Massachusetts Personal Injury Library
Imported Drugs Raise Safety Concerns for FDA
As the public becomes more aware of imported products from countries which have less strict safety standards than the U.S., as indicated by the millions of recalled toys from China in the past year, the Federal Drug Administration wants consumers to beware of imported drugs as well.
The exact amount of imported drugs that come into the United States is hard to track, and the high volume makes it impossible to examine them all. The FDA’s Office of Criminal Investigations, is working to uncover major black market pharmacy rings selling illegal pharmaceuticals.
The safety risks involve the use of prescription drugs without a physician’s supervision, and the danger of buying drugs of unknown origin and quality. The drugs could be old, contaminated, or counterfeit. The FDA warns against using unapproved drugs– just because a drug is approved in a foreign country, that doesn’t mean it’s approved in the United States. Drug standards and regulations vary from country to country and the FDA is responsible only for those marketed and sold inside the United States.
Drugs sold in the United States must have proper labeling that conforms with the FDA’s requirements, and must be made in accordance with good manufacturing practices. As part of the FDA’s high standards, drugs can only be manufactured at plants registered with the agency, whether those facilities are domestic or foreign. If a foreign firm is listed as a manufacturer or supplier of a drug’s ingredient on a new drug application, the FDA travels to that site to inspect it. After the FDA approves a drug, manufacturers still are subject to FDA inspections and must continue to comply with good manufacturing practices, according to the FDA website.
U.S. pharmacists and wholesalers also must be licensed or authorized in the states where they operate, to limit how drugs can be distributed and lessen the likelihood that counterfeit or poor quality drugs will turn up. These safeguards of getting drugs onto U.S. pharmacy shelves is commonly referred to as a “closed” distribution system.
Counterfeit drugs can surface anywhere but are more common in foreign countries than in the United States. And while the Internet has given customers the convenience of buying drugs from the privacy of their own homes, it’s also opened up the possibility of illegal drugs being sold.
The FD&C Act states that prescription drugs made in the United States and exported to a foreign country can only be re-imported by the drug’s original manufacturer. Even when original manufacturers re-import drugs, the drugs must be real, properly handled, and relabeled for sale in the United States.
The FDA sends warning letters over the Internet to suspicious sites. About 30 percent of Internet sites that receive the FDA’s letters stop their illegal activity, according to the website. The FDA also sends copies of the letters to the home governments of the Web sites when the locations can be identified.
The FDA’s enforcement efforts focus on drugs for commercial use, fraudulent drugs, and products that pose an unreasonable health risk.
Potential Health Risks With Imported Drugs:
- Quality assurance concerns. Medications that have not been approved for sale in the United States may not have been manufactured under quality assurance procedures designed to produce a safe and effective product.
- Counterfeit potential. Some imported medications–even those that bear the name of a U.S.-approved product–may be counterfeit versions that are unsafe or even completely ineffective.
- Presence of untested substances. Imported medications and their ingredients, although legal in foreign countries, may not have been evaluated for safety and effectiveness in the United States. These products may be addictive or contain other dangerous substances.
- Risks of unsupervised use. Some medications, whether imported or not, are unsafe when taken without adequate medical supervision.
- Labeling and language issues. The medication’s label, including instructions for use and possible side effects, may be in a language you do not understand or may make medical claims and suggest specific uses that have not been adequately evaluated for safety and effectiveness.
- Lack of information. An imported medication may lack information that would permit you to be promptly and correctly treated for a dangerous side effect caused by the drug.
For resources on the FDA website regarding prescription drugs safely, go to Buying Prescription Medicines Online: A Consumer Safety Guide and go to Verified Internet Pharmacy Practices Sites (VIPPS), National Association of Boards of Pharmacy http://www.nabp.net (click on “Accreditation Programs”) for approved sites.
