If the Pharmaceutical Drug Approval Process Fails, Who’s to Blame?

By Staff Writer

When pharmaceutical drug companies are being monitored for the safety of their products, it’s troubling to think of a patient experiencing an unintended or ill side effect from a prescription drug that is supposed to be helping, not hurting.

According to the U.S. Food and Drug Administration, it is the responsibility of the company seeking approval to market a drug to conduct laboratory and animal tests on the safety and effectiveness of a proposed new prescription treatment and then to submit that information to FDA for review.

Preclinical trials can take up to four years to complete, and include the following:

• Whether the drug has the effect it is supposed to have
• How much of the drug to give to a patient and how often
• What side effects are associated with the drug and how they can best be managed
• How a drug is broken down in the body and how long it stays in the body
• Which foods, drinks, or other drugs can be used at the same time or should be avoided

Even with the most tedious trials, some common medications, such as beta blockers, ADD and ADHD medications, have been found to cause problems if they are not monitored closely and taken properly.

But, who is at fault if a drug has an adverse effect on a patient? Is it the company for not ensuring the drug’s safety, the government for not being stringent enough on its review, the doctor for prescribing the medication in the first place, or the pharmacist who bottled it?

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

Learn more about the complexities of defective pharmaceutical cases.

With offices in Knoxville, Nashville and Memphis, award-winning attorney Sid Gilreath and his highly skilled legal team are taking defective pharmaceutical cases right now. To determine if your case calls for further legal action, schedule a free consultation with Gilreath & Associates today, or continue browsing our blog to learn more about similar cases of defective medication, medical malpractice and negligence.

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