The relationship between the U.S. Food and Drug Administration and pharmaceutical, biotech and medical device makers is becoming increasingly strained as a more rapid development cycle meets more robust regulation, according to a new report.
A new PricewaterhouseCoopers report indicates that while communication between the life sciences industry and its chief regulator has improved in recent years, expectations on both sides has complicated the process.
The good:
- 38 percent of companies said their working relationship with FDA has improved over the past two years.
- 80 percent said that FDA is providing better guidance about its expectations.
- 68 percent said they are incorporating this feedback into product development.
- 64 percent of companies said that meeting with FDA before submitting review materials improved the quality of their applications. (87 percent said it expedited their applications.)
The bad:
- Only 53 percent said FDA consistently encouraged these meetings.
- Six in 10 companies expressed frustration that FDA had changed its position during a review.
- Four in 10 feel that some products were denied because of FDA’s inadequate review resources.
The ugly:
- Just 8 percent of drug and device makers think FDA is doing enough to advance personalized medicine.
- 56 percent said the FDA lacks the capability to implement its Critical Path Initiative, which aims to bring innovative, high priority therapies to market quickly.
Why are these issues cropping up, you ask? On the part of the medical companies, there’s a need to develop medical products faster. But the FDA is responding to a growing public demand for increased medical device and drug safety.
There’s a lot at stake: currently, bringing a new drug to market can take up to 12 years in research and development and costs well in excess of $1 billion.
Currently, a solid 93 percent of American consumers say they are confident about the safety and effectiveness of drugs and medical devices approved for use in the U.S. Two-thirds agree that the U.S. has the highest standards in the world for drug safety.
But 56 percent of Americans also said they would be willing to use drugs and devices approved outside the U.S. — that is, before they’re approved by FDA.
And 54 percent of Americans think it takes up to five years to develop a new drug or medical device.
There are a few caveats about the negative FDA feedback, according to PwC. The 2007 FDA reauthorization — which gave the FDA new responsibilities without new resources — and the Prescription Drug User Fee Act (which authorizes the FDA to collect fees up to $1.25 million per application from these companies to fund an accelerated review process) may be responsible for the souring relationship.
- 46 percent of industry respondents said fees paid by their companies have accelerated the review process.
- 48 percent said the FDA has not been clear about the intended purpose of user fees or transparent about the way they are applied.
- 30 percent said the user fees are excessive compared with the time that FDA staff spends on reviews.
- 22 percent said user fees create a potential conflict of interest. (On the other hand, 50 percent said they did not.)
A regulatory agency that’s both funded by taxpayers and the industry it regulates. It’s no surprise, then, that there’s some friction when both groups aren’t on the same page.
A few more interesting stats from the survey:
- 72 percent of Americans have confidence that the FDA monitors product safety after products are approved and being sold to the public. 28 percent do not.
- 36 percent of Americans say they have lost confidence in the FDA over the past two years as a result of product recalls and other safety issues. 51 percent remain confident.
- 88 percent say that the benefits of medicine and medical technology outweigh the risks.
- 97 percent of consumers said the reputation of a drug- or device-maker is important to them. Half said it’s “very important.”
Conducted by Biocom, the study surveyed 50 companies and 1,000 U.S. consumers in 2010.
