Senate generic bill more rigorous than FDA regs
In addition to the Senate bill, the U.S. Food and Drug Administration (FDA) announced regulations in mid-June that would streamline the process for making generic drugs available to consumers. The FDA regulations are similar to the Senate bill in some ways, although the Senate bill proponents claim their legislation is more rigorous in closing the loopholes in the Hatch-Waxman Act.
Like the Senate bill, the FDA regulations would limit a drug company to only one 30-month delay of a generic drug’s entry into the market while a patent challenge is being resolved.
The regulations also clarify the types of patents innovators must submit for listing in the "Orange Book," the FDA’s official register of approved pharmaceutical products. The changes are consistent with concerns raised last year by a Federal Trade Commission report on generic drugs.
The FDA also has begun internal reforms to improve the efficiency of its review process for generic drugs, such as implementing a new system of early communications with generic drug manufacturers that submit applications. In addition, the FDA will provide additional guidance for generic manufacturers preparing and submitting applications. The new resources and other reforms are expected to reduce the total time to approval for most new generic drugs by three months or more over the next three to five years.
The FDA also plans to expand its consumer educational programs and partnerships involving generic drugs, as well as to undertake more scientific studies of generic drug bioequivalence.
The FDA estimates the changes in the regulations will save consumers $35 billion over 10 years.