News

Posted On: 06/19/2007

Harris Poll Shows Public Perceptions of FDA

PharmaManufacturing.com

The public's confidence in the U.S. Food and Drug Administration (FDA) appears to be rebounding after two years of declining confidence, but the agency has more work to do. Half of all adults in the U.S. still believe that the FDA is doing a fair or poor job when it comes to ensuring the safety and efficacy of new prescription drugs. Nearly six in ten give the agency negative ratings on ensuring that truly innovative drugs come to market more quickly.

These are some of the results of an online survey of 2,482 U.S. adults, ages 18 and older, conducted by Harris Interactive(R) between May 22 and 24, 2007 for The Wall Street Journal Online's Health Industry Edition (http://www.wsj.com/health).

Legislators on Capitol Hill are actively seeking to address the public's concerns. New provisions were recently passed by the U.S. Senate as part of the Food and Drug Administration Revitalization Act that would give the FDA new powers, including the ability to issue fines to drug companies if they fail to do follow-up safety studies or use false or misleading advertising. The Senate also passed legislation that would establish electronic networks to scan medical and prescription drug records for indications of drug safety issues. The FDA's expanded mandates will be funded by increased user fees paid by prescription drug companies.

The public's perceptions of these initiatives, on the whole, are ambivalent at best; half of all adults are confident that that these oversight mechanisms would help improve drug safety.

The public is more dubious about legislation passed in the U.S. House of Representatives that would provide funding to the Agency for Healthcare Research and Quality (AHRQ) to compare prescription drugs in order to determine which are most cost effective. Only one in five adults is confident that cost-effectiveness comparisons would help contain healthcare costs for the U.S. as a whole or help to contain costs for individuals like themselves. One in three adults is confident that cost-effectiveness comparisons would help ensure that patients receive safe and effective prescription drug treatments.

Public opinion is split as to whether or not allowing the FDA to issue fines would limit people's access to new and innovative treatments. Equally large numbers of adults worry that establishing systems to scan medical and pharmacy records for indications of safety issues would limit innovation. More than half of all adults are concerned the cost effectiveness comparisons will limit the public's access to new and innovative prescription drugs.

The public is skeptical about the relying on user fees to fund these new oversight activities. Six in ten adults agree that the agency's reliance on user fees could lead to less rigorous scrutiny when reviewing new prescription drugs. Less than one in three adults believe that having the industry fund these activities is a good way to save taxpayers money.

TABLE 1- RATING THE FDA
"Based on what you know or have heard, how good a job do you think the FDA (Food and Drug Administration) does on ... ?"

  Base: All Adults                                                       Not
                          Positive* Excellent Good Negative** Fair Poor Sure
   Ensuring the     2004 %   56         14     43     37       27   10   7
   safety as
   well as the        2006 %   36          7     29     58       35   23   6
   efficacy of
   new                   2007 %   45          7     37     49       29   20   6
   prescription
   drugs

   Ensuring that    2004 %   29          4     25     62       34   28   9
   truly innovative
   prescription      2006 %   22          4     18     70       34   37   8
   drugs come to
   market more    2007 %   34          3     30     58       31   26   9
   quickly

  *Excellent or good.  **Fair or poor.
  Note: Percentages may not add up exactly to 100% due to rounding.

TABLE 2 - PUBLIC PERCEPTIONS OF POTENTIAL FDA REFORMS

"The U.S. Senate recently passed a bill that would provide the FDA with new responsibilities.  How confident are you that the following measures would help improve drug safety?"

  Base: All Adults

                       Extremely/
                       Very          Extremely    Very
                       Confident/    Confident    Confident    Confident
                       Confident
                       (NET)
  Establishing a
  computerized
  network to
  scan insurance
  and pharmacy
  records for       %      52            6           12           34
  indications of
  safety issues
  with new
  prescription
  drugs

  Increasing
  fines for
  pharmaceutical
  companies who
  fail to comply
  with FDA
  requests for      %      52            8           12           32
  label
  revisions or
  additional
  studies of
  prescription
  drugs

  Allowing the
  FDA to fine
  pharmaceutical    %      54            9           14           31
  companies for
  false or
  misleading ads

                       Not Very/                  Not at
                       At All        Not Very     All          Not Sure
                       Confident     Confident    Confident
                       (NET)
  Establishing a
  computerized
  network to
  scan insurance
  and pharmacy
  records for       %      37           26           10           11
  indications of
  safety issues
  with new
  prescription
  drugs

  Increasing
  fines for         %      37           25           12           11
  pharmaceutical
  companies who
  fail to comply
  with FDA
  requests for
  label
  revisions or
  additional
  studies of
  prescription
  drugs

  Allowing the
  FDA to fine
  pharmaceutical    %      36           24           12           10
  companies for
  false or
  misleading ads

  Note: Percentages may not add up to 100% due to rounding.

