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Wednesday, April 24, 2013

PCORI To Launch Comparative-Effectiveness Research Network.

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The Washington Post (4/24, Kliff) "Wonkblog" reports a "new nonprofit is putting millions" of Federal healthcare reform money "towards an effort to turn routine doctor visits into a treasure trove of data on what medical treatments work best." The Patient Centered Research Outcomes Institute, which the Affordable Care Act created to "support comparative effectiveness research," announced Tuesday that it "would move forward on that mission" by spending "$68 million to fund a network of health-care systems that cover as many as 12 million patients."

CQ (4/24, Adams, Subscription Publication) adds that the Food and Drug Administration's Center for Drug Evaluation and Research Director Janet Woodcock, MD, "noted that the FDA has been involved for decades in trying to support comparative effectiveness research and find out more about the products that the agency approves for use in the United States." According to Dr. Woodcock, "What the FDA needs and what the medical community needs is actionable information."

According to Government Health IT (4/24, Sullivan), the "hybrid model will include patients, health systems, payers, physicians and researchers as active participants in the research. To that end, PCORI detailed two cooperative funding agreement opportunities to support the creation of Clinical Data Research Networks (CRDN) and Patient-Powered Research Networks (PPRNs)." For the CRDNs, PCORI "will award $56 million to as many as 8 existing or new networks, while the PPRNs funding total is $12 million, available to 18 networks," according to the statement the institute released yesterday.

Modern Healthcare (4/24, Robeznieks, Subscription Publication) notes that PCORI Executive Director Dr. Joe Selby announced the funding during a roundtable discussion in the District of Columbia. "Putting patients' interests first in such an endeavor can make a difference and 'smooth the friction' between stakeholders," Selby "said of the project's patient-first focus." American Medical Association President-Elect Dr. Ardis Hoven, who was one of the roundtable participants, "called the effort 'an exciting opportunity,' and noted its potential for advancing the use of information gleaned from clinical registries into medicine." Organizations interested in participating in the network "must file a letter of intent by June 19 and must complete an application by Sept. 27."

Thursday, April 18, 2013

Group Launches Data-Analytics Contest For Health Providers.

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.

Modern Healthcare (4/18, Conn, Subscription Publication) reports, "There are $300,000 in prizes up for grabs in a new, two-year healthcare data-analytics contest, but first, the sponsors of the competition want healthcare providers and others to identify their knottiest data difficulties so future contestants will have some meaningful problems to solve. 'Today, we call on the entire healthcare community-particularly those serving on the front lines in providing care-to submit the most difficult data challenges facing their organizations as they implement new models of care,' said Dr. Richard Merkin, president and CEO of contest co-sponsor Heritage Provider Network" in a press statement (pdf). The Marina del Rey, California-based "independent practice association, along with the Advisory Board, a healthcare consultancy, and the Bipartisan Policy Center, a Washington-based policy advocacy organization, are co-sponsors of what's being dubbed as the Care Transformation Prize Series."

Wednesday, April 17, 2013

House Committee Levels Sharp Criticism At FDA Over Meningitis Outbreak.

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.

Yesterday, Food and Drug Administration Commissioner Dr. Margaret Hamburg appeared at a hearing before the House Energy and Commerce Subcommittee on Oversight and Investigations in which both Democrats and Republicans leveled sharp criticism upon the FDA for its role in failing to prevent what became a deadly meningitis outbreak caused by tainted steroid products from the New England Compounding Center. Major print media and Washington insider sources carrying the story underscore the harsh nature of the criticisms leveled at the FDA, particularly from Republicans. After admitting that her agency could have acted in a more aggressive fashion and conceding the need for better policing of compounding pharmacies, Hamburg took the opportunity to ask for Federal legislation requiring all compounding pharmacies to register with the FDA.

The Washington Post (4/17, Kindy) reports, "After reviewing 27,000 pages of documents from the Food and Drug Administration, Republicans and Democrats came to different conclusions about the agency's ability to prevent one of the worst public health crises in American history." Yesterday, "Republican members of the House Energy and Commerce Committee said...that its six-month investigation into the FDA's role in last fall's meningitis outbreak shows the agency knew for a decade about serious safety lapses at the specialized pharmacy that made the tainted drugs but failed to act." In addition, Dr. Hamburg, the "only person scheduled to testify at the hearing, was sharply criticized about the agency's efforts with the" New England Compounding Center (NECC).

The New York Times (4/17, A15, Tavernise, Subscription Publication) reports that on Tuesday, Dr. Hamburg "told Congress...that her agency should have acted more aggressively against compounding pharmacies like the one that was responsible for a deadly meningitis outbreak last fall. In a hearing before a House Energy and Commerce subcommittee, she said the agency had become overly concerned about avoiding lawsuits, and as a result did not police the industry as effectively as it could have." Hamburg stated, "I think we allowed ourselves to be far too cautious because of fears of litigation that might further undermine our authority."

