Survey Offers Mixed Results of FDA's Performance - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Survey Offers Mixed Results of FDA's Performance


ePT--the Electronic Newsletter of Pharmaceutical Technology

PricewaterhouseCoopers (PwC) released the results of a survey that analyzed the relationship of life-science companies with the US Food and Drug Administration and industry's views of the agency. The survey also examined consumers’ perception of product safety and effectiveness of pharmaceuticals and medical devices. A key finding from the 2010 survey was that was that life-sciences companies feel communication with FDA has improved steadily since passage of the FDA Modernization Act of 1997, but cited concerns over the level of the agency’s resources required to keep pace with the agency’s functions.

Specifically, the survey found that:

  • Thirty-eight percent of life-sciences companies surveyed said they feel that the overall working relationship with FDA has improved over the past two years, and 80% said that FDA is providing better guidance about its expectations. Sixty-eight percent of companies said they are incorporating this feedback into product development.
  • Sixty-four percent of companies said that meeting with FDA before submitting review materials improved the quality of their applications, and 87% said it expedited their applications. However, only 53% of companies surveyed said that FDA consistently encouraged these meetings.  
  • Six in ten companies expressed frustration that FDA had changed its position during a review, and four in ten feel that some products were denied because of FDA’s inadequate review resources.
  • Only 8% of drug and device makers think FDA is doing enough to advance personalized medicine.
  • More than half (56%) of respondents who are familiar with the FDA’s Critical Path Initiative think that FDA lacks the capability to implement the initiative.

The survey respondents also had mixed opinions about the effectiveness of user fees for prescription drugs. Almost half (46%) said that user fees have not accelerated the review process, and 30% thought the fees were excessive compared with the time FDA spends on review. Forty-eight percent of companies felt that FDA has not been clear about the intended purpose of user fees nor transparent about the way they are applied.

Despite some reservations from life-science companies, the public as a whole is generally satisfied with the agency’s performance although consumers cite ground for improvement. The survey found that 93% of US consumers are confident about the safety and effectiveness of drugs and medical devices approved for use in the US, and two-thirds agree that the US has the highest standards in the world for drug safety and effectiveness. Seventy-two percent of respondents have confidence that the FDA monitors product safety after products are approved and sold to the public.

However, although approximately one-half (51%) of respondents think FDA does a good job, more than one-third (36%) of US consumers say they have lost confidence in the FDA over the past two years as a result of high-profile safety concerns and product recalls. Also, more than half (56%) said they would be willing to use drugs and devices approved outside the US before they are approved by FDA.

In addition to FDA’s role in drug safety, consumers also were interested in knowing about a company that produces a given drug or device. Nearly all respondents (97%) said that the reputation of the company that makes a drug or device is “important” to them, and 49% said it was “very important.”

The 2010 survey was distributed electronically to potential respondents in the life-sciences industry, including companies that develop biologic, drug, and medical-device products. Findings represent respondents from 50 companies. The survey was completed in the summer of 2010. The PwC consumer survey was conducted online among a cross-section of 1000 US adults and was completed in October 2010.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
35%
Breakthrough designations
12%
Protecting the supply chain
35%
Expedited reviews of drug submissions
12%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here