WSJ-Americans Growing Less Confident In FDA's Job on Safety, Poll Shows

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http://online.wsj.com/public/article/SB114831296787359612-uW9Ve_ZtSkQ20zMT5k2fNvR14Uw_20060622.html?mod=tff_main_tff_top Americans Growing Less Confident In FDA's Job on Safety, Poll Shows THE WALL STREET JOURNAL ONLINE May 24,

2006 Americans have become less confident in the Food and Drug Administration's ability to ensure the safety and efficacy of new prescription drugs. Fifty-eight percent of people in a new Wall Street Journal Online/ Interactive health-care poll said they feel the FDA does a fair or poor job in this regard, while 36% said the agency does a good or excellent job. Two years ago, the numbers were reversed: then, 56% felt the FDA did a good or excellent job in the ensuring safety and efficacy of new prescription drugs, while 37% felt the agency did a fair or poor job in this regard. Of 2,371 adults surveyed in the latest poll, 80% said they are somewhat or very concerned about the agency's ability to make independent decisions that will ensure patients have access to safe and effective medicines. The poll, conducted online May 12-16, found that 82% feel the FDA's decisions are influenced to some extent or a great extent by politics rather than medical science. Here a full results of the poll: --Beckey Bright "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 Positive* Excellent Good Negative** Fair Poor Not Sure Ensuring the safety as well as the efficacy of new prescription drugs 2004 56% 14% 43% 37% 27% 10% 7% 2006 36 7 29 58 35 23 6 Making decisions about which drugs can be marketed over-the-counter without a prescription 2004 41 7 34 50 33 17 9 2006 31 6 25 62 3 24 7 Making decisions about which brand name prescription drugs can be marketed as genetics 2004 38 6 31 51 30 21 11 2006 27 6 21 63 34 28 11 Ensuring that truly innovative prescription drugs come to market more quickly 2004 29 4 25 62 34 28 9 2006 22 4 18 70 34 37 8 *Excellent or good. **Fair or poor. Note: Percentages may not add up exactly to 100% due to rounding. * * * "Based on what you know or have heard, how good a job do you think the FDA (Food and Drug Administration) does on…?" Summary of Excellent/Good responses Base: All Adults Total Party Affiliation About FDA Ability to Make Independent Decisions Democrat Republican Independent Concerned Not Concerned Ensuring the safety as well as the efficacy of new prescription drugs 36% 34% 49% 28% 33% 60% Making decisions about which drugs can be marketed over-the-counter without a

prescription 31 29 39 28 28 51 Making decisions about which brand name prescription drugs can be marketed as genetics 27 28 34 21 25 42 Ensuring that truly innovative prescription drugs come to market more quickly 22 22 29 14 22 28 * * * "Which one of these do you think is most important for the FDA to focus on?" Base: All Adults Total 2004 2006

Ensuring the safety as well as the efficacy of new prescription drugs 54% 58% Ensuring that truly innovative prescription drugs come to market more quickly 23 21 Making decisions about which drugs can be marketed over-the-counter without a prescription 9 5 Making decisions about which brand name prescription drugs can be marketed as generics 7 7 Not sure 7 9 * * * "Overall, how important is it that people like you have access to the following?" Base: All Adults Very Important/ Somewhat (NET) Very Important Somewhat Important Not Very/ Not at All Important (NET) Not Very Important Not at All Important Not Sure New and better drugs, no matter what they might cost 71% 28% 44% 21% 15% 6% 8% Affordable prescription drugs even if they aren't the newest ones available 93 70 22 4 3 1 4 New, experimental drugs whose efficacy and safety aren't proven, but that may offer a new treatment choice for patients who otherwise are out of options 72 32 39 21 14 7 7 Complete information about the safety issues associated with prescription drugs 94 75 19 3 2 1 3 Note: Percentages may not add up to 100% due to rounding. * * * "Based on what you know or have heard, to what extent do you feel like the FDA's decisions are influenced by politics rather than medical science?" Base: All Adults Total Party Affiliation FDA's Ability to Make Independent Decisions Democrat Republican Independent Concerned Not Concerned Great/Some Extent (NET) 82% 87% 77% 88% 89% 64% To a great

extent 46 51 36 53 53 18 To some extent 36 36 41 35 36 46 Minor Extent/Not at All (NET) 9 5 16

