Prescription Drug Testing Requirements

To sell a drug in the US, drug developers must prove the drug’s benefits are determined to outweigh both known and potential risks to the population. This means comparing the drug and its side effects to the other treatments on the market for the same condition. The FDA also requires the drug company perform two “well-designed clinical trials” to assess the drug’s effects and side effects. These clinical trials occur in phases to assess drug toxicity and other factors. Some of these clinical trials may take years. Ultimately, the drug developers apply for the drug to be approved for marketing and the FDA takes an average of six months to review and approve.

Generic Prescription Safety Requirements

Generic medications are central to wellness in our society. Upwards of 80% of all drug prescriptions filled are filled with the generic brand. Because generic drugs are more cost effective, many people opt for the generic brand instead of the name brand, and save hundreds of dollars doing so.

However, there’s a law in effect which states that generic drugs must have the same FDA-approved labeling that the brand name drug has. The Supreme Court decided in 2011 that under federal law, generic brands cannot change their warning labels without the brand name drug doing so first, and unless the FDA instructs them to do so.

Not all of a medicine’s side effects are discovered in the development and initial testing of a brand name drug. This means that generic drug manufacturers may discover new side effects in their own testing as they work to mimic the brand name medicine’s effects. However, if they aren’t allowed to update the label to warn the person taking the medication, their discovery doesn’t benefit anyone. Further, the law exempts them from the liability for the side effect, even though they know about it, because they weren’t allowed to update the label.

Generic drug makers aren’t currently required to duplicate the clinical studies used by the brand name drug they’re copying. That means they can produce a similar medicine with a lot less research.

Off-Label Prescription Injury in Indiana

When a doctor prescribes an FDA-approved drug for something other than what the drug was originally intended, it is called off-label drug use. Doctors may suggest using medications for different conditions for many reasons, such as the drugs intended to treat your condition haven’t worked, or maybe a drug hasn’t been invented for what you need.

Doctors can prescribe off-label drugs for treatment, and there are risks that patients need to be aware of before they agree to fill the prescription. But, the doctor also has a duty to make sure they will not cause adverse effects. It’s important to remember that medicine is a practice. The desire to find solutions to unique problems can lead to helpful innovation, but it can also be harmful. Here’s a look at the risks and liabilities involved when a doctor prescribes a drug for off-label use.

Risks of Taking a Prescription for Off-Label Uses

Off-label drug use is fairly common practice, but it can have harmful effects when proper care isn’t taken ahead of time. For example, Zofran was approved by the FDA to remedy nausea in chemotherapy patients. The drug company then began marketing Zofran to pregnant women for morning sickness. Because it wasn’t approved for this use, doctors began to prescribe it off-label to pregnant women. But later, it was found that Zofran could cause birth defects. The drug had never been tested on pregnant women for the purpose of treating morning sickness, so there was no data to support or negate the use of the drug in pregnant women.

There were many mistakes in this case. The drug company was ultimately found liable because they were promoting the off-label use of a product even though it had never been tested on humans for morning sickness. However, the doctors also share some of the responsibility. It is the responsibility of the health care provider to use sound research and evidence in order to act in the best interest of the patient. In this case, many doctors were swayed by marketing materials that they should have realized had no scientific grounding.

The FDA recommends asking your doctor some key questions before agreeing to off-label prescription drug use, including:

  • Why does the doctor think this drug will help better than an approved one?
  • What studies have been done to support using the medicine to treat your condition?
  • What is the drug approved for?
  • Will your health insurance cover using this medicine to treat your condition?

How Common is Off-Label Drug Use in Medicine?

Nearly 75% of drugs prescribed to children are off-label, because most research conducted and medicine approved by the FDA is for adults. This means pediatric dosing errors and other errors may result in a child injured by getting the wrong medicine. In order to treat children’s diseases and conditions it’s common to prescribe off-label drugs, but parents must still ask all the essential questions we’ve discussed. A similar situation is true for cancer patients. Many treatments for cancer patients require experimentation with medications through off-label drug usage.

There have been cases where off-label drug use causes negative side effects after mixing with other medications the patient is already on. The doctor is responsible for obtaining medication history then also taking that into consideration before prescribing off-label medicines. The doctor must also make sure the patient is aware if proper research hasn’t been done on people taking similar medications.

Off-Label Dosing or Administration of Medicine

Off-label drug use is not the only way a medicine can be used for different reasons than it was created. It is also when the approved dosage is adjusted, or when the drug is given in a different way, like dissolved into food rather than taken by a capsule. This widens the room for error even more.

There are always risks when using off-label drugs. No matter how much your doctor knows about the drug, it still has not been approved by the FDA for this use, meaning testing and clinical trials might not have examined certain symptoms or side effects. If you and/or your doctor were misinformed or not told the truth by the pharmaceutical company, the liability can get more complicated. This is why working with an experienced medical malpractice attorney will make a fair treatment of your situation and case more likely.

Prescription Drug Attorneys in Indiana

The top thing to remember is that if you’ve had an issue with a drug, there’s a good chance that others have too. After you find local representation for your case, the attorney will research to see if others are bringing a similar case, both locally and nationally. If there are many cases being brought forth, the group of judges overseeing the cases can have them all sent to one district court judge. This way, attorneys don’t need to teach and explain medicine to a number of different judges, but can instead just show one judge what the medicine is supposed to do, and what happened instead.

If the case gets moved to one judge, this is called a multi-district litigation, an MDL for short.

Multi-District Litigation Explained

You’ve probably heard of a class action lawsuit from commercials. MDLs are different than class action lawsuits. In a class action lawsuit, there’s one blanket settlement that all of the plaintiffs share. In an MDL, while the cases are grouped together, everyone keeps their own attorney, and each one receives their own, individual settlement based on their needs.

Typically, the pharmaceutical drug in question has caused damaging side effects to individuals who have been prescribed to take them. However, it may be due to negligent labeling. As generic medications become more prevalent, their labeling isn’t being updated. As these medications are distributed and new warnings are discovered, the labels simply aren’t updated appropriately.

Local Indiana Prescription Drug Attorney

If you have been the victim of an undisclosed side effect of a pharmaceutical drug, it’s important that you have a local attorney representing you. A local attorney that knows the ins-and-outs of local legal systems can help provide the best representation.

Everyone experiences things differently. Because of these different experiences, it’s hard to determine what is right for each plaintiff. This is why MDLs are settled individually—to make sure you get the compensation you need to keep your life as normal as possible.

To help mitigate this, some plaintiffs hire local attorneys to represent them, so that they are able to file a lawsuit for a different award or sum of money—one that is more representative of their needs.

The Indianapolis medical negligence attorneys at CFCLB want to help you get what you need to move forward in life with peace of mind. From fighting for you in court to helping you plan for every new challenge you may face, we’re your advocates. If you experienced an undisclosed side effect and believe you have a case, contact us today for a free consultation.