Pharma Warning Letters Spike in U.S. with Big Drop in China; India Up 13%

Jan 20, 2020 | FDA, Food and Drug Administration, Quality Assurance, Warning Letter

Pharma Warning Letters Spike in U.S. with Big Drop in China; India Up 13%

The Indian press publicized Indian pharma companies overall improving track record by pointing to U.S. FDA inspection-driven warning letters targeting American-based companies—these pharma domestic company write-ups spiked 184% in 2019. While there is a “perception” of poor manufacturing practices on that great sub-continent, the press there suggests its quality is rising while there was a spike in America. Companies mentioned are not the big brand pharma companies in America that, all things being equal, are extremely well-run, high-quality organizations. With the meteoric rise of China in drug development, the article could have perhaps showcased the dramatic reduction in Warning Letters China experienced by Chinese companies during a period of intense growth.

An FDA Waring Letter can relate to a number of issues as the FDA regulates vast swathes of the U.S. economy. When it is discovered that a drug maker has violated FDA regulations, the agency notifies the manufacture and this often is accomplished in the form of a Warning Letter. This instrument will identify the violation (e.g. poor manufacturing processes, deviation from label, etc.) and will include a demand to take corrective action. The FDA will undertake follow up inspections to make sure corrective actions was in fact implemented. The FDA Warning Letter database is available to the public

2019 Warning Letters

The Times of India reports that for fiscal year 2019, America’s warning letters shot up to 54 (from 19 in 2018) while India had 17 warning letters (up from 15 in 2018) and China experienced 14 (down from 21 in 2018). TrialSite News did not conduct its own research to verify these figures.

Material Impact

The Times of India notes that when a company receives an FDA Warning Letter its’ product sales can be hindered hence materially damaging the company—after all, America is the world’s largest drug market and when it comes to the vast generics market Indian companies, according to the Times of India, represent 35% of that market, which they claim is $70 billion. TrialSite News cannot be sure of that figure. The top 10 generic drug producers include the following Indian companies and their corresponding rank:  Sun Pharmaceuticals Industries (#4); Lupin (#5); Cipla (#6) and Dr. Reddy’s (#9).

No Real Discernable Trends

Warning Letters can happen for a variety of reasons such as data integrity issues (32 out of 98 of total company Warning Letters in 2019) or poor-quality management systems for example. It is challenging to decipher larger trends from this article but there is a rapidly growing number of Chinese biopharma companies and corresponding clinical trials volume for example. Yet the number of Warning Letters was noticeably lower there.   

The Times of India reported that an FDA official informed them that inspections may fluctuate from region to region in any given year based on a number of factors from actual routinized inspections to those driven by bursts of marketing authorization applications to following up on specific reports of issues. The FDA only has so many inspectors and with vast countries such as India and China undoubtedly constraints are many. 

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