Legal & Regulatory

HDA Research Foundation highlights constraints and additional costs of reimportation

News follows court ruling against advertising retail drug prices

CDER activity is one of the few exceptions

Cross-contamination and missing documentation are cited in warning letters

Meanwhile, federal enforcement actions over improper patient assistance continue to arise

Investigative journalist Katherine Eban returns with an indictment of generic drug quality

Association will promote its members' value to the public via digital advertising and publishing

Rochester Drug Cooperative’s former CEO, Laurence Doud, is arrested

Counterfeit Xanax (alprazolam), plus meth and other controlled substances, were sold on the dark web

A final rule is still in the works at HHS, but some manufacturers are testing the inclusion of prices in TV ads

The Big Three, plus Rochester Drug, face civil penalties over opioid distribution

The Pharmaceutical Distribution Security Alliance proposes an industry governance process

Trace Histories employs blockchain technology

Combination of a pioneering traceability provider and a leading consulting firm

Rupture happens at a crucial time in Washington for the pharma industry

Presidential campaigns only magnify an already intense debate

Regulation enables better coordination of where opioids are going

Agency tries to get a handle on cross-border trade

Issues include apparently diverted opioids and mislabeled medications

Will restricting use of rebates in federal programs carry over to commercial insurance?

Senate and House committees begin the legislative process for addressing drug pricing

Nov. 27, 2018, was to be a red-letter day in the 10-year program to implement an end-to-end pharma traceability system. Did industry meet the deadline?

Programs provide copay and other financial assistance

$360-million settlement involved assistance funneled through a charity

HFAP builds out from its hospital-accreditation business

More-complete information is desirable on some applications

New survey finds weaknesses in patient privacy, funding oversight

Nov. 28 marks the first day when the US industry meets the DSCSA serialization mandate