circleAt that time The FDA learned When Indian testing laboratories were reported to have submitted false data for more than 400 drugs, most of them generic, authorities should have removed them from the market, but instead allowed them to continue to be prescribed and distributed for at least a year while drug companies retested them for equivalence to the original brand-name drugs.
As someone whose research focuses on hidden and underestimated side effects of prescription and over-the-counter drugs, I know the FDA’s decision is wrong. That’s why I An open letter to the authorities The FDA is calling for the withdrawal of approvals of these drugs until new, clean data can be submitted, reviewed, and approved. The European Medicines Agency (EMA) has already Distribution suspended Of the more than 400 drugs,
I also asked the FDA to release the names of the 400 suspect drugs, but the agency refused because it considers information about how, where, and by whom the drugs were tested to be “confidential commercial information.”
Commercial interests should not be put above patient health and safety.
be JAMA viewpoint article “The FDA has been working to improve the safety and security of its products and services, and we are committed to providing the highest level of customer service possible,” said Dr. Gregory B. Schneider, MD, PhD …
Certainly, if the FDA were to revoke approval of these tainted drugs, it would be painful for patients, doctors, and pharmacists as they would have to adjust prescriptions. But it would be a necessary pain. Most of the drugs are generic, which plays a very important role in keeping the price of drugs lower than they would otherwise be, and is crucial in maintaining the supply of medicines needed to protect patients from manufacturing shortages. But generic drugs can only meet these needs if people trust them and if they are truly equivalent to brand-name drugs.
Pharmaceutical companies would also suffer financially if they were suddenly unable to sell these drugs. Should These companies will likely work harder to ensure they do not accept and pass on fraudulent data to the FDA.
The FDA found “significant anomalies” in the lab data. I wrote a letter to the laboratory.“In five of your studies, multiple pairs of subjects with nearly identical data were identified. Additionally, in two of these studies, individual subjects were identified who had nearly identical results when given the test and reference drugs. While it is 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 instances of falsification.
If the FDA identified these discrepancies, the drug companies that paid for the testing should have done the same. The responsibility lies with the drug companies and they should foot the bill, not the American people.
of FDA Adverse Event Reporting System FAERS makes it possible (and easy) for patients, doctors, and pharmaceutical companies to report unexpected side effects and adverse events. To date, the FDA has not found an increase in problems with these tainted medicines. But that’s no excuse for FDA inaction. These medicines may contain too little of the active ingredient, causing therapeutic undertreatment, or too much, causing a toxic reaction. They may contain impurities, or may be manufactured with additives that could cause an allergic reaction. Because of flawed test data, we just don’t know.
An individual who is prescribed a drug has the right to assume that the drug contains the ingredients promised on the label.
FDA’s mission is to protect the American people from unsafe or ineffective medicines. With the more than 400 contaminated drugs that FDA recently learned about, I say to FDA: Now is the time to stand up for America, not for drug companies.
Suzanne Robotti: Medshadow Foundationis a nonprofit organization focused on investigating and explaining hidden and underestimated side effects of over-the-counter and prescription drugs, and has served as the consumer representative on the FDA’s Committee on Drug Safety and Risk Management since 2017.
