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Venture capitalist advises startup owners to give the FDA some respect

on May 14, 2012 Source:

Healthcare venture capitalists are no fans of the U.S. Food and Drug Administration and the regulatory challenges the agency poses for medical startups and device companies.

They blame many of the problems besetting healthcare investing squarely on the agency, as delays caused by reviewers push investor payday further out.

But at the recent MedTech Investing Conference in Minneapolis, moderator Bill Harrington, managing partner at Osage University Partners, half-jokingly cautioned that there will be no whining on the matter.

And at least one panelist on a session discussing where medical tech VCs are investing took him seriously.

After a short complaint about the FDA coming from another panelist — John Ryan of Onset Ventures — Juliet Bakker, founder and managing director of Longitude Capital, said that her advice to portfolio companies is to always be respectful of the FDA.

“After all, they are here to protect us,” she said.

Bakker added that on many occasions companies and regulatory consultants don’t “bother to answer the questions that the FDA has asked” or give the answers that they want to give. That, she said, creates delays. And delays are anathema to the venture capital and startup community eager to see a return on investment.

“The better part of valor is to respect the FDA,” Bakker said.

“Great advice,” said Harrington, before moving to the next question.

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