Understanding FDA Oversight for Global Healthcare Products
According to Deloitte, the healthcare industry is on the way to becoming 26% of the GDP, exceeding $12 trillion by 2040. The development of new drugs and high-tech medical devices continues to evolve, providing much needed care for individuals with various ailments, and contributing hefty profits to manufacturers. Though it can appear the healthcare industry is quite lucrative, it is up to multiple global regulatory bodies to ensure drugs and medical devices meet strict standards, ensuring safety for patients, providers, and manufacturers.
The Food and Drug Administration (FDA) has these processes in place both in the US and internationally, regulating imported and exported goods to prevent exploitation and maximize safety, preventing fraudulent drugs and devices from entering the market. Below you’ll find valuable information concerning how the FDA oversees global trade and what regulations exist for these manufacturers.
How Does the FDA Oversee International Trade?
Anything product or device that affects the health of the body will be regulated by the FDA.
Their reach extends into different areas of the healthcare, agricultural, and consumer goods industries, including:
- Tobacco products;
- Cosmetic products;
- Pet food;
- Veterinary devices;
- Surgical implants, prosthetics, and other medical devices;
- Over-the-counter and prescription drugs;
The FDA will review these goods that are imported and exported from and to other countries to make sure they fit within proper safety parameters and will not harm the public. Both commercial and personal imports will be subject to review– these goods can be denied entry if they are deemed illegal to sell, contaminated, or willfully mismarketed.
One case study in particular offers a glimpse into how the FDA can exert its regulatory powers over product manufacturers. The FDA reserves the right to inspect the premises of any manufacturer that operates within the scope of their control and can inspect facilities overseas that intend to import goods to the US. When reviewing the premises of Nippon Fine Chemical Co., Ltd in Japan, FDA inspectors were prevented by Nippon staff members from viewing the quality control lab, something that indicated improper operational procedures to the inspectors.
The FDA diligently followed up on complaints of contaminated drugs distributed from this manufacturer. Their findings, which were limited due to the imposition of the workers, forced the FDA to bar the manufacturer from exporting any goods to the US.
Drug and Medical Device Import Regulation Processes
There are a few different ways the FDA regulates the production and trade of drug and medical device goods. For imported drug and medical device products, you cannot ship unapproved pharmaceuticals and devices, even if they are not for commercial use. Any drug and medical device products may be inspected by the US Bureau of Customs & Border Protection upon entry to the country.
Overseas drug manufacturers importing goods to the US must register their businesses with the FDA: Federal Register Notice, which includes providing information about all the commercial drugs and devices produced and distributed by the manufacturer. Should the FDA require a more thorough review of the imported goods, the manufacturer has the ability to send the shipment to a third storage location, where the FDA will be able to access and assess the goods accordingly. From there, this information will undergo an Automated Electronic Review, which involves using analytics software to determine the risk of injury when using the imported goods.
Customs should always be notified of the shipment and arrival of commercial healthcare products. When shipping products to the US, manufacturers must include information about their company and facility, the products included in the shipment, and any registration or approval confirmation for the production of the drug. This communication can be handled by a broker through a system provided by Customs called the Automated Commercial Environment, which provides a correspondence link between the broker/manufacturer, Customs, and the FDA.
The FDA always retains the right to refuse imports that do not comply with the Federal Food, Drug, and Cosmetic Act, except for in certain cases, such as with imports that are not intended for use or sale in the US. Manufacturers can submit an appeal, which may include updating the product or shipping details to comply with the Act.
Meeting FDA Standards and Establishing Safety Protocols in Drug and Medical Device Manufacturing
As long as you have every intention to produce and distribute a safe product, you will naturally fall in line with FDA regulations. To prepare for importing goods, set up a strategic plan that involves outlining your objectives, managing the import plan, and delegating tasks accordingly, along with setting clear objectives so your team understands the regulatory process and what steps are required of them.
First and foremost, the manufacturing facility and processing plant for drugs and medical devices must be sanitary. All products must be packed in a sanitary manner as well. Drugs and medical devices must not have any evidence of “adulteration”, which refers to contamination through filth or illegal substances.
It is also crucial to have accurate labels on all of your products that are imported to the US. Should one shipment of goods be labeled for pharmaceuticals, they should never contain X-ray equipment, prosthetics, or any other products that are outside of what has been specifically labeled.
You should also be careful and compliant when filling out any paperwork associated with the imports of healthcare goods. Register your business and the import appropriately, give notice of the shipment to Customs, and offer any and all additional paperwork the FDA may require upon their initial inspection of the goods. Should you refuse or not meet any of these standards, the FDA can detain the products until a hearing has been brought forth. If the goods are deemed illegal or not in compliance with FDA standards, they will be sent back to the exporter or they can be destroyed, causing you as a manufacturer to lose out on a great deal of money.