Oral contraceptives (birth control pills) have been around for decades, and many are now available as generics. In general, generics cost less than brand-name medications. Despite saving money, some users question whether generic birth control pills are as “good” as brand-name pills. To confuse the situation, new brand-name birth control pills have been developed that specifically claim other benefits in addition to protection from pregnancy, such as treatment of acne. The cost of these brand-name pills is much higher. To understand the generic vs. brand-name debate, it is first important to understand how drugs are developed.
Clinical evidence doesn’t support the idea that generic birth control pills have different failure rates or side effects than their name-brand counterparts.
When a drug is first discovered and developed it goes through a drug review process. This involves many steps: chemistry experiments to discover the active chemical structure of the drug, manufacturing and testing the chemical drug product, inspections of the manufacturing process, and many other developmental studies. Then there are animal studies to check safety and efficacy — and if the drug works without major side effects. Finally, clinical studies are conducted in people; these studies test to assure bioavailability (the amount of time it takes for the body to absorb the drug). These last tests, in animals and people, show bioequivalence. Bioequivalence means the drug must enter the body, be absorbed in the same time frame, and work in the body the same way consistently.
When a new drug is finally approved by the FDA, it has met strict standards regarding its strength, purity, quality, potency, safety, and clinical effectiveness. New drugs are awarded patents for 20 years, but by the time they come to market, much of that time has run out due to all of the testing requirements. Generics are usually less expensive — manufacturers do not need to repeat discovering the drug, nor must they redo animal and human studies to assure the drug is safe and works as intended. The generic companies also do not need to spend as much money on advertising, marketing, and promotion.
Today, about 70 percent of the total prescriptions dispensed are generic, saving $824 billion in medication costs during the last decade. The FDA’s Office of Generic Drugs’ mission is “to ensure through a scientific and regulatory process that generic drugs are safe and effective for the American public.”
Birth control pills are the most common form of reversible contraception used in the United States. For generic birth control pills to be approved by the FDA, they must contain the same active ingredient in the same strength, the same dosage form such as tablet or capsule, and the same route of administration such as oral or injection. They must also be bioequivalent. There are myths in circulation that claim the FDA allows generic drugs to differ in bioequivalence by 45 percent, but this is not true. According to the FDA, the difference between brand-name and generic is actually 3.5 percent, which is about the same difference you would find testing different lots (groups) of branded drugs against each other.
The manufacturing plants where generics are made must also be inspected for the same safety issues as the plants that manufacture brand-name meds. As an aside, many of the same plants and drug companies manufacture both the brand-name drug and its generic equivalent!
So, generic drugs can differ in packaging, shape, color, and inactive ingredients like colors or flavors. They may have different storage requirements. But the real questions remain: Are generic birth control pills as effective in preventing pregnancy? Do they have similar side effects?
There have been anecdotal reports of problems when switching to generics, but there has not been any clinical evidence to show that with perfect use, generic drugs might have different failure rates or side effects. Used properly, birth control pills are almost 99 percent effective in preventing pregnancy. And, there has not been any evidence to show that generics have different effectiveness when used properly.
It is possible that new or different packaging may confuse patients, or that patients have less confidence in generics and may be more aware of side effects because they have been told they are now taking a generic brand. Breakthrough bleeding is the most common reason a patient might discontinue a birth control pill, but that side effect may be related to many other issues, such as missed pills, smoking, and possible drug interactions.
The FDA has stated that generic birth control pills are clinically equivalent and interchangeable with their brand-name counterparts. There has been no clinical-based evidence or studies to disprove this. The American College of Obstetricians and Gynecologists supports using brand-name birth control pills or continuing the same generic if there are concerns regarding patient compliance or based on clinical experience. The College also recommends that consumers be informed when a different birth control pill is substituted for a previously prescribed type of birth control pill.
Planned Parenthood can provide you with more information about birth control pills and other contraceptive choices. You can make an appointment at a Planned Parenthood health center to discuss your options with a clinician.
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