The FDA has a practice of blacking out the names of generic drugs on inspection reports for foreign factories that have safety and quality violations. This decision was made decades ago by agency lawyers, who were concerned about being sued by drugmakers. As a result, patients, doctors, and pharmacists are left in the dark about whether their medications are safe and effective.
Inspectors have found safety and quality issues at many of these factories, including one factory in central India that contaminated its sterile manufacturing area with spore-forming organisms. Despite this, the FDA allows the drugs to be shipped to the US market without revealing the manufacturer’s name.
The lack of transparency makes it difficult for patients to make informed choices about their medication. “If you take out the most critical piece of information, which is ‘What drug is it?'” says Dr. Peter Lurie, a former FDA Associate Commissioner. “You’re left with this kind of vague accusation on which nobody can act because nobody has enough information to be able to do anything.”
The FDA has proposed changing its policy to require that labels include the names and addresses of manufacturers. However, it still does not publish a list of every drug approved for the US market along with its factory address.
This lack of transparency is concerning for patient advocates, who say it can lead to confusion and mistrust in the pharmaceutical industry. “We want our food labels to tell us exactly how much carbohydrates are in them,” says Lisa Salberg, founder of a nonprofit for people with hypertrophic cardiomyopathy. “But the things we are taking to combat diseases, we literally know nothing about.”
Source: https://www.propublica.org/article/fda-hides-drug-names-contaminated-factories