The US Food and Drug Administration (“FDA”) released quarterly data on two programs intended to increase generic competition and to speed approval of priority generic drugs. The programs, which were included in the FDA Authorization Act of 2017 (“FDARA”), include the priority review program and competitive generic therapy (“CGT”) designation. Data from FY2018 through Q3 FY2019 shows that, while the number of priority ANDAs awaiting action by the FDA or sponsor has steadily increased since FDARA implementation, the priority ANDAs awaiting FDA action have leveled off, particularly between Q2 FY2019 and Q3 FY2019. However, CGTs awaiting FDA action show the opposite trend, continuing to increase over that time period.
As we previously reported, this data report comes against the backdrop of pressure on the FDA from a variety of sources to speed generics to market. Each year since FY2016, the FDA has increased its numbers of generic approvals. However, it is not clear if this ever-increasing number of approvals is translating into lower costs for patients. A recent report from Pew Charitable Trust, entitled FDA Approves More Generic Drugs, but Competition Still Lags, indicated that the increase in approved generics from 2013 to 2017 “was largely driven by approvals of the fourth, fifth, sixth and even later versions of generics.” However, the report noted that these later generic entrants likely do not improve prices for consumers, as the largest price drops typically occur when the second and third generic drugs enter the market.
Meanwhile, also in August, the Government Accountability Office (“GAO”) released a report indicating that only 12% of the 2,030 generic drug applications reviewed from FY2015 to FY2017 were approved in the first review cycle, and called on the FDA to “take additional steps to address factors that may affect approval rates in the first review cycle.” The GAO notes that the FDA has taken steps to increase first review cycle generic drug approvals, but also provides recommendations for additional steps the FDA could implement to speed approval. For instance, the FDA should improve “the clarity and content of FDA’s comments to applications.”
In preparing the report, the GAO interviewed a selection of stakeholders about the approval process. These stakeholders expressed concern that labeling changes to the brand name drug corresponding to their generic drug which occur mid-cycle “could delay or prevent generic drugs’ approval in the first review cycle,” and, further, some respondents said they believe that brand name drug “labeling changes may be strategically timed to delay approvals.” The FDA noted that they thought such a scenario was unlikely, but the GAO suggested that the FDA should conduct an analysis “that would enable it to assess the validity of the concerns.”
In response to the report, Acting FDA Commissioner Ned Sharpless said the FDA supports the GAO’s findings. Sharpless also noted that the generic drug approval process has “become increasingly efficient,” and further that “[t]he number of review cycles is decreasing for new applications, thanks to increased transparency & communications to help industry allocate resources & prepare better, more complete submissions.”