7 6 29 To a minor extent 7 4 13 6 5 25 Not at all 2 1 3 1 2 4 Not Sure 9 8 7 5 5 8 Note: Percentages may not add up exactly to 100% due to rounding. * * * "Based on what you know or have heard, how concerned are you about the FDA's ability to do the following?" Base: All Adults Very/ Somewhat Concerned (NET) Very Concerned Somewhat Concerned Not Very/ Not at All Concerned (NET) Not Very Concerned Not at All Concerned Not Sure Make independent decisions that will ensure that patients have access to safe and effective medicines 80% 43% 37% 13% 11% 2% 7%

Effectively communicate safety concerns about prescription drugs to doctors and the public 76 38 38 17 14 3 7 * * * "Based on what you know or have heard, how concerned are you about the FDA's ability to do the following?" Summary of Very/Somewhat Concerned Base: All Adults Total Party Affiliation Democrat Republican Independent Make independent decisions that will ensure that patients have access to safe and effective medicines 80% 89% 71% 84% Effectively communicate safety concerns

about prescription drugs to doctors and the public 76 84 70 78 * * * "The FDA uses consultants on its advisory committees to evaluate the safety and efficacy of prescription drugs before they are approved and after they are on the market. These committee members must disclose if they have consulting agreements with any drug companies or own drug company stock. Do you think the members of these committees should be allowed to do the following things, or not?" Base: All Adults Yes, Should be Allowed No, Should Not be Allowed Not Sure To have consulting agreements with prescription drug companies 17% 66% 17% To hold or purchase stock for prescription drug companies 11 74 16 Methodology: Interactive conducted this online survey within the U.S. May 12-16, 2006, among a national cross section of

2,371 adults. Figures for age, gender, race/ethnicity, education, income and region were weighted where necessary to align with population proportions. Propensity score weighting was also used to adjust for respondents' propensity to be online. In theory, with a probability sample of this size, one can say with 95% certainty that the results have a sampling error of +/- 3 percentage points of what they would be if the entire adult population had been polled with complete accuracy.

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WSJ-Americans Growing Less Confident In FDA's Job on Safety, Poll Shows

http://online.wsj.com/public/article/SB114831296787359612-uW9Ve_ZtSkQ20zMT5k2fNvR14Uw_20060622.html?mod=tff_main_tff_top

Americans Growing Less ConfidentIn FDA's Job on Safety, Poll Shows

THE WALL STREET JOURNAL ONLINEMay 24, 2006

Americans have become less confident in the Food and Drug Administration's ability to ensure the safety and efficacy of new prescription drugs.

Fifty-eight percent of people in a new Wall Street Journal Online/ Interactive health-care poll said they feel the FDA does a fair or poor job in this regard, while 36% said the agency does a good or excellent job.

Two years ago, the numbers were reversed: then, 56% felt the FDA did a good or excellent job in the ensuring safety and efficacy of new prescription drugs, while 37% felt the agency did a fair or poor job in this regard.

Of 2,371 adults surveyed in the latest poll, 80% said they are somewhat or very concerned about the agency's ability to make independent decisions that will ensure patients have access to safe and effective medicines.

The poll, conducted online May 12-16, found that 82% feel the FDA's decisions are influenced to some extent or a great extent by politics rather than medical science.

Here a full results of the poll:

--Beckey Bright

"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

Positive*

Excellent

Good

Negative**

Fair

Poor

Not Sure

Ensuring the safety as well as the efficacy of new prescription drugs

2004

56%

14%

43%

37%

27%

10%

7%

2006

36

7

29

58

35

23

6

Making decisions about which drugs can be marketed over-the-counter without a prescription

2004

41

7

34

50

33

17

9

2006

31

6

25

62

3

24

7

Making decisions about which brand name prescription drugs can be marketed as genetics

2004

38

6

31

51

30

21

11

2006

27

6

21

63

34

28

11

Ensuring that truly innovative prescription drugs come to market more quickly

2004

29

4

25

62

34

28

9

2006

22

4

18

70

34

37

8

*Excellent or good.

**Fair or poor.

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

* * *

"Based on what you know or have heard, how good a job do you think the FDA (Food and Drug Administration) does on…?"

