The Institute of Medicine (IOM) is taking the U.S. Food and Drug Administration (FDA) to task. In a new report, the IOM says the FDA should conduct more regular reviews of drugs to better catch and track safety issues.
In order to better inform patients and the doctors who treat them, the FDA then needs to create a publicly available document so the public can understand what risks they are really taking when prescribed a drug, without which you cannot have a true informed consent. That analysis of the drug should continue over its lifetime, says the IOM study.
As it stands now, the public marketing of a drug is really the final clinical trial. Almost all drugs have some sort of side effect and in a diverse and large population these complications begin to show up. However, if you are not looking for them, many people will be injured before something is done.
That’s what happened to Merck’s painkiller Vioxx, which remained on the market while about 27,000 patients suffered heart attacks or strokes. It took five years to track the problem enough to pull Vioxx from the market. This was as totally preventable pharmaceutical injury if only someone was watching.
The Institute of Medicine provides scientific expertise when called upon to produce a report. The FDA does not have to follow the recommendations and Reuters reports they are not binding. A spokeswoman for the FDA said the agency supports “the general concept of enabling the public to be able to clearly monitor relevant safety issues for all drugs.”
Without additional funding, the agency which is already way over its head in terms of the monitoring of our food, drugs and medical devices, will never be able to implement this recommendation.
The current regulation is for the FDA to check on a drug’s safety after it’s been on the market for 18 months or 10,000 patients have taken the drug, whichever comes later. And how does the FDA ever know about ‘adverse events’? That is up to the doctors, patients or drugmaker to submit any reports it gets of complications to the agency. Imagine the incentive a drugmaker has to report on itself?
Until 2007 there was nothing the FDA could do to force compliance of reporting regulations. But that year a law was passed to give the FDA some muscle to compel manufacturers to conduct post-approval safety trials or to change a label when safety concerns arise.
Reuters reports on a FDA report issued last month that said the agency now spends as much money tracking a drug after it is on the market as during the pre-approval process.
To make the point, the FDA says it ordered 385 post-market studies over the last four years and to force a label change 65 times.
Remember- reports coming into the FDA represent just a fraction of what is occurring in the real world.