DOCSLIB.ORG

New Acting US FDA Commissioner Shares Agency's Clinical Trial

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
New Acting US FDA Commissioner Shares Agency's Clinical Trial Pharma intelligence Pinkpink.pharmaintelligence.informa.comSheetVol. 81 / No. 11 March 18, 2019 informa New Acting US FDA Commissioner Shares Agency’s Clinical Trial Reform Message DERRICK GINGERY [email protected] he US FDA’s incoming acting com- cies to promote innovation and safety for missioner shares an enthusiasm families,” Gottlieb wrote. T for clinical trial system reform that At NCI, Deputy Director Doug Lowy has should mesh well with the message many been named acting director. senior agency officials have been pushing for years. SHARPLESS PUSHED National Cancer Institute Director Nor- NCI ON TRIAL REFORM man (Ned) Sharpless will become acting Sharpless is a proponent of increasing FDA Commissioner upon Scott Gottlieb’s clinical trial efficiency, including by elimi- departure next month. A physician and re- nating unnecessary exclusion criteria and searcher, Sharpless specializes in leukemia encouraging wider trial access. In a 2018 and has studied the role of stem cells in interview with the American Association cancer and aging. He has been NCI direc- For Cancer Research, Sharpless said he tor since October 2017. wanted to prioritize trials that avoid dilut- Sharpless immediately sought to calm Ned Sharpless ing the participant pool and designs that fears that he planned substantial changes will find ineffective treatments faster. at FDA. He tweeted shortly after the an- Sharpless co-authored a viewpoint ar- nouncement that “rest assured that our ticle on modernizing clinical trials that ap- shared goals for patients and the public’s peared in the Feb. 5 issue of the Journal health will translate into my duties.” of the American Medical Association. He In a message announcing Sharpless’ ap- Sharpless is a discussed NCI efforts to right-size clinical pointment, Gottlieb also said he “shares trials, such as by forgoing traditional con- our mission and I know he will be em- proponent of increasing trol arm interventions and instead using braced warmly” by the staff. trial efficiency, “synthetic controls created with data from Gottlieb wrote he already is well known previous trials” when a highly active agent to many FDA employees and “plays on a including by eliminating is tested. Sharpless also wrote that NCI is weekly basketball team with some of our exploring pragmatic trials conducted in medical review staff.” unnecessary exclusion clinical practice settings and through “aug- “Under his skilled leadership, I’m con- mented annotation and aggregation of fident the transition will be seamless and criteria and encouraging new and existing trials data to answer rel- the FDA will continue to secure its con- wider trial access. evant clinical questions without additional sumer protection role and advance poli- CONTINUED ON PAGE 4 FROM THE EDITORS OF SCRIP REGULATORY AFFAIRS, THE RPM REPORT, GOLD SHEET, PINK SHEET DAILY AND PINK SHEET REGULATORY UPDATE BREXIT PATENTS Breakthrough Designation Brexit Deal Rejection Sounds Alarm Bill To Revise US Subject Matter Rescissions: Who Might US FDA Bells For Pharma Industry, p. 9 Patent Eligibility Standard Expected Drop Next? p. 13 By ‘Early Summer,’ p. 20 Are you looking to reach and do business with senior decision makers in pharma and medtech? We offer a range of marketing opportunities whether you are looking to: • Raise brand awareness • Produce content marketing/thought leadership content • Generate leads • Engage directly with potential clients as well as cementing existing relationships To fi nd out how our team can help visit: https://pharmaintelligence.informa.com/marketing-services JN723 Marketing Services Advert.indd 1 2017/11/13 6:08 PM 6 18 23 exclusive online content inside: COVER New Acting US FDA Commissioner Shares Agency’s US Visa Concerns Led ICH To Choose Clinical Trial Reform Message Canadian Meeting Site US FDA https://pink.pharmaintelligence.informa.com/PS124921 5 Leaving On A High Note: US FDA Commissioner’s The US, one of ICH’s original three member authorities, was Departure Fits A Pattern spurned in favor of Canada for the pharmaceutical regulatory harmonization initiative’s next meeting in the region because of 18 Trump FY 2020 Budget Renews Push To Reform some participants’ difficulties obtaining US visas. 