Summary of Excellent/Good responses

Base: All Adults

Total

Party Affiliation

About FDA Ability to Make Independent Decisions

Democrat

Republican

Independent

Concerned

Not Concerned

Ensuring the safety as well as the efficacy of new prescription drugs

36%

34%

49%

28%

33%

60%

Making decisions about which drugs can be marketed over-the-counter without a prescription

31

29

39

28

28

51

Making decisions about which brand name prescription drugs can be marketed as genetics

27

28

34

21

25

42

Ensuring that truly innovative prescription drugs come to market more quickly

22

22

29

14

22

28

* * *

"Which one of these do you think is most important for the FDA to focus on?"

Base: All Adults

Total

2004

2006

Ensuring the safety as well as the efficacy of new prescription drugs

54%

58%

Ensuring that truly innovative prescription drugs come to market more quickly

23

21

Making decisions about which drugs can be marketed over-the-counter without a prescription

9

5

Making decisions about which brand name prescription drugs can be marketed as generics

7

7

Not sure

7

9

* * *

"Overall, how important is it that people like you have access to the following?"

Base: All Adults

Very Important/ Somewhat (NET)

Very Important

Somewhat Important

Not Very/ Not at All Important (NET)

Not Very Important

Not at All Important

Not Sure

New and better drugs, no matter what they might cost

71%

28%

44%

21%

15%

6%

8%

Affordable prescription drugs even if they aren't the newest ones available

93

70

22

4

3

1

4

New, experimental drugs whose efficacy and safety aren't proven, but that may offer a new treatment choice for patients who otherwise are out of options

72

32

39

21

14

7

7

Complete information about the safety issues associated with prescription drugs

94

75

19

3

2

1

3

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

* * *

"Based on what you know or have heard, to what extent do you feel like the FDA's decisions are influenced by politics rather than medical science?"

Base: All Adults

Total

Party Affiliation

FDA's Ability to Make Independent Decisions

Democrat

Republican

Independent

Concerned

Not Concerned

Great/Some Extent (NET)

82%

87%

77%

88%

89%

64%

To a great extent

46

51

36

53

53

18

To some extent

36

36

41

35

36

46

Minor Extent/Not at All (NET)

9

5

16

7

6

29

To a minor extent

7

4

13

6

5

25

Not at all

2

1

3

1

2

4

Not Sure

9

8

7

5

5

8

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

* * *

"Based on what you know or have heard, how concerned are you about the FDA's ability to do the following?"

Base: All Adults

Very/ Somewhat Concerned (NET)

Very Concerned

Somewhat Concerned

Not Very/ Not at All Concerned (NET)

Not Very Concerned

Not at All Concerned

Not Sure

Make independent decisions that will ensure that patients have access to safe and effective medicines

80%

43%

37%

13%

11%

2%

7%

Effectively communicate safety concerns about prescription drugs to doctors and the public

76

38

38

17

14

3

7

* * *

"Based on what you know or have heard, how concerned are you about the FDA's ability to do the following?"

Summary of Very/Somewhat Concerned

Base: All Adults

Total

Party Affiliation

Democrat

Republican

Independent

Make independent decisions that will ensure that patients have access to safe and effective medicines

80%

89%

71%

84%

Effectively communicate safety concerns about prescription drugs to doctors and the public

76

84

70

78

* * *

"The FDA uses consultants on its advisory committees to evaluate the safety and efficacy of prescription drugs before they are approved and after they are on the market. These committee members must disclose if they have consulting agreements with any drug companies or own drug company stock. Do you think the members of these committees should be allowed to do the following things, or not?"

Base: All Adults

Yes, Should be Allowed

No, Should Not be Allowed

Not Sure

To have consulting agreements with prescription drug companies

17%

66%

17%

To hold or purchase stock for prescription drug companies

11

74

16

Methodology:

Interactive conducted this online survey within the U.S. May 12-16, 2006, among a national cross section of 2,371 adults. Figures for age, gender, race/ethnicity, education, income and region were weighted where necessary to align with population proportions. Propensity score weighting was also used to adjust for respondents' propensity to be online. In theory, with a probability sample of this size, one can say with 95% certainty that the results have a sampling error of +/- 3 percentage points of what they would be if the entire adult population had been polled with complete accuracy.

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