What is a Generic Drug?The patent laws allow genericversions of drugs to be created20 years after first approval.
Any company that creates a drug is granted an exclusive patent for 20 years. It may spend up to 10 years on testing before getting the drug to market, limiting time to recoup costs. Once the patent expires, other companies can make a generic version.
Manufacturers of generics don't have to repeat the expensive and extensive clinical research done by makers of innovator drugs. However, "generic manufacturers need to prove that their drug is bioequivalent," says Gary Buehler, director of the Office of Generic Drugs for the Food and Drug Administration (FDA). That means the generic version must deliver the same amount of active ingredients into the bloodstream and in the same amount of time as the innovator drug. Generics also must be the same in strength, dosage form (pill or capsule), administration (oral or injection), and able to meet the same requirements for purity and quality.
Developing a medically acceptable generic drug is challenging, however. A noteworthy example is the estrogen-replacement drug Premarin, which millions of postmenopausal women take to help prevent osteoporosis and heart disease. Premarin, which is made from the urine of pregnant mares, contains a complex mixture of more than 100 different hormones. "Premarin is a naturally derived product, and the problem is making a product that has the same active ingredients," says Buehler. "We have had groups looking at this, but nobody has been able to do this yet."
A review in the Journal of the American Medical Association examined 127 generic drug applications approved by the FDA in a year. Researchers studied the data used to evaluate the bioequivalence of generic and brand-name drugs, and found that in all 127 drugs studied, both would provide the same intended clinical benefits.
Because of inactive ingredients -- such as filler, flavoring, and color -- generic drugs do not resemble their brand-name competitors in appearance. This difference keeps patients from confusing them. And the bottle must identify a generic drug as such on the label.
Using Generics Safely
Take time to discuss your prescription with your doctor. Ask whether you're getting the brand-name drug or its generic version, and ask why it's the best choice.
Make sure your pharmacist confirms what prescription you've been given, and explains the medication's potential side effects and any special instructions for taking it. Also bring up any concerns about the price and quality of over-the-counter brand-name drugs versus generic versions. The pharmacist's experience will help you make wise decisions in giving your family effective products.
When consulting your doctor or pharmacist, make sure you have current records of drugs that family members are taking, including any over-the-counter medications.
Many health plans want consumers to take generic drugs because they are less expensive. The co-payment is typically higher for the brand name. "I can get a name-brand drug, but I have to pay the difference, and it's a very big difference," says Jim Guire, a retired medic and firefighter who lives in Gloucester, Virginia. He takes four drugs a day for a heart condition that left him disabled at age 35.
Generic drugs generally cost about 30 to 60 percent less than their brand-name versions. Put another way, the average generic prescription is about $45 cheaper than its brand-name counterpart. The Congressional Budget Office estimates that generic versions sold at retail pharmacies save consumers about $10 billion a year.
Every state allows pharmacists to fill a prescription with an FDA-approved generic drug if one is available. The exception is a doctor's stipulation on the script that the patient use the brand-name medication.
Therapeutic Drug Substitution
Consumers need to be aware of the difference between generic and therapeutic substitution, says Duane Kirking, Ph.D., a professor of pharmacy at the University of Michigan College of Pharmacy. Therapeutic substitution means substituting the prescribed drug with a cheaper drug in the same class or family but with a different chemical makeup. Some managed care plans promote therapeutic substitution to pharmacists and doctors as a way to control costs, he says. But your doctor is the only person who can allow that change.
When the Brand Is Best
There is a small group of prescription drugs known to have a narrow therapeutic index (NTI) -- that is, a narrow difference between the median effective dose and the median lethal dose. Most pharmacists prefer not to substitute a generic version for these drugs because the slightest change in medicine might cause a reaction in a patient.
Most NTI drugs are used to treat serious medical conditions, such as asthma, heart attack, stroke, epilepsy, and depression. Some examples of NTI drugs include digoxin, dilantin, and lithium. Gary Glisson, a pharmacist with 22 years of experience in Nashville, North Carolina, says he would not fill a script for an NTI drug with a generic version. He isn't willing to take the risk. "I would pay the difference," he says.
Most other generic drugs are "perfectly safe," says Philip R. Alper, M.D., an endocrinologist and clinical professor of medicine at the University of California, San Francisco. But he, too, occasionally insists on brand-name drugs. For example, Alper prescribes only brand-name drugs for people with delicate thyroid problems. "When you allow for generic, the pharmacy can use whichever one it pleases, and there may be more variation in that than in a single, branded drug," he says. "This may not be best for patients who need very fine-tuning."
You may need to buy a brand-name drug for another good reason: Either the patent for the brand-name drug is still in place, or the FDA has not approved a generic version. Not having a cheaper choice is frustrating, especially for older people on fixed incomes or those with chronic conditions. Martha Rauth, 67, of Omaha, Nebraska, spends $514.70 a month on prescription drugs to treat congestive heart failure. There are no generic versions for three of the 12 pills she takes daily. The three drugs -- Pravachol and Lipitor (the biggest selling cholesterol drugs) and AcipHex -- each cost her more than $100 for a 30-day supply.
The patent process is constantly changing, and most big-selling drugs will get generic versions sooner or later, says the FDA's Buehler. "People think an innovator drug that costs more than the generic must be better because it costs more," says Buehler. "[The FDA] believes that when it comes to drugs, that's not true."