180-Day Exclusivity CLINICAL TRIALS MSD Escapes Action By UK Competition Body Over 6 EU Address Complex Clinical Trial Designs In New Guideline Remicade Discount Scheme 7 Clinical Trial Data Highlight Korean Pharma’s https://pink.pharmaintelligence.informa.com/PS124928 R&D Shift Into Innovation The UK Competition and Markets Authority has announced that there are “no grounds for action” against MSD in relation to a BREXIT discount scheme the company introduced in England to fend 9 Brexit Deal Rejection Sounds Alarm Bells For off biosimilar competition for Remicade. But the competition Pharma Industry watchdog had some words of warning for other companies considering discount schemes designed to protect a dominant REGULATORY UPDATE market position. 13 Breakthrough Designation Rescissions: Who Might US FDA Drop Next? CREATES Act: Republican Lawmakers Worry About 23 EU Calls For Action To Reduce Environmental Impact Frivolous Lawsuits By Generic Firms Of Pharmaceuticals https://pink.pharmaintelligence.informa.com/PS124922 Association for Accessible Medicines’ Davis tries to counter PRICING DEBATE concerns that the long-stalled measure would incentivize 25 Part D Premiums ‘Won’t Go Up’ With HHS Rebate Proposal, lawsuits against brand companies; witnesses at a House Azar Maintains subcommittee hearing on drug pricing legislation also testified PATENTS that the BLOCKING Act would create an overly broad and 20 Bill To Revise US Subject Matter Patent Eligibility complicated framework for triggering 180-day exclusivity. Standard Expected By ‘Early Summer’ Real-Time Oncology Review Quickly Grows Popular; MANUFACTURING QUALITY Venclexta Is Latest To Join Pilot 21 Pfizer Must Correct Data Integrity Problems Seen At https://pink.pharmaintelligence.informa.com/PS124907 India Plant Globally, FDA Says Genentech/AbbVie drug becomes the seventh product known 22 FDA Warning Letter To Teva Highlights Need For Accurate to be pilot-testing US FDA’s new pathway; our infographic details Root Cause Investigations the program’s goals and how it has been used so far for more efficient reviews of supplemental oncology indications. ADVISORY COMMITTEES 26 Recent And Upcoming FDA Advisory Committee Meetings Don’t have an online user account? You can easily create one by clicking on the THOUGHT LEADERSHIP IN ASSOCIATION WITH “Create your account” link at the top of the online page. RWS LIFE SCIENCES Contact [email protected] or call: 10 One Route, Many Languages: Managing Translation 888-670-8900 or +1-908-547-2200 for additional information. Complexities in the EMA Centralised Procedure pink.pharmaintelligence.informa.com March 18, 2019 | Pink Sheet | 3 CLINICAL TRIALS CONTINUED FROM COVER tember 2005. He was confirmed by the enrollment.” Senate as the permanent commissioner in Sharpless said in the article that NCI is December 2006. positioning its clinical trial portfolio to “com- Sharpless’ appointment means that FDA’s pliment, rather than compete with efforts Sharpless would appear top two leaders are outsiders. Sharpless from industry,” given that industry now is spent much of his career in academia, while the majority funder of cancer trials. to have the inside Principal Deputy Commissioner Amy Aber- “Trials sponsored by the NCI that comple- nethy, who also was rumored for the acting ment those supported by industry, can, for track to becoming commissioner position, joined the agency example, focus on low-prevalence cancers the permanent less than a month ago (Feb. 19), after having for which there is limited commercial incen- worked in industry. (Also see “Commissioner tive to sponsor clinical investigations, such FDA commissioner, Succession Plan? Abernethy As Gottlieb’s as pediatric cancers, uncommon cancers, Number Two Offers One Option” - Pink Sheet, rare subtypes of more common tumors, although there is no 17 Dec, 2018.) and special patient populations,” he wrote. indication yet that Sharpless’ interest in the subject will be DRUG PRICING, OTHER welcome at FDA, especially by Center for President Trump will QUESTIONS MAY EMERGE Drug Evaluation and Research Director Should he be nominated to become the per- Janet Woodcock, who along