Who would be a better president for biotech? Hillary Clinton or Donald Trump? Is there even a difference? And what did the industry think of that controversial Duchenne muscular dystrophy drug approval? Did it mark a drop in FDA standards? We asked our audience and heard back — loud and clear.
Endpoints News pulled off its first snap poll at the end of last week, with publisher Arsalan Arif sending out a single query to a targeted segment from our 10,000 email subscribers. About 95% of our audience is directly engaged in the biopharma business, with a big focus on drug development. Our goal: get a sense of the industry’s thinking on presidential politics and that recent controversial FDA OK for the Duchenne drug eteplirsen.
The responses came in hard and fast, leaving little doubt how the majority is feeling on both issues. Altogether, Arif collected 494 responses from qualified biopharma industry professionals.
1. Who would be the better President for the biopharma industry? (Please, no personal feelings.)
First, on the election. Rather than simply ask who people are planning to vote for, we went for a somewhat different take. Who do you think will most likely be better for biotech? Donald Trump or Hillary Clinton? A slight, overall majority marked Clinton as the better of the two candidates for the industry. Trump came in at about half that number. And he beat out “no difference” by a mere 7 points, with 1 in 5 failing to see any kind advantage in one over the other.
Clinton may be winning the biotech vote, but with so many disaffected professionals unable to mark a preference, you can’t say that any kind of majority is over-the-moon about the idea of a Clinton presidency. Trump, though, is a distant second in the hearts of the biotech industry. Come the November election, Clinton takes the biotech vote — heavily clustered in Democratic strongholds like Boston and the Bay Area — in a cake walk.
2. Should the FDA have approved Exondys 51/eteplirsen?
|All||Clinton +||Trump +||No diff.|
|No||66% (324)||67% (173)||65% (87)||63% (64)|
|Yes||34% (170)||33% (86)||35% (47)||37% (37)|
There’s no doubting how to interpret these numbers. Two thirds of the people we polled felt that the FDA should not have approved Sarepta’s Exondys 51 (eteplirsen). This was a non-partisan favorite. There was virtually no difference on which way they leaned on the presidential showdown, either. Whether they thought Trump or Clinton was better for biotech, the majority clearly felt that the agency had made a mistake.
Sarepta helped foment one of the biggest patient advocacy campaigns ever mounted for an approval. But several top FDA officials made it clear that the company had never successfully made its case for this drug. FDA Commissioner Robert Califf also cited the company for playing fast and loose with some of the data the company used to make its case with patients and investors. But he bowed to the decision made by CDER director Janet Woodcock. And that, says the majority, was a mistake.
3. Did the approval of Exondys 51/eteplirsen mark a drop in the FDA’s standards?
|All||Wrong approval||Right approval|
|Yes||68% (337)||92% (299)||22% (38)|
|No||32% (157)||8% (25)||78% (132)|
Roughly the same number of industry pros who objected to the approval also concluded that the conditional approval for marketing marked a drop in the agency’s standards. It is noteworthy, though, that 22% of the industry professionals who felt it was the right decision also felt that it marked a drop in approval standards. A much smaller percentage of the “wrong” vote – 8% – did not feel that it reflected a drop in standards.
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