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Editorial:GMP’s—A Framework for Industry or Just an Answer to the FDA?

By Len Monheit
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If the only reason for participating in the comment period for the proposed GMP rule is to help shape the final rule, then maybe you should save your breath. If participating is part of a larger strategic effort to determine how industry should self-protect and self-enforce quality, contamination and labeling then maybe it’s worthwhile. To do this, as a first step, we must acknowledge that a problem exists.

A first glance at FDA’s proposed GMP’s issued in March suggested that FDA had proposed a workable rule (or at least a start) for a system which would help to ensure dietary supplements were properly labeled, contained what they said they did, and were managed in a system that limited possibilities of contamination and adulteration. Although there would be costs for industry companies to comply, many felt that having a rule in hand was more a benefit than a liability. Some may still feel this way.

It’s becoming increasingly obvious that dealing with the GMP rule alone will not set the stage for future industry success. After all, this rule would have no direct bearing on two critical issues facing the industry, product efficacy and product safety--issues under serious attack. And with inconsistent data and lack of clarity in parts of the proposed rule, it will be many years before any impact is felt, either operationally or in the marketplace. In that time period, unless action is taken to the contrary, present discouraging trends will continue. In fact, the cost and risk will continue to discourage new capital investment.

It was also quite obvious, even after initial examination of the 500-odd page document, that without serious incremental financial resources for the FDA to draw upon, administration and enforcement of even a small part of the regulations would be difficult, if not impossible. We now find out that the FDA does not expect additional enforcement resources for GMP’s.

Over the past weeks, Q and A sessions have been held across the country, and the message coming from these interactive sessions is causing increasing worry, so much so that trade associations have requested extensions to the comment period, presently scheduled to close June 11, extensions to deal with-as they must, this current GMP crisis.

At a session held this week prior to SupplySide East in New Jersey, FDA presenters didn’t respond to the more important questions and concerns of the attendees, however they did acknowledge legitimate concerns and excellent questions raised. (One can’t help but wonder why these excellent questions were not considered in the nine years since DSHEA.) FDA presenters suggested industry avail themselves of the opportunity to submit comments and questions on the proposed rule so that they were considered in the final rule, and so that ‘real’ issues and concerns were logged in the official commentary.

At these sessions, industry should not have been surprised. FDA was not prepared to, nor was it appropriate for them, to argue the fine points of the rule, or to answer questions about interpretation or enforcement. After all, it is quite possible that the final rule will look quite different from what is presently on the table – so why answer speculatively now.

At the SupplySide East session, when the discussion regarding economic impact and justification for the rule began,a mood of puzzlement settled on the audience. First of all, data from 1999 was presented as the basis for many of the FDA’s ‘assumptions’, showing, among other things, that 35% of companies in the industry followed no GMP’s. Then came an acknowledgement that the major cost hits to industry would be for record keeping and final product testing. ( A cost of $20 per final product test was apparently used for impact analysis calculations) FDA estimated the total cost of compliance with the rule as proposed was $38,000 per year for very small organizations, $61,000 per year for small companies and $47,000 for mid to large companies, who, it was assumed, already had a reasonable state of compliance. It was suggested that one of the ways to manage this cost of compliance was to strengthen supply chain relationships to better cover this compliance cost – translated another way to mean-- pass the cost back and forth across the supply chain.

It was then announced that the average size of the organizations in the industry was ‘8 people’ and that many of these, especially the very small ones, would be placed in jeopardy by being unable to bear the compliance cost. For this reason a three year phase-in plan for smaller business was proposed, as well as the use of small business compliance assistance programs. Larger companies would have a one year implementation period once the final rule was published. Total industry compliance cost was expected to be around $87 million, based on numbers the FDA had put together, including 1999 survey data from an unidentified list of organizations.

On the other side of the impact analysis equation, attendees heard that FDA expected economic benefit to the tune of $105 million in savings from fewer illnesses, $109 million in economic ‘savings’ from consumers who would spend so much less time searching for only high quality supplements, plus $3 million system savings due to reduction in the number of recalls. FDA presenters admitted that in reality the savings side of the equation was not a critical number, rather just a required part of the justification process. Audience disbelief and shock over the assumptions and numbers was overwhelming.

FDA presenters acknowledged their data might be flawed, and asked for industry to show data to the contrary. Presumably this data, both historical and trending, is being put together by companies and associations and will be submitted before the conclusion of the comment period, June 11, 2003 or whatever extended date is proposed. The impact analysis will become even more complicated since the supplements industry will also be dealing with the cost of implementation of several sections of the Bioterror legislation at the same time.

If the purpose of the regulations is to ensure future viability of this industry and to allow it to contribute positively to public health, there are a number of steps that must be taken now and in the one to three to five or even ten years before a final rule is implemented.

If the only reason we are concerned about the cost of implementing quality management systems and regulations is to present a case to the FDA, then perhaps we should wait for the survivors to benefit years hence, when a final rule is implemented.

Responding to the FDA over recent months has created an industry dialogue that must not only be used reactively in the form of comments on proposed rules. It represents a chance for the industry to get its act together and set its own future course. Failure to take advantage of this opportunity could be fatal.

Link for comments on Proposed rule:

Refer to docket number: 96N-0417

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