Margaret Ann Hamburg currently serves as Commissioner of the U.S. Food and Drug Administration. She has served as Vice President for Biological Programs, Nuclear Threat Initiative, and Assistant Secretary for Planning and Evaluation of U.S. Department of Health and Human Services, and as Commissioner of the New York City Department of Health and Mental Hygiene. She was nominated in March 2009 by President Barack Obama to become the Commissioner of the FDA. Hamburg says that she will visit India to talk with generic-drug makers. A generic drug is a copy that is the same as a brand-name drug in dosage, safety, and strength, how it is taken, quality, performance, and intended use. Bloomberg News reports that the Commissioner plans to ask the drug firms and Indian regulators to “build new partnerships” during her visit beginning February 10.
Generic drugs are less expensive because generic manufacturers don’t have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment–including research, development, marketing, and promotion–by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, other manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don’t have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs; one reason for the relatively low price of generic medicines is that the competition increases among producers when drugs no longer are protected by patents.
Wockhardt Ltd. and Ranbaxy Laboratories Ltd. two Generic-drug makers have been banned from selling medicines in the U.S. from Indian plants because of quality concerns. In addition Bloomberg News reports that around 9 percent of spice imports from India were also found to be contaminated with salmonella. India exports the most spices to the U.S. of any country.
Generic drugs are safe, effective and FDA-approved. According to Gary Buehler, M.D., director of the FDA’s Office of Generic Drugs, “People can use them with total confidence.”
In the U.S., the Patient Protection and Affordable Care Act, which President Obama signed on March 23, 2010, authorized the Food and Drug Administration to approve generic versions of biologic drugs and grant biologics manufacturers 12 years of exclusive use before generics can be developed. These bio similar products are usually protected by surrounding patents which may also delay the time for their production.
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