Researchers question Gottlieb ties, balk against NIH cuts

This is according to a new survey from the Science Advisory Board (SAB), seen by U.K. pharma news site PMLiVE, of 558 FDA researchers, pharma/biotech and clinical scientists. It found that almost two-thirds thought his ties to companies were a cause for concern.  Gottlieb sits on the board of several small biopharma companies, is an adviser to GlaxoSmithKline and formerly to Bristol-Myers Squibb, and has also received money from other biopharmas over the years.

He has, however, looked to address these concerns (other past commissioners have also had financial ties to biopharmas), and in a recent letter to the ethics head of the Department of Health and Human Services Gottlieb said he would recuse himself from any decisions on matters in which he has a financial interest.

President Donald Trump, who picked Gottlieb for the top FDA job (rejecting Barack Obama’s pick, Robert Califf) and is awaiting his confirmation, has already outlined plans to cut back on regulation at the FDA, which he has said is “slow and burdensome,” and wants to cut billions from the NIH budget over the coming years (and about $1.2 billion this year), as well as increasing FDA user fees to make up for a shortfall in funding.

When asked, more than half of respondents said the industry should not pay more in FDA fees, but it did reveal that more than a third of FDA scientists felt it should do so.

On the issue of potential axing of budgets across the NIH, a 77% majority said it “would diminish funding for small businesses and drug discovery.”

Just over half (56%) said the FDA’s current approval process was “fair,” with just 17% believing that there were unnecessary procedures that should be cut out. But conversely, 57% agreed with Trump’s “slow and burdensome” quote; however, three-quarters said that this could not be solved by resorting to approving new meds based on safety alone, something that has been touted in the past.

And the majority of those surveyed also agreed that the FDA should work on data transparency, which includes releasing information on both approved and rejected meds, and move more toward the slow but steady regulatory transparency drive from its European counterpart, the European Medicines Agency (EMA).

REFERENCE:  Fierce Biotech; 14 APR 2017; Ben Adams

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