 TABLE 3 - PUBLIC PERCEPTIONS OF COST-EFFECTIVENESS COMPARISONS

"The U.S. House of Representatives recently passed a bill that would provide $3 billion to the Agency for Healthcare Research and Quality to compare prescription drugs in order to determine which are the most cost-effective. Funding would come from the federal government, health plans and employers. Health plans would then use this information to help decide which therapies are most appropriate for their plan members. How confident are you that these kinds of cost-effectiveness comparisons would ... ?"

  Base: All Adults
                      Extremely/
                      Very           Extremely    Very
                      Confident/     Confident    Confident   Confident
                      Confident
                      (NET)
  Help contain
  healthcare        %      22            2            4           16
  costs in the
  U.S.

  Help contain
  healthcare
  costs for         %      23            2            4           17
  people like
  you

  Help ensure
  that patients
  receive safe
  and effective     %      31            1            5           25
  prescription
  drug
  treatments

                       Not Very/                  Not at
                       At All        Not Very     All         Not Sure
                       Confident     Confident    Confident
                       (NET)
  Help contain
  healthcare        %      67           41         27            10
  costs in the
  U.S.

  Help contain
  healthcare
  costs for         %      66           39         27            11
  people like
  you

  Help ensure
  that patients
  receive safe
  and effective     %      58           35         23            11
  prescription
  drug
  treatments

  Note: Percentages may not add up to 100% due to rounding.

TABLE 4 - POTENTIAL IMPACT OF REFORMS ON INNOVATION

"How concerned are you that the following measures would limit people's access to new and innovative prescription drugs in the future?"

  Base: All Adults
                        Extremely/
                        Very         Extremely    Very
                        Concerned/   Concerned    Concerned    Concerned
                        Concerned
                        (NET)
  Establishing a
  computerized
  network to scan
  insurance and
  pharmacy records   %     47           6            10           31
  for indications
  of safety issues
  with new
  prescription
  drugs

  Increasing fines
  for
  pharmaceutical
  companies who
  fail to comply
  with FDA                  %     46           5            10           31
  requests for
  label revisions
  or additional
  studies of
  prescription
  drugs

  Allowing the FDA
  to fine
  pharmaceutical        %     43           6             8           29
  companies for
  false or
  misleading ads

  Funding federal
  research to
  provide health
  plans with cost-       %     55          10            13           31
  effectiveness
  data for
  prescription
  drugs

                       Not Very/                  Not at
                       At All       Not Very      All          Not Sure
                       Concerned    Concerned     Concerned
                       (NET)
  Establishing a
  computerized
  network to scan
  insurance and
  pharmacy
  records for        %     39          29           10           14
  indications of
  safety issues
  with new
  prescription
  drugs

  Increasing
  fines for
  pharmaceutical
  companies who
  fail to comply
  with FDA          %      41          30           11           13
  requests for
  label revisions
  or additional
  studies of
  prescription
  drugs

  Allowing the
  FDA to fine
  pharmaceutical     %     45          31           14           12
  companies for
  false or
  misleading ads

  Funding federal
  research to
  provide health
  plans with
  cost-              %     31          22            9           14
  effectiveness
  data for
  prescription
  drugs

  Note: Percentages may not add up to 100% due to rounding.

 TABLE 5 - PUBLIC PERCEPTIONS OF USER FEES

"Currently some of the FDA's drug review activities are funded by user fees paid by pharmaceutical companies. To what extent do you agree or disagree with the following statements about these user fees?"

  Base: All Adults
                           Strongly/                           Neither
                            Somewhat     Strongly   Somewhat    Agree
                            Agree        Agree      Agree       Nor
                            (NET)                               Disagree
  Having
  pharmaceutical
  companies fund FDA     %    29            7         21          34
  activities is a
  good way of saving
  taxpayers money

  Having
  pharmaceutical
  companies fund FDA
  activities means
  that the FDA won't          %    57           26         31          28
  be as rigorous as
  it should be when
  reviewing new
  prescription drugs.

                            Strongly/    Somewhat   Strongly
                            Somewhat     Disagree   Disagree
                            Disagree
  Having
  pharmaceutical
  companies fund FDA     %      37          17         20
  activities is a
  good way of saving
  taxpayers money

  Having
  pharmaceutical
  companies fund FDA
  activities means
  that the FDA won't           %      15          10          4
  be as rigorous as
  it should be when
  reviewing new
  prescription drugs.

  Note: Percentages may not add up to 100% due to rounding.