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by Mark S. Senak
Eye On FDA



The answer is probably simple. The answer is probably everyone.

I think all can agree on that. This week, as PDUFA is being discussed on the Hill, Consumer Reports released a poll of approximately 1000 individuals in a phone survey and found that that consumers want the FDA to have more authority over the drug industry on specific points. I could not get my hands on a copy of the actual survey to see what the questions where, but here is how Consumer Reports reported them.

96 percent agree that the government should have the power to require warning labels if safety problems are identified--with 80 percent of those "strongly agreeing" to that authority. Currently, the FDA must negotiate safety warning labels with a drug maker.

93 percent agree that the FDA should have the power to order follow-up safety studies, with 65 percent "strongly agreeing" to that authority. Currently, the FDA generally does not have the authority to require that a safety study be performed once a drug is on the market

84 percent agree that advertisements for a prescription drug with safety concerns should be prohibited, with 59 percent "strongly agreeing" to such limits.

92 percent of Americans agree that pharmaceutical companies should make public the results of all of their clinical trial studies, which reveal a drug's effectiveness as well as possible hazardous side effects. Of those, 68 percent "strongly agreed" that drug studies should be made public.

The nature of the responses does raise some questions about the questions. Does anyone not agree that warning labels should be added if safety problems are found? Warning labels are already added if safety problems are found. There have been a slew of black box warnings coming out of FDA, even though there has been no rinding that I know of that specifically demonstrates the actual effect on black box warnings in achieving their goal. Then an overwhelming number of people were in favor of banning advertising for drugs with safety concerns - but all drugs have safety concerns. All cars have safety concerns. All airline flights have safety concerns. I'm not sure I understand the context of the question.

I'm not saying the survey is wrong, or that its findings are off. I'm saying there isn't enough information in the material that I could find to tell me.

Lastly, I think that an important question I don't see is - do you want the FDA to have more authority, or do you want the FDA to do a better job with the authority it already has? It might be a question that made people think.


Source: EyeOnFDA.com



RELATED READING:
- What a Ban on DTC Means for Public Relations
- Leaving PDUFA Alone
- PDUFA Dollars Up, Warning Letters Down

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