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The Process for Pharmaceutical Drug Approval — Is it Foolproof?

According to a study conducted by the Mayo Clinic, 7 out of 10 Americans take at least one prescription drug. The most common being an antibiotic, followed by antidepressants and opioids. 20 percent of the American population is on at least 5 prescription medications.

The hopes of anyone taking prescription drugs are generally to feel better and be able to function well with whatever their issue may be. As one takes medication, most likely they assume it is safe for them. However, this is not always the case.

The process of approving a drug to be prescribed to patients involves many steps.

  • The preclinical phase is the beginning of the process and can take as long as 3 to 4 years.

  • If phase one is successful, it is generally followed by an application to the FDA for an investigational new drug (IND). The FDA decides if it is safe enough to move forward in testing humans. (at this point, lab animals have generally been given the medication)

  • A local institutional review board (IRB) made up of both scientists and non-scientists from various hospitals review the entire clinical trial protocols, which describe the type of people who may participate in the clinical trial, the type of tests and procedures, the length of the study, the dosage amounts and the entire objective of the study as well as various other details. They are making sure that all steps have been taken to minimize any potential harm to study partcipants.

  • Next, anywhere from 20 to 80 healthy volunteers take place in the study. This phase is generally to see what type of side effects the medication may cause.

  • If that phase passes where the levels of toxicity are not unacceptable, then the next phase will begin where they are testing to see if the medications actually are able to help the certain illness or disease that it is meant to help.

  • From here it goes to a higher phase where several hundred to 3,000 people are tested on the medication.

  • If the drug has passed to this point, the FDA must continue more research and studies on the medication regarding its' safety and optimal use.

  • The next phase is the NDA (new drug application) where the drug sponsor asks the FDA to consider approval of the medication.

  • Check here for more details and information regarding FDA drug approval.

As you can see the process is not easy or quick. However, even with such a grueling and tedious process, there can still be problems. Below are some of the most common medications that can cause problems if they are not monitored closely and taken properly.

Keep in mind, any medication can be susceptible but these are just the most common.

  • Beta Blockers (medications that reduce blood pressure)
  • ADD and ADHD medications
  • Arthritis medications
  • Blood thinners
  • Chemotherapy drugs
  • Diabetic drugs
  • Pain Killers
  • Prozac and other anti-depression medications

When you feel you may have adversely affected by a pharmaceutical drug, there are many different avenues to consider. Was it the physician that prescribed the wrong type of medication or dosage? Perhaps it was the pharmacist that filled your bottle with the incorrect medication which could result in a malpractice suit. Or, was it the manufacturer of the medication where it could be a defective products lawsuit?

These situations can get very tricky and it is best to have an attorney with experience in defective pharmaceuticals, a very specialized area of law.

Legal claims involving medical malpractice and pharmaceutical drugs must be filed within a certain timeframe. Do not delay consulting with an attorney, as this can be used in either reducing your settlement or throwing your case out altogether.

Attorneys at the Gilreath Law Firm (…offices in Knoxville, Nashville and Memphis) have extensive experience with defective pharmaceutical cases, and can determine if your case warrants further legal action. Please contact our Tennessee firm to schedule a consultation, or continue browsing our blog and Tennessee Personal Injury Guide to learn more about defective medications, medical malpractice and much more!

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