generic manufacturer plants are inspected to assure that they are following the same procedures as their reference company, to assure the same quality. It is mandated that all generic drugs must be tested to ensure that they are bioequivalent to their reference medication. A generic company must provide evidence that their drug is the same in dosage form, strength, route of administration, and intended use. Bioequivalence is achieved if the rate and extent of absorption of the generic does not show a significant difference to the rate and extent of absorption for the listed drug. Failure to prove this will result in the disallowance of the generic to be produced. Due to this system of data submission and reviews, generic medications in the United States are more likely to be scrutinized than in any other country. This system gives high assurance that generic drugs are both safe and effective.

Before a generic medication is approved and marketed, the manufacturers must demonstrate bioequivalence to the chosen (i.e. innovator) product. Bioequivalence means that the extent and rate of absorption do not show a significant difference from the chosen product. This is assessed using pharmacokinetic studies comparing the blood plasma levels against the innovator drug. Usually, generic companies will test their product against the chosen product in a small crossover volunteer study. They do not usually have to repeat pharmacodynamic studies or toxicology studies. The generic company must submit an Abbreviated New Drug Application (ANDA) for FDA review and approval. The ANDA is a comprehensive document containing data about the new drug. This is to permit the FDA to review the methods used by the generic companies to ensure the product quality.

Major points in ANDA include:

• Chemistry data about the generic drug and the chosen dru;
• General description and the development of the generic drug;
• Summary bioequivalence data;
• Actual or proposed labeling and the patient information;
• Safety and effectiveness data for over-the-counter drugs.

Generic medications are required to be equivalent to brand name medications by the Food and Drug Administration (FDA). According to the FDA, a generic medicine is allowed on the market if it is "identical in dose, strength, route of administration, safety, efficacy, and intended use." It is important to understand how the testing works for generics compared to that of brand name medications. Brand name medications go through lengthy and expensive processes to prove safety and efficacy so that the company can patent the medication and make a profit. The patents for these medications last 20 years, at which point other companies are able to replicate the medication and sell generics. These other companies are not required to go through the same process as the brand name companies. Instead, they are required to show only that their medication is bioequivalent to the original product. This means that the generic medication must show in testing that it has the same rate and extent of absorption in the bloodstream as the original product. Typically, the testing is done in 24-36 human volunteers and is highly monitored. Volunteers are given a single dose of the generic medication and the blood is tested to ensure that it is being absorbed similarly to the brand name product. These tests are averaged and the generic is given the approval based on the average absorption compared to the brand name product.

Due to rigorous regulations, generic medications must meet the same high standards as brand name medications with regard to the quality, performance, and intended use. Every new drug is evaluated by the Medicines Control Agency (MCA) to ensure that they meet the quality standards. The manufacturers of generic medications must provide evidence on the quality of a drug by producing a detailed dossier on the drug. This is then checked by the MCA to ensure that it contains the same amount of active ingredient and has the same effect as the original brand name drug. This means that consumers can trust that they are using a drug that is safe and performs the same as they are used to. This regulation can also drive down the cost of original brand name drugs if there are generic versions available. A cost savings to the consumer of up to 33% is also provided by the NHS on generic drugs compared to the original brands. This is equivalent to £2 billion a year. The strict regulation and cost savings of generic drugs ensures that the NHS can provide an effective treatment at relatively low cost.

Switching between a generic medication and its brand name counterpart may also lead to decreased compliance if a patient is confused between two similar-looking or similarly named products. This could lead to problems if the patient uses both products or stops using one after being unclear about the change. Measures should be taken to avoid confusion, and using a generic medication that is similar in appearance and name to the original branded version may not always be the best choice.

There are potential risks associated with every medical product. It should be noted that the risks associated with generic medications are the same as with the equivalent brand name medication. In some cases, the risks may be greater as the formulation of the generic medication may differ from the original branded version. Any medical change should be monitored for risks, and this is a decision that should be made between the patient and the healthcare professional. If the healthcare professional has any concerns about risks, they may advise against switching to a generic medication. "The key for any patient is to work with their physician so they can make an informed choice," says Gary Buehler, Director of FDA's Office of Generic Drugs. "There are many approved generics available, and our goal is to get the message out to consumers that [getting a generic drug] is a wise and safe choice."

