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Breakthrough therapy means hasty FDA approval

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It certainly is a miraculous time in which to be living. The advances society has made in technology and science are mind-boggling, and you may be among those who appreciate the modern conveniences that make the world a safer, healthier place.

Among the most important advancements of recent years are drugs and medical devices that allow many to live productive lives with health conditions that may have formerly left them debilitated. You likely feel confident using pharmaceuticals that carry approval from the Food and Drug Administration, but recent investigations show there is more than one way to gain the approval of the FDA.

What is Breakthrough Therapy?

Getting beneficial drugs and devices into the hands of suffering patients is a noble goal, and the FDA cites that goal as its motivation to fast-track some drugs through the approval process. If your doctor prescribed the Nuplazid to treat psychosis associated with Parkinson’s disease for a loved one, you may have felt a sense of relief that such a drug existed. Unfortunately, over 700 patients have reportedly died while using the drug. If your loved one was among them, you have a right to answers.

The FDA approved Nuplazid through a program called Breakthrough Therapy designation. This program allows promising drugs to pass the approval process with substantially less scientific evidence of their effectiveness in treating the condition or of their safety. Drugs that win approval through Breakthrough Therapy are typically those designed to help people suffering from serious conditions. You may be painfully aware that no other drug is available to treat the psychosis many victims of Parkinson’s disease suffer.

The problem with rushing approval

When your loved one was taking Nuplazid, you may have noticed very little change in his or her symptoms. This is typical of many breakthrough drugs, which the FDA may approve using only clinical data and without the larger studies most other drugs undergo. Because of the desperation of some conditions for which no other treatment exists, the FDA may justify approving a drug that has not had extensive testing.

Often, the drug manufacturers are aware of a drug’s grave side effects, but those with diseases such as Parkinson’s, cancer and Alzheimer’s are vulnerable and desperate to find relief. If your loved one’s doctor prescribed a medication like Nuplazid that received FDA approval through a fast-track program, you may be feeling the pain of having watched your loved one suffer and perhaps die as a result. You have every right to seek legal advice about the options available for pursuing justice.

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