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.

As patients, we expect the prescriptions our doctors give us to be safe to take. However, a recent study found this might not be the case. Researchers determined one out of every three medications poses additional safety risks after approval from the U.S. Food and Drug Administration (FDA).

The study, published in the Journal of the American Medical Association (JAMA), looked at 222 separate medications approved by the FDA between 2001 and 2010 and tracked them through February 2017. Researchers discovered the FDA took some kind of action on nearly 32% of the medications.

Three of the tracked medications were completely removed from the market and 61 were given black box warnings, the most severe warning issued by the FDA. Unfortunately for patients, the average amount of time it took for the FDA to take action on a medication was 4.2 years.

Patients Facing Increasing Drug Dangers

The high number of medications posing additional safety risks coupled with the length of time the FDA takes to issue warnings, leaves patients facing increasing dangers from prescription drugs. One of the reasons behind increasing drug dangers is that drug companies often use very small samples of patients and many of their drug studies only last six months or less.

Because drug manufacturers produce insufficient clinical data, the true effects of their products are not known until long after they are released onto the market. The increasing dangers of prescriptions drugs put patients in a tough position.

Know Your Rights

Drug manufacturers are required to warn both patients and doctors of the risks associated with their products. This allows patients and doctors to make informed decisions about their care. When a pharmaceutical company harms patients through failing to warn of risks, improper labeling, inadequate testing, or other negligent actions, it can be held legally responsible for the resulting damages.