News & Analysis as of

The FDA’s Latest One-Two Punch to Combat Drug Shortages

On October 31, 2013, the U.S. Food and Drug Administration (“FDA”) unveiled its latest steps for preventing and resolving prescription drug shortages. First, the agency announced a proposed rule requiring manufacturers of...more

Major Changes in Drug Compounding and Drug Distribution Requirements (Part 1 of 2)

On September 28, 2013, the U.S. House of Representatives passed the Drug Quality and Security Act (H.R. 3204). The bill is compromise legislation crafted by the Senate Health, Education, Labor, and Pension ("HELP") and House...more

Compounding Legislation Goes Through Another Change: New House Bill on Federal Oversight

U.S. Rep Griffith Releases Revised Draft Bill Providing Federal Oversight over Compounding Pharmacies - On July 11, 2013, U.S. Representative Morgan Griffith (R-Va.) released a revised draft House Bill ("Griffith...more

A Short-Lived Victory for Generic Drug Manufacturers?

On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where...more

FDA Issues Guidance Detailing Specific Requirements for Quality Agreements for Commercial Drug Manufacturing

On May 28, 2013, the U.S. Food and Drug Administration (FDA) published a draft guidance ("the Guidance") detailing the FDA's current thinking on contract manufacturing arrangements for drugs. Specifically, the Guidance...more

Business Litigation Report -- April 2013

In This Issue: - Firm News: DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards - Main...more

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

United States v. Caronia: Second Circuit Rules Manufacturers Cannot Be Criminally Prosecuted for Off-Label Promotion of Drugs...

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical manufacturers and their...more

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