Medicine
Have you ever wanted to know some of the reasons why unsafe drugs make it through the FDA approval process? Who approves drugs in the United States and what criteria they are using? Here are a few facts about the FDA approval process.
You may have seen the ads for prescription medications with lengthy lists of side effects that sound worse than the condition the drug treats. Some of the latest drugs and medical devices have caused serious injury and even death to those who use them. These cases eventually end up in medical personal injury cases in the court system. If you are wondering who approves drugs in the United States and what criteria they are using, here are a few facts about the approval process:
How Drugs Are Approved
New drugs that are developed by pharmaceutical manufacturers must go through a process of testing to ensure that the medication is both effective for a medical condition and safe to use. Initial tests are done by the manufacturer, which then must pay the U.S. Food and Drug Administration to do their own tests. The pharmaceutical manufacturer having such a strong interest in a positive result can create the appearance of a conflict of interest. Related articles
Fast-Tracking Needed Drugs
In the case of some serious medical conditions, the need for new treatments is great enough to require a faster approval process. Although this strategy can often save lives and provide greater function for some conditions, the risk of life-threatening side effects may be increased. Balancing the need for a new drug with sufficient testing to ensure its safety are important considerations for both the manufacturer of the medication and the approval agency.Problems With Drug Studies
In some cases, new drugs replace old ones that are already on the market. The new medications may involve greater risk without providing greater effectiveness than the old drug, but may provide drug companies with larger profits. The tests do not always cover some groups of patients with other medical problems or are not conducted over a long period of time. Problems and injuries may occur after a period of use, when neither the patient nor the physician is expecting them.When Drugs Go Wrong
Inadequate testing of new drugs can result in serious injury or death for patients. Some consumers are advocating for independent funding for the Food & Drug Administration to ensure no undue influence is being exerted to approve drugs and that any potential dangers of an approved drug are made known to consumers via warning labels and easily-accessible information. An outside watchdog agency could also add an additional layer of protection for consumers. Greater care during clinical trials could ensure that consumers are adequately protected from unsafe drugs.If you are prescribed a new medication, talk to your doctor about side effects and other problems that are known to be a problem. When side effects develop, inform your doctor immediately for advice. When drug-related injuries occur, contact a medical personal injury attorney for information about your right to compensation under the law.
| By Emma Sturgis | Embed |
About the Author: Emma is a freelance writer from Boston, MA. Information on the importance of including necessary warnings with pharmaceutical products was provided by a specialist from CPR Law. Questions? Say hi on Twitter @EmmaSturgis2
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