It seems to me that one of the primary motivations for pharma to pursue additional indications is to expand the duration of patent protection for their pharmaceutical products. In the normal course of events, this more than makes up for the cost of the clinical trials needed to support the expanded indication, especially as the pricing is market driven rather than regulated. Of course, if they can market the agent without such additional costs, they will do so, and this is where the free speech doctrine becomes problematic – giving industry incentive to pursue short term gains without the protection of the public that accrues from continued investigation of efficacy. I suspect that if this decision is upheld sometimes companies will pursue additional indications as well, but only when the likelihood of success and the financial advantage to them are both overwhelming. In other instances, they will not (and one cannot exclude the attraction of a short term increase in the stock price to a chief executive with decision-making power who has options and is ready to exit the company). Not a pretty picture at all.

But, getting back to the original post, I want to point out the broader problem with the Second Circuit opinion and with the Supreme Court precedents on which it builds. Much government regulation – much useful government regulation – involves arguable violations of corporate “free speech rights.”

The securities acts largely act through restricting what, when, and how companies can talk about their stock, as well as forcing them to say some things (in ways we don’t allow newspapers or individuals to be forced to say things).

Labor law carefully restricts what employers and unions can say and when.

The APRs that banks and other lenders quote are arguably violations of the companies’ free speech rights.

So are the required mileage figures for cars – the government fores those poor, downtrodden auto companies not only to tell customers the gas mileage, but to do it as calculated in a way specified by that very tyrannical government. The horror!

The commercial free speech doctrine is going metastatic, aided and abetted, with malice (toward regulation) aforethought, by conservative legal defense funds, and the reuslt, unless the Court changes course, could be morbidity and mortality, not just for people taking drugs promoted for off label uses, but for government regulation broadly.