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. Continue reading