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US FDA Commissioner Nominee on Fast Track with Nov. 20 Hearing

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Vol. 81 / No. 45 November 11, 2019 nation of replacement in almost 15 years. US FDA Commissioner Nominee (See chart below.) Among the potential nominees consid- ered were Ned Sharpless, then acting com- On Fast Track With Nov. 20 Hearing missioner and now back at NCI, and Brett M. NIELSEN HOBBS [email protected] Giroir, the Health and Human Services assistant secretary for health who is now tephen Hahn’s nomination to lead November, seven months after the pre- acting commissioner, as part of the Fed- the US Food and Drug Administra- vious confirmed commissioner, Scott eral Vacancies Reform Act shuffle that the S tion was a long time coming, but it Gottlieb, left the post. (Also see “Stephen administration performed on Friday. (Also appears that Senate leadership is hoping Hahn For US FDA Commissioner: Will Aca- see “Giroir Becomes Acting US FDA Commis- that his time as nominee will be pleasantly demic Experience Suffice For Confirma- sioner, Giving Agency Experienced Political short, with a hearing in the Health Com- tion?” p. 4.) Hand” - Pink Sheet, 1 Nov, 2019.) mittee now scheduled for 20 November. The lengthy process to pick Hahn result- Tapping the runner-up as the de facto Sen. Lamar Alexander, R-TN, an- ed in the longest gap between departure interim commissioner isn’t unusual (think nounced on 6 November that he was of a confirmed commissioner and nomi- CONTINUED ON PAGE 4 supporting the nomination. “I had an excellent meeting with Dr. Wait Times For New Commissioners Hahn and believe he is well-qualified Hahn was the longest gap between the resignation of the previous commissioner to lead the FDA. As an oncologist, Dr. and nomination in over a decade. Hahn knows firsthand the importance of bringing new, lifesaving drugs and David Kessler 9.8 .53 months devices quickly through the regulatory process as well as the need for innova- Jane Henney 15.86 3.93 months tion for patients with debilitating and Mark McClellan* 20.2 20.2 months chronic pain. As a successful chief exec- utive, he will bring a guiding hand to an Lester Crawford 10.63 5.13 months agency tasked with protecting the pub- Andrew von Eschenbach 5.67 8.73 months lic’s health,” Alexander, who chairs the 1.73 health committee, said in a statement. Margaret Hamburg* 2.13 months “This is a crucial perspective at a time Robert Califf 5.37 5.3 months when FDA is implementing the 21st Scott Gottlieb* 1.7 Century Cures Act, regulating tobacco 1.7 months and vaping products, addressing the Stephen Hahn 7 opioid crisis, and protecting our nation’s 0 2 4 6 8 10 12 14 16 18 20 food supply.” Months Hahn, currently the chief medical executive at the MD Anderson Cancer Time Between Resignation of Previous Commissioner and Nomination Center, was nominated by President Time from Nomination to Confirmation Trump to be FDA commissioner on 1 Note: * indicates nomination following presidential inauguration FOR THE LATEST INSIGHT ON BIOPHARMA REGULATION AND POLICY, VISIT: PINK.PHARMAINTELLIGENCE.INFORMA.COM UK NICE DRUG REVIEWS DRUG REVIEWS Everyone Wants A Piece Of The EMA Accepts First Diabetes Drug China Alzheimer’s Approval Raises UK’s NICE, p. 9 Onto PRIME, p. 10 Hope But Also Questions, p. 12 Open for Entries THE 25TH OTC MARKETING AWARDS Entry deadline: 6 December 2019 GALA DINNER & AWARDS PRESENTATION THURSDAY, 5 MARCH 2020 | ROYAL LANCASTER LONDON, UK https://pharmaintelligence.informa.com/otc FOR SPONSORSHIP OPPORTUNITIES CONTACT: Rob Coulson E: [email protected] T: +44 (0) 7825 845 666 FOR ALL OTHER ENQUIRIES: Natalie Cornwell E: [email protected] Sponsored by Supported by T: +44 (0) 7827 993 776 JN2265 OTC Awards 2020 Open for Entries Advert US Letter.indd 1 2019/09/20 20:02 7 11 12 exclusive online content inside: COVER US FDA Commissioner Nominee On Fast Track HIV PrEP Patent Dispute Escalates As HHS Files Suit Against Gilead With Nov. 20 Hearing https://pink.pharmaintelligence.informa.com/PS141154 Trump administration wants the HIV drug maker to license HHS US FDA patents related to pre-exposure prophylaxis. Lawsuit follows 5 Stephen Hahn For US FDA Commissioner: Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents. Will Academic Experience Suffice For Confirmation? 7 US FDA Expands ‘Cures’ Hiring Authority To Fill Variety Rx Pricing, Rebating Should Be Back To Business Of Open Positions As Usual In 2020, PBMs Say https://pink.pharmaintelligence.informa.com/PS141153 Political focus of drug pricing debate has shifted away from UK NICE pharmacy benefit managers, CVS Health’s Merlo suggests. 