The Role of the Food and Drug Administration in Approving Drugs

Test tubes filled with colored fluid
The Food and Drug Administration is the federal department which is responsible for regulating the approval of medications and medical devices such as Xarelto and IVC filters. The FDA has an approval process during which pharmaceutical companies must meet legal requirements and standards.

Unfortunately, the Government Accountability Office (GAO) has reported on several occasions that the FDA lacks adequate staffing and resources to effectively manage its responsibilities. This criticism focuses on a number of problems regarding the FDA’s approval process including:

  • Conflicts of interest in the agency’s relationships with pharmaceutical companies.
  • Failure to have mandatory adverse events reports.
  • Flawed approval procedures.
  • Faster approvals leading to more safety concerns.

Here at the law offices of Hotze Runkle, we understand the damages that can occur when faulty medical devices and dangerous drugs are allowed out into the public. We believe it is vital that victims and potential patients understand the risks associated with these products. Thus, we make it our duty to inform the public about vital information that can help you better understand the situation.

How does the FDA approval process work?

The FDA approval process can be a relatively long proceeding. There are a number of steps that must be completed in order for pharmaceutical companies to have their products approved, although, recent laws such as the 21st Century Cures Act are beginning to deregulate and quicken the process.

The FDA approval process includes:

  • Preclinical Trials: This process begins before the FDA is involved and essentially works towards proving a given drug or medical device is safe on animals. Data is collected and provided to the FDA in the form of an Investigational New Drug application. If accepted, the company can begin testing their product on humans.
  • Phase I Clinical Trials: Drugs are administered to healthy participants who do not have the disease for which the drug is aimed to treat. This phase is intended to determine the safety of the drug, side effects, and how the drug is processed out of the human body. If there are no unacceptable risks, the clinical trials continue on./li>
  • Phase II Clinical Trials: Phase II focuses on drug safety and efficacy, and is provided to individuals with the disease. During this part of the process, 2 groups of volunteers (ranging from dozens to hundreds) are given either the drug or a placebo. The data is analyzed, and if successfully completed, the FDA and pharma company work together to develop a large-scale trial.
  • Phase III Clinical Trials: This is the largest of the three clinical trials and continues to focus on safety and effectiveness. Demographic variables are introduced at this point and researchers look to see if the drug or medical device is working as it is intended to.
  • New Drug Application: After the clinical trials have been successfully completed, the company submits a new drug application. They will provide data about the preclinical period as well as from the three-phased clinical trials. An advisory committee may be created to review the data and provide advice to the FDA regarding its efficacy and safety. The FDA then makes its decision.

Criticisms of the approval process.

As previously mentioned, the Government Accountability Office has taken note of some of the largest criticisms against the agency.

One of the most substantial criticisms against the FDA approval process is that the preclinical trials and the three clinical trials are all developed and performed by the companies themselves. Meaning there is a high potential that internal company researchers and scientists can essentially lie about results and effectively leave out any negative information that could result in an FDA denial.

While this could appear as mere speculation, a 2006 survey created by the Union of Concerned Scientists found that almost one-fifth of FDA scientists had been asked to exclude vital information or change technical data on their conclusions in reports and FDA documents.

Perhaps even more stunningly, a 2005 report by professional journal Nature found that 70% of FDA panels who were involved in creating clinical guidelines regarding medication usage included at least one panel member who had financial links to the companies whose products were being surveyed.

While the FDA did eventually set forth new guidelines that would no longer permit such behavior, the damage was conceivably done.

Have you or a loved one been severely injured as a result of taking medications such as Xarelto or because of faulty medical devices like IVC filters? Let the national litigation team of Hotze Runkle serve your needs and provide you with the commitment to get the job done.

If you or a loved one has suffered adverse effects as a result of an IVC filter implantation or as a direct result of taking the anticoagulant, Xarelto, contact a team that fights to earn your trust—contact Hotze Runkle.

Our team of experienced and high qualified lawyers has the ability to make pharmaceutical companies pay for the damaged they have caused. Reach us today at (877) 919-0830 to learn more about how we can put our years of experience to work fighting for you and your family.