Proposed GMPs Seen as Costlier Than FDA Estimates
Springs MD, 10 September 2003
American Herbal Products Association (AHPA) filed comments yesterday
related to the FDA's estimates of the costs and benefits associated
with the agency's proposed good manufacturing practice (cGMP) for
dietary supplements, as published by FDA on 13 March 2003.
comments from AHPA filed per 30-day extension
had submitted comments to the proposed rule last month to address
most of the issues that AHPA member companies had identified as
important. AHPA had also requested and obtained an additional 30
days to file comments on the economic factors that were discussed
in yesterday's comments.
document submitted yesterday expressed concerns that the agency
may have, in analyzing the economic impact of the proposed rule,
overstated the economic benefits and understated the costs.
FDA stated that the annual benefit of the proposed cGMP will
be $218 million, AHPA suggests that the actual benefit may
be only $21 million, or even less. Similarly, FDA calculated
the annual industry cost to be $86 million, while AHPA's evaluation
estimates the actual cost to be at least $700 million if the
agency fails to consider appropriate modifications to the
Note: If AHPA's estimates are correct, the cost would be 814%
higher than FDA projections and the benefits only 10% of FDA
continues to support the implementation of cGMP specific to dietary
supplements," stated Michael McGuffin, AHPA's President. "The concerns
we have expressed about the excessive costs of FDA's proposal, however,
must be addressed in the rulemaking process. AHPA encourages the
agency to seriously consider the revisions we suggested in our earlier
comments, to establish a more affordable, but equally effective
website has comments
on GMP economic impact in PDF format (www.ahpa.org/03Sept09CommentscGMPEconomicsFinal.pdf).
Herbal Products Association (AHPA).