with Gottlieb nominate him. manent commissioner, Sharpless may run has argued for many of the same reforms. into questions about industry ties and drug Woodcock has called for an end to to systematically collect real-world data pricing, just like his recent predecessors. the trial system’s use of digital paper and and helping develop new clinical outcome Sharpless holds several patents, includ- adoption of a more modern system (Also assessments. (Also see “US FDA Targets Mi- ing some that appear related to drug see “Reliance On ‘Digitized Paper’ Is Slowing graine, Schizophrenia And Opioid Sparing treatments. Those may give Senators an Drug Development – US FDA’s Woodcock” - Drugs For Clinical Outcome Assessment De- opening to question him on the cost of Pink Sheet, 14 Nov, 2018.), as well as greater velopment” - Pink Sheet, 25 Feb, 2019.) medicines, as well as various patent reform use of master protocols and basket trials. proposals, during a confirmation hearing. (Also see “Master Protocols Are Both Wel- IS A NOMINATION FOR Congress has often debated whether come And Inevitable – US FDA’s Woodcock” PERMANENT
Load more

Recommended publications
  • Crawford E-Transcript.Ptx
    VIDEOTAPED DEPOSITION OF LESTER M. CRAWFORD, D.V.M., PH.D. CONDUCTED ON WEDNESDAY, MAY 24, 2006 Page 1 1 UNITED STATES DISTRICT COURT 2 EASTERN DISTRICT OF NEW YORK 3 - - - - - - - - - - - - - - X 4 ANNIE TUMMINO, et al., : 5 Plaintiffs, : 6 v. : No. 05-CV-366(ERK/VVP) 7 ANDREW C. VON ESCHENBACH, : (Korman, C.J.) 8 as Acting Commissioner of : (Pohorelsky, M.J. 9 The Food & Drug : 10 Administration, : 11 Defendant. : 12 - - - - - - - - - - - - - - X 13 14 Videotaped Deposition Of 15 LESTER M. CRAWFORD, D.V.M., Ph.D. 16 Washington, D.C. 17 Wednesday, May 24, 2006 18 9:11 a.m. 19 20 Job No. 1-78974 21 Pages 1 - 244 22 Reported by: Jacquelyn C. Jarboe L.A.D. REPORTING & DIGITAL VIDEOGRAPHY - (800) 292-4789 (202) 861-3410 (800) 292-4789 (301) 762-8282 (703) 288-0026 (410) 539-3664 VIDEOTAPED DEPOSITION OF LESTER M. CRAWFORD, D.V.M., PH.D. CONDUCTED ON WEDNESDAY, MAY 24, 2006 Page 2 1 Videotaped deposition of LESTER M. CRAWFORD, 2 D.V.M., Ph.D., held at the offices of: 3 4 5 Arnold & Porter LLP 6 555 Twelfth Street, Northwest 7 Washington, D.C. 20004 8 (202) 827-1152 9 10 11 12 13 14 Pursuant to agreement, before Jacquelyn C. 15 Jarboe, Notary Public in and for the District of 16 Columbia. 17 18 19 20 21 22 L.A.D. REPORTING & DIGITAL VIDEOGRAPHY - (800) 292-4789 (202) 861-3410 (800) 292-4789 (301) 762-8282 (703) 288-0026 (410) 539-3664 VIDEOTAPED DEPOSITION OF LESTER M. CRAWFORD, D.V.M., PH.D.
    [Show full text]
  • FDA Finally Approves Plan B—But with Restrictions
    FDA finally approves Plan B—but with restrictions New York Janice Hopkins Tanne The US Food and Drug Administration has finally approved the emergency contraceptive Plan B for sale over the counter to women aged 18 or over. Plan B is a two pill, high dose regimen of the oral contraceptive levonorgestrel. It is about 90% effective in preventing pregnancy when taken within 72 hours of unprotected sex. Plan B will be available towards the end of the year at a cost of $25 (£13; €20) to $40. Women will have to request it from a pharmacist in a pharmacy that is licensed to sell it or from a health clinic. They will have to show government issued identification, such as a driver’s licence, proving they are aged 18 or older. Younger women will need a doctor’s prescription. Men aged 18 or older will also be able to buy the drug for their partner, a move that has raised concern that they may buy it for women under 18. It will not be sold at petrol stations or in convenience stores. The manufacturer, Barr Pharmaceuticals, will survey pharmacies to see that they follow the rules. The FDA’s acting commissioner, Andrew von Eschenbach, approved Plan B three days after President Bush said that he supported approval of the drug for women aged over 18, with prescription only access for younger women. In his approval letter Dr von Eschenbach noted that buyers of nicotine patches and some other drugs already had to prove they were at least 18. The approval came nearly three years after the FDA’s own expert advisory committees and professional staff recommended that the drug be available over the counter for women of all ages.
