Register for this FREE Solution Provider Webinar: Biomarker Strategies for More Efficient Early-Phase Drug Development in Alzheimer’s Disease

Register for this FREE Solution Provider Webinar
Biomarker Strategies for More Efficient Early-Phase Drug Development in Alzheimer’s Disease
May 21 | 11:00 AM-12:00 PM ET | Online

Brought to you by DIA in cooperation with ICON Plc

The development of validated biomarkers for Alzheimer's disease is essential to improve early diagnosis and accelerate the development of new therapies. It will aid in understanding the mechanism of action of a drug, identifying efficacy or toxicity signals at an early stage of development, and in identifying patients likely to respond to treatment. Biochemical and neuroimaging markers can facilitate diagnosis, predict AD progression from a pre-AD state of mild cognitive impairment (MCI), and monitor efficacies of disease-modifying therapies.

In this FREE webinar, you will learn:
· Drug Development in Alzheimer's Disease – Using Data Analytics to Turn Challenges into
Opportunities
· The Use of Molecular Markers in CSF and Plasma in Alzheimer Disease – The Laboratory Perspective
· Advances in Imaging Biomarkers in AD Drug Development to Enable Accelerated Approval –
Fluorodeoxyglucose PET and Functional MRI
· Recent FDA Draft Guidance on Developing Drugs for Alzheimer’s Disease – Key Considerations
Presenters:
· John Allinson, VP Biomarker Lab Services, ICON Development Solutions, UK
· Niels Prins, MD, PhD, MSc, CEO, Alzheimer Research Center (ARC), Netherlands
· Michael N Liebman, PhD, President/Managing Director, IPQ Analytics, United States
· Klaudius Siegfried, PhD, VP & Global Leader Therapeutic Area CNS (Central Nervous System), ICON
Clinical Research, Germany
Overview | Register Online for FREE!


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Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages

Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages
Authors Janet Woodcock and Marta Wosinska of FDA explore why and how these shortages may have been created. From the abstract: “The fundamental problem we identify is the inability of the market to observe and reward quality. This lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing quality investments. The US Food and Drug Administration’s (FDA’s) need to use its regulatory flexibility, on behalf of patients, to avoid shortages of medically necessary drugs may further strengthen the incentive to “push the envelope” on quality. These dynamics may have produced a market situation in which quality problems have become sufficiently common and severe to result in drug shortages.”


See DIA's Content Currents EDITION PUBLISHED: APRIL 12, 2013 for more new and important global regulatory developments and their impact on pharmaceutical, biotechnology, and medical product development.


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Take advantage of DIA’s live webinars

Stay ahead in your field with DIA's live webinars
Take advantage of DIA’s live webinars to learn about the latest issues in your field. Upcoming webinars include:

• Eight-Part Webinar Series: Assessing the Benefits and Risks of Medicines, Part 5: Stated Choice Methods for Valuing Benefits and Risks (April 24, 11:00 a.m. - 12:30 [p.m. ET)
• Two-part Webinar Series: Impact of the New European Pharmacovigilance Legislation and Important Updates (April 25 and 26, 10:00 a.m. - 11:30 a.m. ET)
• Using Patient-Reported Outcomes to Assess Product Safety and Tolerability: Methodological and Regulatory Considerations (May 17, 11:00 a.m. - 12:30 p.m. ET)

View more upcoming webinars.

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Webinars: Important Updates on New European Pharmacovigilance Requirements

Important Updates on New European Pharmacovigilance Requirements Two-Part Webinar Series: Impact of the New European Pharmacovigilance Legislation and Important Updates April 25-26 | 10:00-11:30AM ET Presenters:     • Stella C.F. Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP        EMA Risk Management Development and Scientific Lead, European Medicines Agency     • Joanna Faith Haas, MD, MSc, FACPM, FISPE, Founding Partner, Haas and Partners     • Steve Jolley, MA, Principal, SJ Pharma Consulting With the new European Pharmacovigilance legislation that went into effect in July 2012, implementation is ongoing. Hear from global experts on the impact of the new Pharmacovigilance legislation and important updates since the legislation went into effect. Does your company understand the processes to perform adequate Benefit-risk assessment? Your product could suffer significant consequences if your company does not have the proper systems and processes in place. In just two 90-minute sessions you will gain a better understanding of how to work to meet EU standards and become better prepared to implement regulatory requirements for signaling and risk management. Featured Topics:     Part One:     • EU Regulatory Framework     • Ongoing Timeframe for Implementation of the New Legislation     • GVP Modules and Implementing Measures     • PV System Master File (PSMF)     • Audit and Inspection     • ADR Reporting     • The Pharmacovigilance Risk Assessment Committee (PRAC)     Part Two:     • Risk Management Plans: Risk Assessment and Risk Minimization     • Periodic Safety Update Reports (PSUR)/ Periodic Benefit-risk Evaluation Report (PBRER)     • Signal Management     • Post Authorization Studies of Safety (PASS) and Efficacy (PAES)     • Implications for International Harmonization     • And More... You’ll Learn:     • New EU regulatory requirements for drug safety     • How to process adverse events to meet EU requirements     • What to expect in a European Pharmacovigilance inspection     • Differences between the old PSUR and the new PBRER This is the webinar your entire Pharmacovigilance team cannot afford to miss. Who Should Attend? Professionals involved in:      • Drug Safety and Pharmacovigilance      • Regulatory Affairs      • Clinical Development      • Benefit-risk Management • Executives (Including C-Level) with Any Legal    Responsibility for Drug Safety • Market Access • Post-approval Studies Did You Know? You can receive 1 elective unit towards your Clinical Safety and Pharmacovigilance Certificate by attending this webinar.   Overview | Register Online April 18 | 11:00AM-12:30PM ET April 24 | 11:00AM-12:30PM ET April 30 | 12:30-2:00PM ET

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Justices Appear Skeptical About Patenting Of Human Genes.

Exerpt from: DIA Daily enewsletter featuring summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. Subscribe to the DIA Daily.

The Supreme Court on Monday heard arguments in a key case about whether or not human DNA could be patented by biomedical firms. Media coverage portrayed the justices as skeptical about the assertions of Utah-based Myriad Genetics Inc., which holds patents on two genes.

        The AP (4/15, Holland) reports that the Supreme Court "seemed worried" during Monday arguments "about the idea of companies patenting human genes." Noting that the US Patent and Trademark Office "has been awarding patents on human genes for almost 30 years," the AP adds that "opponents of Myriad Genetics Inc.'s patents on two genes linked to an increased risk of breast and ovarian cancer say such protection should not be given to something that can be found inside the human body." Myriad argues that "the company's genes can be patented because the DNA that Myriad isolated from the body has a 'markedly different chemical structure' from DNA within the body."

        The Wall Street Journal (4/16, Bravin, Subscription Publication) reports that challengers to the Myriad patents, including a medical researchers' group represented by the American Civil Liberties Union, argue the genes themselves, like all natural products, cannot be patented, but methods for isolating them or using them might be.

        The New York Times (4/16, Liptak, Subscription Publication) reports that in "lively" exchanges, the justices "struggled to find a narrow way to rule on the momentous question of whether human genes may be patented." Noting that the court's ruling "will shape the course of scientific research and medical testing," and "may alter the willingness of businesses to invest in the expensive work of isolating and understanding genetic material," the Times adds that the Obama Administration, through Solicitor General Donald Verrilli Jr., "largely supported" the challengers, and argued that the court's ruling last year in Mayo Collaborative Services v. Prometheus Laboratories "suggested that the correct answer in the case argued Monday was that merely isolating a gene was not sufficient for patent protection."

        USA Today (4/16, Wolf) reports, "Using analogies ranging from baseball bats to chocolate chip cookies, a majority of justices said Myriad Genetics' isolation of the breast cancer genes was largely a force of nature, not invention. At the same time, the justices indicated a compromise could be in the works, siding with the company on its patent for a type of DNA that goes beyond merely extracting the BRCA1 and BRCA2 genes from the body."

        The Washington Post (4/16, Barnes) reports, "Even the normally confident justices expressed some trepidation as they considered the complexities of patent law and the mysteries of biochemistry." The Post notes that the justices' "caution is warranted," as the ruling "could shape the future of medical and genetic research and have profound effects on pharmaceuticals and genetically modified crops."

        The Los Angeles Times (4/16, Savage) reports, "During the argument Monday, most of the justices questioned the decision of the U.S. Patent and Trademark Office to grant Myriad Genetics a patent on two isolated gene sequences that signal a high risk of breast or ovarian cancer."

        Bloomberg News (4/16, Stohr, Decker) reports that "the case has ramifications for the growing field of personalized medicine as well as efforts to map the human brain and discover new uses for embryonic stem cells." Challengers to Myriad's patents include the American Medical Association, Association for Molecular Pathology, and the American College of Obstetricians and Gynecologists.

        Politico (4/16, Norman) notes that "much of the research community has bristled against patenting genes for decades, even as the policy at the patent office has consistently favored it. The American Medical Association weighed in against the practice, but some biotech interests argue that outlawing the patenting of genes could discourage companies from investing in genetic research."

        In a second article, the Los Angeles Times (4/15, Brown) reports that, according to Dr. Eric Topol, director of the Scripps Translational Science Institute in La Jolla, "Myriad's patents on the genes 'have really held back the field,' as the company has issued cease-and-desist letters to some academic centers attempting to study the BRCA1 and BRCA2 genes." Topol claimed that "Myriad's patents also have a chilling effect on genomics research because the company's tight control over BRCA1 and BRCA2 test results has prevented scientists from accessing useful data about genes and associated traits."

        Although supporters claim that the "patent only covers isolated molecules that are outside the body," ABC News (4/16, De Vogue) quotes Sandra Park, a senior attorney with the ACLU, as stating: "The patents are framed as covering and claiming the isolated genes. What that means is that the moment the gene is removed from the cell, Myriad owns it. The scope of the patent is incredibly broad." The ACLU argues "that although Myriad has not exercised its authority to stop all research, it has a monopoly on clinical testing in the U.S., and the ability to discourage research because laboratories are dissuaded from pursuing scientific work that requires using patented genes." In an amicus brief on behalf of the American Medical Association and others, Lori B. Andrews, a professor from Chicago-Kent College of Law, claimed that "patents on human genes impede the provision of health care, thwart public health objectives, shackle innovation and violate ethical tenets."

        On its website, NBC News (4/15, Williams) reports that the ACLU claims that Myriad's exclusive patent "creates a monopoly that denies women the ability to seek a second opinion, based on another test of the genetic material, and dissuades other laboratories from pursuing research on the patented genes." The ACLU contends that, because Myriad's breast cancer "test costs roughly $3,000, many women cannot afford it or lack the necessary insurance coverage." Regarding availability of the test, Myriad "says the cost of the test is covered by private insurance, Medicare, and Medicaid."

        The Salt Lake (UT) Tribune (4/16) reports that "one area where ACLU attorney Christopher Hansen seemed to stumble was when justices pressed him on whether invalidating gene-related patents would mean companies and investors would be much less likely to pour money into research and development. Hansen said that a company could get recognition for its work and that money for research would always be available, a statement that Kennedy said wasn't sufficient." The Tribune notes that "the court is expected to rule before the end of the summer."

        BBC News (4/16) reports that "the ramifications of any decision by the Supreme Court are uncertain," but "one thing is certain: A deeper understanding of how genes affect health is already starting to transform medicine. It is helping to deliver targeted drugs to the right patients as well as tests for cancer risk genes."

        Also reporting on the story are Reuters (4/16, Hurley), McClatchy (4/16, Doyle), CNN (4/15, Mears), NPR (4/15, Totenberg), Daily Mail (UK) (4/16, Lawson), HealthDay (4/16, Steele), and MedPage Today (4/16, Pittman).

        More Commentary. In a column for USA Today (4/15, Turley), George Washington University law professor Jonathan Turley writes, "The Myriad case raises fundamental questions on the meaning of property, including the treatment of the human genome as akin to a Hoover vacuum. As the Supreme Court deliberates over the very ownership of our genes, there has never been a national debate over the commoditization of American life. If we do not want to live by the leave of a new property class, we have fight for our rights."

        In his Los Angeles Times (4/15, Healey) column, Jon Healey writes that "the justices were clearly concerned about preserving innovation in medicine and biotechnology," but "the issue presented by Myriad Genetics' patents on the BRCA genes cuts both ways, leading to a potential split among the justices." Healey notes that, "during Monday's oral argument, several justices seemed worried about the implications of allowing patents over something extracted from nature."

        However, in a "Blowback" opinion piece in the Los Angeles Times (4/14, Meldrum), Peter D. Meldrum, president and chief executive of Myriad Genetics, writes in support of Myriad's patents on BRCA1 and BRCA2, which he claims "do not cover human genes from anyone's body." Claiming that the patents were a "product of creative, human ingenuity," Meldrum adds, "Without our patents, our tests could not have been developed." He concludes that "the issue before the Supreme Court is not about Myriad," but rather it "is about the consequences to the life sciences - and for innovation."

        In his column for the Washington Post (4/16) , Dana Milbank writes that "Based on the justices' questioning, there was little doubt that corporations such as Myriad have a legitimate claim to the DNA in our bodies. The argument was mostly about whether corporations own the material itself or merely have the exclusive rights to use our genes for research and commerce."

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Editor in Chief's Commentary: Therapeutic Innovation & Regulatory Science | March 2013

Commentary

Dr. Stephen P. Spielberg
Editor-in-Chief
I’m incredibly excited to have joined the DIA at a time when medical science is advancing at an ever-increasing rate. Building on the foundation laid down by the Drug Information Journal, Therapeutic Innovation & Regulatory Science, known as TIRS, is part of DIA’s efforts to ensure the flow of information to all our members – more than 17,000 around the world. The rate of accrual of new knowledge challenges all of us to assure that the brilliance of our science is converted efficiently and effectively into new safe, effective, high quality, and sustainably available medical products.

The title of our new journal implies innovation, and we intend to publish outstanding science reflecting innovation from molecular biology, drug development and clinical trials, through real world assessment. I hope we can create a practical and impactful forum for scientific exchange. Because we live in a time of rapid change in all disciplines characterized by increasingly dense language communication within our disciplines, so too we need innovation in communication, bringing together all who share in the drug development and utilization processes.

We hope to establish a broad-based editorial board reflecting disciplines traditionally thought of as part of the drug development and evaluation processes, and expanding and integrating new areas, including patient advocacy groups and health economists. Never before has accomplishing the goals of improved therapeutics been as much of a “team sport” as it is today, and TIRS will reflect these challenges and opportunities, in print and in collaboration with DIA in multiple other formats.

The “regulatory science” part of the TIRS name reflects the increasing need of all sectors, including the regulatory community, to work at the cutting edge of innovation, being neither advocates nor impediments to innovation, but dispassionate evaluators, in the words defining the US FDA both “protectors and promoters of the public health.” Using the neutral turf of the DIA, TIRS will be an integral part of bringing together all the players needed to advance human therapeutics.

A personal reflection as I join the DIA in this effort… I entered medical school more than 45 years ago, and have been privileged to witness the most remarkable advances in science and medicine in the history of humankind. I, and I am sure all DIA members, worry about the future, the sustainable implementation of science on behalf of us all. I worry when I hear discussions that separate “patients” from the rest of us. All of us, often in the flash of seconds of time, become patients, suddenly dependent on the therapeutics about which we have just opined. It is in all our interests to work together to “get it right.” Please join us at TIRS as we navigate this process, and help create a global forum for knowledge exchange and interpretation to raise the level of health and well-being worldwide.

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Before you visit the exhibit hall at an annual conference or scientific session, how much planning do you do?

• Before you visit the exhibit hall at an annual conference or scientific session, how much planning do you do?
  

I arrive with a list of whom I will meet and which exhibits I will visit.

I have an idea of whom I will meet and what exhibits I will visit, but I want to see what else catches my attention.

I have no plan beyond finding out which exhibits are interesting.

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Comparative Effectiveness Research Series ~ online training

Purchase two of the following online courses in one transaction and save 10%. Purchase all three in one transaction and save 20%. Discount will be reflected in the final step of the checkout process. Strategies for Comparative Effectiveness Research for Regulatory, Compliance, and Legal Professionals in Life Sciences Promotion April 23 | 11:00AM-12:30PM ET In 90 minutes, you will get a combination of background instruction into the principals of CER, current and future impact on the broader regulatory industry, along with implications for future communications, marketing, monitoring, and resource planning. Real-world examples will be used to help explain changing implications of new sources of data and outcomes measures, detailing the transition to newer CER based advertising and promotional material and how to effectively incorporate these into developing corporate sales and marketing, value research, and product attribute messaging. Faculty: Danny A. Benau, PhD, Director, Biomedical Writing Programs, University of the Sciences Darshan Kulkarni, JD, PharmD, MS, Principal Attorney, The Kulkarni Law Firm Andrew M. Peterson, PharmD, PhD, Dean, Mayes College, University of the Sciences   Overview | Register Online Essentials for Comparative Effectiveness Research for Medical Affairs and Health care Professionals June 5 | 1:00-2:30PM ET Understand changes to today’s practices, when and why they are being transitioned to the newer CER format, and methods to effectively include these changes into future studies, payor and patient interactions and value focused research. Faculty: Danny A. Benau, PhD, Director, Biomedical Writing Programs, University of the Sciences Stephanie Michelle Knight, Associate Director, Pfizer Inc. Andrew M. Peterson, PharmD, PhD, Dean, Mayes College, University of the Sciences   Overview | Register Online Implication of Comparative Effectiveness Research for Clinical Research Organizations September 18 | 11:00AM-12:30PM ET This 90-minute online offering will allow you to quickly understand current practices, when and why they are being transitioned to the newer CER format, and methods to effectively include these changes into your future investigations. Faculty: Danny A. Benau, PhD, Director, Biomedical Writing Programs, University of the Sciences Darshan Kulkarni, JD, PharmD, MS, Principal Attorney, The Kulkarni Law Firm   Overview | Register Online   Newly Released Webinar: Preparing for the Physician Payment Sunshine Implementation: Research, Marketing & Education April 29 | 1:00-2:30 PM ET All transfers of value to covered recipients must be tracked by covered manufacturers starting August 1. This 90-minute webinar will provide a high-level overview of the basic requirements of the final rule for implementing the Physicians Payment Sunshine Act, before turning to many of the gray areas where manufacturers are struggling to understand what they need to track and report. This webinar will focus on the requirements for research-related activities, indirect payments, and the determination of value for many educational efforts. Industry experts will help you go beyond a cursory understanding of the rule to help their organizations determine how they will ensure compliance and avoid the costly fines.   Overview | Register Online April 9, 11, 16 & 18 12:00-1:30PM ET April 10 12:00-1:30PM ET April 25-26 10:00-11:30AM ET

Report: Twin Cities Area Continues To Be A Medical Device Hot Spot.

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From Minnesota, the Minneapolis Star Tribune (4/10, Moore) reports that "the Twin Cities' cluster of medical device and life-sciences companies slipped a notch in 2012, but the area continues its stronghold as a medical device hot spot, according a recently released report." The report, put together by the firm Jones Lang LaSalle, did not specify why Minneapolis-St. Paul went from eighth to ninth place. Instead, it measured "employment in high-tech research and in the hospital/medical fields, the number of life sciences establishments, and the prevalence of National Institutes of Health (NIH) and venture capital funding." The Star Tribune points out that biotechnology and pharmaceutical companies are considered under the life-sciences category in the report, as well as medical device companies. While the Twin Cities has the latter (Medtronic, St. Jude Medical), it lacks the former.

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Japanese drugmakers, government team up to fight disease

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Japan's government has joined the Bill and Melinda Gates Foundation as well as drugmakers Astellas, Eisai, Daiichi-Sankyo, Shionogi and Takeda to form the Global Health Innovative Technology fund to develop diagnostic tests, drugs and vaccines to fight disease in developing countries. The group will collaborate on research with significant impact, says Dr. Kiyoshi Kurokawa, the fund's chairman. The Japan Daily Press(4/8)

For complete article, http://japandailypress.com/japanese-pharma-companies-to-help-medicine-research-in-developing-countries-0826592

Judge Reverses Age Restrictions On Morning-After Contraceptives.

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US District Judge Edward Korman's decision Friday to reverse age restrictions on over-the-counter access to emergency contraceptive products was covered by all three broadcast networks, two which led with the story. Most of the media coverage noted Judge Edward Korman's frustrations with Health and Human Services Secretary Kathleen Sebelius having overruled a 2011 Food and Drug Administration recommendation to allow emergency contraception to be sold OTC to all ages; and several outlets noted that Korman, who presides over the District Court of Eastern New York, also placed some of the blame on the FDA for restricting access to the morning-after products in the past.

        The CBS Evening News (4/5, lead story, 3:10, Pelley) opened by reporting, "Anyone of any age may soon be able to walk into a drugstore and buy the morning-after pill. ... Throwing the dictionary at the Administration, Judge Edward Korman called the rule 'arbitrary, capricious, unreasonable and obviously political.'" CBS (Cordes) added that at the time of her 2011 decision, HHS Secretary Kathleen Sebelius "had argued younger girls might not understand the drug's labeling, leading to misuse."

        NBC Nightly News (4/5, lead story, 2:50, Williams) opened by saying, "This is a medical issue. It's a social issue. It's a moral issue for a lot of people." NBC (Gosk) added, "Barring an appeal, the legal battle over the drug and who should be allowed to buy it is over." On ABC World News (4/5, story 3, 2:15, Muir), Amy Robach reported, "Girls can soon be able buy the morning-after pill, 'Plan B', as easily as a bottle of aspirin."

        The AP (4/5) reported President Obama "had supported the 2011 decision setting age limits, and White House spokesman Jay Carney said Friday the president hasn't changed his position. 'He believes it was the right common-sense approach to this issue,'" Carney said.

        In a front-page story, the New York Times (4/6, A1, Belluck, Subscription Publication) reported that Judge Korman's decision "counteracts an unprecedented move" in 2011, by Secretary Sebelius, who "overruled" an FDA recommendation. In 2011, FDA Commissioner, Dr. Margaret A. Hamburg released a statement "saying that after rigorous study, it was safe to sell Plan B One-Step [levonorgestrel] over the counter for all ages." Moreover, the Times pointed out that scientists, "including those at the FDA, have been recommending unrestricted access for years, as have major medical groups, including the American Medical Association, the American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics."

        ABC News (4/6, Lupkin) on its website pointed out that Plan B, which prevents a "fertilized egg from attaching itself to the uterine wall," has been sold OTC in "China since 1998, and a study published in 2011 in the journal Human Reproduction involving 2,521 women found no adverse side effects. The most common side effects were vaginal bleeding and headaches."

        USA Today (4/5, Stanglin) reported that in his "59-page ruling," Judge Korman "said that Sebelius, in overruling the FDA, had forced the agency to 'to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability.'" Korman also "noted that the FDA itself had engaged in its own foot-dragging over the years, dating from the Bush administration, when the plaintiffs first began trying to get it to rule on Plan B more than 12 years ago. 'The FDA has engaged in intolerable delays in processing the petition,' he wrote."

        According to the Washington Post (4/6, Kliff, Dennis), the FDA initially, "approved Plan B as a prescription emergency contraceptive in 1999" and in 2003, its manufacturer asked the agency permit OTC sales of the drug but the "FDA rejected that request, citing a lack of data on how the drug affected young teenagers." However, two "FDA officials resigned" in 2005, after the "agency announced plans to indefinitely postpone any further review" of permitting OTC sales of Plan B. "Susan Wood, former director of the FDA's Office of Women's Health and one of the officials who resigned in 2005, thinks the changing political landscape could finally put an end to the decade-long controversy."

        Bloomberg News (4/6, Pearson, Armour) added that Korman "excoriated" the FDA for the delay in making Teva Pharmaceutical Industries' "Plan B, available over the counter. ... 'These emergency contraceptives would be among the safest drugs sold over the counter,' Korman wrote, and 'the number of 11-year-olds using these drugs is likely to be minuscule.'" FDA spokesperson Erica Jefferson "declined to comment on the ruling or the possibility of an appeal to the US Court of Appeals in New York."

        The Christian Science Monitor (4/6, Richey) said Korman, a "Reagan nominee, has presided over the Plan B litigation for years. In 2009, he ordered the Food and Drug Administration to expand availability of the drug without prescription to 17-year-olds."

        The Wall Street Journal (4/6, A3, Kendall, Anderson, Subscription Publication) reported that on Friday, Korman gave the FDA 30 days to lift the age restrictions from the Plan B emergency contraceptive and its generic equivalents. NBC News (4/6, Aleccia) in its "Vitals" blog added that Korman gave the FDA "the option of limiting the expanded access to the Plan B One-Step single-pill product if the agency 'actually believes there is any significant difference between the one- and two-pill products.'"

        The Philadelphia Inquirer (4/7, McCullough) noted that at present, the Plan B One-Step and Next Choice are "available without a prescription only to women 17 and older. The products are also kept behind the pharmacist's counter; purchasers must show a government-issued ID with proof of age."

        According to the Los Angeles Times (4/6, Morin) "Booster Shots" blog, the "ruling comes in response to a lawsuit filed by the Center for Reproductive Rights, which argued that restrictions placed on the drug imposed unreasonable delays for women of all ages" because the age prohibitions forced pharmacists to keep the products "behind counters so that they were not available outside regular business hours." US Department of Justice spokesperson Allison Price "said the government was 'reviewing the appellate options and expects to act promptly.'"

        Meanwhile, The Hill (4/5, Viebeck) "Healthwatch" blog noted that the Korman's decision "won praise from the medical community and supporters of abortion rights, who have litigated cases involving emergency contraception since 2001. 'Today science has finally prevailed over politics,' said" Center for Reproductive Rights CEO Nancy Northup.

        Similarly, CQ (4/6, Norman, Subscription Publication) said supporters "characterized the ruling as a major victory that will open the door to wider use of a safe and effective drug." Conversely, that puts "Obama and Sebelius on the side of some of the same groups that they are fighting in court over a separate requirement that all FDA-approved contraceptives - including the morning-after pill - be covered in workers' health insurance plans as preventive services under the health care law," CQ noted.

        In contrast, the Boston Globe (4/6, Kotz) reported that critics said the ruling means "young teens might indiscriminately incorrectly use the morning after pill as a method of birth control and that it might encourage sexual promiscuity. 'The decision will give young girls a serious drug,' said Anne Fox, president of the Massachusetts Citizens for Life, an antiabortion group. 'I think it's very irresponsible,'" Fox added. In the meantime, the Federal government is "expected to release its final rules for coverage of birth control methods such as oral contraception and intrauterine devices within the next few weeks."

        The ruling was also covered by the Atlantic (4/6, Hamblin), the New York Daily News (4/6, Marzulli, McShane), the New York Post (4/6, Maddux), Politico (4/6, Smith), the CNN (4/5, Landau) website, MSNBC (4/6, Cowley) on its website, the Time (4/6, Sifferlin) "Healthland" blog, the Dayton (OH) Daily News (4/6, McCarty), the Daily Caller (4/6, May), the NPR (4/6, Rovner) "Shots" blog, Reuters (4/6, Dye), BBC News (4/6), MedPage Today (4/6, Neale) and HealthDay (4/6, Reinberg).

        NYTimes: Ruling Admonishes Administration's Politically Motivated Decision. The editorial board of the New York Times (4/6, A16, Subscription Publication) opined that Korman's decision to overturn the Obama Administration's "ban preventing girls younger than 17 from purchasing emergency contraceptive" products OTC, was a "well-deserved rebuke to a politically motivated decision that overrode sound science and the health needs of young girls in order to placate political opponents of emergency contraception."

        NYSun: "Plan C" Should Deal With Parental Authority. The New York Sun (4/8) editorializes that Korman's ruling "has ignited quite an uproar" among parents on both "the right and left, including, it turns out, the President." Korman did not make it "his job to rule on the moral issues" or on "what one might call the good parenting issues," both of which are "better dealt with in the Congress or what we are sometimes prone to call 'Plan C.'" The Sun concludes that at this point, the "right move for Congress would be to reinforce the authority of the parents, who, after all, would be paying for any pills any 11 year old purchases."

        Bloomberg News: Sebelius Should Let Ruling Stand. Bloomberg News (4/5) editorialized that many physicians have "explained," that they oppose age restrictions because the morning-after products are "most effective if taken within 24 hours of unprotected sex" and quite often, there "isn't time for users to see a doctor before going to the pharmacy." In fact, Bloomberg News pointed out, "last November, the American Academy of Pediatrics recommended that its members work around the age restriction by prescribing the drug to teens in advance." The editorial also noted that several other physician groups, including the AMA, have voiced support for lifting the access restrictions on emergency contraceptives. Now, with the "presidential election that loomed" over Secretary Sebelius' "2011 action well past, she should let the judge's order stand," Bloomberg News concluded.

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