Me-Too Drugs


Xconomy San Diego — 

[Editor’s Note: We asked selected Xconomists a series of questions designed to zero in on the big issues of the year, including “What would you be willing to throw a punch over?”]

The FDA is the easy target for those of us who are in drug development. But what I am most mad about is the unwillingness of our industry to focus and invest in innovative, high-impact drugs instead of “me too” knockoffs. Thus, my “anger” is focused on institutions that myopically insist on investing in low-risk, copycat ideas that undermine the true strength of our industry over the long term.

Risk-taking and innovation in drug discovery are critical to our field. Aspiring merely to be fast followers instead of striving for innovation is putting our competitive advantage at risk. The entrepreneurial spirit has been key to America’s success in many industries, especially biotech, but there have been several recent events that are stifling innovation.

The downturn in the economy has obviously dampened the financing of new ideas. Changes to patent law arguably encourage long, drawn-out opposition hearings that could be detrimental to the smaller inventor. However, my key concern for our industry is the lack of new and innovative drugs, despite the stunning pace of scientific progress over the last several decades. Not enough companies are focused on innovation and not enough people in charge are taking the right level of risk to actually come up with a new idea that can have a substantial impact on human health. Innovation is the alpha and the omega of our industry and should always be cherished as a way to create valuable and meaningful high-impact drugs.

Kleanthis G. Xanthopoulos, Ph.D. is the former president and CEO of Regulus Therapeutics, a company developing drugs based on microRNA technology. Follow @

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2 responses to “Me-Too Drugs”

  1. I disagree. The real negative to drug innovation is the Hatch-Waxman legislation of 1984 which permits rapid approval of generic drugs. R&D-oriented pharmaceuticals companies should never have agreed to its passage. To rectify this situation, I maintain that future new pharmaceuticals, including biotechnology drugs, should be granted ‘perma-patents”, similar to copyright laws, whereby companies would retain patents indefinitely in return for gradually lowering their introductory prices, say after seven years, which is the current administration’s idea of how long exclusivity for a new drug should last. Only in this manner will we see a return to companies reinvesting sizeable sums in R&D, as well as venture capital firms returning to fund biotech start-ups in a more comprehensive manner. It is ludicrous that generic drug companies, which do minimal innovative R&D, sell today at higher P/E ratios than innovative drug and biotech companies, which are dedicated to bringing out new medications that further health care.