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The Generic Pharmaceutical Association Commends FDA For Clarifying Medicare Modernization Act Provisions On Generic Drugs

Published: Nov 03, 2004

ARLINGTON, Va., Nov. 3 /PRNewswire/ -- The Generic Pharmaceutical Association (GPhA) today commended the U.S. Food and Drug Administration (FDA) for publishing its guidance document that clarifies certain aspects of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), calling the document generally consistent with the overall goals of the Act.

"GPhA is pleased that the guidance document overall is consistent with the process outlined by the MMA," said GPhA President and CEO Kathleen Jaeger. "By more clearly defining effective dates, the 30-month stay provisions and the 180-day exclusivity scenarios, the guidance document will make it easier for generic drug manufacturers to better understand some of the most prominent changes under the MMA.

"We will continue, however, to carefully review the impact that this draft guidance document may have on our member companies in the context of the opportunity to submit comments," said Jaeger.

The FDA guidance document, "Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," clarifies and explains the following:

   * Changes regarding referencing a listed drug in an application;
   * The availability and termination of 30-month stays;
   * The notice requirements for paragraph IV patent certifications;
   * The applicability of the 180-day exclusivity period; and
   * The effective dates that apply to the MMA's generic drug provisions.

The document is available online at http://www.fda.gov/cder/guidance/6174dft.pdf.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 51% of the total prescriptions dispensed in the United States, but less than 8% of all dollars spent on prescription drugs. The Generic Pharmaceutical Association is committed to improving lives for less. For further information, please contact GPhA at 703-647-2480, or visit our web site at http://www.gphaonline.org/.

The Generic Pharmaceutical Association

CONTACT: Andrea Hofelich of The Generic Pharmaceutical Association,+1-703-647-2495

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