Dear Readers,

This issue looks at four health issues recently argued by the FTC. First, we deal with the FDA’s REMS (risk evaluation and mitigation strategies) program and how it seems to conflict with the FTC’s desire to encourage generic competition. The FTC is examining branded pharmaceutical firms’ refusal to sell samples of restricted distribution products to firms seeking approval to market generic versions. The contributing authors ask some relevant questions such as — under which circumstances a monopolist’s refusal to deal with a rival constitutes exclusionary conduct that violates Section 2 of the Sherman Act? whether there is merit in using antitrust laws to force brand-name drug companies to share samples of their products with generic rivals to further competition and reduce the cost of prescription drugs, or is congressional action a better route?

We also look at the implications of the Actavis decision (that held reverse-payment settlements are subject to antitrust analysis) – whether the Actavis ruling applies to non-cash considerations as well? What constitutes reverse payments? We then look at the FTC’s victory in the St. Luke’s Physician merger decision and the FTC’s action in North Carolina Dental (dealing with state action doctrine) — a case picked up by SCOTUS. We haven’t heard the last of any of these, so understanding them before they reach volatility is vital.

As always, thank you to our great panel of authors.

Sincerely,

CPI Team