Thursday, January 27, 2011

Measure To End Abusive "Pay For Delay" Deals Resurfaces In Senate

Back in January through March of 2010, as the healthcare reform measure was wending its way through Congress, Mr. Obama (sagely) made a decision to side-car the reform of abusive pharma "pay for delay" deals. That bought the support of pharma for closing the donut hole, and brought them to the table as advocates, rather than opponents. In short, the President wisely chose to "keep the powder dry, for another day". It seems that day is now approaching.

Back then, I suggested, then repeated predicted that this initiative would be reintroduced in 2011 -- once the heavy lifting of what became known as the Affordable Care Act was complete -- i.e., became law. Well.

It is Janauary 2011, and Senators Kohl and Grassley have reintroduced the reform of pharma's "pay for delay" provisions, as a new bill (a PDF format file). The law would require pharma CEOs to certify to the FTC, and the DoJ that the deals -- as written, are exactly the deals, as executed, and enforced -- thus avoiding the current "wink and nod" routines between generic- and branded-manufacturers:

. . . .The purposes of this Act are — (1) to enhance competition in the pharma1ceutical market by stopping anticompetitive agreements between brand name and generic drug manufacturers that limit, delay, or otherwise prevent competition from generic drugs; and (2) to support the purpose and intent of antitrust law by prohibiting anticompetitive practices in the pharmaceutical industry that harm consumers. . . .

The Chief Executive Officer or the company official responsible for negotiating any agreement required to be filed under subsection (a), (b), or (c) shall execute and file with the Assistant Attorney General and the Commission a certification as follows: ‘I declare that the following is true, correct, and complete to the best of my knowledge: The materials filed with the Federal Trade Commission and the Department of Justice under section 1112 of subtitle B of title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, with respect to the agreement referenced in this certification: (1) represent the complete, final, and exclusive agreement between the parties; (2) include any ancillary agreements that are contingent upon, provide a contingent condition for, or are otherwise related to, the referenced agreement; and (3) include written descriptions of any oral agreements, representations, commitments, or promises between the parties that are responsive to subsection (a) or (b) of such section 1112 and have not been reduced to writing.". . . .

A very good step -- one very much in the right direction, as sunshine is often the best antiseptic. We will keep you informed. A sincere H/T the gentleman Ed Silverman, at Pharmalot. [Click image, above right, for a story on how the proposed CEO certification provisions might change things -- as obviously, failing to fully disclose the whole arrangement to DoJ/FTC would have both criminal (and civil) consequences -- for the involved CEOs.]

1 comment:

Anonymous said...

We can only hope that the recent changes in Congress do not sink this bill.