PDUFA? Huh?

  • by: |
  • 11/30/2010

Executives at 50 medical companies think FDA has improved it relationships with them, but say the agency is not keeping up with advances in technology, the survey by PricewaterhouseCoopers LLP and Biocom, an association of 550 California life sciences companies, found.

PwC and Biocom interviewed 1,000 adults and executives at 50 drug, device and diagnostics companies of varying sizes for the report, available at www.pwc.com/us/fdasurvey.

Among the companies, 80 percent said FDA is providing better guidance about its expectations but just 38 percent said the overall working relationship with FDA has improved over the past two years.

Only 8 percent of drug and device makers said FDA is doing enough to advance personalized medicine.

While 93 percent of U.S. consumers are confident about the safety and effectiveness of drugs and medical devices approved by the FDA, 56 percent said they would be willing to use drugs and devices approved outside the United States.

More than 50 percent of consumers said they think FDA does a good job, but 36 percent said they have lost confidence in the FDA over the past two years as a result of high profile safety concerns and product recalls.

"Consumers want safer, more effective drugs and devices and access to the latest medical innovation. Industry wants fast and efficient product approvals," PWC's Michael Mentesana said in a statement.

"But the promise of faster product development has yet to be realized and the quality and productivity of the FDA-industry relationship would be better on both sides if there was more collaboration and clarity around expectations."

One of the most misunderstood areas is the Prescription Drug User Fee Act or PDUFA, which requires companies that make drugs pay up to $1.25 million per drug application.

FDA says this cash has helped speed up drug approvals but the survey found that 46 percent of company executives do not believe approvals are any faster.

And 70 percent of consumers disapprove of having companies help pay for FDA's work. Only 36 percent knew that industry helps pay for FDA and just 68 percent fully understood the agency is paid for by taxes.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog