Approval of drugs

How should new drugs be approved? We tend to believe that a drug is perfect, a completely safe and faultless cure for what it is intended for (and often for what it is not). Then when there are side effects we suddenly regard it as too dangerous to use and it must be banned immediately. Both views are wrong. There should be a balance of risks and rewards. New drugs especially have risks. Some people will be hurt. What should be done? We have developed a value system with the belief that a person who is injured should not be left without compensation, increasing the damage, a reasonable choice. Thus there should be insurance. We have an insurance system, malpractice, but it is an irrational one.

Drugs are approved after testing. But it is impossible to test enough people and still have drugs approved in a reasonable amount of time and at reasonable cost. Thus there has to be post-market surveys, which is recognized and required, but not enforced. This is easily fixed. Approval should be for 2 years (although different types of drugs might require different lengths of time). For reapproval post-marketing data must be submitted. This should be done several times until the risk profile, and the drug’s value, is clear. Thus post-marketing surveys will be ensured.

And insurance for drugs and new types of surgeries should be required. That will provide compensation in a rational manner. And it will inform people of the risks so that they can make more rational decisions. There will be a statement on the label “one quarter of the cost of this is for insurance, which is high”. Patients and doctors can then discuss whether the risks are worth taking. As more experience is gained and the potential dangers lessened the premium will generally be decreased. Related is the overmarketing increasing the dangers; too often drugs are pushed for off-label uses for which they should not, or rarely, be used. Overmarketing will increase the premium, increasing the price and emphasizing the danger of the drug, making it less desirable. There will not have to be fights at the FDA on banning the drug. The insurance company will have its money at risk so it will greatly increase the premium, if the drug is misused, providing a warning, and decreasing sales. The drug companies will thus have an incentive not to overmarket. Both liberals and conservatives should like this. We will have fewer risks from drugs, and the ones will be better known, the government’s role will be decreased, people will be freer to make their own decisions, private enterprise and the market will decide.

If the drug companies are honest they will have nothing to fear if the drug causes problems. If they are dishonest they will not only have to fight malpractice suits, but fight the insurance companies. And the premiums for all their other drugs will increase. This will make honesty and transparency much more attractive than now.


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