Many drugs have a generic form, and usually this generic is less expensive than the brand-named drug form. For example, such popular drugs like: Ciprobay, Zithromax, Xenical, Proscar, Tamoxifen, Eldepryl and not so known like: Seroquel, Nolvadex, Arimidex and Metformin have a generic form. Questions arise as to the authenticity of generics, if they provide the same benefit as brand-name drugs, and if different and/or more side effects are caused when solely using generics.
Firstly, in the United States, generics are regulated by the Federal Drug Administrationís (FDA) Center for Drug Evaluation and Research (2011). The mission of the center is to evaluate all new drugs (prescription and over-the-counter) to make sure they are safe and effective. There is even a distinct office devoted to the monitoring of generic drugs (Office of Generic Drugs: Chemistry and Bioequivalence Review). As such, all generic drugs must be the bioequivalence of their brand-named drug versions. If two drugs are bioequivalent, then they have the same pharmacokinetic characteristics so that one can be substituted for the other. When studies are conducted on animal research models, the generic drug and the name-brand drug must not greatly differ when the dose and conditions are the same.
In 1984, the FDA was first given the role of approving generic drugs. The guidelines for approval have improved over the years so that all generic drugs must meet these conditions: 1) contain the same ingredient as the name-brand drug; 2) be the same in strength, dosage, and path of administration; 3) have the same use; 4) bioequivalence; 5) same in identity, strength, purity, and quality; and 6) be made under the FDAís good standards practices and regulations (FDA, 2003).
Still concern exists regarding the equivalence of generic drugs to their name-brand counterparts. In one review article by Kesselheim et al. (2008), the authors compared 47 studies that researched the comparisons between 8 different subclasses of cardiovascular generics and name-brand drugs. These studies used clinical measurements such as heart rate, blood pressure and urine output to compare cardiovascular drugs like β-blockers (Coreg vs. carvedilol), diuretics (Lasix vs. furosemide), and calcium channel blockers (Norvasc vs. amlodipine maleate). One study out of 47 did find significant differences in regard to the diuretic drug, furosemide. But overall, the conclusion of the review article was that generic and brand-name cardiovascular drugs produce the same clinical results in human participants. They suggested that switching from the drug, warfarin to the FDAís bioequivalent generic drug can be safe, but monitoring should be conducted during the switch period.
Not only are generic drugs supposed to be bioequivalents of name-brand drugs, but generic drugs cost much less than name-brand drugs. According to the FDA, the cost to an individual that buys generic drugs is 80-85% lower than the cost associated with name-brand drugs. In 2009, a study published a National Prescription Audit documenting the average cost of generic drugs at $6.00, $29 for name-brand drugs, and $40 for non-preferred name-brand drugs (Aitken et al., 2009). Costs of drugs are a special concern for the elderly who may need the life-saving properties of a particular drug but are on a reduced income.
To save some income, seniors may choose to use generic-only medication. In a study that described the usage and financial status of seniors that switched from name-brand drugs to generics, these seniors had involuntarily switched from a capped name-brand drug plan that they had in 2001 to an unlimited generic only plan in 2002. The study conducted by Tseng et al. (2006) surveyed these seniors by asking them if they had changed any financial cost cutting strategies such as: 1) changed to less expensive drugs; 2) used current drugs less often than prescribed; 3) stopped taking their drugs; 4) did not start new prescriptions; 5) used free drug portions; 6) used someone elseís drugs; or 7) purchased drugs from other countries than U.S. The seniors were also asked when or if these cost cutting strategies occurred in 2001 (when they had the name-brand plan) or 2002 (when they had the generic drug plan). Of the 611 seniors surveyed, 71% had an income of $30,000 or less. Of their total income, they spent $2,484 in 2001 on drug costs, used 12.2 unique drugs or which most (52%) were name-brand drugs (Tseng et al., 2006). In the switch to generic only coverage in 2002, seniors used less medication (15%), stopped using their drugs (15%), or did not start new drugs (10%) compared to their usage in 2001.
Overall, 25% of seniors surveyed decreased their drug usage after the switch to the generic-only drug plan. This study was conducted when only about 7% of the name-brand drugs had generic equivalents.
Hence, most of the seniors did not have the option of using generics. If these generics had been available, the financial costs associated with the generic-only plan may have been reduced and the seniors may not have reduced their medications but continued to take the recommended dosages. Tseng et al. (2006) reported that 95% of seniors are aware of generics and 90% would use these generics if their physician recommended them.
Though there is a paucity of clinical evidence to support the conclusion that generics and brand-name drugs are bioequivalent, there exist opinions that interchanging brand-names for generics should not be conducted. These opinions may be generated from first-hand knowledge (and not clinical results), or may be influenced by the companies that produce brand-name drugs. Nowadays we can say, that generic drugs FDA approved, effective and safe.
About what is generics read here.
Aitken, M., Berndt, E.R., and Cutler, D.M. 2009. Prescription drug spending trends in the United States: looking beyond the turning point. Health Aff (Millwood) 28(1): 151-60.
FDA-Approved Bargain Drugs: Generic Products must meet high standards. 2003. Federal Drug Administration Publication No. FS 02-7.
Kesselheim, A.S., Misono, A.S., Lee, J.L., Stedman, M.R., Brookhart, M.A., Choudhry, N.K., and Shrank, W.H. 2008. Clinical equivalence of generic and brand-name drugs used in Cardiovascular disease. A Systematic Review and Meta-Analysis. Journal of American Medical Association 300 (21): 2514-2526.
Tseng, C.W., Brook, R.H., Keeler, E., Steers, W.N., Waitzfelder, B.E., and Mangione, C.M. 2006. Effect of Generic-only drug benefits on Seniorsí Medication use and Financial burden. American Journal of Managed Care 12: 525-532.