The Food and Drug Administration sharply reduced regulations in 2017 while approving a record-setting number of generic drugs, a new report found.
The report released Thursday by the consulting firm PricewaterhouseCoopers’ Health Research Institute said the agency approved a record number of generic drugs and products to treat rare diseases in 2017. The report comes a little more than a year after President Trump directed all federal agencies to significantly roll back regulations.
The FDA approved 763 generic drugs last year, a 14 percent increase from the 651 approved in 2016. The agency approved 46 new drugs compared to 22 in 2016 and 45 in 2015.
A major reason for the spike in generic drug approvals has to do with a yearslong effort to speed up the pipeline. In 2012, the agency established a generic drug user fee program similar to its user fee programs for drugs and devices. The program works by generic makers paying a fee when submitting new application and the FDA using the money to hire new staff and improve approval times.
The Trump administration and the GOP-controlled Congress have pinpointed faster generic approvals as a way to help lower high drug prices. Trump signed into law legislation last year to let the FDA speed up approval of a generic to foster competition with a product that jumps high in price.
Meanwhile, the FDA slowed its release of new regulations last year. The agency released 140 regulations in 2017 compared to 198 in 2016 and 152 in 2015, according to the report. The figures represent regulations in all of the FDA’s divisions including food, pharmaceuticals, biotech, tobacco, and devices.
The number of regulations is the lowest since 2012, when 113 proposed regulations were released.
Trump after he was inaugurated in January 2017 signed an executive order that agencies would have two eliminate two regulations for every new rule they proposed.
However, the FDA has used regulatory guidance instead of regulations for its proposals.
In 2017, the agency put out 174 draft or final guidance documents for all FDA divisions. During the Obama administration, the FDA on average put out 152 guidance documents a year.
The FDA did not reduce the number of inspections compared to prior years. The agency issued 11.5 more inspection reports for poor performance to companies in 2017 than in 2016.
“However, reports to drug and biologics companies remained almost unchanged in number in the last five years,” the report said.
The report noted that while the agency isn’t issuing new regulations, “it’s still using other existing statutory and regulatory authority at a similar pace.”
There are some exceptions, though, namely around warning letters that the agency sends to companies to alert them to glaring deficiencies with products, marketing, or manufacturing practices.
Last year, the agency issued 510 warning letters compared to 650 in 2016, PricewaterhouseCoopers found.
