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Generic Drugs Research Report.

1 May, 2003

David Gross, AARP Public Policy Institute

Learn more about AARP Public Policy Institute For many years, generic drugs have been a key tool for helping consumers, health insurers, and public payers to reduce their prescription drug costs. Their availability is particularly important in view of renewed rapid health care cost increases, a substantial share of which is attributed to prescription drugs.

At the same time, the cost savings should not be considered separately from quality of care issues. In this AARP Public Policy Institute Issue Brief, David Gross provides basic information about generic drugs, focusing on their contribution to reducing prescription drug costs; the generic drug approval process; evidence on generic drug safety and effectiveness; state laws regarding generic substitution; and provider and consumer attitudes toward generic drugs.

http://www.aarp.org/research/health/drugs/aresearch-import-724-IB61.html

Are Generic Drugs Safe?

25 May, 2007

From Amber J. Tresca

When it comes to drugs, do you really "get what you pay for?" It's the most difficult question you've encountered at the store since the first time you were asked "Paper or Plastic?" You're at the pharmacy filling your prescription and the pharmacist turns to you to ask, "Is the generic version O.K.?" Your pulse quickens as you frantically weigh your options: generic drugs cost less, but are they really the same as the brand name version? Should you get the generic and save a few bucks?

The answer is a resounding 'maybe'. In most cases, generic drugs are considered safe due to the testing process used by the Food and Drug Administration (FDA).

Pharmaceutical companies invest big money into developing their drugs. In order to recover those costs, which can be in the hundreds of millions of dollars, the U.S. government issues a patent or exclusivity on the drug.

A patent is defined as "the right to exclude others from making, using, offering for sale, or selling". In other words, no other drug company can create the same drug in its laboratories and sell it. Patents can last for as long as 20 years, but each specific patent is different. A patent can be issued at any time during the drug approval process. Therefore, a drug may be patented, but not yet approved by the FDA for use by patients.

A similar right called exclusivity may also be granted to the pharmaceutical company. Exclusivity is defined as the "exclusive marketing rights granted by the Food and Drug Administration (FDA) upon approval of a drug". Created to strike a balance between the creation of new drug and generic marketing, exclusivity may or may not coincide.

The length of exclusivity is dependent on the type of drug for which it is being granted, and can be anywhere from 3 to 7 years. When the patent and exclusivity have expired, other pharmaceutical companies can recreate the drug and market it themselves under a different name. This opens up the market for competition, and drives the cost of generics down.

Generic drugs must have the same active ingredients as the name brand, but the inactive ingredients could be different. Inactive ingredients may include colors, preservatives, or other fillers. However, just because a generic has the same inactive ingredients it is not automatically considered a generic equivalent.

A pharmaceutical company that wishes to market their generic drug must offer proof of bioequivalency to the FDA. In order to be bioequivalent, the active ingredients in a generic drug must be absorbed at a similar rate and in a similar amount as the brand name drug. The generic does not have to act exactly the same as the brand name drug, but it does have to fall within certain guidelines set by the FDA. These guidelines may vary from drug to drug.

To be sure that the generic drug you are offered has been established as bioequivalent to the brand name, check with your pharmacist. Your pharmacist has access to information about generic drugs from the FDA's Orange Book. The Orange Book contains listings of drugs and their bioequivalency status. The electronic version is searchable by active ingredient and proprietary (brand) name.

If your doctor has written a prescription for a drug using the brand name for that drug, the pharmacist must fill it with that specific drug. The pharmacist can call your doctor and talk about substituting a generic form of the drug. Or, you can talk with your doctor about generic vs. prescription drugs when the prescription is written.

If you are surprised at the drug counter with the question about brand name or generic, call your doctor's office. The doctor who prescribed the drug for you will know if you can get the desired results with the generic.

http://ibdcrohns.about.com/cs/prescriptiondrugs/a/genericdrugs.htm

Health Focus: Are Generic Drugs As Good?

13 Oct, 2006

They’re cheaper. And they’re usually as effective. But there are important exceptions.
INTELIHEALTH FEATURE - You’ve seen them in the supermarket: No-name or store brand medications that promise to be as effective and cheaper than the brand-name variety. They can cost half as much as a name brand. But are they as effective?

