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Volume 361:1917-1919 November 12, 2009 Number 20 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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Twenty-five years ago, Congress enacted the Waxman–Hatch Act to facilitate the approval by the Food and Drug Administration (FDA) of low-cost generic drugs that are bioequivalent to approved brand-name drugs. This law has been largely successful, in that generic drugs now account for more than 70% of prescriptions dispensed in the United States (and for 20% of dollars spent on medications). In most cases, a generic version becomes available immediately after the patent protection for a brand-name drug ends. This year, Congress is considering legislation to translate this approach to biologic drug products — larger, more complex molecules that are . . . [Full Text of this Article]

Source Information

From the Engelberg Foundation, Palm Beach, FL (A.B.E.); and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston (A.S.K., J.A.).

This article (10.1056/NEJMp0908496) was published on October 14, 2009, at NEJM.org.

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