Senator Calls on FDA to Reduce ANDA Backlog

Regulatory NewsRegulatory News | 06 October 2015 |  By 

As soaring drug prices remain in the national spotlight, the US Food and Drug Administration (FDA) needs to do what it can to reduce its backlog of generic drug applications, Sen. David Vitter (R-LA) said in a letter to FDA Acting Commissioner Stephen Ostroff.

With 86% of all US prescriptions filled as generics, the backlog of nearly 3,000 Abbreviated New Drug Applications (ANDAs) at FDA's Office of Generic Drugs (OGD) ultimately constrains market competition and makes drugs overall more expensive, according to Vitter.

"The bottom line is that this extensive backlog serves as a major obstacle to a market-based, competitive response to manufacturers who choose to run up prices. This is unacceptable," Vitter said.

And Vitter isn't the only politician looking to grab some of the spotlight and call for a reduced ANDA backlog. Democratic presidential hopeful Hillary Clinton similarly called on Congress two weeks ago to fully fund OGD "to clear out their multi-year generic drug approval backlog, which has kept competitors off the market, and can help lower overall prescription drug prices."

FDA Response

But the letter and proposal come as FDA noted in an update Tuesday that it's actually making some strides with its generic drug review program, particularly with so-called "first generic drugs," which offer the initial competition to their brand-name counterparts.

As of 1 September, OGD has approved more than 50 first generic drugs so far this calendar year, which is notable as this subset of generic drugs is typically blocked from FDA approval by patents and exclusivities that incentivize new drug development. Some of those first generic approvals include versions of Nexium, Copaxone and Abilify.

"We have hired and trained additional staff members, enhanced operational infrastructure, and improved communications within the agency to facilitate reviews and inspections. Further, we have significantly enhanced communications with industry," FDA said.

Political Posturing?

And the ANDA backlog isn't exactly new. In fact, the nature of the ANDA review and approval process will guarantee that there is always a backlog because ANDAs are submitted and approved on an ongoing basis and because OGD has been receiving significantly more applications than it's been approving, or could even hope to approve, each year since it began approving generics.

For instance, in 2014, OGD received a record-high 1473 ANDAs and approved 409 of those that same year. 

In March, according to Lachman Consultants, OGD provided a look at the number of ANDA submissions vs. the number of ANDA approvals from 2002 to 2014 and revealed that the number of submissions outpaces the number of approvals by multiples ranging from about 1.5:1 to about 3:1 each year.  

Letter to FDA Acting Commissioner Ostroff



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