Why Drug Approval and Recall Systems Leave Patients Vulnerable to Harmful Drugs

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The drug is on the market, so it must be safe, right? Although this assumption is entirely reasonable, it is not always true. The FDA approval and recall processes can allow harmful pharmaceuticals to remain on the market until the injuries and deaths of patients make problems too obvious to ignore.

The U.S. Food and Drug Administration (FDA) initially approves medications based upon information provided by the manufacturer. The drug companies bear the responsibility of conducting laboratory and clinical testing. The data collected by the company is then passed to the FDA's Center for Drug Evaluation and Research (CDER) for review. The government agency does not perform its own research, but instead relies on the manufacturer’s studies to determine whether a drug is safe and effective.

Flaws in studies — or, sometimes, fraudulent tests — may produce inaccurate and misleading data. Furthermore, after spending millions on research and development, drug corporations have a strong incentive to get a drug approved despite lingering concerns about safety and efficacy.

In addition, it is up to the medical company to recall defective drugs. Only in rare circumstances does the FDA order a company to involuntarily withdraw a drug from the market. Usually, the corporation makes a voluntary decision only after substantial evidence exists that the drug may cause harm. This means that several patients may be hurt or killed before the medication is removed.

In light of this alarming news, how can you protect your family from dangerous pharmaceuticals?

  • Do your research — Check the FDA’s drug recall list before taking the medication and review the list periodically if using the medication long-term.
  • Be proactive about your health — Report adverse health symptoms you suspect have resulted from the medication.
  • Discuss your health concerns with your doctor — Don’t assume your doctor prescribed the correct medication if you aren’t getting better or if you are feeling worse.
  • Consult a personal injury attorney — A personal injury lawyer can advise you on your legal rights if you or your family member suffered injury because of a defective pharmaceutical product.

Topics:  FDA, Prescription Drugs, Product Recalls

Published In: Personal Injury Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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