Since the Federal Food and Drug Act came into law in 1906, the Food and Drug Administration (FDA) has had a century to develop their methodology for insuring drug safety. After expanding to an annual budget of $1.5 billion and a staff of 10,000, they continue to seek additional responsibilities–such as the same control and approval authority for over-the-counter vitamins and nutritional supplements that they exercise over prescription drugs. Now they announce that, whatever their other priorities are, they have not been able to adequately insure the safety of prescription drugs and want to establish an additional bureaucracy in the form of a new “Drug Safety Board” to do so. The first proposed solution to administrative failure in government, no matter how vast the agency, always seems to be more regulation, more staff, and bigger budgets.
The FDA has undoubtedly prevented much harm from unsafe drugs that might otherwise not have been vetted–although this could have been accomplished by other means. But it added enormously to the development cost of new drugs, thereby substantially adding to their price, and delaying their benefits being available to patients–sometimes for many years. It has also, with cruel indifference, prevented access to experimental drugs by terminally ill patients who are near death and willing to take some risk to stay alive. With all this control and lengthy review, we clearly still have drug safety problems, and it is time to explore options other than adding to the size and power of the FDA.
First of all, we need to realize that neither the FDA nor anyone else can do the impossible. When a new drug comes to market, no one can know all of its side effects, nor the impact on all other medical conditions that a patient might have, nor how it might interact with any dosage of any combination of an infinite number of other drugs–nor the cumulative effect of ten, twenty, or thirty years of use. If omniscience is required, no new drug will come to market. The good news, however, is that computers and the Internet now provide excellent tools to accumulate and tabulate data on the impact of every new drug. Unexpected consequences can now quickly be detected and dealt with. The incredible benefits to health and longevity that new drugs have achieved in recent years clearly require that we make it possible for new drugs to come to market at reasonable cost.
We need to open up the approval process for new drugs to private laboratories, both corporate and non-profit. This could take the form of both monitoring and observation of the testing by the drug companies themselves, and testing by independent research facilities in the final stages of development. Independent laboratories would be liable only for the accuracy, integrity, and robustness of their research, not for all possible future side effects of new drugs. Such research should be funded by the drug companies themselves, paid to third party institutions that would randomly assign the research to the independent laboratories that meet qualification standards.
These reforms could be undertaken over an extended period, selecting one category of drugs at a time. It could apply only to new research, so that work currently underway would not be interrupted. We should explore this and other alternatives to placing our health exclusively in the hands of omniscient and omnipotent government. The FDA cannot be omniscient, and we must not allow it to seek omnipotence.
The best protection for patients is the self-interest of drug companies. The beauty of private research is that is has to get results. Drug companies will prosper only if they bring drugs to market that are effective without unreasonable side effects–and as they maintain a reputation for doing so. In addition to whatever independent review process is used, we may also rely on the self-interest of legions of trial lawyers to pursue any malfeasance that might circumvent the review process.
Freedom is a more thorough and relentless defender of safety than layers of bureaucracy. Expanding freedom can benefit our health far more than concentrating power.
