Key Takeaways:
- The FDA rarely tests generic drugs for quality concerns, relying heavily on manufacturers to self-test and report problems.
- Independent labs, universities, and the Department of Defense have raised concerns about contaminants and quality failures in generic medications.
- ProPublica’s testing found irregularities in two samples of widely prescribed generic drugs, bupropion and metoprolol, which could compromise their effectiveness.
- The FDA’s hands-off approach to testing has led to a lack of transparency and accountability in the generic drug industry.
- Experts argue that routine testing of generic drugs is necessary to ensure their safety and effectiveness.
Introduction to the FDA’s Approach
The FDA’s approach to ensuring the quality of generic drugs has been called into question. Despite warnings from doctors, universities, and the Department of Defense about contaminants and other issues, the FDA rarely tests generic drugs for quality concerns. Instead, the agency relies on drug companies to do their own testing and report any problems. This approach has been criticized as inadequate, and experts argue that it puts patients at risk.
The Risks of Generic Drugs
Generic drugs are widely used in the United States, accounting for about 90% of prescriptions. However, the FDA’s lack of testing has led to concerns about the quality of these medications. ProPublica’s testing of several generic versions of widely prescribed drugs found irregularities in two samples, including a version of bupropion that dissolved more slowly than the brand-name drug. This could leave patients without the right therapeutic levels for treatment, and potentially lead to serious health problems.
Expert Concerns
Experts, including former FDA officials and doctors, have expressed concerns about the agency’s approach to testing generic drugs. Albinus D’Sa, a chemist who spent over 25 years in drug safety at the FDA, said that the agency’s testing is "not in the public interest." Dr. James Hancey, an Oregon psychiatrist, said that receiving incorrect amounts of bupropion throughout the day is a serious quality threat that puts vulnerable patients at risk. Dr. Art Kellermann, a longtime member of the National Academy of Medicine, said that irregular levels of metoprolol can pose a danger, especially for people with congestive heart failure or a history of heart attacks.
The FDA’s Response
The FDA has not responded to questions about why it doesn’t do more testing, and how it can know that generics are safe without a more robust program. On its website, the FDA says it has relied on a "more targeted, risk-based" approach to testing since 2018, choosing samples of drugs that have safety, effectiveness, or quality concerns. However, this approach has been criticized as inadequate, and experts argue that it is not sufficient to ensure the safety and effectiveness of generic drugs.
Independent Testing
Independent labs, such as Valisure, have taken it upon themselves to test generic drugs for quality concerns. Valisure’s testing has found irregularities in several generic medications, including bupropion and metoprolol. The company’s testing has also found that some generic medications are contaminated with heavy metals, such as lead and arsenic. Robert Lodder, a chemist at the University of Kentucky, has also been testing generic medications and has found that about 10% of the drugs he has tested have failed his initial assessment.
A Matter of National Security
The Department of Defense has also expressed concerns about the quality of generic medications. Col. Vic Suarez, a global supply chain commander in the Army, has been advocating for additional drug-quality testing and has taken the idea to top leaders. The DOD is using the independent lab Valisure to test more than 40 drugs that officials consider the most essential in the military health system. Early results show that about 10-15% of those drugs are high risk, meaning they were found with elevated levels of contaminants, didn’t have the right dosage, or dissolved differently than higher-quality generic or brand versions.
The Need for Transparency and Accountability
The FDA’s lack of transparency and accountability in the generic drug industry has led to a lack of trust among patients and doctors. Experts argue that routine testing of generic drugs is necessary to ensure their safety and effectiveness. The FDA’s hands-off approach to testing has led to a lack of oversight, and experts argue that it is not sufficient to protect public health. As Dr. Harry Lever, a retired Cleveland Clinic cardiologist, said, "It comes down to the fact that the FDA is not doing its job. Everything you are swallowing should be tested — there should be no question about it."