Free to Choose Medicine

Deaths from an approved drug become a top story for the nightly news and can lead to Congressional inquiries. Avoiding such negative publicity is the overriding goal of the Food and Drug Administration (FDA). The resulting extreme tunnel focus on safety causes delayed access to innovative drugs, which in turn causes millions of people to suffer and many to die needlessly.

When drug development, testing, and market access to drugs are viewed as a system, it is clear the appropriate system goal should be better drugs, sooner, at lower cost. However, “sooner, at lower cost” is ignored by FDA while it demands ever more testing. Today, a pharmaceutical company spends ten years in clinical testing for a new drug in hope of securing FDA approval. The total cost of an approved drug is about a billion dollars.

The nightly news misses the fact that FDA itself is the bottleneck in the system and fails to report that the result is an enormous invisible graveyard of those who were, are, and will be denied access to new drugs.

Consumer choice would break FDA’s monopoly on access to new drugs. That is the way to turn this problem into an opportunity. The core idea, which should appeal to Republicans, Democrats, and Independents alike, is that we need to be free to make our own informed decisions about whether to use not-yet-FDA-approved therapeutic drugs – that is, new drugs that have successfully passed safety trials, generated preliminary efficacy data, and may offer us the opportunity to improve our health or even save our life. I call this “Free To Choose Medicine.”

Consider how Free To Choose Medicine would have helped those with advanced prostate cancer, which kills 30,000 men every year. Many of those patients literally marched to Washington to rally against FDA’s excruciatingly slow process to approve Provenge, a strikingly innovative cancer vaccine that triggers the body’s natural immune defenses. Patient advocacy groups called for immediate access to Provenge. One memorable advertisement by the advocacy groups was headlined, “Dysfunction at the FDA: Prostate Cancer Victims Face Needless Suffering and Premature Death.”

FDA, with its habitual arrogance and seeming invincibility, is accustomed to ignoring the voices of patients, and it ignored, for many years, the demands of these men.

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