PHILIP MORRIS USA v. FDA: DECLARATION OF DAVID L. ASHLEY [REDACTED] Dec. 8, 2015

December 13, 2015 9:44 pm by Gene Borio

The PDF is Here

EXCERPT:

1. I am the Director of the Office of Science in the United States Food and Drug Administration’s Center for Tobacco Products in Silver Spring, Maryland. . . . As Director of the Office of Science, I am familiar with FDA’s review and authorization of substantial equivalence (SE) reports . . .

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5. [REDACTED-gb] as FDA explained in its Guidance, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 2), the agency does not intend to enforce the premarket review requirements for products where (1) the new tobacco product is distinct from, but has the same characteristics as, a product that is subject to a provisional SE Report for which FDA has not yet issued an order; (2) the manufacturer submitted a Same Characteristics SEReport; and (3) the manufacturer waits 90 days from FDA’s receipt of the Report to commercially distribute the new tobacco product or, where the new tobacco product is already on the market as of September 8, 2015, the manufacturer submitted a Same Characteristics SE Report by October 8, 2015.

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END EXCERPT

FULL TEXT:

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

PHILIP MORRIS USA INC., et al.,
Plaintiffs,

V.

UNITED STATES FOOD AND DRUG ADMINISTRATION, et.al.,
Defendants.

Case No. 1:15-cv-01590

DECLARATION OF DAVID L. ASHLEY

I, David L. Ashley, Ph.D., hereby declare as follows:

1. I am the Director of the Office of Science in the United States Food and Drug Administration’s Center for Tobacco Products in Silver Spring, Maryland. I assumed this position on June 4, 2010. As Director of the Office of Science, I am familiar with FDA’s review and authorization of substantial equivalence (SE) reports, including the performance measures and timeline of review of submitted reports.

2. FDA bas established a set of performance measures for reviewing Same Characteristics SE Reports. FDA created this separate set of performance measures for Same Characteristics SE Reports as these Reports are placed in a separate queue from regular SE Reports,and FDA hopes to be able to review them expeditiously. For example, for fiscal year 2016, FDA aims to review and act on 7Q% of Same Characteristics SE Reports within 90 days of receipt. FDA anticipates that the time required for review will continue to decrease as both applicants and FDA gain experience with Same Characteristics SE Reports. This projection is reflected in the performance measures for fiscal years 2017 and 2018, which aim for 75% and 800/o of Same Characteristics SE Reports to be reviewed within 90 days of submission.A copy of these performance measures has been posted on FDA’s website at www.fdagovffobaccoProduct… accoProductReviewEvaluation/ SubstantialEq uivalence/ucm475489.htm.

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5. [REDACTED-gb] as FDA explained in its Guidance, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 2), the agency does not intend to enforce the premarket review requirements for products where (1) the new tobacco product is distinct from, but has the same characteristics as, a product that is subject to a provisional SE Report for which FDA has not yet issued an order; (2) the manufacturer submitted a Same Characteristics SEReport; and (3) the manufacturer waits 90 days from FDA’s receipt of the Report to commercially distribute the new tobacco product or, where the new tobacco product is already on the market as of September 8, 2015, the manufacturer submitted a Same Characteristics SE Report by October 8, 2015.

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Pursuant to 28 U.S.C. § 1746, I decJare under penalty of perjury that the foregoing is true and correct.

Executed on this 8th day of December,2015.

David I. Ashley, Ph.D.

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