‘Dysfunctional’ FDA Unable to Monitor Drug Safety

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An independent panel made up of experts who study matters of science for the government has revealed its pointed findings — and it’s certainly not positive for those of us whose health relies on prescription drugs. The Institute of Medicine says the country’s Food and Drug Administration (FDA) needs to fix how it monitors drug safety with the help of more staff and more funding.

 The issue doesn’t lie with brand-new drugs that have gone through stages of tests before manufacturers apply to the FDA for approval. These drugs are being tracked for years before they even hit your local pharmacy. Instead, the real issue has to do with the safety of medications that are already on the market. After all, the long-term effects are not known for any drug and often the complete picture of what adverse events they might cause is not clear, either.

 For a parcel of proof, look at what’s happened to the class of much-lauded painkillers called COX-2 Inhibitors. “Rofecoxib,” “celecoxib,” and others have had their share of problems, such as reported links to heart issues, and they’ve been yanked from the pharmacy shelves.

 The Institute also says in order to alert consumers that less is known about potential side effects, any new drug (less than two years old) should carry a “new drug” symbol on it. And at any drug’s five-year anniversary of being on the market, the FDA should formally review everything it knows about it — the risks, the benefits, everything.

 The Institute isn’t doing this just for the fun of being critical; the FDA actually asked for this review following the deep criticism it received after news broke out about rofecoxib’s hidden effects, which put people at a greater risk of having a heart attack.

 The Institute says since the COX-2 Inhibitor situation, the FDA has improve its system of monitoring approved drugs, but still faces “major obstacles.” Most sternly, it calls the FDA’s organizational culture “dysfunctional.” It is also lacking in the area of making the public aware of the risks and benefits of most drugs — being a communications breakdown. The FDA is steadily losing credibility with the public as its trustworthiness has corroded.

 None of this is great news, because the FDA is supposed to be the watchdog for the drug industry, keeping the public safe. It should know full well what your risk is of suffering side effects from any drug. After all, these are pills that intentionally disrupt your chemical balance and bodily functions. Shouldn’t we — the ones swallowing them — know everything there is to know about them?