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:
The bad:
The ugly:
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.
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:
Conducted by Biocom, the study surveyed 50 companies and 1,000 U.S. consumers in 2010.
This post was originally published on Smartplanet.com