- The Washington Times - Thursday, July 6, 2006

This week, the Food and Drug Administration commemorates 100 years of protecting and advancing public health. In 1906 President Theodore Roosevelt signed into law the Pure Food and Drug Act. It created a Bureau of Chemistry that prohibited the misbranding and sale of adulterated foods and medicines. Rather than waiting until the products were on the market or consumed, the bureau was able to use the same advances science used to manufacture a new generation of products in order to determine which were unsafe before they were sold. By making regulation a science-based rather than a rule-based activity, the FDA of that time both protected the public health and advanced the development of medicines into the next century.

Today, the FDA stands at a similar crossroads. The science of drug discovery has advanced to the point where we can turn proven scientific insights into treatments (based on genes and the roles they play) into personalized medicines. For example, the FDA, the National Institutes of Health and companies have developed biological indicators to predict an individual’s response to cancer drugs. By understanding who is likely to respond to which drug, biomarkers can change the risk/benefit ratio for patients in clinical trials by only enrolling people who will benefit, as well as reducing the likelihood of adverse events.

There are also a growing number of advanced approaches that can be used to monitor, predict and avoid negative drug responses. The technology exists to create proactive online registries at the time of drug approval to collect safety data. And it could include the collection and analysis of blood tests that use genetic information to predict sensitivity or possible adverse reactions to a wide array of medicines. Half of the population is at risk of adverse metabolic drug reactions that can be predicted with a simple blood test.

This proactive and science-based approach to safety is embraced by the FDA and included in FDA legislation crafted by Sens. Mike Enzi and Ted Kennedy. Their legislation encourages the evolution toward targeted, predictive and preventive approaches to drug development with the creation of Reagan-Udall Applied Biomedical Research Institute.

The Reagan-Udall Institute would provide the framework for the FDA, the private and academic sectors and the NIH to create the advanced development and regulatory tools required to accelerate the development of faster and safer cures. And much like the public-private consortium established to improve the efficiency of the semiconductor industry in the 1980s, it envisions that the products of the partnership will be shared widely, improving both the integrity of product development and the reliability of products industry-wide.

Further, the Enzi-Kennedy bill transforms the way information about the safety of medicines is collected, evaluated and monitored. The legislation recognizes that the current patchwork of after-the-fact paper submissions of adverse events just won’t cut it for next-generation medicines. It strongly encourages investment in electronic data capture services to promote collection of real-world data from registries and also promotes observational studies looking at a medicine’s uses to other ongoing safety studies.

Combining information and sharing it with the FDA can flag potential safety problems and be used to accelerate prescribing the medication. Also, the FDA can use such data to develop predictive drug models in much the same way that software developers use error information from users to continually retool and improve their designs on a real-time basis.

A competing bill, introduced by Sens. Charles Grassley and Christopher Dodd, creates a separate agency that, among other ill-considered ideas, would require additional clinical studies and more paper submissions of adverse events. It would also starve the agency of the funds needed to upgrade the systems that process millions of pieces of data in days instead of years. Worse, the bill emphasizes collection of safety data after a drug is on the market without any upgrade in the scientific quality of information or technology of data systems.

And that places patient safety at risk. A recent NIH study found it took clinicians months to first learn that some patients were having strokes and then halt a particular study. The reason for the delay: double data-paper entry, the 19th-century stenographic practice which would be required by Grassley-Dodd.

The Enzi-Kennedy proposal embodies the values and science-based approach to protecting the public that was behind the original legislation that brought the FDA into existence a century ago. Enzi-Kennedy reduces risk by encouraging personalized medicine. Along with the creation of the Reagan-Udall Institute, it will launch a generation of more effective and reliable medicines.

Robert Goldberg is vice president for strategic initiatives for the Center for Medicine in the Public Interest. Peter Pitts is president of the Center for Medicine in the Public Interest and former associate commissioner for external affairs for the FDA.


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