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The 1962 Amendments and the Era of Modern Medicine

Remarks delivered by Douglas Throckmorton,  M.D.,
Deputy Director for Regulatory Programs
FDA Center for Drug Evaluation and Research
at "Celebrating a Public Health Milestone"
White Oak Campus of the Food and Drug Administration
Simultaneous Webcast to FDA Employees
October 2, 2012

It is an honor to be here today and to hear all of these wonderful perspectives that show the profound impact that the passage of the Kefauver-Harris Amendments has had on FDA’s mission. I’d like to offer a few comments as a part of the leadership of the Center for Drug Evaluation and Research.

The history of drug development in the United States is one of continued progress punctuated by critical moments that changed the course of that progress in valuable and important ways. We’re here to celebrate the 50th anniversary of one of the most important of those moments, the passage of the Kefauver-Harris Amendments, or the Drug Amendments of 1962. Working in the Center for Drug Evaluation and Research for over 15 years, I have seen first-hand the impact that Act has had, and I’d like to add my voice to those celebrating it and to highlight some of the tremendous progress it has brought in evidence-based medicine and public health in the United States. Because of this progress, I am proud to point to the many important drugs developed for patients and to be able say that the drug review process in the United States is recognized as the gold standard.

First, the Kefauver-Harris Amendments fundamentally changed how we develop and use drugs in the United States, beginning with the requirement that products demonstrate efficacy for a defined patient population. This requirement has resulted in the development of drugs with defined benefits for patients who need them. Meeting this standard required the development of a completely new science centered on controlled clinical trials, including their planning, conduct and assessment. In response to the requirement to assess efficacy, things we now take for granted as central to the assessment of new medical products were developed, such as the routine use of the randomized controlled trial and the emergence of statistical science to guide the analysis of trials. Since the Kefauver-Harris Amendments were passed, additional work has embedded these principles in drug development and the result is greater assurance that the drugs we approve are efficacious and useful.

Other important changes in drug development came about as a result of the 1962 Drug Amendments. For instance, drug companies not only had to provide substantial evidence of a drug’s effectiveness, but they also had to report adverse events to FDA. Additionally, the information on safety and efficacy had to be submitted to the FDA for review and those applications had to be approved by the Agency before a drug could be marketed. This assured that expert review by FDA scientists would occur before new drugs were used by thousands of patients.

The 1962 Amendments also ushered in new requirements to protect patients in clinical trials as well as to improve the information given to patients about the drugs they take. First, the law required that people who participated in clinical trials did so after giving informed consent to assure they knew both the potential risks and benefits of the new treatment. The 1962 Amendments also gave the FDA authority to regulate advertising by drug companies to assure that the information given to patients was balanced and accurate. The results of these requirements in the 1962 Amendment are seen in the quality and value of the medicines we all take every day and in the protections in place for patients who enroll in clinical trials.

As we celebrate the passage of the 1962 Amendments we also need to remember the people behind the events, the people who continue to inspire the work we do. The story of Frances Kelsey is one that we talk a lot about in CDER. I began my career there as a primary medical reviewer, and the story of her courage resonates with all of our medical officers and other reviewers because it’s a story that illustrates the enormous responsibility we have as individuals working at the FDA to protect the public from dangerous drugs. Her courage is captured in the FDA mission, which continues to focus on making sure that the benefits of a drug outweigh all known risks. Her courage is also reflected in the work done daily by the incredibly dedicated staff working in FDA and in CDER who make the amendments come to life every day as a part of their jobs. I couldn’t be prouder to work with such a dedicated group of people.

Without a doubt, then, the Kefauver-Harris Amendments have changed the way new drugs are approved and regulated in the United States in profound and lasting ways. As a scientist and physician working in CDER I can’t imagine doing the job we do without the innovations that came about as a result of the law. Nothing will ever replace the rigorous evaluation of safety, quality, and effectiveness that happens at the FDA before a drug can be sold. These are our fundamentals.

Today, in CDER, we are working on several initiatives that build on these exact same principles to enhance the development of new drugs for patients who need them.

For instance, through our 21st Century Review Initiative FDA is continuing to make the drug review process more organized and efficient. Through our Safety First Initiative, we work to ensure drug safety after a drug is on the market by giving pre-marketing drug review and post-marketing safety equal focus and attention. Armed with that information, we are also working to improve our communications to patients and prescribers, so that they can make the best possible decisions about what therapies are best for which patients. And always, we focus attention on the quality of drug manufacturing, because quality is the underpinning of everything we do.

The results of these efforts are borne out in the innovative, life-saving therapies we have been able to approve for people who need them. Our dedicated staff continues to apply the science that came about as a result of the Kefauver-Harris Amendments to speed efficient product review. Singling out individual products is hard, but last year FDA was able to bring almost 40 new drugs to the market, many of them in critical areas of need such as cancer, cystic fibrosis, and devastating viral infections like HIV and hepatitis C. These are significant drugs for diseases that need effective therapies, and we’ve accomplished these approvals thanks to the foundation laid by the Kefauver-Harris Amendments.

On behalf of CDER, then, I want to close by thanking you all for your participation in this important event. I am proud and honored to be a part of this organization and to work with the dedicated staff of the FDA. Together we are all working to build on the foundation of the Kefauver-Harris Amendments to fulfill the FDA mission to advance public health by helping to speed innovations to make drugs more effective, safer and more affordable for the American people.