    [Show full text]
  • 1 United States District Court Eastern District of New York
    Case 1:05-cv-00366-ERK-VVP Document 285 Filed 03/30/09 Page 1 of 52 PageID #: <pageID> UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NEW YORK -----------------------------------------------------------------X ANNIE TUMMINO et al., Plaintiffs, MEMORANDUM & ORDER - against - No. 05-CV-366 (ERK)(VVP) FRANK M. TORTI,∗ Acting Commissioner of the Food and Drug Administration, Defendant. -----------------------------------------------------------------X KORMAN, J.: Plan B is an emergency contraceptive that can be used to reduce the risk of unwanted pregnancy after sexual intercourse. When used as directed, it can reduce the risk of pregnancy by up to 89 percent. Plan B acts mainly by stopping the release of an egg from an ovary. It may also prevent sperm from fertilizing an egg that has been released or, if fertilization has already occurred, block implantation of the resulting embryo in the uterus. Plan B does not have any known serious or long-term side effects, though it may have some mild and short-term side effects, such as nausea or abdominal pain, in some users. The approved dosage of Plan B is two pills taken 12 hours apart, each containing 0.75 mg of levonorgestrel, a synthetic hormone similar to the naturally occurring hormone progesterone. Because the drug works best when taken within 24 hours of sexual intercourse, it is commonly referred to as a “morning-after pill.” Nevertheless, the drug is effective if the first dose is taken within 72 hours of sexual intercourse. ∗ Pursuant to Federal Rule of Civil Procedure 25(d), Acting Commissioner Frank M. Torti has been substituted for former Commissioner Andrew C.
    [Show full text]
  • Vrwinter06weblinked.Pdf
    eterinary REPORT WINTER 2006 | VOL. 29 | NO. 1 2 Meet David Williams State-of-the-art 3 small animal surgery suites and ICU/ER College Unveils Facility Plan 25 Thank You, College Supporters Equine Sports Medicine Clinic Academic Commons, to support expanded veterinary class size Dean’s Column In this issue Spotlight on the Veterinary Teaching Features Hospital New Clinical Department By Herb Whiteley Head . 1 For many alumni and friends of the College, the Veterinary Teaching Facility Plan . 2 Hospital is the most visible and tangible aspect of our institution. The Ugandan Connection . 4 This is where your beloved companion animals and valuable agricul- tural assets—or those of your referred clients—receive expert care. Illinois Program Has Global This is where your future veterinarian or your future colleagues in Impact on Animal Health . 5 practice receive their capstone education. Without a Operation Polar Bear . 6 This is where the newest surgical approaches, best diagnostic tests, doubt, the and state-of-the-art treatment protocols are developed and tested. Joan Embery . 7 Without a doubt, the Veterinary Teaching Hospital participates in Veterinary News from the Zoos . 7 all aspects of our mission and vision, contributing indispensably to the Teaching College’s leadership in veterinary education, scholarship, and public engagement. Hospital College News . 8 This past summer, the teaching hospital became an independent participates College unit equivalent to the three academic departments and the Research News . .10 in all aspects Veterinary Diagnostic Laboratory. A new faculty-level position, director New Faces . .12 of the Veterinary Teaching Hospital, was created. of our mission This leader will work very closely with Dr.
