Running a Risk
Bloomberg News has conducted a year-long investigation into regulation of the generic-drug industry by the U.S Food and Drug Administration (FDA), going through “hundreds of pages of inspection documents, more than 10 years of inspection data and thousands of pages of pretrial depositions,” as well as interviewing “more than two dozen current and former FDA inspectors and agency officials, lawmakers and industry experts,” according to a recent article in the publication by Anna Edney. In an effort to supply more affordable drugs to the public, it seems that some irregularities have been allowed or overlooked, according to the story.
While trepidations regarding quality control and data integrity have been fixated on overseas companies, the problems appear to affect generic drugs made in America as well. According to Edney, “the issues surrounding them are twofold: a drop-off in inspections in many places and, in some cases, the softening of penalties when problems are found.”
The article revealed that the FDA approved 971 generic drugs in the fiscal year ending September 30, 2018, according to the accounting firm PricewaterhouseCoopers, representing a 94-percent increase from fiscal 2014, when 500 generic drugs were approved. However, the number of FDA surveillance inspections to ascertain that existing drug-making plants meet U.S. standards was reduced by 11 percent, to 1,471, in fiscal 2018, as compared with fiscal 2017. In fiscal 2017, the inspections decreased 13 percent from the previous year.
Because the FDA began concentrating on overseas drug manufacturers, surveillance inspections of just U.S. drug factories decreased by 11 percent, to 693, from fiscal 2017 to fiscal 2018, the most infrequent in a decade. The inspections have been decreasing since 2011. Nonetheless, surveillance inspections of overseas factories decreased by 10 percent, to 778 from fiscal 2017 to fiscal 2018, the second year-over-year decline as these inspections decreased by 9 percent from fiscal 2016 to fiscal 2017. There had been a trend of rising inspections over much of the prior decade. An exception was India, where inspections rose by 18 percent in fiscal 2018.
When Scott Gottlieb took office as FDA commissioner in May 2017, he said that bringing more generic drugs to market was a top priority. He reasoned that the additional competition would act to reduce drug prices, which President Donald Trump sought to do. While both political parties have praised this action, there is concern that fast-tracking of approvals could be at the expense of oversight that should ensure that drugs already on the market are safe and effective, Edney’s article said.
While the FDA claims that the U.S. has “the safest drug supply in the world,” the FDA does not test finished drugs or ingredients regularly. Company testing may be the final step in some cases, testing in other countries may be accepted. Further tests on some products show that they lack enough of an active ingredient, do not dissolve as they should or contain a substance that could be harmful to a patient. In short, lawmakers are concerned that the FDA may be reducing quality control while approving more generics.
Representative Diana DeGette (D-Col.), chair of the House’s investigations subcommittee with oversight of the FDA, summarized, “Americans need to know that their medications are safe and effective. And it’s the FDA’s job to ensure that, from the factory floor to the shelves of our pharmacies.”
