Helping the Media to "Tell It Like It Is"

The budget and appropriations process for FY 14 is going to be endlessly complicated -- on par with last year and potentially the most confusing ever. This was reinforced by a larger than normal number of media calls from reporters trying to understand the impact of sequestration and “what comes next.”

In most cases, what the reporters were really looking for was whether sequester at FDA would hurt the American people and, if so, how. Their hope was for some dramatic example that would put the damage at FDA on par (in a graphic media sense) with furloughs of USDA meat inspectors and the emerging “crisis” created by furloughs of air traffic controllers.I patiently explained that the $209 million sequestration loss at FDA was, indeed, devastating. As a result:

  • Food will be less safe and consumers may be hurt,

  • Drug and device approvals will be slower, conflicting with promises made to consumers and companies,

  • Problems with imports and globalization will become more numerous (e.g., 2,100 fewer food inspections)

However -- and this frustrated the reporters and me -- I couldn’t honestly tell them that there was a single dramatic example that would help them make headlines and (in their dreams) win them Pulitzers. The result of sequestration at FDA is best described as “death by a thousand cuts.” There will be delays in a broad range of responsibilities and a massive increase in the threat of things that might go wrong ... but nothing that could be defined in advance as dramatic changes that will be visible to the general population.

And no, I urged them, the diffused nature of the cuts didn’t make the damage any more palatable or less impactful. FDA’s legislatively mandated responsibilities have been growing steadily (four major new laws since 2009), while globalization is galloping forward and the science behind FDA-regulated products is growing more complex and time-consuming each year. Further, Congress seems certain to add additional responsibilities this year; for example, in the area of regulation of compounders.And so the reporters were told the truth as we know it: we don’t know where the money will come from to pay for the work FDA must do ... and we cannot predict the consequence if money isn’t found and problems emerge in FDA-regulated product (nearly 25% of all consumer spending).Finally, I pointed out to the reporters that that is why the Alliance exists: we are, quite literally, all of FDA’s stakeholders, working together for a strong, well-funded FDA. We know that a strong FDA benefits all Americans, regardless of the nation’s budget woes.

Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance for a Stronger FDA.

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