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Tiffanie McDowell

Partner | She/Her/Hers

Overview

Tiffanie McDowell is a partner in Crowell & Moring's Orange County office, where she practices in the firm's Antitrust and Competition Group and Health Care groups. Her practice focuses primarily on complex antitrust litigation, pharmaceutical advertising, pricing and access issues, and health care recovery.

Tiffanie represents health care and life sciences clients in actions involving patent settlement agreements, product line extensions and alleged product hopping, regulatory approvals and gaming, pharmaceutical pricing and advertising, and market allocation and licensing agreements. She has defended health plans in government investigations, actions involving the 340B program, and actions involving drug access and pricing issues. Tiffanie regularly counsels clients on issues related to rebate agreements and formulary access, PBM agreements and the drug supply chain, drug pricing (including under Medicare, Medicaid, and 340B) and access issues, pharmaceutical advertising, and drug overcharge and reimbursement issues.

From 2017 to 2018, Tiffanie served as a judicial law clerk to the Honorable John F. Walter of the United States District Court for the Central District of California. Before joining Judge Walter’s chambers, Tiffanie was a floating law clerk to the Honorable Dale S. Fischer in the Central District.

Career & Education

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    • University of Missouri, B.S., cum laude, political science, 2006
    • University of Missouri, B.A., cum laude, international studies, 2006
    • University of Missouri, B.B.A., cum laude, international business, 2006
    • University of San Diego School of Law, J.D., Academic Scholarship, cum laude, 2012
    • University of San Diego School of Law, LL.M., Dean's Academic Scholarship, cum laude, taxation, 2014
    • University of Missouri, B.S., cum laude, political science, 2006
    • University of Missouri, B.A., cum laude, international studies, 2006
    • University of Missouri, B.B.A., cum laude, international business, 2006
    • University of San Diego School of Law, J.D., Academic Scholarship, cum laude, 2012
    • University of San Diego School of Law, LL.M., Dean's Academic Scholarship, cum laude, taxation, 2014
    • California
    • California

Tiffanie's Insights

Client Alert | 3 min read | 11.16.23

Throwing the (Orange) Book at Pharmaceutical Manufacturers: FTC Challenges Over 100 Drug Product Patents Listed in FDA Publication

On November 7, 2023, the Federal Trade Commission (“FTC”) announced it is challenging over 100 patents as improperly listed in the Food and Drug Administration’s (“FDA”) publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is commonly known as the Orange Book. The FTC sent warning letters to ten drug and medical device manufacturers identifying patents for inhalers, autoinjectors and anti-inflammatory multi-dose bottles that the FTC believes are improperly listed. In the letters, the FTC indicated it is using the FDA’s regulatory dispute process to challenge the listing of these patents in the Orange Book because improperly listing patents may violate antitrust laws and impede competition. The FTC’s actions appear to be consistent with its recent and increased scrutiny of the healthcare and pharmaceutical industries....

Tiffanie's Insights

Client Alert | 3 min read | 11.16.23

Throwing the (Orange) Book at Pharmaceutical Manufacturers: FTC Challenges Over 100 Drug Product Patents Listed in FDA Publication

On November 7, 2023, the Federal Trade Commission (“FTC”) announced it is challenging over 100 patents as improperly listed in the Food and Drug Administration’s (“FDA”) publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is commonly known as the Orange Book. The FTC sent warning letters to ten drug and medical device manufacturers identifying patents for inhalers, autoinjectors and anti-inflammatory multi-dose bottles that the FTC believes are improperly listed. In the letters, the FTC indicated it is using the FDA’s regulatory dispute process to challenge the listing of these patents in the Orange Book because improperly listing patents may violate antitrust laws and impede competition. The FTC’s actions appear to be consistent with its recent and increased scrutiny of the healthcare and pharmaceutical industries....