The Los Angeles Times (4/17, Morin) "Science Now" blog reports that Commissioner Hamburg "endured heavy criticism Tuesday as House members accused the agency of failing to act on complaints against the New England Compounding Center, the Massachusetts firm linked to an outbreak of deadly meningitis. Under harsh questioning from Republican and Democratic lawmakers, FDA Commissioner Margaret Hamburg conceded that her agency could have handled the situation better." Hamburg told the committee, "I wish we had been more aggressive, and I can assure you that we are being more aggressive now."

The AP (4/17) reports, "Republicans and Democrats took turns chastising the FDA for not being aggressive enough in going after compounding pharmacies like the New England Compounding Center, the specialty pharmacy which produced tainted pain injections that have sickened more than 700 people and killed 53 others. In the second hearing on the outbreak, FDA Commissioner Margaret Hamburg reiterated that her agency needs clearer authority to go after compounding pharmacies, which have challenged the FDA's authority in court since the 1990s." According to Hamburg, the FDA "is working to crack down on compounding pharmacies, despite legal challenges."

Bloomberg News (4/17, Edney) points out, "Republicans have questioned whether the FDA could have shut down the pharmacy based on incidents dating as far back as 2002. They also want to know why the FDA didn't re-inspect NECC after stating it would in a 2006 warning letter and related correspondence two years later." However, "Democrats on the committee came to the FDA's defense, citing a law that left the agency with ambiguous authority over compounding pharmacies, as well as industry lobbying to undermine federal regulation and failures by states to oversee the businesses adequately."

The Tennessean (4/16, Barton) reports that Hamburg "described the evolution of large-scale compounders like NECC, with production far exceeding that of neighborhood pharmacists who compound, or mix drugs, in response to prescriptions that apply to just one patient. 'It is clear that the industry and the health-care system have evolved and have outgrown the law, and FDA's ability to take action against (large-scale compounding) has been hampered by gaps and ambiguities in the law, which have led to legal challenges to FDA's authority to inspect pharmacies and take appropriate enforcement actions,' Hamburg testified."

Modern Healthcare (4/17, Block, Subscription Publication) reports that at yesterday's hearing, Hamburg "warned lawmakers...that if Congress doesn't clarify and strengthen the FDA's authority over certain types of compounders, another NECC-type situation could happen." In particular, "Hamburg asked for legislation that requires all compounders to register with the agency. In addition, she called for uniform quality standards to abide by and mandatory reporting of adverse events to the FDA. Currently, section 503(a) of the Food, Drugs and Cosmetics Act exempts compounders from certain regulations that apply to other drug manufacturers."

The Hill (4/17, Viebeck) "Healthwatch" blog quotes Hamburg as saying, "The tools we have for regulating these firms are simply not the right fit." She called "for new powers to regulate firms like the NECC, which fall between compounder and drug manufacturers. States traditionally oversee the former category, while federal authorities oversees the latter."

CQ (4/17, Ethridge, Subscription Publication) reports that "Democrats on the subcommittee agreed that confusion prevented the agency from acting effectively to respond to complaints and concerns with the company. Several backed Hamburg's request for Congress to act to clarify the agency's authority, as well as give it new regulatory powers over compounding pharmacies." But, "Republicans said they were not sure that the agency was ready to implement any new authorities, and several accused the agency of using the conflicting court decisions as an excuse for not taking more aggressive action."

Also covering the story are Politico (4/17, Norman), Reuters (4/17, Clarke), the NBC News (4/17, James) "Vitals" blog, and MedPage Today (4/17, Pittman).

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Tuesday, April 16, 2013

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."

Monday, April 15, 2013

High Court To Hear Key Case On Human Gene Patents.

DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning.

The New York Times (4/15, A1, Pollack, Subscription Publication) reports that the Supreme Court "is poised to take up the highly charged question of whether human genes can be patented," but "another question could trump it: Has the field of genetics moved so far so fast that whatever the court decides, it has come too late to the issue?" The Times continues, "The hearing comes as rapid scientific advances are producing an explosion of new information about human genes, as well as those of animals, plants and microbes, yielding new approaches to detecting and combating diseases."

The Christian Science Monitor (4/14, Richey) reports, "The issue arises in a challenge to patents held by Myriad Genetics, a Utah-based diagnostic testing and research firm that developed a way to detect genetic mutations (called BRCA1 and BRCA2) that scientists associate with a higher risk of breast and ovarian cancer. The process is described by the company's lawyers as akin to locating a particular grain of sand in a space the size of the Empire State Building. The tests have helped over a million patients identify risks and develop treatment strategies," but "the American Civil Liberties Union and the Public Patent Foundation charge that Myriad Genetics is actually hindering scientific innovation and undercutting access to medical care for patients who need it."

Bloomberg News (4/12, Stohr, Decker) reports that "trade groups for the biotechnology, agriculture and drug industries are siding with Myriad," claiming that "gene patents have led to valuable treatments." Meanwhile, "doctor groups such as the American Medical Association are backing the challengers to the patents. They have partial support from the Obama administration, which is urging the court to uphold parts of Myriad's patents and void other aspects."

