The FDA should withdraw approval of more than 400 tainted medicines

When the FDA learned that a testing facility in India had submitted fraudulent data for more than 400 drugs (most of them generics), the agency should have withdrawn them from the market. Instead, it has allowed these drugs to continue to be prescribed and distributed for at least a year as the pharmaceutical companies retest them for equivalency to the original brand-name drugs.

As someone whose work focuses on the hidden and minimized side effects of prescription and over-the-counter drugs, I know the FDA’s decision is wrong. That’s why I published an open letter to the agency asking that approval be withdrawn for all of these medicines until new, clean data has been submitted, reviewed, and approved by the FDA. The European Medicine Agency (EMA) has already suspended distribution of these 400-plus drugs.

I also requested that the FDA release the names of those 400 questionable drugs. But it has declined, because the FDA considers the information surrounding how, where, and by whom any drugs are tested as “confidential commercial information.”

Commercial interests should not be put ahead of patients’ health and safety.

According to a Viewpoint essay in JAMA by two Harvard-affiliated researchers, early on the FDA imposed upon itself a strict limit on disclosing testing and related information that pharmaceutical companies submit to the agency as a way to protect their employees from the risk of lawsuits. The JAMA article offers a blueprint for rescinding this misguided guideline and restoring trust and transparency in the FDA.

To be sure, there would be pain if the FDA withdraws the approvals for these tainted drugs because patients, doctors, and pharmacists will have to scramble to adjust prescriptions. But it is necessary pain. Most of the drugs are generics, which play an incredibly important role in keeping the price of drugs lower than they might be and are crucial to maintaining the pipeline of necessary medicines to protect patients from manufacturing shortfalls. But generic drugs can only fill these needs if people trust them and if they are truly equivalent to brand name medicines.

There would also be financial pain for the pharmaceutical companies if they suddenly could not sell these drugs. But that pain should be felt by these companies so they will work harder to ensure they don’t accept bad data and pass it along to the FDA.

The FDA detected “significant anomalies” in the testing lab’s data. The agency wrote to the testing lab: “In five of your studies, we identified multiple pairs of study subjects that have nearly identical data … Additionally, in two of these studies, we identified individual study subjects that produced nearly identical results when treated with the test drug and the reference drug. While it would be unusual for two subjects in a single study to have nearly identical data, this occurred for multiple pairs of subjects, in multiple studies…” The letter detailed many other falsifications.

If the FDA identified these discrepancies, the pharmaceutical companies that paid for the testing should have done the same. Theirs is the responsibility and should bear the cost. Not the American public.

The FDA Adverse Event Reporting System (FAERS) makes it possible — even easy — for patients, doctors, and pharmaceutical companies to report unanticipated side effects and adverse events. To date, the FDA has not found any uptick in problems with these tainted drugs. But that does not excuse the FDA’s inaction. These medications could have too little of the active ingredient, causing undertreatment, or too much, causing a toxic response. They could contain impurities or could have been made with additives that can cause allergic reactions. Because of the flawed testing data, we just don’t know.

An individual prescribed a drug has the right to assume that it has the composition promised on the label.

The FDA’s mission is to protect Americans from drugs that are unsafe or ineffective. When it comes to the more than 400 tainted drugs it recently learned about, I say to the FDA: This is your time to stand for America, not for pharmaceutical companies.

Suzanne Robotti is the founder and president of MedShadow Foundation, a nonprofit organization focused on researching and explaining the hidden and minimized side effects of over-the-counter and prescription drugs, and has been a consumer representative on the FDA’s Drug Safety and Risk Management Committee since 2017.