Who Is the FDA?

The Food and Drug Administration (FDA) is a federal agency within the U.S. Department of Health and Human Services and is one of the government’s executive departments. It monitors a wide variety of products, ranging from medicines and medical devices to food and other products, such as Roundup, airbags, earplugs, and talcum powder. With so many different consumer products to monitor and approve, as well as millions of reports on products that are already on the market, the FDA has a lot to keep track of. For new products, the FDA has to rely on the information and results of tests and clinical trials provided by the company applying for approval.

What Is the FDA’s Approval Process?

Before the FDA approves any product, food, drug, or medical device, it requires the applicant company to thoroughly test its product and provide the results to the FDA. The process differs depending on the type of product, but the company must prove that the benefits of the drug or device outweigh the potential side-effects and that it is safe for consumers. Once a company has completed its testing and clinical trials, it has to submit all evidence and results to the FDA for approval before it’s allowed to market the product.

Every type of product, including medical devices and pharmaceutical drugs, that the FDA monitors has a fast-track approval process available to companies. This accelerated evaluation process can be beneficial in that life-saving medical treatments can reach patients faster, but it also means that there’s less time for thoroughly evaluating products and medicines. If there’s a need for a particular medical device or drug to treat a life-threatening condition, that device or drug could be sped through the evaluation process and approved despite the existence of potentially harmful side-effects.

Conflicts of Interest Between FDA, Manufacturers, and Research Scientists

Companies can put pressure on the FDA to approve their products because they donate money to fund the FDA’s research. In addition, companies can influence the doctors who participate in the evaluation and approval process by “donating money” to them in order to try to smooth over or speed up the outcome. So much of the FDA’s funding comes from pharmaceutical companies (up to 75% for some divisions of the FDA), so the FDA’s ability to act as a regulator is affected.

Pharmaceutical Lobbyists & Political Influence

Drugs that are banned in Europe and elsewhere in the world make it onto the market in the United States. Drugs that have failed clinical trials are often approved, later causing harmful side-effects to the patients that take them. The approval of Oxycontin in 1995 without clinical trials contributed to the beginning of the opioid epidemic. If a drug isn’t approved, companies will resubmit the next year and pressure the FDA into approving them, this time without the advisory board members who had warned of the drug’s risks the year before.

With the pressure companies are capable of placing on the FDA and research scientists, as well as the fast-track approval process available, it’s possible for products to make it onto the market before dangerous side effects are fully understood. If you or a loved one has been harmed by a defective product of any kind, Farah & Farah is here to help. Our team of highly skilled attorneys has years of experience in fighting companies whose products have harmed patients and consumers, so you can seek the compensation you deserve.

The product liability experts at Farah & Farah are experienced in a wide variety of defective product cases, including:

Defective Drugs

Defective drugs are medications that have been found to have risks and dangers that can harm or injure the patients who rely on them to treat medical conditions. In many cases, defective drugs have more severe side effects than the company warned about, or were found to have caused harm or injury to patients taking the drugs.

Defective Medical Devices

Defective medical devices are devices used to treat a medical condition that have caused harm or injury to the patients they were supposed to help. These can be both devices used externally or internally to the patient. However, many medical devices have been found to be defective, causing harm or injury to the patient.

Defective Airbags

Auto designers, manufacturers, and distributors have a responsibility for the safety of the products they sell to U.S. consumers. In recent years, major auto manufacturers have recalled millions of vehicles across the country as a result of defective airbag systems that injured drivers, especially those manufactured by Takata Corp.

Roundup

Roundup is a weed killer used both in private and public gardens and on a wide scale in agriculture. Glyphosate, its primary ingredient, has been found to still be present in food sold in stores. In addition, some people who use Roundup regularly have claimed that it has caused them to develop cancer.

Talcum Powder

Talcum powder is an over-the-counter product that is used to treat rashes and absorb moisture. It’s been linked to ovarian cancer in women, as well as lung damage and breathing complications in infants. The manufacturer has stood by its product, claiming that it is safe, despite growing evidence of its risks.

What If I’ve Been Injured by A Defective Product?

Mistakes made by the manufacturer and distributor of a defective product may have harmed you and your family in irreparable ways. Injuries and deaths due to defective products can take a heavy toll on quality of life and on family finances due to lost wages, medical bills, and pain and suffering. Seek the compensation and justice you deserve. Let one of Farah & Farah’s experienced attorneys represent you and take on the company that harmed you or a loved one. Contact us now for a free consultation about your case. You pay nothing unless your case is successful.