Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.

Lawyers say agency will have to bolster its administrative record as judges tackle complex policy and scientific issues previously left to FDA. Some cases, such as challenges to exclusivity decisions, may be reopened.

Lawyers say agency will have to bolster its administrative record as judges tackle complex policy and scientific issues previously left to FDA. Some cases, such as challenges to exclusivity decisions, may be reopened.

Commission issues compulsory orders for information to two organizations that negotiate drug rebates on behalf of CVS Caremark, Express Scripts and other PBMs. It issued similar orders to the six largest PBMs last year.

In unanimous decision, court finds Amgen patent offered persons skilled in the art “little more than advice to engage in ‘trial and error.’” Lawyers say the ruling prevents function claims from monopolizing a therapeutic target and retains status quo on enablement requirement.

Complaint marks first time agency has raised novel theories of competitive harm in pharma merger and is rare instance in which it has filed a complaint without a consent decree. Last time FTC has gone to court to block a pharma merger was in 2008.