The Role of the FDA in Making Sure Medications are Safe During Pregnancy

What is the FDA?

The United States Food and Drug Administration (FDA) is a federal agency that is responsible for protecting the health of the public. It does this by ensuring the safety, effectiveness, and security of medicines and medical devices, the nation’s food supply, cosmetics, and products that emit radiation. The FDA also regulates tobacco products—their manufacturing, marketing, and distribution—to protect public health and reduce tobacco’s availability to minors.

The FDA encourages and advances innovation of medicines and medical products in an effort to make them more effective, safer, and more affordable. They also make sure that the public gets accurate, scientific-based information about the products and foods that are used to maintain and improve health.

Finally, the FDA has a role in America’s counterterrorism activities. The FDA ensures the availability of medical products that may be needed in response to deliberate and naturally occurring public health threats.

What does the FDA regulate?

The FDA regulates a very large scope of products and devices and its authority is very broad. Here are some examples (not a complete list) of things it regulates:

  • Foods, including dietary supplements, bottled water, food additives, and infant formulas
  • Drugs, including prescription drugs (both brand-name and generic) and non-prescription (over-the-counter) drugs
  • Biologic products, including vaccines for humans, blood and blood products, cellular and gene therapy products, and tissue and tissue products
  • Medical devices, including simple items like tongue depressors and bedpans, complex technologies such as heart pacemakers, dental devices, and surgical implants and prosthetics
  • Electronic products that give off radiation, including microwave ovens, x-ray equipment, laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps
  • Cosmetics, including color additives found in makeup and other personal care products, skin moisturizers and cleansers, nail polish, and perfume
  • Veterinary products, including livestock feeds, pet foods, and veterinary drugs and devices
  • Tobacco products, including cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco

What is an “FDA-approved” product?

Before a medicine or product can be advertised and sold to the public, the FDA must review its safety and effectiveness. The process can be rigorous and time-consuming (and expensive) and involves experts in the fields related to the product. If a product is deemed “FDA approved,” it means that it has been determined that it is safe and effective enough to be available to the public. But, the FDA doesn’t stop there: it can review products after they have been approved if safety issues arise.

What is not FDA approved?

The FDA only approves products: It does not approve companies, healthcare facilities, laboratories, or manufacturers. Such places may be required to register with the FDA, and the FDA may inspect such places to make sure they are complying with safe, quality practice standards.

The FDA also does not approve compounded drugs—that is, medicines that are created by a pharmacist or physician for an individual patient. Such medications are made according to specific patient requirements to fit their needs. For example, if a patient cannot use a manufactured product due to a drug allergy or a dosage form that is difficult to use, a compounded product with the same (or similar) ingredients can be made to make it easier to use for that specific patient.

The FDA does not approve infant formulas. The FDA can regulate the manufacturers to make sure they are complying with federal nutrition standards, and manufacturers must register with the FDA and notify them before marketing a new product. The FDA inspects manufacturing facilities to make sure they are safe and comply with good manufacturing practices.

The FDA does not approve dietary supplements or natural or homeopathic products. Such products do not undergo testing or review of safety or effectiveness before marketing. Manufacturers of supplements must notify the FDA of the availability of products and the FDA can review a supplement’s safety if concerns arise after it becomes available to the public.

What does the FDA have to do with drug labels?

One way the FDA ensures that the public has safe and scientifically sound information is by reviewing and approving the information provided with drugs and devices that is available to the public. Every drug has specific information that can be obtained in the drug packaging, on the manufacturer’s website, or from the FDA. These labels contain more information than most consumers will ever need, but know that the information is provided so that you have all the facts you need to understand the drugs you are taking.

Recently, the FDA updated the way drug labels are formatted and presented. The new labeling requirements mandate the categories that must be explained and how they are organized. Many of the changes relate to information about drug use during pregnancy and lactation.

Specifically, the FDA used to categorize drugs using a letter-based system to describe a drug’s safety during pregnancy. But, after decades of use, the system was poorly understood and did not improve the public’s understanding or use of products. The FDA abolished the categories and made the pregnancy-, lactation-, and reproduction-related information more user-friendly.

What does the FDA have to do with my pregnancy?

When you are pregnant, you want to do everything in your power to keep yourself and your growing baby safe. That includes not taking medicines or using products that might be harmful. The FDA is a great resource for learning about the drugs you consider taking, and you should be confident that the FDA-provided information is accurate and scientifically sound.

The FDA’s job is to ensure the availability of safe and effective medicines and health-related products. If a product is FDA-approved, you know that it has been tested and reviewed and deemed safe; you should not be so confident about products that are not FDA approved. Consult a drug’s labeling information for specific information related to pregnancy and always consult your doctor or pharmacist if you have any questions or concerns about the drugs you are taking.

Watch this video about the Pregnancy and Lactation Labeling Rule (PLLR):

Jennifer Gibson
Dr. Jennifer Gibson earned a Bachelor of Science degree in Biochemistry from Clemson University and a Doctor of Pharmacy degree from the Medical College of Virginia School of Pharmacy at Virginia Commonwealth University. She trained as a hospital pharmacist and is the author of clinical textbooks, peer-reviewed journal articles, and continuing education programs for the medical community, as well as a contributor to award-winning healthcare blogs and websites. In her free time, she enjoys running, reading, traveling, and spending time with her family.

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