What Does Pharma Think Of The FDA? Not Much
8 CommentsBy Ed Silverman // November 30th, 2010 // 12:12 pm
There’s nothing like a survey of pharma executives to uncover some plain speaking. And so the Pricewaterhouse Coopers life sciences team contacted 50 leading lights - either the ceo, coo, a vp or director of regulatory affairs and quality - from 50 different companies and asked them what they thought about the FDA and how the agency is performing. The upshot? Things do not look so good.
To wit, 30 percent saw no improvement in the FDA approval process in the past two years; 40 percent believe the FDA denied a drug due to inadequate resources; only 53 percent believe the FDA encourages pre-submission and end-of-phase meetings, down from 69 percent four years ago; 38 percent say their working relationship with the FDA has improved, down from 70 percent in 2006; only 32 percent say the FDA is doing a better job of providing feedback and only 12 percent say FDA turnaround time is improving.
As for user fees, just 24 percent think the FDA deploys user fees as intended and only 32 percent believe user fees accelerate product review times. Meanwhile, just 28 percent say the purpose and use of users fees are transparent and 30 percent think the fees are excessive, given FDA resources expended on product reviews. Interestingly, only 22 percent believe user fees create a conflict of interest (see the report here).
On the other hand, 78 percent say FDA guidance documents on the product development process have increased their understanding of agency expectations, 68 percent think they have done a better job of incorporating FDA feedback into their development plans, and 63 percent say the FDA changed its position on at least one review.
Only 14 percent the FDA should have authority to approve a product based on economic or clinical value, although 88 percent agree that personalized medicine will change the industry business model, and 8 percent say the FDA is sufficiently advancing personalized medicine. Meanwhile, 56 percent think the FDA lacks the ability to implement its own Critical Path initiative.
PWC also queried 1,000 adults to gauge public perceptions and found just 40 percent say the industry is doing enough to address concerns about detecting, assessing and preventing adverse events, while 46 percent say the same thing about the FDA. Not surprisingly, 58 percent believe politics has too much influence on the approval process.
Finally, 93 percent are confident about the safety and effectiveness of drugs and devices approved, and two-thirds agree the US has the highest standards in the world for drug safety and effectiveness. Yet, 56 percent would be willing to use drugs and devices approved outside the US, before they are approved by the FDA.
Richard Meyer
Great information Ed thanks for posting. It’s funny but I would have thought the negative numbers for the FDA would have bee higher. It has been my experience that everyone from medical to regulatory and marketing thinks the the FDA is behind the times and doesn’t get it. In addition more and more people are starting to worry that the FDA is making decisions based on “politics” not patients interests.
M Helm, MD
Too bad we don’t also have survey results of FDA staffers’ opinions of PhRMA.
The last paragraph is surprising to me. I guess folks rapidly forget about the big safety and effectiveness failures reported on the news. Admittedly, I pay a great deal more attention to these matters and how FDA stacks up to other agencies that most folks.
Betsy
I thought it was rather strange to ask pharma personnel what they thought of the FDA when their own employees often staff FDA’s approval processes.
industry insider
You don’t need FDA to encourage end of Phase meetings. Ask for one and they are required to meet with you.
David Avitabile
Interesting to see senior executives from pharma criticizing the FDA in a presumably anonymous survey. You’d think that by almost the total lack of criticism of our regulatory process by the life sciences industry in the media that industry was happy with the FDA.
Meanwhile, companies are foregoing US approval and marketing their drugs elsewhere first. This is not good news for patients in the United States, and it is certainly not a positive reflection on the FDA if the process becomes so risk-averse that companies don’t bother seeking approval in the US market. Investment in US-based life sciences companies is declining, and the number of clinical trials being conducted in the US is also declining. Again, bad news for US patients, bad news for the life sciences industry in the United States, and bad news for the FDA.
There will never be such a thing as a 100% safe drug, no matter how bureaucratic our bureaucracy becomes. Apparently, our regulatory authorities have overlooked this fact.
I think it would be a very interesting exercise for a credible source to try and estimate how many patients in the United States (cancer patients, for example), have died waiting for drugs to be approved that might have extended their lives. I’ve never seen that kind of data. Perhaps our friends over at Public Citizen would be willing to give that a shot.
I guess the old adage is true however. If you don’t criticize, you have no right to complain.
Reality
What does the FDA think about pharma? Pure evil!!
Steven Grossman
50 carefully selected company executives tells very little about industry’s views of FDA. I don’t have the story, but I am sure there is more to tell, both good and bad if a broader sample had been questioned.
Salient point
The 1000-adult survey depicts the public’s ambivalence about safety: almost everyone feels well protected by FDA; but the majority are comfortable stepping outside FDA’s protective cloak if necessary. Until something goes wrong, I suppose.