Your PharmaScope 2016

Sander Flaum
Sander Flaum

Had anyone told me last spring the New York Mets would be in the World Series come October, I would have laughed. But at playoff time, had they predicted that the Mets would make it to the Series and lose, I would have likely agreed.

So instead of predicting the future of the Mets in 2016, I'll take a stab at forecasting what's likely to happen if certain patterns continue in our industry.

See also: A Faster FDA Approval Rate Key to Price Debate

Let's start with the three troublesome trends.

Inversion. If corporate tax rates are not lowered soon, I'm afraid the flight of domestic pharma corporations to foreign tax havens will grow from a trickle to a stampede. Congress, despite having what one might think would be a pro-business philosophy, seems to care little about the economy.

Pricing. If we don't clean up our act and do something about predatory pricing scandals, we'll wind up with Washington bureaucrats telling us what we can charge for our products. At the same time, we also need to convince the public and the government that life-extending breakthroughs don't come free of cost. Developing cures for HCV and similarly complex diseases is an expensive and risky ordeal.

ODA Exploitation. If some in our industry continue to exploit the Orphan Drug Act by manipulating it as a ploy to get drugs approved for rare diseases while covertly planning to expand their use to treat common conditions, I foresee that we'll wind up with something like the Japanese
system, which taxes “excess” profits and penalizes success.

So much for bad news. Anything good?

Forge a True Partner. If we keep up the pressure on the FDA, I predict we'll continue seeing record-breaking approval rates for new drugs. In 2015, astonishingly 45 new drugs were approved—more than in any year since 1996!

Progress Looms. If the advances we're seeing in treatments for cancer using immunotherapy, genomics research and other breakthrough strategies continue, we'll be on the verge of ridding humankind of one of its oldest curses.

Leaders Must Step Up. If the emerging cadre of responsible and innovative pharma leaders manages to thrive despite the attacks on our industry, we'll be poised for a return to our halcyon days in the 1970s, '80s and '90s. Back then, leaders like Roy Vagelos at Merck, Bob Luciano at Lederle and Schering-Plough and Bill Steere at Pfizer helped transform our industry from a producer of “patent medicines” into a dynamo of pharmaceutical science.

One last prediction:

No Way, AMA. If the AMA succeeds in prohibiting DTC promotion of prescription drugs and thereby denying patients the right to know about new treatments for which they may be eligible, then . . .

Well, never mind. That ain't going to happen. I predict that we'll be seeing the romantic Cialis couple in their matching bathtubs for some time to come.

Speaking of which, I hope to see all of you, too, at some point in 2016. Be healthy and happy.


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