9 Everyone Wants A Piece Of The UK’s NICE Gene And Cell Therapies In Asia: New Korean Law DRUG REVIEWS To Change Landscape Of Cutting Edge Biologics https://pink.pharmaintelligence.informa.com/PS141155 10 EMA Accepts First Diabetes Drug Onto PRIME South Korea will undergo many changes as it gears up for a new 12 China Alzheimer’s Approval Raises Hope law on cutting edge regenerative medicine and biologics, which But Also Questions will be implemented next year. Until then, further discussions will be needed to set details of the rules that can step up the industry’s competitiveness and bring the country more in line SUPPLY CHAIN with global standards. 11 UK Adds MMR Vaccine To Export Ban List Another Ebola Vaccine Among New Filings At EMA https://pink.pharmaintelligence.informa.com/PS141156 ADVISORY COMMITTEES The European Medicines Agency has received 11 new marketing 14 Recent And Upcoming FDA Advisory Committee Meetings authorization applications, including three for orphan products from Vertex, MYR Pharmaceuticals and AstraZeneca. ONLINE ONLY! join the conversation FDA PERFORMANCE We are tweeting, liking and sharing the latest industry TRACKER news and insights from our global team of editors and analysts — join us! Regularly updated information about new submissions, pending applications and FDA actions, online-only interactive content at your fingertips 24/7 at @PharmaPinksheet pink.pharmaintelligence.informa.com/product- reviews-and-approvals/fda-performance-tracker pink.pharmaintelligence.informa.com November 11, 2019 | Pink Sheet | 3 US FDA Time To Senate Hearings For FDA Nominees CONTINUED FROM PAGE 1 Joshua Sharfstein or Lester Crawford) For the last three commissioners, time to hearing corresponded with time and putting Giroir at FDA could actually to confirmation. help speed Hahn’s nomination along. Democrats have expressed concern about Girior’s policy work on abortion 54 Margaret Hamburg and on reproductive issues, so they may 64 be disinclined to try to hold up Hahn’s confirmation since it would mean keep- 63 ing Girior at the head of the agency. Robert Califf 159 Hahn doesn’t appear to have any indus- try conflicts that have held up previous 26 nominees. (Also see “Hahn May Not Run Scott Gottlieb 56 Into Questions About Industry Ties Like His Predecessors” - Pink Sheet, 1 Nov, 2019.) But senators could always try to hold Stephen Hahn 19 up the nomination because of concerns they have about policy issues within the 0 20 40 60 80 100 120 140 160 FDA’s orbit, be they drug pricing, vap- ing, or CBD. So while a quickly scheduled Days from Nomination to Hearing Days from Nomination to Confirmation Scheduled hearing hearing is a good sign, it’s no guarantee of a smooth confirmation. Hamburg and Califf had the disadvantage of needing to go through the Senate Still, a long wait for a nominee fol- while it was controlled by the opposition party. lowed by a quickly scheduled hearing could signal a quick confirmation. Mark FDA Commissioner Confirmation Votes McClellan’s 2002 nomination was the longest waited for at 20.2 months, but Gottlieb got the fewest. the second-quickest time from nomi- nation to confirmation, 22 days, with a David Kessler 100 hearing coming after just 12 days – while the Senate was controlled by Democrats. Jane Henney 100 (See top chart left.) Mark McClellan 100 Quick doesn’t always mean pleasant, though. While McClellan passed the Sen- Lester Crawford 78 16 ate by voice vote, Scott Gottlieb, who had the third-quickest nomination at 56 days Andrew von Eschenbach 80 11 and got a hearing in 26 days, ended up with the fewest votes of any FDA nomi- Margaret Hamburg 100 nee ever, a tally that probably reflected Robert Califf 89 4 resistance politics at the beginning of the Trump administration as much as any Scott Gottlieb 57 42 concerns with him in particular. (See bot- 0 10 20 30 40 50 60 70 80 90 100 tom chart left.) Yes No Passed by Voice Vote Passed by Unanimous Consent Published online 6 November 2019 LET’S GET We are tweeting, liking and sharing the latest industry news and insights from our global team of editors and analysts, join us! SOCIAL @PharmaPinksheet 4 | Pink Sheet | November 11, 2019 © Informa UK Ltd 2019 US FDA Stephen Hahn For US FDA Commissioner: Will Academic Experience Suffice For Confirmation? DERRICK GINGERY [email protected] ne of Stephen Hahn’s best as- eral administrative experience. Kessler sets as the nominee for commis- served from November 1990 until late O sioner of the US Food and Drug February 1997. Administration may also be his biggest Hahn was a senior investigator at the cause for concern. NCI for about a year, but since July 1995 From an administrative perspective, Hahn he has practiced medicine in the private is a government neophyte. The chief medi- sector at the University of Pennsylvania cal executive of MD Anderson Cancer Cen- and MD Anderson Cancer Center. ter has never held a significant leadership Like Hahn, Kessler also came to FDA position at a government agency, let alone from an academic hospital setting.
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