Approving Pharmaceutical Drugs – Does the Process Work?

According to the U.S. Centers for Disease Control and Prevention (CDC), 48.5 percent of people from 2007 to 2010 had taken at least one prescription drug within a 30-day time period. And, 75.1 percent of physician visits in the United States involved drug therapy. With such a high volume of prescription drug use in the United States, the validity of the prescription drug approval process in the U.S. has been brought into question.

How does the drug approval process work?

Before a patient can use a prescription drug, the U.S. Food and Drug Administration (FDA) must first approve the drug. According to the FDA's website, the very first step in the process is laboratory and animal testing of the drug. If all goes well, the drug is then tested on humans. Assuming no major problems occur, the drug manufacturing company requests approval from the FDA. Approval from the FDA is based on:

        1. The drug's testing results
        2. Manufacturing information
        3. The company's proposed drug label (use, risks, and warnings about the drug must be posted)

Finally, the above components are reviewed and a decision about the drug is made. The FDA's ideal timeframe for completing a review is 10 months. However, testing of the drug can take years.

Dangerous Drugs Today

Despite the fact that the testing and approval process of prescription drugs is extensive, there are many dangerous drugs on the market today. Some of these drugs include antidepressants, birth control pills, testosterone replacement therapy treatment, and diabetes medications. The drugs have been linked to a number of dangerous health conditions, ranging from heart attack and stroke to birth defects. The fact that dozens of dangerous drugs have been approved by the FDA, used by patients, and have caused adverse health effects for users is troublesome.

Defective Pharmaceuticals Lawsuits

The manufacturer of a prescription drug has a duty to create a drug that is relatively safe for a patient to use. If a drug maker fails to create a drug that is safe – or fails to disclose all of the risks associated with the drug – then the manufacturer may be held liable for the harm that a patient sustains.

Unfortunately, defective pharmaceuticals and dangerous drugs are prevalent. If you or a loved one has taken an unsafe drug and been harmed as a result, then you need an attorney on your side who can help you to file a lawsuit for damages. In some cases, you can also file a medical malpractice claim against the healthcare professional who prescribed you the defective pharmaceutical.

Contact a Dangerous Drug Attorney Today

The FDA has failed to keep certain dangerous drugs off of the market. If you've sustained any injury or harm from a prescription drug, then you deserve compensation for your injuries. To begin, contact a dangerous drug attorney in your area immediately.

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Workers Compensation
Attorney Profile:

Meet Colorado Workers' Compensation, Personal Injury and Insurance Dispute Attorney R. Mack Babcock

Prior to founding The Babcock Law Firm, LLC, R. Mack Babcock spent many years on the other side of workers' compensation , personal injury and insurance disputes representing some of the largest insurance companies and corporations in Colorado as an attorney at a midsize insurance defense firm.

Babcock is a member of the Colorado and Denver Bar Associations, the Colorado Trial Lawyers Association and the Workers' Compensation Educational Association.  In early 2008, he was elected as the Colorado House District 43 Committee Chairperson for the Douglas County Colorado Democratic Party. In connection with this position, he is responsible for finding a candidate(s) to run for House District 43, overseeing the campaign(s), organizing volunteers, and also sits on the executive committee for the Douglas County Democratic Party.