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# Woodcock and Shkreli Share Same Witness Table at Hearing
- URL: https://www.fdaweb.com/woodcock-and-shkreli-share-same-witness-table-at-hearing/
- Published: 2016-02-04T12:00:00.000Z
- Updated: 2026-09-15T02:33:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134681

> FDA continues to be drawn into the drug pricing debate, with CDER director **Janet Woodcock** gaining unwanted attention as she sat at a witness table during a Congressional hearing with what media have dubbed the most hated man in America or on the Internet — former Turing Pharmaceuticals CEO **Martin Shkreli**. There was a media circus surrounding Shkreli, who has been sharply criticized for significantly raising the price of the antiparasitic drug Daraprim by 5,556% to $750 per tablet in order to maximize profits for himself and other shareholders. As expected, he declined to answer questions from lawmakers on the advice of counsel and invoked his Fifth Amendment right to avoid self-incrimination. He was dismissed from the hearing and left with an entourage of cameras snapping away.  
>  
> During her [testimony](https://oversight.house.gov/wp-content/uploads/2016/02/Woodcock-FDA-Statement-1-26-Prescription-Drugs.pdf?ref=fdaweb.com) before the House Oversight and Government Reform [Committee](https://oversight.house.gov/hearing/developments-in-the-prescription-drug-market-oversight/?ref=fdaweb.com), Woodcock reiterated generic drug user fee program accomplishments she discussed last week during a Senate HELP committee hearing ([see story](https://www.fdaweb.com/keep-fda-out-of-drug-pricing-equation-woodcock/)). She said she was confident that the generic drug review program is on stable footing, and that the ANDA backlog that existed in 2012 at the beginning of the user fee program will be gone by 2017.  
>  
> Woodcock noted that there have been struggles in getting the user fee program to its current level. Over the past few years, the Center has received a much larger than expected ANDA submission volume — user fee review goals and planning were based on the assumption that about 750 ANDAs per year would be received. “However, in FYs 2012, 2013 and 2014, we received over 1,000, nearly 1,000, and nearly 1,500 applications, respectively,” she said. “We had to modify our planning and execution accordingly.”  
>  
> Regarding ongoing challenges, Woodcock said one relates to submission quality. “Historically, it has taken on average about four review cycles to approve an ANDA as a result of deficiencies by generic drug sponsors in submitting complete and quality applications,” she said. “This has resulted in the submission of numerous amendments to correct deficiencies in the original ANDAs and comprises a huge amount of re-work for FDA and industry alike. Currently, for example, nearly 900 applications are back with industry awaiting resubmission to correct deficiencies in the original applications. New filing policies will help, but more work by both the agency and industry will be necessary to have the filings be ‘right the first time.’”  
>  
> Another challenge, according to Woodcock, is the need for more research in the generics space. “Some drugs lack generic competition because there is no convincing bioequivalence test method available,” she said. “In these instances, a more extensive clinical study is needed to show equivalence of a generic to a brand name drug. Similarly, methods for showing chemical sameness for certain complex drugs are not available. GDUFA provided funding for research efforts to work out these problems. So far, GDUFA has funded $34.9 millionin research programs that will open up previously blocked pathways. However, scientific research takes time, and results will need to be translated into guidance for industry.”