Janet Woodcock - FDA | FierceBiotech
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`Biotech
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`Janet Woodcock - FDA
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` by Damian Garde |
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`The gatekeeper of biopharma's biggest market
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`Name: Janet Woodcock
`Title: Director of the FDA's Center for Drug Evaluation and Research
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`FDA meetings have made for intriguing theater over the past year. Advocates chastise the agency for its perceived gender
` bias. Pharma execs squabble about safety data that happen to defend their multi-billion-dollar products. Parents of children
` with rare diseases read tearful entreaties for the agency to approve new drugs with debatable supporting evidence.
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`Each, wittingly or otherwise, is trying to get through to Janet Woodcock, a 20-plus-year FDA veteran who runs the agency's
` drug-approval arm and has the power to alter the course of the industry.
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`Woodcock is director of the FDA's Center for Drug Evaluation and Research, a division tasked with vetting new drug
` applications. Under her leadership, the agency is approving more and more new drugs each year--45 last year and 41 in
` 2014--all the while facing mounting criticism from critics who say the FDA is too close to the business it regulates, industry
` insiders who claim the process is still too slow, and patient advocates who argue the agency needs to rethink its approach
` to rare diseases.
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`Case in point: Duchenne muscular dystrophy.
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`Two companies, BioMarin Pharmaceuticals ($BMRN) and Sarepta Therapeutics ($SRPT), are petitioning the agency to
` approve treatments that could help about 13% of boys with the deadly, muscle-wasting disease. Each is armed with data
` from small studies in which their candidate drugs charted only intermittent effcacy, below the standard usually required to
` win FDA approval. There are no approved treatments for the disease, and parents of DMD patients are clamoring for
` anything that might improve and extend the lives of their children, even if it's a long shot.
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`http://www.fiercebiotech.com/special-report/janet-woodcock-fda[7/6/2016 9:01:22 AM]
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` P. 1
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`UT Ex. 2041
`SteadyMed v. United Therapeutics
`IPR2016-00006
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`Janet Woodcock - FDA | FierceBiotech
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`The question facing Woodcock becomes: Should the FDA bend its standards in response to unmet need, or would relenting
` open up a loophole that biopharma companies could later exploit to the detriment of patients?
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`Woodcock always stays on-message in her public comments, sticking to the point that the agency makes its decisions
` based solely on safety and effcacy data. But the FDA, under her watch, has been increasingly fexible in the approval
` process.
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`CDER's cancer division, led by Richard Pazdur, has repeatedly approved new cancer medications with shallow effcacy
` records, clearing them to treat only the most desperate patients until companies come back with enough data to justify
` broader use. And the agency seemed to cave to public pressure last year when it approved Addyi, a twice-rejected female
` libido treatment whose scant effectiveness didn't outweigh its side effects in the eyes of many critics.
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`Each case boils down to the same fundamental issue: What makes a drug approvable? Woodcock, as gatekeeper of the
` world's biggest drug market, plays a sizable role answering that question, giving her the power to shift the dynamics of
` biopharma.
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`-- Damian Garde (email | Twitter)
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`For more:
`Special Report: The biggest winners--and losers--in the 2015 race for new drug approvals
` Sarepta gets creative in bolstering its case for quick eteplirsen approval
` FDA slaps down BioMarin's Duchenne's drug as rival nears a moment of truth
` FDA clears a controversial female libido drug despite 'modest' effects and dangerous risks
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`Read More:
`
`‹ Anne Wojcicki - 23andMe
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` Up
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`http://www.fiercebiotech.com/special-report/janet-woodcock-fda[7/6/2016 9:01:22 AM]
`
` P. 2
`
`UT Ex. 2041
`SteadyMed v. United Therapeutics
`IPR2016-00006