The FDA Matters blog serves a broad readership of people "involved in FDA matters and for whom FDA matters."
Readers turn to the FDA Matters blog for insight, information and a fresh perspective about the agency and its interactions with Congress, media and stakeholders. In serving our readers, FDA Matters is not interested in ideology...only in how FDA can best serve the American people and the global community. Since there are many views on this: dialogue is encouraged and dissent is fine. Strong feelings are welcome, as long as they are politely expressed.
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More Columns Coming; The Alliance for a Stronger FDA
FDA Matters appreciates your patience. New columns will be coming in June, with fresh insights into FDA and the FDA-regulated world. Meantime, I write a weekly column in the Friday Update, published by the Alliance for a Stronger FDA. If you want to receive the Friday Update when it's published each week, you can sign [...]
FDA’s Indifferent Attitude Towards the First Amendment
The FDA doesn’t care about the First Amendment rights of the companies it regulates. It cares even less about the “free speech” rights of those companies’ sales and marketing representatives.
And why should the agency care? One of FDA’s primary missions is to protect the public health and safety of the American people from illegal, adulterated and misbranded products. Doing so involves restraining food, drug, device and cosmetics companies from committing fraudulent and deceptive acts that are not protected by companies’ commercial free speech rights.
Nonetheless, FDA Matters envisions opportunities for FDA and industry to broaden permissible product communications. The key is understanding history, not constitutional law.
A Salmon on Every Plate/The Hard Road of Innovation
Chicken was once an expensive delicacy. In 1928, America’s quest for a better diet and a better standard of living was summarized by the campaign promise of “a chicken in every pot.” Today, chicken is a ubiquitous, low-cost source of protein, which we largely take for granted. Despite depletion of ocean-based stocks, fish hold similar potential.
To begin this transformation, FDA must approve a scientifically-based innovative product—a faster growing genetically-engineered (GE) Atlantic salmon. When FDA Matters wrote about this subject 18 months ago, I believed the agency was near to approval of this first-ever food product from a GE animal. It is still not resolved and there are implications for all innovations that require FDA approval.