    [Show full text]
  • Division of Extramural Activities Annual Report 2002
    Division of Extramural Activities Annual Report 2002 National Institutes of Health National Cancer Institute Molecular Diagnosis of Cancer Gene expression profiling using DNA microarrays is a technology that arose as a consequence of the Human Genome Project. With DNA microarrays, it is possible to determine the activity (“expression”) of tens of thousands of genes in parallel on microarray plates. The expression of genes influences the biological behavior of a cell because it dictates which proteins the cell can make and gives cells their unique characteristics. In the DNA microarray images shown at the bottom of the cover illustration, each spot represents a different human gene. Red, yellow, and green spots indicate that a gene is expressed at high, intermediate, and low levels, respectively. The pattern of expression of all of the genes in a cell constitutes its gene expression “profile.” Using DNA microarrays, different types of normal and malignant cells can be distinguished from one another because they have distinct gene expression profiles. Shown at the top of the cover illustration are photomicrographs of lymph node biopsies from two patients with diffuse large B cell lymphoma. The tumor at the right belongs to the germinal center B cell-like subgroup of diffuse large B cell lymphoma. Patients with this lymphoma type have a relatively favorable 5-year survival rate of 59% following multi-agent chemotherapy. The tumor at the left belongs to the activated B cell-like subgroup of diffuse large B cell lymphoma. Patients with this lymphoma type have a less favorable 5-year survival rate of 31%. Although the tumors from these patients were indistinguishable histologically, they had striking differences in their gene expression profiles, as exemplified by the microarray images shown below each lymphoma subgroup.
    [Show full text]
  • Carefirst Doctors Earn $1.4 Million in P4P Rewards
    46 Practice Trends I NTERNAL M EDICINE N EWS • November 15, 2006 P OLICY & PRACTICE tive care. During the first year, participat- CMS Curbs Improper Claims ing physicians will be paid for reporting Medicare is on track in 2006 to further re- Ex-FDA Chief Crawford Guilty Pilot P4P for Small Practices baseline information. In the 2 succeeding duce the number of fraudulent and inap- Former Food and Drug Administration The Centers for Medicare and Medicaid years, practices will submit quality data; propriate claims being submitted. CMS is Commissioner Lester M. Crawford, Services is seeking 800 solo and small- to they can earn up to $10,000 per physician reporting that 4% of claims were im- D.V.M., has pleaded guilty to lying about medium-sized group practices to partici- or up to $50,000 per practice for meeting proper in 2006, down from 5% the previ- stock he held during his tenure, in viola- pate in a 3-year pilot pay-for-performance benchmarks endorsed by the National ous year and from 14% in 1996, leading to tion of federal conflict-of-interest and project. The Medicare Care Management Quality Forum. The measures are similar $11 billion less in improper payments over stock ownership rules. Dr. Crawford was Performance Demonstration is limited to to those being used in Medicare’s Physician the last 2 years. To determine the error charged with two misdemeanors and is practices in Arkansas, California, Massa- Voluntary Reporting Program. At the end rate, CMS randomly sampled 160,000 scheduled to be sentenced Jan. 22 in Fed- chusetts, and Utah that are the main of the 3-year project, CMS and the Agency claims submitted from April 2005 to eral District Court in Washington.
    [Show full text]
  • Emergency Contraception: Plan B
    Order Code RL33728 CRS Report for Congress Received through the CRS Web Emergency Contraception: Plan B November 9, 2006 Judith A. Johnson Specialist in Biomedical Policy Domestic Social Policy Division Erin D. Williams Specialist in Bioethical Policy Domestic Social Policy Division Vanessa K. Burrows Legislative Attorney American Law Division Congressional Research Service ˜ The Library of Congress Emergency Contraception: Plan B Summary On August 24, 2006, the Food and Drug Administration (FDA) announced the approval of an application to switch Plan B, an emergency contraceptive, from a prescription-only drug to an over-the-counter (OTC) drug for women 18 years of age and older. Plan B will only be sold in pharmacies or healthcare clinics. It will continue to be dispensed as a prescription drug for women 17 years old and younger. Plan B is a brand of post-coital contraceptive that is administered within a few hours or days of unprotected intercourse. Emergency contraception prevents pregnancy; it does not disrupt an established pregnancy. Approval of the switch to OTC status for Plan B has been controversial. Some Members of Congress urged the FDA to deny OTC status for Plan B. Individuals who are critical of the decision to switch to OTC believe that Bush Administration policy and FDA actions were based on political and ideological considerations rather than on sound science. Conservative religious and pro-life groups believe Plan B may increase unsafe sexual activity and should be used only under the supervision of a healthcare professional and, therefore, should not be available OTC. Their major concern with Plan B, however, is that it might prevent the implantation of an embryo in the uterus, which to pro-life groups constitutes abortion.
