On December 1, 2023, amendments to Federal Rule of Evidence (FRE) 702 geared toward emphasizing and explaining the responsibility of the judge as a “gatekeeper” for expert testimony took effect. On December 18, 2023, one of...more
On July 24, 2023, a new final rule from the Drug Enforcement Administration (DEA) became effective, with important consequences for companies and individuals registered to manufacture, distribute, or dispense controlled...more
On May 15 and 30, 2023, the Northern District of California conducted two “summary jury trials" in a pharmaceutical lawsuit brought by patients who claimed that taking the U.S. Food and Drug Administration (FDA)-approved...more
Here at Foley, we routinely represent companies, whether manufacturers, distributors, service providers, or others that are, by necessity, registered to do business in most or all of the fifty states. For years, the U.S....more
The recent trial in a case now settled highlights the potential expansion of public nuisance claims under California law, and in large-scale public nuisance actions more broadly.
On April 24, 2023, opening arguments...more
The Fourth Circuit Court of Appeals is now the latest in a growing number of courts holding that an objectively reasonable interpretation of governing law defeats the requisite element of intent or “scienter” under the False...more
For the first time since the enactment of the Medicaid Drug Rebate Program (MDRP), the Centers for Medicare and Medicaid Services (CMS) revised the National Medicaid Drug Rebate Agreement (NDRA) entered into between drug...more
On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more
3/6/2018
/ Anti-Kickback Statute ,
Attorney General ,
CGMP ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Misleading Statements ,
Off-Label Promotion ,
Opioid ,
Pharmaceutical Industry ,
REMS
Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more
9/21/2016
/ Abbreviated New Drug Application (ANDA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Classification ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Manufacturers ,
MDRP ,
Medicaid ,
Medicare ,
Prescription Drugs ,
Rebates
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more
7/6/2016
/ Antitrust Litigation ,
Biosimilars ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Injunctive Relief ,
Pharmaceutical Industry ,
PHRMA ,
Prescription Drugs ,
Price Transparency ,
Proposed Legislation ,
REMS ,
Research and Development ,
Senate Judiciary Committee