There is a fine balance between providing lifesaving medicine to the public and protecting the public from potentially harmful medicine. This is the line the U.S. Food and Drug Administration (FDA) must walk as it regulates drugs and medical devices. However the agency is making tremendous strides in patient safety by allowing more drug inspections in manufacturing facilities overseas.
The FDA recently announced it is taking steps toward the implementation of the amended Pharmaceutical Annex to the 1998 U.S.-European Union (EU) Mutual Recognition Agreement (MRA). This agreement allows regulators from both countries to use each other’s inspections of pharmaceutical manufacturing facilities to ensure they are meeting the appropriate health and safety standards. The FDA will now recognize the authority of drug regulatory agencies in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom to inspect facilities to see if they meet with FDA requirements.
This will have a huge impact on the availability of new medicines, as many medicines approved by the FDA are partially or completely manufactured overseas. Before recognizing these drug authorities, the FDA alone was responsible for overseas inspections. However, with massive numbers of drug companies and facilities, overseeing them all was a difficult task for the FDA.
The partnership prevents duplication of facility inspections, allowing more resources to be devoted to countries and facilities where there may be a greater risk of substandard manufacturing practices. By partnering with other countries, more facilities are inspected more often to ensure they are using good manufacturing processes.
Unfortunately, these overseas strides only seek to remedy a small part of what medications and devices can do to harm patients. Sometimes drugs meeting the FDA’s manufacturing requirements still cause significant injuries to patients. Oftentimes dangerous side effects are only discovered after a drug has hit the market. Drugs like anti-nausea medications and heartburn relievers can cause permanent injuries to unknowing patients.
What Patients Can Do
All medications and medical devices come with risks. However, patients have a right to know all of these risks upfront, so they can make informed decisions about their care. The FDA releases warning letters to the public when a manufacturer fails to meet FDA standards, including manufacturing standards and/or safety standards. Patients can look up the compliance history of any drug, manufacturer, or facility on the FDA’s website. By investigating the history of a drug or device, patients can make better informed decisions about their healthcare.