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What the FDA Does—and Doesn’t Do—to Protect Patients

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The FDA regulates medicines and medical devices but does not compensate you if something goes wrong

It is the job of the Food and Drug Administration (FDA) to make sure that the medications and medical devices that are on the market in the United States are safe. The agency typically requires that safety tests are performed by the pharmaceutical company before the FDA reviews the company’s application for FDA approval. Unfortunately, this doesn’t always result in safe medications.

Sometimes Dangerous Drugs or Medical Devices Enter the Marketplace With FDA Approval

There may be several different reasons why a drug that is later found to be unsafe entered the U.S. market with FDA approval. For example, some drugs may:

  • Not have undergone adequate testing.
  • Have side effects that are not known until the drug is used by many people after approval.
  • Become contaminated during the manufacturing process.
  • Lack adequate warnings for physicians and patients.
  • Be dangerous in some other way.

In these cases, it is the FDA’s responsibility to warn the public and to issue a recall if necessary for public safety.

Don’t Count on the FDA to Compensate You for Medication or Medical Device Injuries

If you’ve suffered a medication or medical device side effect, then you can report your injury to the FDA. The FDA relies on reports by patients and doctors to monitor the safety of prescription medications once the medications are approved and used in the marketplace. Your report may cause the FDA to investigate the safety of a particular drug, especially if other reports of similar side effects are received by other patients or doctors. Eventually, the FDA may require the drug manufacturer or distributor to take certain actions. But note this: it is not the FDA’s role to compensate you for your injuries.

But That Doesn’t Mean You Can’t Be Compensated

You have to protect your own recovery. One way to do this is to contact a pharmaceutical class action lawyer. An attorney can help you understand your rights, provide you with tips and resources to protect your pharmaceutical injury claim, connect with others who have also been hurt, and fight for the recovery that you deserve.

You do not have to wait for the FDA to take action. Instead, you can contact us today via this website or by phone at 1-800-800-5678 to learn more.

Jason F. Abraham
Managing Partner, Hupy and Abraham

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