Hatch Takes FDA to Task on DSHEA DuringFDLI Conference

Hatch Takes FDA to Task on DSHEA DuringFDLI Conference

WASHINGTON--The Food and Drug Law Institute (www.fdli.org)held its annual FDLI/Food and Drug Administration (FDA) Educational Conferencein mid-April. Among the speakers in attendance were Shelia Anthony, acommissioner with the Federal Trade Commission; Daniel Troy, FDA chief counsel;and Sen. Orrin Hatch, R-Utah. Sen. Hatchs remarks covered what he considersthe top priorities for FDA in the coming year, primarily in the areas ofpharmaceuticals and generics. However, he also addressed FDAs implementationof the Dietary Supplement Health and Education Act (DSHEA). Following areexcerpts of his remarks:

It is now almost eight years since [DSHEA] was signedinto law.

Depending on whether you are the FDA or Orrin Hatch, thislaw either threw away any chance FDA had to regulate supplements, or gave them awhole host of new regulatory tools.

Regardless of which side you take, almost eight years laterwe have little or no enforcement of the law. That has to change.

That is why Senator Harkin and I worked to add funding toboth the FDA and HHS [Health and Human Services] appropriations last year. Weneed to make sure the sections of the law assuring consumers of truthful andnonmisleading labeling are being upheld.

That is also why we have pressed FDA, HHS and OMB [Officeof Management and Budget] several times to free the dietary supplement GMP [goodmanufacturing practices] proposed regs which have been held hostage for severalyears.

That is also why we have worked to provide additionalfunding for adverse events monitoring.

But for those who criticize this carefully negotiated law,a law which passed both the House and Senate by unanimous consent, I have onesimple suggestion: Instead of disparaging the law and whispering to the pressthat the agencys hands are tied and that the law needs to be changed, letstry to implement the law that is already on the books--and put a littleumph in the job.

There has been a whisper campaign that FDA is afraid to actbecause it will anger me and others in Congress. So, let me be the first to tellall of you I expect the agency to implement and enforce the law.

Do I expect the agency to fabricate law as it did in thepast? No.

Do I expect the agency to carry out some vendetta abouttremendously popular, safe, healthful products? No.

But do I expect them to uphold their duties under thelaw? You bet I do!