Is FDA Ignoring Complaints About Generic Drug Quality?
[Thursday, October 31, 2019]

For the last several years, questions have been raised in public about the quality of drugs imported into the US from India and China, mostly based on FDA audit findings and Warning Letters. At the same time FDA has repeatedly insisted that its system for review and inspections is adequate to protect the US drug supply chain and that generic drugs imported into the country are compliant with the US regulations. In the last two years, FDA approved record numbers of generic drugs, most of which are manufactured at sites located in India and China further indicating lack of FDA’s serious concerns about the quality of these drugs. For the consumers these contradictions are very confusing; should one trust FDA in that generic drugs available in the US are safe or should one avoid drugs manufactured outside the US based on public analysis. It’s important to put the information in context. It is FDA’s mandate to regulate and inspect the facilities manufacturing drugs before allowing them in the US market and disclose to the public whatever it finds. An FDA inspector could spend several days at a facility going through every aspect of the facility with a toothcomb. They make copious notes, interview anyone they want, and tour all the areas of the facility as needed. FDA inspectors are professionals trained to detect fraud, and a facility being audited is legally bound to present any and all information requested. The negative findings of the FDA inspection end-up on the FDA 483s but there are a lot of notes that stay confidential. FDA also relies on alternate sources to find information about a given site, including whistleblowers and other regulators. And in recent years, FDA has been collaborating with other regulators to share compliance related information. The system is not perfect, as is evident from the numerous audit findings listed in the FDA 483s and the Warning Letters but still it would be fair to say that the regulators are better placed to judge the quality of products than an average person. The non-FDA published reports, on the other hand, are mostly based on reviews of FDA 483s and Warning Letters, and sometimes interviews, and private investigations. Since manufacturers are under no obligation to cooperate, they don’t. Most information available to private investigators is anecdotal at best because if they found any specific findings, they would turn them over to the regulators to act. So, reports by private investigators of compliance are bound to have many holes and anecdotes. This does not mean that their intent is wrong, just that their information is limited. The public perception that FDA is ignoring the complaints is inaccurate; FDA must base its actions on data it has. Yes, there are scrupulous players out there, but we know about them because FDA caught them. It may sound too naïve to an average consumer to trust the FDA over highly sensationalized news from trusted sources but that would not serve the consumers well. One needs to let the regulators do their job. And yes, they can do better but so far it is the best we got.