News & Analysis as of

Food and Drug Administration (FDA) › Financial Conduct Authority (FCA)

King & Spalding

Free Speech & Pharmaceutical Promotion — U.S. ex rel. Solis v. Millennium Pharmaceuticals, Inc.

King & Spalding on

Off-label prescription drug use — using drugs to treat ailments not indicated on FDA-approved labeling — is among the thorniest legal issues facing the pharmaceutical sector. On one hand, off-label prescriptions are lawful...more

Patterson Belknap Webb & Tyler LLP

FDA Promises Guidance on Lawful Off-Label Promotion

Patterson Belknap Webb & Tyler LLP on

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

Saul Ewing LLP

Court enforces False Claims Act’s first-to-file rule to bar complaint alleging details of off-label promotion scheme about which...

Saul Ewing LLP on

In Brief - When an alleged scheme to market drugs for unapproved “off-label” uses had already been identified by an earlier complaint, a later complaint providing additional details, but alleging the same “essential...more

Obermayer Rebmann Maxwell & Hippel LLP

News from the Health Law Gurus™

Obermayer Rebmann Maxwell & Hippel LLP on

Passwords Affected from Heartbleed – HealthCare.gov, the website for the federally-facilitated health insurance exchanges under the Affordable Care Act, reset user passwords in the aftermath of Heartbleed, a security flaw in...more

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