I have a letter from Donna Shalala, the Secretary of HHS, and I quote from the letter that has been distributed throughout the Senate this afternoon. Secretary Shalala says: It will be nearly impossible to meet the substantial investment requirement under the Hatch substitute. She concludes saying: It would be virtually impossible for a manufacturer to obtain FDA approval for a generic drug product during this transition period.
William Pryor: “I have a letter from Donna Shalala, the Secretary of HHS, and I quote from the letter that has been distributed…”
Editor's note · Context
Discussing concerns about the Hatch substitute related to FDA approval for generic drugs.
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