Raid!

When officials at Bristol-Myers Squibb and Sanofi Aventis announced last March they would pay an undisclosed sum to Apotex Inc. to hold off selling a generic version of their blockbuster blood thinner Plavix ($3.8 billion in sales a year), they told investors that there "significant risk that required antitrust clearance will not be obtained."

Investors got phase II of that message yesterday when FBI agents working for the antitrust division of the Justice Department raided the offices of BMS chief executive Peter Dolan looking for documents related to the transaction. The company's stock plunged.

When the Hatch-Waxman act was passed in 1984, industry got longer periods of exclusivity for new drugs to account for delays at the FDA in exchange for more rapid entry of generics into the market once those patents expired. What all too many generic manufacturers like Apotex learned is that it was just as lucrative to sell back those rights as to actually make and market the drug.

Congress needs to either prohibit such payoffs entirely, or rescind the additional exclusivity given big Pharma for delays at the FDA. Maybe somebody should attach it as a rider to the FDA appropriations bill moving through Congress.