    [Show full text]
  • Lester Crawford
    PROFILE Lester Crawford Veterinarian Lester Crawford has been nominated to be who directs the Washington-based Center for Science in the Public Commissioner of the US Food and Drug Administration. Can he Interest (CSPI), warns that Crawford’s “past… in industry raises ques- provide the agency with the leadership it so desperately needs? tions about his appropriateness to lead the beleaguered [FDA],” which Jacobson refers to as an “agency in crisis, especially on the drug side.” Whether FDA is truly in crisis is debatable, but Crawford will be work- President George W. Bush gave Lester Crawford a special valentine this ing in a politically sensitized atmosphere where drug safety is high on year, telling him on February 14 that he was being nominated to be com- the agenda not only of liberals but also of staunch conservatives, such as missioner of the Food and Drug Administration (FDA). A long-term, if Republican Senator Charles Grassley from Iowa and Republican Senator only quietly ardent, suitor to the post, Crawford has served four separate Michael Enzi from Wyoming. The day after Crawford was nominated stints at the agency, including twice as acting commissioner. he announced plans to form a new drug safety oversight board, whose Little wonder, then, that he was relaxed enough around the time of reviews will include biotech therapeutics, and to open new channels for the White House announcement in mid-February to display some of disseminating information about product safety for the sake of “greater the glad-handing and wisecracking
    [Show full text]
  • Former FDA Commissioner Pleads Guilty to Two Charges New York Janice Hopkins Tanne
    Former FDA commissioner pleads guilty to two charges New York Janice Hopkins Tanne Lester Crawford, the former commissioner of the US Food and Drug Administration, pleaded guilty in a district court in Washington, DC, last week to two charges: conflict of interest and failing to disclose financial holdings in companies that the FDA regulated. Each charge carries a maximum penalty of a year in prison and a fine. Dr Crawford will be sentenced on 22 January 2007. Dr Crawford’s lawyer, Barbara Van Gelder, told the Associated Press news agency that she expected Dr Crawford to be fined and placed on probation. The Washingtonian magazine said she is the lawyer to call if “you find yourself drawn into an awkward congressional investigation, or worse, a grand-jury investigation by the Justice Department or the US Attorney’s office” (Washingtonian Dec 2004, p 94). The US Department of Justice had charged Dr Crawford with failing to disclose investments on forms required of senior officials at the FDA. He made false statements saying that he and his wife had sold stocks in organisations regulated by the FDA, such as PepsiCo, Sysco, Kimberly-Clark, and Embrex, or did not declare their holdings. He also did not disclose income from holdings in Embrex stock options or from ownership of Kimberly- Clark or Sysco stock. The conflict of interest charge related to Dr Crawford’s ownership of Sysco and PepsiCo stock and his role as chairman of the FDA’s obesity working group, which made recommendations about relabelling the energy content of food products, such as soft drinks.
    [Show full text]
  • Ensuring a Stable Supply of Influenza Vaccine Erica Seiguer
    JULY 2005 Issue Brief Protecting the Nation’s Health: Ensuring a Stable Supply of Influenza Vaccine Erica Seiguer For more information about this ABSTRACT: The looming threat of an influenza pandemic concerns government study, please contact: officials worldwide as they attempt to address shortages and flaws in the vaccination Mary Mahon system. Currently, only two vaccine manufacturers are licensed for U.S. production. Public Information Officer This fact, combined with the complexity of production, has resulted in a supply that The Commonwealth Fund can be easily interrupted. Policymakers are considering various options to spur 1 East 75th Street New York,NY 10021-2692 research and development, stabilize the supply of vaccines, and improve their priori- Tel 212.606.3853 tization and distribution. Fax 212.606.3500 E-mail [email protected] * * * * * Policy Context Recent flu vaccine production problems have underscored the uncertainty of an adequate and stable vaccine supply. For the 2004–2005 flu season, the U.S. supply is about 65 million doses, compared with the 100 million expected, due to the suspension of production at one of the two vaccine manufac- turers licensed by the Food and Drug Administration. Mismatches between supply and demand for vaccines in both directions have become common occurrences in recent years.The social and economic consequences of yearly influenza epidemics are significant. About 36,000 Americans die each year from influenza, and approximately 200,000 are hospitalized.The annual direct costs of medical care are estimated at $1 billion to $3 billion. When compounded with the indirect costs to business of declines in worker productivity (both from employee absenteeism due to illness and for caring for family members), costs for the 2004–2005 season are expected to Additional copies of this and 1 other Commonwealth Fund total $20 billion.
