Constitutionality of The GMPs; Another Challenge

Coda Corp USA booklets for sale, Code of Federal Regulations, FDA, Title 21

The federal regulations collectively referred to under Title 21 as “the GMPs” are unique portions of our federal code.  Their uniqueness lies in the broad language used by the legislators who constructed them. This type of language differs widely from other regulations issued at the federal level, which are generally specific, including extensive detail.

While it has been our experience that many people working within these regulations often find this broad language frustrating, as it is sometimes easier to be told exactly what to do, the language of the code was constructed in this broad way in order to allow the private sector to determine the methods of meeting the regulations that best suit their individual business models.
Constructing code that provides private sector organizations the ability to determine compliance models that best suit individual business models is critical to realizing the objectives of the FD&C Act.
The objective of the FD&C Act is to protect the health and safety of humans.
Constructing legislation that meets this objective required the legislators (Congress) and the regulators (FDA) to consider any situation that could endanger the health and safety of humans.  This risk assessment indicated that there were two (2) primary risks to health and human safety:
1.      Allowing product of poor quality to be distributed (uncontrolled and unmonitored production and distribution)
2.      Depriving the public of new and unique therapies (creating code that presented an undue burden on industry)
The second of these considerations is precisely why Title 21, and in particular the GMPs has been written so broadly.  It was written with the intention of allowing the private sector as much liberty as possible in order to promote the efficient delivery of product to market.
However, this fact appears as though it might have been lost in translation as the broad nature of the language of the GMPs has been challenged legally by the private sector several times since their codification.
Most recently, a coalition of nutritional supplement manufacturers filed a federal suit challenging both the nature of the GMPs for their industry, because they are “impermissibly vague in violation of the Due Process Clause of the Fifth Amendment,” and because the Act grants the FDA authority to “arbitrarily and capriciously” take action while enforcing them under the Administrative Procedure Act.
The U.S. District Court for the District of Columbia recently dismissed that challenge.  For our readers that would like to read the full opinion, follow this link
For the remainder of this blog, we will look at the portions of the ruling that we feel would be the most useful take-aways for the Quality Assurance and Regulatory Affairs professionals in our industry.
Take Away #1: The Rule Making Process
The court ruling provides a detailed description of the extensive process that is executed prior to the final codification of new regulations.  The court states clearly that the best time for industry to voice legal concerns was within the public comment period.
The rule making process for these particular regulations spanned more than a decade and included the following actions:
  • Publishing an Advanced Notice of Proposed Rulemaking in the Federal Register (1997)
  • Touring manufacturing facilities in order to observe current practices
  • Hosting five (5) public meetings
  • Reviewing and responding to more than 100 comments submitted by industry
  • Publishing the Draft Proposed Rule in the Federal Register
  • Hosting three (3) more public meetings and various outreach activities
  • Reviewing and responding to over 400 more comments
  • Publishing the Final Rule in the Federal Register (2007)
As illustrated by the Court’s pointed reference to this period, we feel it is critical to remind industry that today’s QA/RA professionals need to have an advanced understanding of the mechanics of administrative law if they are to be equipped to efficiently and responsibility interact with the agency that regulates our industry.
We all have met industry members that firmly believe that these regulations are in some way debatable, and contribute that belief to their relative corporate cultures, but this ruling re-iterates that the most effective way to participate in that debate is to participate in the rule making process.
It is critical to remember that new rules that affect our industry are never codified without this multi-year process wherein government publicly converses with industry about its proposed regulatory scheme.  This conversation is formally and publicly recorded and can and does provide a later basis for judicial review.
As a result of the extensive rule making process, Courts are constitutionally obligated to grant broad deference to administrative agencies like the FDA.  This careful balance may not be perfect, but it took most of the twentieth century to evolve, and is the most heavily scrutinized area in the history of American jurisprudence.
In order to perform effectively in this industry, you must understand and respect this reality.
Take Away #2: Broad vs. Narrow Discretion
The plaintiffs point out in their complaint that other agencies are more specific in their regulations and thus their argument asserts that the GMPs are “impermissibly vague.”
Plaintiffs specifically point out that OSHA requires, for example, a range of acceptable lighting intensities for particular work areas to ensure adequate illumination, while the GMPs take a broader approach requiring that facilities must be “adequately” sized for the intended process.  As discussed earlier in the blog, this enables each regulated company to reach their own definition of “adequate,” allowing the private sector to take up the mantle of responsibility and find the best way to meet the regulations, with respect to our individual processes.
We all realize that there may be individual inspectors that over-scrutinize, but the broader evidence strongly suggests when the agency that is the FDA exercises its discretion under the law, it does so with the intention of providing a minimal rule set to ensure that the regulations pose a minimal burden to the private sector.
We believe that the discretion given to the private sector by this type of language contributes to lowering the cost of production and encouraging innovation.
We also believe that the intended benefits to the private sector and to society will not be realized unless the members of the Quality and Regulatory groups of our industry understand and embrace this regulatory paradigm.
Take Away #3: Operating a Business in a Regulated Industry
As stated in the complaint, the plaintiffs take the position that the regulations will force some nutritional supplement manufacturers out of business.  For the reasons mentioned above, a more enlightened view point would recognize that that the discretion provided to the private sector by the GMPs can provide added value to a business, and that the regulatory scheme has been battle-tested along its path from proposed to enforceable law.
The perspective voiced by the plaintiffs seems to stem from a belief that the government is increasing the burden of the business-to-consumer transaction.  We recognize that the absence of regulations altogether may in fact lower the burden on industry and, as such, theoretically lower the cost of the final product.  However, we also believe that the absence of the GMPs would lower the quality and reliability of the product.
As all of us who have studied the theory of lean manufacturing recognize, when you lower reliability, you increase variability, waste, and ultimately cost, negating the suggestion that rescinding the GMPs would achieve a more sustainable market, and virtually assuring an elevated risk to human health and safety.
In Conclusion
While this dust-up between government and industry clearly came down in favor of the government, the real victor is the American public.  Industry and government can and must operate as a partnership to ensure that only safe products enter the marketplace.
Simply put, there is a reason that the supply of products regulated under Title 21 are the safest products in the world, and that the pace of innovation is higher in this country than in any other.
The GMPs work, and we should do everything that we can to ensure that those operating within their framework understand and appreciate them in order to pass on the benefits of them to the American consumer.
Quality Assurance is a promise.
Let’s keep it.
© Coda Corp USA 2011.  All rights reserved.
Gina Guido-Redden and Nathan Cole
Post a comment or leave a trackback: Trackback URL.

Post a Comment

Your email is never published nor shared. Required fields are marked *


You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>