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The Food and Drug Administration (FDA) has released its “Strategic Plan for Regulatory Science,” a sweeping initiative to modernize the tools and methods that the agency uses to evaluate whether the products it regulates are effective and safe for consumers.

Regulatory science is the foundation of decision-making at FDA. Researchers across FDA gather data, do tests and think of new, better and faster ways to scientifically establish that regulated products enhance—without harming—the lives of the American public.

Products regulated by FDA include biologics (such as blood products and vaccines), human drugs, medical devices, foods, cosmetics, tobacco products, and animal feed and drugs. The broad scope of FDA’s plan covers the personal health of the consumer, the strength of the economy and the security of the nation.

“As new discoveries yield increasingly complex products, FDA’s experts need to be equipped to make science-based decisions resulting in sound regulatory policy,” says Commissioner of Food and Drugs Margaret A. Hamburg, M.D.

“It’s really about using science to protect and promote public health,” says Jan N. Johannessen at FDA’s Center for Drug Evaluation and Research. “Advancements in science create tremendous opportunities to improve how products are developed and evaluated.”

“We want to ensure that these advances benefit patients,” says Johannessen.  “Our research is vital to ensuring the safety and effectiveness of the products we regulate,” adds Carolyn A. Wilson, PhD, at FDA’s Center for Biologics Evaluation and Research.

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The framework of the regulatory science initiative was originally released in October 2010. The new plan fills in the details and focuses on eight key areas:

Modernizing toxicology—the study of chemical, biological or physical agents that can be harmful—and improving the ability of tests, models and measurements to predict product safety issues. This includes, where feasible, the development of new methods that could reduce or replace animal testing.Crafting new tools and approaches for the development of personalized medicine—getting the right medicine to the right person at the right time.Supporting new and improved manufacturing methods by researching how new technologies affect product safety, effectiveness and quality.Ensuring that FDA is ready to evaluate innovative and emerging technologies with the necessary expertise and infrastructure.Expanding and improving FDA’s information technology infrastructure and the application of those resources to support sophisticated analyses of data.Implementing the prevention-focused food-safety system mandated by the Food Safety Modernization Act passed by Congress and signed into law by President Obama in January.Speeding the development of safe and effective medical countermeasures to protect against threats to U.S. health and security, such as chemical, biological, or nuclear threats or naturally occurring infectious disease outbreaks. Such countermeasures include drugs, vaccines, diagnostic tests and personal protective equipment.Developing a communications strategy that will help FDA adapt to rapidly evolving technologies that are changing how people receive and share information.

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“As new discoveries yield increasingly complex products, FDA’s experts need to be equipped to make science-based decisions resulting in sound regulatory policy.”

Why should you care about regulatory science?

What it boils down to, says FDA’s Chief Scientist Jesse Goodman, is that people want new drugs, healthy food and other products that work. They want them to be developed and approved quickly, but they also want these things to be safe.

And that’s where regulatory science comes in. Here are a few examples of how this science has worked so far:

A clinical trial model was developed to help scientists quickly test the most promising drugs in development to treat women with rapidly growing breast cancers. The drugs are targeted to the biology of each woman’s tumor using specific genetic or biological markers.By studying data from hundreds of clinical trials, FDA found that antidepressants can increase the risk of suicide in people under 25. This resulted in FDA placing warnings on the labeling and medication guides for these drugs. After the Deepwater Horizon disaster released in excess of 92 million gallons of oil into the Gulf of Mexico in 2010, FDA developed a more rapid, highly sensitive chemical testing method to ensure that seafood from the Gulf is safe for consumption.

“The headlines are replete with examples of the critically important scientific role the agency plays in addressing crises, such as contaminated heparin, melamine in pet food, outbreaks of foodborne illness, and questions about vaccine safety, seafood safety, or readiness for pandemic influenza,” the strategic plan states.

“A strong FDA science infrastructure provides the essential foundation for ensuring scientific excellence and integrity in all of our regulatory and public health decisions and activities.”

Or, as Goodman says succinctly, “Strong and up-to-date science in these areas will help us do our jobs better—to help people be as healthy, safe and secure as possible.”

