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Paul Rubin

is a corporate partner based in the Washington, D.C. office and a member of Debevoise and Plimpton’s Healthcare Group. He is noted as a recognized practitioner for Regulatory Healthcare by Chambers USA (2018) and is an LMG Life Sciences: “Life Sciences Star” (2013–2018). Mr. Rubin represents FDA-regulated drug, device and consumer product companies on a wide range of issues, ranging from strategic regulatory counseling to complex compliance and enforcement matters. He also routinely conducts regulatory due diligence for private equity funds and strategic acquirers in corporate transactions. In addition to his FDA practice, Mr. Rubin also has substantial experience helping clients navigate complex advertising and promotion-related issues, including FTC investigations, negotiating FTC settlements/consent decrees, disputes before the National Advertising Division of the Better Business Bureau (NAD) of BBB National Programs and advertising lawsuits under Section 43(a) of the Lanham Act.

For more information or to contact Mr. Rubin, please visit his Firm Profile Page.

Recent Articles by Paul Rubin

Infringing Influencers? Federal Judge Says Sponsored Blogger Can Face Trademark Infringement Liability

When an influencer is paid to promote a brand – and the brand’s name is trademark-infringing – can the influencer be on the hook for the infringement? A federal district court just said yes. The result could widely expand trademark litigation against influencers – and could reshape how companies and their influencers relate to one another contractually.

Rule Requiring Prescription Drug Price Disclosures in TV Ads Will Create Complex Lanham Act Enforcement Issues and First Amendment Implications

A Final Rule issued by the Centers for Medicare and Medicaid Services (CMS) on May 8 (the “Final Rule”) that requires direct-to-consumer (DTC) television advertisements for a prescription drug or biologic covered by the Medicare or Medicaid programs to disclose the product’s “list price,” will become effective on July 9, 2019. The Final Rule mandates price disclosures for any covered drug that is $35 or more for a one-month supply or the usual course of therapy, and includes a unique enforcement mechanism whereby CMS would rely for enforcement on private lawsuits filed pursuant to Section 43(a) of the Lanham Act. In a conference call with reporters, Department of Health and Human Services (HHS) Secretary Alex M. Azar II analogized the new requirement to mandatory price disclosures required for the automobile industry—despite the fact that cars are not reimbursed by the government, subject to co-pays, prescribed by third parties who function as gatekeepers, or subject to complex arrangements with prescription benefit managers (PBMs) and other healthcare providers. The strained analogy to automobile price disclosures reflects the legal complexities implicated by this requirement and the absence of relevant precedent.