The Philadelphia Inquirer (4/15, Sell) reports that "research groups, patient advocates, and the American Medical Association, among others, argue that Myriad's assertion of patent rights to the genes stifles future research and the use of existing, lower-cost diagnostic tools because they involve those genes. Armed with the patent-induced market exclusivity, Myriad charges about $3,000 for a test for which other labs previously charged $200 or less." According to Myriad, "separating pieces of genes requires skilled human intervention and creates a new entity, worthy of a patent, and that 30 years of patent protocol should not be changed."

The Salt Lake (UT) Tribune (4/15, Harvey) reports that, "without that patent protection, the company says it is unlikely that kind of money would have been poured into research and development. It also points out that research by others has not been stifled, with 10,000 research papers published about BRCA1 and BRCA2." The Tribune notes that "Myriad officials have said that the patents in question are only a small part of its portfolio, and that a negative decision won't have a significant impact on the publicly traded company's finances."

Also reporting on the story are the Boston Herald (4/15, Kantor), Boston Business Journal (4/15, Subscription Publication) on its "Bioflash" blog, Reuters (4/15, Begley), The Hill (4/15, Baker) on its "Healthwatch," Atlantic Wire (4/15, Estes), Forbes (4/12, Fisher), McClatchy (4/12, Doyle), and Modern Healthcare (4/13, Subscription Publication).

More Commentary. The Washington Post (4/15) editorializes, "The legal precedent stresses that products of nature aren't patentable, so the justices may well rule against Myriad. But either way, their ruling shouldn't be the end of it. Balancing the benefits of free-flowing research against the value of mobilizing private money to detangle genetic code is a hard policy call that Congress should make."

The New York Times (4/15, Subscription Publication) editorializes, "The petitioners in the case - doctors, scientific researchers and women's health organizations - argue that the isolated genes are not materially different from genes before extraction, and that allowing Myriad a patent on them would allow the patenting of nature itself, at untold cost to scientific research, medical treatment and patients. We agree with the petitioners, while recognizing that this case is one of the most important and complex disputes involving the intersection of science, law and commerce in a generation." The Times notes that the Administration is conflicted over the case. "The patent office sees the patents as valid and consistent with its duty to protect and promote invention; Solicitor General Donald Verrilli Jr. and the Justice Department oppose them on grounds that what nature makes cannot be patented and Myriad's isolation of DNA did not change it enough to alter nature and be eligible for a patent."

USA Today (4/14) editorializes, "By locking up the BRCA genes and making its $3,340 test the only one doctors can use without the company's permission, Myriad stifles independent scientific inquiry and the sort of competition that might produce better or cheaper tests. Myriad says it spent hundreds of millions of dollars developing its test, and no one could reasonably object if the company patented only its test. But the gene patents go too far."

In an op-ed for USA Today (4/14) Peter D. Meldrum, president and CEO of Myriad Genetics, Inc., writes, "To create tests for hereditary breast cancer and ovarian cancer, our company and its investors spent more than $500 million over 17 years before we were able to recoup this investment." Meldrum continues, "Our tests have been used by more than 1 million women to determine whether they are at increased risk of developing hereditary breast, colon, uterine and ovarian cancer. We think it is right for a company to be able to own its findings, just as pharmaceutical and other companies do all the time."

In an opinion piece in the Dallas Morning News (4/12), Jeffrey A. Rosenfeld, assistant professor of medicine at the New Jersey Medical School, writes about how "DNA belongs not to you but rather to many companies and institutions that have patents on the DNA from your cells. Forty-one percent of the genes in your genome are not legally yours, according to a long list of gene patents granted since the 1980s." Referring to the Myriad Genetics case, Rosenfeld concludes: "Fortunately, the Supreme Court has a chance to rectify this genetic injustice."

Despite the controversy surrounding the case, columnist Bradley J. Fikes writes in the U-T San Diego (4/13, Fikes), "No matter which way the Supreme Court rules on the Myriad Genetics BRCA breast cancer gene test patenting case, the importance of such patents is diminishing over time. Biotechnology is moving beyond patents derived from naturally occurring gene sequences. The most important biotech patents nowadays are becoming synthetic gene and RNA sequences, proteins and other indisputable contrivances of human ingenuity."

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Wednesday, April 10, 2013

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

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.

Monday, April 8, 2013

Judge Reverses Age Restrictions On Morning-After Contraceptives.

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.

Wednesday, April 3, 2013

Western Drugmakers Expected To Practice Caution After Patent Defeat In India.

Reuters (4/3, Hirschler, Kulkarni) reports on Western drugmakers' reaction to a landmark patent defeat in India. Amit Backliwal, who heads South Asian operations for IMS Health, remarked, "India is too big to ignore. Companies will definitely get cautious, and it definitely means a change in their business model, but I don't think they will pull out." Raghunath Mashelkar, former director general of the Council for Scientific and Industrial Research and an architect of India's IP policies, added, "Drugmakers will have to work out strategies for the lower sections, to give affordable access to medicines and make money by large volumes and smaller margins. And then they will look at the middle and the upper sections and make money through smaller volumes but higher margins."

US Business Reacts To Ruling.Reuters (4/3, Palmer) reports that the US Trade Representative's office is considering its response to the ruling, while the US-India Business Council and other business groups have criticized it.

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