Pharmaceutical Litigation Attorneys
Pharmaceutical Litigation
Helping the Injured Seek Justice and Financial Compensation.

FDA Approval System

Protecting Patients from Dangerous Drugs and Medical Devices

The Food and Drug Administration (FDA) is an agency in the United States Department of Health and Human Services. It has many responsibilities, all related to protecting the public health. The agency’s responsibilities pertaining to drugs and medical devices are to ensure that these are safe, effective and properly labeled. The FDA also helps the public get accurate information about medical devices and drugs that can be used to improve their health. Other responsibilities include tobacco regulation, protecting the public from electronic product radiation and protecting the public health related to foods, veterinary drugs, vaccines, cosmetics and dietary supplements.

Drug Regulation

The Center for Drug Evaluation and Research (CDER) is the part of the FDA that regulates both prescription and over-the-counter drugs. In addition to regulating prescription medication such as antidepressants, pain killers and antibiotics, CDER regulates over-the-counter products such as sunscreen, fluoride toothpaste and even antiperspirant. All prescription drugs must have FDA approval to be sold in the United States. The process typically involves laboratory tests, human tests, and then the filing of an application with the FDA that includes information on the test results, manufacturing information and the proposed label for the drug, such as its intended purpose, risks, benefits, etc. The FDA will review this application and may approve the drug if it finds that its benefits outweigh known risks and it can be properly manufactured.

Medical Device Regulation

Like drugs, medical devices are regulated by the FDA. The Center for Devices and Radiological Health (CDRH) has the task of regulating companies that import, design, manufacture, repackage and re-label medical devices. A company interested in selling a medical device in the U.S. must file either a 510(k) or premarket approval (PMA) application with the FDA. A 510(k) is filed if the device is “substantially equivalent” to a device that is already approved and marketed for the same use. A PMA application is filed in other circumstances. With a PMA application, the company must prove that the device is reasonably safe and effective.

When FDA-Approved Drugs and Devices Fail

At times, FDA-approved drugs or medical devices cause injury to patients. The information provided to the FDA may have been incomplete or inaccurate. The drug company or manufacturer of the medical device may have been negligent in testing the drug or product. Certain side effects may only arise after long-term use of the product. A manufacturer may market the drug or device for the wrong purpose or may make misleading statements as to the purpose of the product. Whatever the reason for the product’s initial approval and subsequent harm, patients may be left injured and families may lose loved ones.

Patients and healthcare providers can and should report adverse reactions to the FDA through the MedWatch system. The agency uses these reports to compile information on prescription drugs and medical devices. It uses these reports to conduct its own studies and may review other studies to ascertain whether a product should remain on the market. Depending on the findings of a study, the FDA may require the warning label for the product to be updated, issuing a safety alert or warning. It may also request that the manufacturer remove the product from the market altogether, through a recall.

Patients who have suffered from serious side effects and complications caused by dangerous or defective medical devices and drugs may also take legal action against the manufacturer in civil court. A pharmaceutical litigation attorney at Napoli Shkolnik PLLC can determine what party should be held accountable in order to help a client seek fair financial compensation for medical care, lost earnings, pain, suffering, emotional trauma and other damages caused by the product.