It has also led to a plethora of expensive drugs to treat conditions like cancer, multiple sclerosis, and type 2 diabetes which are all more effective than a placebo but often haven’t been tested much against each other. the others to determine which are the most effective.
In today’s complex world, more clarity is needed to determine what kind of efficacy the FDA should require. And should that be the FDA’s only job?
For example, should drug manufacturers prove that their drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness – the relative health value of a product versus its price – a measure used by the UK healthcare system? And in what cases is efficacy against a surrogate marker, such as an antibody level, a good enough alternative in determining whether a drug will have a significant impact on a patient’s health?
In most industrialized countries, said Aaron Kesselheim, professor of medicine at Harvard Medical School who studies drug development, marketing and law and recently served on an FDA advisory board, broad access to the domestic market is a two-step process. The first part certifies that a drug is sufficiently safe and effective. This is immediately followed by an independent health technology assessment to see where it fits in the therapeutic arsenal, including, in some countries, whether it is useful enough to sell at the price offered. But there is no such automatic process in the United States
When Pfizer requests approval, the FDA may well authorize a booster for the US market. The Centers for Disease Control and Prevention, likely with expert advice from the National Institutes of Health, will then have to decide whether to recommend it and for whom. This the appeal to judgment usually determines whether insurers will cover it. Pfizer is likely to benefit generously from government clearance, and the company will earn revenue even if only the very worried, who can pay out of pocket, decide to get the vaccine.
To make a recommendation on a booster, government experts say they need more data. They could, for example, as Dr Anthony Fauci suggested, possibly give the green light to the additional vaccine injected only for a small group of patients at high risk of fatal infection, such as the very old or transplant recipients who are taking drugs. immunosuppressive drugs, as other countries have done.
But until the United States refines the FDA’s “safe and effective” standard or adds a second layer of control, when new products hit the market and manufacturers promote them, Americans will have to decipher. which version of effective and necessary matters to them.