FDA’s Woodcock: Generic Drug Application Backlog Will be Eliminated Before GDUFA II

Regulatory NewsRegulatory News | 28 January 2016 |  By 

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told senators Thursday that FDA is making significant progress in reducing the backlog of abbreviated new drug applications (ANDAs) for generics and the agency expects that it will be fully caught up by the next re-authorization of the Generic Drug User Fee Act (GDUFA) in 2017.

Since 2012, when the first GDUFA was created to provide FDA with industry funds to ensure a more consistent timeline for generic drug approvals, FDA has had to deal with a backlog of about 6,000 ANDAs.

Woodcock told members of the Senate Committee on Health, Education Labor & Pensions (HELP) that over 90% of those 6,000 applications have received some kind of review or communication from FDA officials.

She noted that FDA has been tasked with a particularly difficult challenge in approving generics under GDUFA that “required us to rebuild the program from the ground up.”

Slower ANDA Approval Times

A number of senators, including Chairman Lamar Alexander (R-TN), criticized FDA for the slow median approval times for generics, noting that median times have slowed from 30 months to 48 months.

“According to one estimate, once there are six or more generic competitors, a drug costs about 10 percent of the brand price—so, these slower approval times mean less competition and higher costs for consumers,” Alexander said.

Currently there are 99 generics with only one generic competitor, 66 with two competitors, and all the rest have multiple competitors, according to FDA statistics presented at the hearing. In addition, 6,218 ANDAs have been addressed since GDUFA began, though about 10% haven’t entered review yet and 2,400 ANDAs are still pending as FDA is still discussions with those companies, while almost 600 have been withdrawn.

Woodcock made clear that the median times cited by Alexander include ANDAs that have technically been backlogged since GDUFA began, though this year, it will take FDA about 15 months to respond to a generic firm on their ANDA. And in October 2016, companies can expect to get a response within 10 months from FDA. Woodcock also noted a case when a generic was approved at nine months, and just last month FDA approved 99 ANDAs.

She also pointed to new product-specific guidance that FDA has been releasing to help companies get new generic drugs to market.

Generic Pricing

 As far as generic drug pricing, several senators raised concerns and Sen. Elizabeth Warren (D-MA) made clear that small tweaks to the ANDA approval system “will not solve the drug pricing problem.”

Woodcock referenced a Department of Health and Human Services (HHS) report released Wednesday on generic drug pricing trends, noting that at present FDA doesn’t define what a generic price spike is.

“We don’t have the expertise to determine what would be a spike,” she added, questioning whether one would consider it a “spike” if a generic that costs 10 cents then sees its price increase to 20 cents.

But Woodcock also said that the agency sifted through the ANDA backlog and identified all of the first generics, or applications which offer a first wave of competition to their brand name counterparts, and that none of the applications left in the backlog are for such drugs. She also said the agency will look into cases where a brand name drug is pulled from the market and an ANDA might have to be expedited to bring more competition to the market.

The HHS report, which supports the idea that the generics market is providing at least some level of competition for brand name drugs, concluded: “Factors such as drug shortages, the ability to obtain new market exclusivities, the distribution system, small market size, and consolidation in the generic drug industry present potential barriers to ongoing competition in the generic drug market, and will be subject of continued study.”

Janet Woodcock Testimony before HELP Committee

HHS: Understanding Recent Trends in Generic Drug Prices



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