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Montana News: FDA Labeling Should Reflect Comparative Efficacy of Drugs
Reprinted from the October 2009 Montana Board of Pharmacy Newsletter.
Lang Lang, Pharmacy Intern
Zipsor™ is the new diclofenac potassium capsule with a liquid filled center. The manufacture of Zipsor, Xanodyne Pharmaceuticals, Inc,1 stated that compared to a placebo, Zipsor is very effective for mild to moderate pain. However, Zipsor was not tested against current non-steroidal anti-inflammatory drug products available on the market, and it is much more expensive than the existing products.2 Food and Drug Administration (FDA) should require manufacturers to provide comparative efficacy information for new drugs, along with safety and efficacy information.
In an article published on the online New England Journal of Medicine in August, Stafford et al3 stated that the US health care expenditure has increased by 71% since 2000. The authors also stated that if health care providers are given the knowledge of the superiority of new products they will have more power in deciding whether or not to utilize the new product. Also, if a patient knows the efficacy of the new drug compared to the existing ones on the market, he or she would be more willing to pay for the more efficacious product. Many drugs currently on the market are approved as “me-too” drugs in order to earn a portion of the market share. The efficacy of these drugs was proven against placebos; however, no clinical trials were held to compare them to drugs in the same class that already exist on the market. Also, newly approved drugs usually cost a lot more than existing products with generics available. The high costs of the new products are allowed by FDA to compensate the manufacturers for the cost of development of the drugs; it also serves as an incentive for companies to thrive for innovation of medications.3 However, clinical trials conducted against a placebo only show efficacy of the new drug, but give no indication whether the efficacy of the new product is worth the cost. In other words, placebo-controlled trials give no cost-benefit relationship for the new product, and provide insufficient information for health care providers and patients.
The Food and Drug Administration Act of 19884 gave FDA responsibility for research, enforcement, education, and information regarding food and drugs. The Kefauver-Harris Drug Amendments of 19624 was passed to ensure that manufacturers are required to prove to FDA the effectiveness of their products before the drugs are approved. These two laws may enable FDA to require manufacturers to submit comparative active-controlled, along with placebo-controlled, studies and the rest of the application. With the mass of drugs currently available on the market, it would be highly beneficial for health care providers and for patients to have studies that demonstrate the superiority of a new drug in order to make educated choices and to maximize pharmaceutical therapy. Active-comparator trials would also help administrators determine the value of a new medication in regard to formularies and a preferred drug list, and to help cut unnecessary cost within health care institutions.
Reference:
1. Approvable Letter for Zipsor. Drugs.com. www.drugs
.com/nda/zipsor_080722.html. Accessed September 9, 2009.
2. Zipsor [package insert]. Newport, KY: Xanodyne; 2009.
3. Stafford RS, Wagner TH, Lavori PW. New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling. Online N Engl J Med. 2009. http://content.nejm.org/cgi/content/full/361/13/1230.
4. Significant Dates in US Food and Drug Law History. US Food and Drug Administration. US Department of Health and Human Servies. www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm128305.htm. Accessed September 17, 2009.