In most cases, the answer is "yes," says Vincent Earl Pearson, Pharm. D., clinical coordinator for drug information for the Department of Pharmacy at Johns Hopkins Hospital. Generic drugs are as safe and effective as brand-name products, and subject to the same quality guidelines set by the Food and Drug Administration to ensure their therapeutic equivalence.

"There is a long list of generic products that I have no problem putting side-by-side with their brand-name counterparts," says Dr. Pearson. "They’re not inferior. People mistakenly believe cost is equivalent to quality."

Generic drugs must contain an identical amount of active ingredients as their brand-name counterparts, and in the identical dosage. The generic drug must deliver the same amount of those active ingredients into a patient’s bloodstream and within the same time frame as the original drug. It must also fall in "acceptable parameters" established by the FDA for bioavailability, which is the extent and rate at which the body absorbs the drug.

So besides price, the only real difference between brand-name and generic drugs tends to be the inactive ingredients used that have no medicinal value. These include fillers, binders, coloring and flavoring, which may explain why generics may differ in the size or shape of pills or capsules.

Then why do brand-name drugs cost so much more? Their manufacturers must bear the up-front costs of researching and developing the drug, a process that can cost hundreds of millions of dollars. Here's how it works: When the new chemical formula is first synthesized in the lab, the company is issued a patent that lasts 17 years. During that time, no other drug manufacturer can market a generic equivalent of that drug.

But since it can take 10 years or more of testing and clinical trials before the drug gets FDA approval, little time is left for the brand-name manufacturer to recover the costs of its new drug. Once the patent ends, other pharmaceutical companies are free to manufacture and market the drug under another name, subject to FDA approval.

Enter the generic manufacturers. Since the chemical composition of the original drug is part of the public record, outside companies can replicate its formula — and sell it under its own name or under the label of a supermarket or department store chain. Sometimes, the original pharmaceutical company will produce its drug in another form in an effort to stay in the market.

These off-brands have the same active ingredients, strength and dosage as their brand-name counterparts. "The only difference between the drugs is that the manufacturer of the generic product does not have to prove to the FDA that it is safe and effective, because that already has been done," says Dr. Pearson. "The approval process of a generic drug takes much less time, usually within about two years from the time the company decides to manufacture it."

So should you always go generic? Not necessarily, says Dr. Pearson. Patients often wonder whether it is dangerous to switch from a generic product if they have been taking a name-brand product. Switching is usually safe — but there are exceptions.

Some drugs, both brand-name and generic, have what is known as a "Narrow Therapeutic Index (NTI)." That means the drug can produce toxic side effects or loss of disease control if it is absorbed or released at even the slightest changes in doses — whether too high or too low. Remember, there are "parameters" for bioavailability that must be met, not an exact number.

This is why many pharmacists, including Dr. Pearson, are unwilling to substitute generic products for drugs with an NTI. "Even the slightest change can result in upsetting the patient’s disease control," he says. "That’s why I would recommend against switching for such drugs. There’s a real possibility that it might upset a patient’s stability. It could be absorbed differently; it could have fillers or dyes that change the absorption or release of the dosage. While there may be side effects to switching, I have no knowledge of it ever being fatal. If there is a switch, it is essential to continually monitor the drug levels in the blood to make sure there is a minimal risk of toxicity.”

Among the drugs known to have an NTI:

• Conjugated estrogen (Premarin), prescribed as hormone replacement therapy for prevention of osteoporosis or heart disease risk.
• Phenytoin (Dilantin) and carbamazepine (Tegretol), anticonvulsants.
• Theophylline (Theo-dur), for asthma and lung diseases.
• Cyclosporine (Sandimmune or Neoral), used as an organ transplant antirejection drug.

Aside from the NTI drugs, it's usually safe to go with a generic drug, which is why some insurance companies will only pay for generic drugs or require an explanation if a doctor or pharmacist insists on a name-brand product. "A patient can say they do not want generic products," says Dr. Pearson. "But that means the insurance company will make them pay the difference in price, and in many cases that can be a substantial amount. Insurance companies may want the patient to pay the whole price. Then you will have to look for an insurance company with a more reasonable co-payment plan. Patients should keep a tight rein on what their insurance company is doing. Read the material they send you in the mail to look for any changes in the policy."

http://ibdcrohns.about.com/gi/dynamic/offsite.htm?site=http://www.intelihealth.com/IH/ihtIH/WSIHW000/333/7228/289719.html