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“We Want the Gold” Standard of FDA Approval, Says PhRMA CEO Ubl

“We Want the Gold” Standard of FDA Approval, Says PhRMA CEO Ubl | Pharma Industry Regulation |

The CEO of the Pharmaceutical Research and Manufacturers of America on Tuesday came out strongly in favor of a rigorous Food and Drug Administration. His remarks come as the Trump administration weighs potential candidates to lead the agency who have suggested they would radically change how it vets new drugs.


Asked by STAT about the notion that the FDA should no longer evaluate drugs for effectiveness, the industry trade group’s Stephen Ubl was unambiguous: “We believe that the FDA review process is the gold standard and should remain so.”


Ubl’s comments about the FDA came during a press conference with journalists after he delivered brief remarks to a small crowd gathered here for a morning of panel discussions with scientists and drug industry executives. Below, some highlights from the press conference:


On the travel ban, which is now being revised after initially banning travelers from seven predominantly Muslim countries: Ubl said PhRMA does not take a position on Trump’s executive order. [PhRMA does not “Go Boldly” there! Read “The Silence of the #Pharma Lambs on Trump's Immigration Policy”;]


On the push for “right-to-try” legislation: Ubl sounded much less enthusiastic than Vice President Mike Pence on the issue. “All companies have compassionate use programs. The FDA has a compassionate use program,” Ubl said. [Read “VP Pence is ‘Peddling False Hopes’ to Dying Patients, Says Ed Silverman”; Is "Right to Try" a good idea? Take my survey here: ]


On PhRMA’s pledge to review its membership criteria after the latest controversial drug price hike, this time from PhRMA member Marathon Pharmaceuticals: Ubl wouldn’t say what kind of companies might get the boot from PhRMA once the membership criteria are revised. But he said the revision process “should take weeks not months.” He also confirmed that while Marathon is still a PhRMA member, it’s possible that after the review it might not be [Read “PhRMA Embarrassed by Marathon is Forced to ‘Review’ Membership Criteria – Is a Purge in the Cards?”;]


On Martin Shkreli: Ubl blamed the industry’s bad press on several “so-called bad actors” [read “PhRMA's Dark Inspirational Video Starts a 6-Month Offensive: ‘Less Hoodies, More White Coats’”;] and Ubl called for for tax and manufacturing incentives to encourage companies to develop generic drugs.

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