However, be careful when it comes to drugs that have a narrow therapeutic index (NTI). According to the FDA, "drugs with a narrow therapeutic index have small differences in dose or blood concentration that may lead to serious side effects or loss of efficacy. For these drugs, even a small difference in generic product and the brand may cause a problem." Step Therapy: Have you been asked to switch your medication lately? This means that certain NTI drugs may be less ideal candidates for substituting your brand-name with a generic. To make a somewhat broad conclusion, it is generally safe to switch to a generic from the brand, but it is always good to speak with your doctor—especially in cases where the replaced drug has been working a certain way for you over a period of time.

Step Therapy: Have you been asked to switch your medication lately?

Yes. The FDA (U.S. Food and Drug Administration) requires generic medications to be bioequivalent to their brand-name counterparts. This means that they must prove to be the same (i.e. within an acceptable range) in terms of rate and extent of absorption. According to Carol Holquist, M.S., R.N., director of FDA's Division of Medication Error Prevention and Analysis, "A generic drug product is one that is comparable to a brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. It is the same as a brand/reference listed drug product in dosage form, safety, effectiveness, strength, stability, and quality, and it can successfully substitute for the brand/reference listed drug. Step Therapy: Have you been asked to switch your medication lately?." This means that if you are on Toprol XL, for example, the FDA has determined that generic metoprolol succinate in this case is interchangeable with the brand name product and thus act as pharmaceutical alternatives.

There is an important difference between something being eligible for a generic form and whether a generic version is deemed to be interchangeable with the brand name for prescribing purposes. Usually, the decision for a manufacturer to produce a generic version is dependent upon whether they think they can get a decent share of the market before the original patent has expired.

The market for each medication differs from country to country and the manufacturer's decision is usually based on an assessment of how many sales they can expect to gain versus the cost of production, getting the product through a registration authority and marketing it to health professionals. If a medication is subject to a lot of changes in dose and frequency, then it is likely to be less cost-effective to produce a generic version.

While a medication is still under patent, generic manufacturers may start a process known as a "section 23 application" to have the product or its uses included in the list of pharmaceutical benefits so that they can release their generic version as soon as the patent expires. In any case, the decision to produce a generic version before the patent has expired is a balance of financial risk versus potential profitability.

A regulatory victory would strengthen the ability to ensure patients receive the appropriate medication by requiring the brand name product when a generic is deemed inappropriate. This could be achieved if the FDA enforced current state laws which require the pharmacist to dispense the exact drug product prescribed. This 'Dispense as Written' protection is infringed upon in many states, often without the consumer or physician realizing it, because laws permitting generic substitution do not effectively communicate that this is the default action at the pharmacy. Additionally, FDA could eliminate the current bioequivalence rating system which often leads to automatic substitution of generic drugs rated AB. This would add extra safeguards for drugs where close monitoring or narrow therapeutic range makes any safety or efficacy difference unacceptable. Ultimately, the decision for strongest FDA regulatory action came from elevating consumer confidence in the safety and value of generic drugs, by ensuring appropriate use of generic substitutions and not promoting them when there is no proven equivalency to the brand product.

Yes. In many states, the pharmacist is permitted to substitute a generic version of a drug unless the physician has indicated the prescription must be filled with the exact brand name product. In addition, the FDA has rated some generic drugs equivalent to their brand name counterparts, but consumers and healthcare providers are often unaware of this and continue to make medical decisions based on the mistaken belief that effectiveness and safety differ. Consumers should be cautious about asking whether a generic drug is right in every case. The main concern relates to a handful of drugs that have a narrow therapeutic index or require monitoring to ensure blood levels remain in a safe and effective range. For these specific drugs, it has been our position that a brand name product is necessary. Our position statements outline which drugs we believe fall into this category along with the justification for this decision.

Patients, or their representatives, have the right to choose. If the prescriber writes "dispense as written" or "D.A.W." on the prescription, the pharmacist must dispense the brand-name drug (i.e. no generic substitution). If the prescriber has endorsed the policy of "no substitution", it is unlikely that the patient will receive a generic medication. The legal requirements for this scenario vary from country to country. In the absence of the above, the patient may still prefer to receive a brand-name medication. Legally, the patient must specifically request a brand-name item. If the patient makes no such request, the pharmacist may use his professional discretion to decide whether a generic substitution is appropriate in the patient's best interest. If the patient has a valid reason for objecting to the generic medication, the matter can usually be resolved by allowing the patient to discuss the issue with the prescriber.