FDA Makes Progress on Improving Drug Competition, Transparency, According to 2018 Report

As rising drug costs continue to burden patients and the healthcare system, FDA Commissioner Scott Gottlieb, MD, has led the charge to encourage competition and drive down prices with expedited generic approvals. The plan seems to be paying off. Nearly 10% of drug approvals in 2018 were generic products for branded drugs that had no FDA-approved generics, according to the 2018 Annual Report of the Office of Generic Drugs (OGD), part of the Center for Drug Evaluation and Research in the FDA.

“We built upon previous goal-breaking achievements and increased our capacity and productivity to create an extremely successful year,” wrote Kathleen Uhl, MD, director, Office of Generic Drugs, who is retiring this year.

In total, there were more than 1000 generic drugs that the FDA approved or tentatively approved in 2018. October and November represented peak months for approvals and tentative approvals with 128 each.

The report highlighted progress made with the Drug Competition Action Plan (DCAP), including streamlining the Abbreviated New Drug Applications (ANDA) review process, enhancing development and review of complex generics, and reducing the possibility for drug companies to “game” the system and forestall generic competition.

As part of OGD’s progress toward streamlining the generic drug review process were, the office issued draft guidance for the industry that highlighted common and recurring issues in applications that may delay the approval of generic drugs. Helping applicants to avoid these issues can reduce the number of review cycles. OGD is also issuing 115 product-specific guidelines to increase transparency on methods for generic drug development and evidence needed to support approval.

Finally, to reduce “gaming” that can delay generic approvals, OGD updated the List of Off-Patent, Off-Exclusivity Drugs Without an Approved Generic, which is published to improve transparency and encourage the development of drugs that have limited competition. The office also published revised draft guidance that describes factors FDA considers when determining whether the primary purpose of a petition is to delay approval of a generic drug.

Among the first generic drug approvals in 2018 were buprenorphine HCI and naloxone sublingual film for the treatment of opioid dependence; epinephrine auto-injector, a generic EpiPen for the emergency treatment of anaphylactic allergic reactions; glatopa injection pre-filled syringes for the treatment of multiple sclerosis; and ticagrelor tablets to treat heart disease, stroke, and diabetes.

“While there is no one solution to the many challenges of high drug costs, the agency is committed to doing all we can, within our jurisdiction, to advance the critically important public health mission of providing the American public with more affordable medicines,” the report stated.