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

“This book is a ‘biography’ in the truest sense of the word,” he claims at the outset. It is “an attempt to enter the mind of this immortal illness, to understand its personality, to demystify its behavior.” He ventures even farther into the realm of the impossible when he promises to address these two questions: “Is cancer’s end conceivable in the future? Is it possible to eradicate this disease from our bodies and societies forever?”

With objectives so vast, and with such a beautiful title, “The Emperor of All Maladies” is poised to attract a serious and substantial readership. And it is an informative, well-researched study. But it is in no way a biography of anyone or anything, and Dr. Mukherjee winds up acknowledging as much before his book is over.

He points out that there is both folly and scientific partisanship in treating “cancer, a shape-shifting disease of colossal diversity,” as “a single, monolithic entity.”

Likewise, questions about whether cancer can be eradicated eventually run up against hard reality. “Cancer is a flaw in our growth, but this flaw is deeply entrenched in ourselves,” the book says. “We can rid ourselves of cancer, then, only as much as we can rid ourselves of the processes in our physiology that depend on growth — aging, regeneration, healing, reproduction.”

How did Dr. Mukherjee allow his otherwise sophisticated book to be presented so reductively? It’s an all too fitting flaw, since the same kind of oversimplification has long been the bane of cancer theory. “The Emperor of All Maladies” provides a survey of the different ways in which cancer has been understood in different eras, from the Greeks’ idea that it was caused by black bile, one of the four liquid humors, to the 19th-century conviction that the most drastic and disfiguring surgery would lead to the best cure. He also writes about the fund-raising, Nixon-era idea of waging war on cancer as if illness were an enemy to be faced in battle.

The biographical aspects of “The Emperor of All Maladies” have more to do with the personalities of anti-cancer combatants than with concocting one for cancer itself. This book pays considerable attention to pioneering figures like William Stewart Halsted, an advocate in the 1870s and 1880s of extreme breast cancer surgery; Sidney Farber, who in the 1940s made great breakthroughs in treating childhood leukemia with dangerously toxic chemicals; and Min Chiu Li, who in the 1950s lost his job at the National Cancer Institute for providing chemotherapy to patients whose symptoms had receded, even though this extended therapy meant the first chemotherapeutic cure of cancer in adults.

In a maneuver as transparently glib as that of calling his book a biography, Dr. Mukherjee also inserts occasional glimpses of his own patients, whose experiences are markedly overdramatized. (“It was now 9:30 in the morning. The city below us had stirred fully awake. The door shut behind me as I left, and a whoosh of air blew me outward and sealed Carla in.”) But none of this personal material is as compelling as the story of how cancer research has progressed through so many different phases.

Here Dr. Mukherjee’s writing is at its most candid and grim. The overarching point made by his narrative is that the whole subject of cancer is dauntingly complex. Even the statistics about mortality rates are tricky, since so much of researchers’ thinking about the prevalence of cancer depends on how they measure progress. And the unmistakable effect of our progress in curing other previously fatal diseases is to make cancer, which is most often found in older patients, look more prevalent than ever.

“The Emperor of All Maladies” is at its most honest in describing the push-pull dynamics of scientific progress. Dr. Mukherjee links a decline in extremely punishing chemotherapy regimens to the fact that patients became less passive. (He credits much of this forcefulness to AIDS activists.) He describes the conflicting interests of surgeons and chemotherapists. He writes most promisingly about the effects of genome mapping on scientists’ ability to understand how cancers progress, and he cites the similar ways in which different cancers create genetic pathways within mutating cells. He is confounding yet fair in writing that “this is either very good news or very bad news.”

Late in “The Emperor of All Maladies” Dr. Mukherjee provides especially apt metaphors for a subject so difficult to grasp. He quotes the Red Queen from Lewis Carroll’s “Through the Looking Glass” to describe the alacrity with which research must move: “It takes all the running you can do, to keep in the same place.” He describes one patient’s maneuvers to keep up with her illness as “like watching someone locked in a chess game.” And he says that the patterns in cancer research repeat themselves just as history does. Among the constants in this struggle are “the hypnotic drive for universal solutions” and “the queasy pivoting between defeatism and hope.”