FDA advances public health, protects consumers, regulates products and is an important force in our national economy. Now, FDA is being challenged by Congress and the President to justify itself as a positive force in the advancement of American innovation and as a contributor to US competitiveness.
This is precipitating an identity crisis at FDA. The agency is constantly establishing new standards (and revising old ones) that will protect consumers and bring new therapies to patients. Now it must also consider whether it is unduly impeding American industry. As this forces FDA to rethink who it is and what it stands for, FDA Matters believes a different FDA will emerge.
The Need for Standards. Most of FDA’s authority has been granted by Congress in response to marketplace abuses that had led to harmful products becoming commonplace. In each case, FDA has used that authority to set standards that all products must meet, creating a level playing field for industry. As a result, producers of quality products are assured that their competitors will also have to meet standards.
How important is this effect? A manufacturer in a highly-competitive, FDA- regulated industry once told me: to survive as a business, our upper boundary is limited by what our most foolish competitor offers for sale. FDA standards (and enforcement of those standards) are what assures that both the well-intended and the foolish deliver products that are at or above a defined level of quality and surety.
We mostly take the benefits of a level playing field for granted. Yet, greed, carelessness and malevolence are always at work behind the scenes trying to create a profitable advantage out of substandard products (e.g. counterfeiting, ingredient substitution).
Abuses aren’t limited to product manufacturing and distribution. Unsafe and ineffective products also result if standards aren’t created and enforced for clinical trial management, proof of efficacy, acceptable clinical trial designs, food additives, data reporting integrity, post-market surveillance and so on. Having these standards also assures fair competition among companies.
The Standards Crisis. By creating, applying and enforcing the highest standards, FDA wants to be seen as the primary force in assuring that Americans have the safest food supply and the safest and most effective therapies anywhere in the world. The agency aspires to always be “the gold standard” for the world.
Two sets of circumstances are forcing the FDA to rethink this particular sense of purpose and self-image. As a result, an identity crisis is slowly building within the agency.
First, the “highest” standard is rarely the best way to stimulate innovation. If FDA had chosen the toughest, most protective and most restrictive standards in the late 1970’s and early 1980’s, the biotechnology industry might not exist today. (see FDA and Things that Might Go Bump in the Night).
The agency faces this same challenge in creating the highest standards that nonetheless help advance nanotechnology, open new vistas in diagnostics and genomics, and encourage breakthroughs in drugs or medical devices. The tension between the “highest standards” and “reasonable and appropriate standards” is a visible and palpable part of the current controversy over revising medical device categories and approval standards. (see Medical Device Melodrama: A Great Story With a New Plot Twist)
Second, there is no global force that levels the playing field among each nation’s regulatory agencies…the way FDA levels the playing field for companies and products in the US market. Efforts at international harmonization of regulatory standards have stretched into decades. Without global standards, there are differences in requirements and even greater differences in interpretation in each national marketplace.
FDA knows that setting standards substantially higher than other nations creates the risk that other countries will introduce new products first. It also makes it more likely those countries can attract more industry, capital and jobs in the global economy. Apart from the issue of bragging rights over whether a drug or device was approved first in the US, considerations of international competition (versus cooperation) have been peripheral, at best, to FDA’s identity.
Conclusion. Right now, FDA is struggling to show that it can be all these things: the gold standard, the toughest, the best, the stimulator of innovation and the advocate for companies and products that meet American standards.
Ultimately, FDA will reconcile these roles because it has no choice. The resulting FDA will not necessarily be better or worse. The change may be dramatic or subtle. The only certainty is FDA’s identity will be different.