Regulatory Focus™ > News Articles > 4 > Gottlieb Offers Solutions for High Generic Drug Prices, Real-Time Postmarket Surveillance

Gottlieb Offers Solutions for High Generic Drug Prices, Real-Time Postmarket Surveillance

Posted 25 April 2018 | By Ana Mulero 

Gottlieb Offers Solutions for High Generic Drug Prices, Real-Time Postmarket Surveillance

As the Trump administration prepares to submit to the US Congress the Fiscal 2019 budget request, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb highlighted two issues that the agency would seek to address with additional funding—rising drug prices and the need for real-time data.

Gottlieb—in a Tuesday statement to the US Senate appropriations committee—proposed a two-part policy solution to “modernize generic drug development and review” in order reduce drug costs with greater market competition and more generic drug substitutions.

The first component involves establishing a structured application for generics to allow “key sections of the generic drug file to be captured in a structured template,” Gottlieb said. This will in turn “speed the review of the application and cut down on the number of review cycles that applications must undergo, thereby reducing generic drug development timelines.”

The second, far more detailed, component calls for a “more active role” among FDA staff to correct outdated generic labeling.

Addressing existing challenges with labeling updates could lead to “more widespread use of existing generic drugs,” Gottlieb argued. These include a lack of a mechanism in place for FDA to update generic labels when drug sponsors voluntarily withdraw marketing applications for brand reference drugs.

“By one rough estimate, there are about 5,600 reference-listed drugs that correspond to generic medicines,” Gottlieb said. “And of these reference drugs, 1,170 are tagged as discontinued or withdrawn by their original, branded sponsors for reasons other than safety or effectiveness,” which in turn causes these to "get frozen in time."

In an interview with Focus last week, Gottlieb said updating a label “can cost between $200,000 and $300,000.” He added that FDA hopes to start the role of proactively keeping generic labeling up to date with oncology products as these “can often provide lower-cost alternatives for expensive regimens.”

President Trump’s budget proposal—released in February—requests a spike in FDA’s budget authority appropriation of $473 million, which is “the largest increase ever proposed for the FDA,” the Alliance for a Stronger FDA previously reported.

This increase would provide, however, the funding needed for FDA to pursue the generic drugs modernization effort, as well as to improve the use of real-world evidence (RWE) for regulatory decision making, Gottlieb noted.

Real-Time Postmarket Surveillance

As part of the second effort, FDA would look to enhance drug and device postmarket surveillance through increased “real-time understanding of medical product performance” with greater use of healthcare data “to take better advantage of data available from electronic health records,” Gottlieb said. Under the proposed budget, $100 million would be allocated for FDA’s RWE efforts.

Gottlieb argued for tools developed to make better use high-quality, interoperable data integrated into clinical care and research to enhance real-time postmarket surveillance, citing the dependence of existing postmarket data monitoring systems (e.g., Sentinel) on claims data as a current barrier.

The call for enhanced real-time data monitoring underscores a global trend among regulators seeking to improve surveillance and interventional actions.

On Monday, the UK’s Medicines and Healthcare Products Regulatory Agency revealed a 5-year plan in which it established certain steps to “become a real-world regulator” by exploring the use of real-time data, such as those obtained through the services of Clinical Practice Research Datalink (CPRD).


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.