    [Show full text]
  • Page 1 2 of 5 DOCUMENTS ANNIE TUMMINO Et Al., Plaintiffs, -Against
    Page 1 2 of 5 DOCUMENTS ANNIE TUMMINO et al., Plaintiffs, -against- FRANK M. TORTI, * Acting Com- missioner of the Food and Drug Administration, Defendant. * Pursuant to Federal Rule of Civil Procedure 25(d), Acting Commissioner Frank M. Torti has been substituted for former Commissioner Andrew C. von Eschenbach as defendant in this case. Earlier in this litigation, Commissioner von Eschenbach was substituted for former Commissioner Lester M. Crawford, the original named defendant. No. 05-CV-366 (ERK)(VVP) UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK 603 F. Supp. 2d 519; 2009 U.S. Dist. LEXIS 23218 March 23, 2009, Decided SUBSEQUENT HISTORY: As Corrected March Women Young Feminist Task Force, as Coordinator of 30, 2009. As Amended March 8, 2013. the Morning-After Pill Conspiracy, and on behalf of Reconsideration denied by, Motion denied by Tummino women who need Emergency Contaception, Lori Tinney, v. Hamburg, 260 F.R.D. 27, 2009 U.S. Dist. LEXIS in her individual capacity, as President of the Gainesville 76585 (E.D.N.Y., Aug. 27, 2009) Chapter of the National Organization for Women, as Coordinator [**2] of the Morning-After Pill Conspira- PRIOR HISTORY: Tummino v. Von Eschenbach, 2007 cy, and on behalf of women who need Emergency U.S. Dist. LEXIS 35465 (E.D.N.Y., May 15, 2007) Contaception, Jennifer Brown, in her individual capacity, as Coordinator of the Morning-After Pill Conspiracy, and on behalf of Women who need Emergency Contra- COUNSEL: [**1] For Annie Tummino, in her indi- ception, Candace Churchill, in her individual capacity, as vidual capacity, as Vice-Chair of the Women's Libera- Coordinator of the Morning-After Pill Conspiracy, and tion Birth Control Project, as Coordinator of the Morn- on behalf of women who need Emergency Contaception, ing-After Pill Conspiracy, and on behalf of women who Francie Hunt, in her individual capacity, as Coordinator need Emergency Contraception., Erin T.
    [Show full text]
  • 1 MILLER REPORTING CO., INC. 735 8Th STREET, S.E
    1 CENTER FOR SCIENCE IN THE PUBLIC INTEREST GOVERNMENT SCIENCE PANELS: FAIR AND BALANCED? Monday, July 24, 2006 MILLER REPORTING CO., INC. 735 8th STREET, S.E. WASHINGTON, D.C. 20003-2002 (202) 546-6666 2 I N D E X Welcoming Remarks - Michael F. Jacobson, Ph.D. 3 Introductions - Snigdha Prakash, NPR 5 David Michaels, Ph.D. 8 George Washington University School of Public Health and Health Services. James W. Conrad, Jr., J.D. 18 Assistant General Counsel American Chemistry Council Questions and Answers 27 Steven E. Nissen, M.D. 31 Interim Chairman, Department of Cardiovascular Medicine Cleveland Clinic Foundation Scott Gottlieb, M.D. 38 Deputy Commissioner for Medical and Scientific Affairs U.S. Food and Drug Administration Questions and Answers 48 Merrill Goozner 54 Director, Integrity in Science Project Center for Science in the Public Interest Frederick R. Anderson, J.D. 65 McKenna, Long & Aldridge, LLP Questions and Answers 73 Questions and Answers from Audience 76 P R O C E E D I N G S DR. JACOBSON: Good afternoon. I'm Michael Jacobson. I'm the Executive Director of MILLER REPORTING CO., INC. 735 8th STREET, S.E. WASHINGTON, D.C. 20003-2002 (202) 546-6666 3 the Center for Science and the Public Interest. I'd like to welcome you to one of CSPI's ongoing series of mini-conferences, press briefings, and different issues related to science and technology. Today's topic is an issue that CSPI's been concerned about for a long time. Corporate influence on Science and Scientific Advisory Committees. Merrill Goozner directs our project on integrity and science and organized this session.
    [Show full text]