- Warning letters from the Food and Drug Administration's Center for Drug Evaluation and Research spiked last year as drugmakers struggled to maintain quality control at their manufacturing sites, according to a new report from PwC.
- Though the FDA actually issued 22% fewer warning letters overall in 2017 versus 2016, the number coming from its CDER unit rose 35% for a total of 85. Data integrity issues and violations to current Good Manufacturing Practices (cGMPs) were the root causes for many of the letters.
- PwC noted that legislation such as the FDA Safety and Innovation Act of 2012 and the Drug Quality and Security Act of 2013 have strengthened the agency's oversight. As such, the uptick in CDER-issued warning letters is "likely due to increased emphasis on drug quality during FDA inspections, and not that the pharmaceutical industry is experiencing increased drug quality issues."
PwC, for instance, acknowledged that the FDA turned its attention from enacting sweeping, formalized regulations to issuing guidance since President Donald Trump and Commissioner Scott Gottlieb took office. The shift falls in line with the anti-regulation tone set by Trump, who signed an executive order in his early White House days requiring that for every new federal regulation enacted, two must be eliminated.
The slowdown may benefit drug manufacturers, which typically chafe at regulations. That hasn't happened so far, though, as evidenced by the increase in CDER warning letters. Additionally, the threat of more robust and wide-ranging regulations like those seen in the Drug Quality and Security Act, which gives the agency more leverage over drugmakers, could grow stronger over time.
"It may be another year or two before the industry begins to see if the Trump administration engages in more or fewer investigations than its predecessor and whether it will focus on new areas of enforcement, such as actions under the Controlled Substances Act or False Claims Act related to the opioid crisis," PwC said.
"If historical trends hold, pharmaceutical and life sciences companies could see an uptick in regulation and policy documents coming out of the FDA, with potentially more consequence. Larger regulations often take more than a year to develop."
Should such regulations materialize, they may very well target manufacturers both in and outside pharma. Along with warning letters, Form 483s — doled out when a facility may be in violation of the Food Drug and Cosmetic Act — rose since Gottlieb took over. They hit 5,155 in 2017, up about 500 from the previous year.
Notably, while the overall tally of Form 483s increased, the number issued to drug companies was relatively on par with annual counts from the last half decade.
In the meantime, the FDA will surely continue to roll out new policy, just not in the usual modes pharma has grown accustomed to.
In 2017, the agency hit a 20-year low in the number of "economically significant" regulations released, with six in total. Conversely, it provided 174 draft or final guidance documents — down from 2016's total of 256 but still well above the 152 per-year average seen under the Obama administration.
Editors note: This story has been updated with additional information from the report.