Health Law

The Wall Street Journal (11/26, Forelle, Kiviniemi) reports, "European antitrust regulators, widening their interest in pharmaceutical manufacturers, raided several drug companies on suspicion of violating European Union rules on anticompetitive behavior."

        Bloomberg News (11/26, Newman) adds that inspections, conducted in a number of EU countries by "officials from the European Commission, the [European Union's (EU)] antitrust authority," happen "three days ahead of a report on possible antitrust abuses in the pharmaceutical industry. The commission began that probe in January after raiding offices of GlaxoSmithKline Plc, AstraZeneca Plc, Sanofi-Aventis SA, France's largest drugmaker, and several competitors." According to the commission, "the raids were prompted by its belief that companies may have broken EU rules against restrictive business practices or the abuse of a dominant market position."

        The Financial Times (11/26, Tait, Jack) notes that "officials in Brussels said the latest 'inspections' were not related to the sector inquiry." Commission officials said, "The knowledge acquired during the sector inquiry has allowed the commission to draw conclusions on where Commission action based on competition law could be appropriate and effective." Drugmakers "had already been worried that the inquiry could lead to individual competition cases being pursued against some operators in the industry -- a pattern that occurred with the Commission's earlier energy sector inquiry." But, "some lawyers...had suggested that these cases were less likely to focus on abuses of the intellectual property system, and more on suspected distortions in the way drugs were marketed."

HealthDay (11/25, McKeever) reported that, according to a study published in the Journal of the American Geriatrics Society, "how well a person on Medicare understands the program's benefits affects their access to healthcare." For the study, investigators "surveyed Medicare beneficiaries from across the United States." They found that one-third of the respondents "considered themselves as being unfamiliar or very unfamiliar with their program's benefits." Respondents' "lack of understanding was widespread across demographic groups."

The Washington Post (11/26, A2, Stein) reports that according to former FDA commissioner David Kessler and other federal officials, President-elect Barack Obama "will inherit a Food and Drug Administration widely seen as struggling to protect Americans from unsafe medication, contaminated food, and a flood of questionable imports from China and other countries. Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring." The Post describes low agency morale and credibility, perceptions of "ideological bias," and "internal dissension." The Post attributes the agency's woes to recent "highly publicized incidents, including the discovery that the painkiller Vioxx caused heart attacks. That has been followed by other safety issues, including questions about the widely used diabetes medication Avandia and several psychiatric drugs." Simultaneously, food supply concerns have emerged.

The AP (11/26, Perrone) reports, "German medical conglomerate Bayer will pay $97.5 million to settle U.S. government allegations that it paid kickbacks to medical suppliers to boost sales of its diabetes products." According to the Justice Department (DOJ), at issue was whether "Bayer bribed 11 diabetic suppliers into switching patients to its products from competitors' offerings." Although the company "did not admit or deny any wrongdoing," a spokeswoman said that it "is 'satisfied that the issues...have been resolved.'" DOJ officials alleged that "Bayer paid Liberty Medical Supply Inc., one of the largest diabetic suppliers, about $2.5 million to convert patients to Bayer supplies between 1998 and 2002," and "10 other diabetes companies" $375,000 in kickbacks "disguised as payments for advertising." The agreement "resolves claims submitted to Medicare by the suppliers for Bayer products from 1998 through 2007."

        The settlement also includes "a corporate integrity agreement with" the Department of Human and Health Services inspector general's office, Modern Healthcare (11/25, Blesch) added.

The AP (11/25) reported, "AstraZeneca PLC and U.S.-based Abraxis BioScience Inc. are considering ending their two-year marketing deal for breast cancer treatment Abraxane (paclitaxel protein-bound) in the United States." On Tuesday, AstraZeneca said "that the Abraxis board will consider in early January whether to end the deal and reacquire exclusive marketing rights for the drug." The U.K.-based company "paid $200 million for the rights to the drug Abraxane in the United States in 2006, hoping the product would become a big seller. Last year, it recorded sales of $62 million."

In the Wall Street Journal (11/25) Health Blog, Sarah Rubenstein wrote, "Barbara Ryan, the outspoken drug analyst at Deutsche Bank, is out with a provocative report, even for her, on the need for drugmakers to get cracking on mergers." She "argues that the time for big deals may finally be right, despite the market turmoil." Some of her reasons include: "Big Pharma is bloated and companies need to cut themselves down to size; there's a patent cliff in 2011 for several drugmakers, and the generic onslaught then will be intense; valuations of the targets are low;" and "the companies that could be buying have good cash flow and getting access to deal financing for wouldn't be a problem for them."

In the Wall Street Journal (11/25) Health Blog, Sarah Rubenstein wrote that after being "ousted from the top spot on the powerful House Energy and Commerce Committee," some of Rep. John Dingell's (D-Mich.) supporters "are apparently encouraging him to take the reins of the panel's health subcommittee." Frank Pallone Jr. (D-NJ) "currently heads the health subcommittee." Issues he has been involved with include "children's health insurance, community health centers, and mental-health parity."

Modern Healthcare (11/25, Lubell) reported, "Senate Budget Committee Chairman Kent Conrad (D-ND) and Sen. Sheldon Whitehouse (D-RI) have asked the Government Accountability Office (GAO) to identify 'best practices' used by states, hospitals, and other countries, to see if these methods could be applied nationwide." In a letter to the GAO, the lawmakers advocated "for a greater focus on improving health outcomes and on increasing prevention and wellness, in addition to reducing waste in the healthcare system." Failing to control healthcare costs, they contended, would have "a detrimental effect on our nation's economy and standard of living."

The AP (11/26) reports, "Pharmacy benefits manager Express Scripts Inc. spent $240,000 in the third quarter to lobby on issues related to Medicare, generic drugs and other matters, according to a recent disclosure form" that was filed with the House of Representatives clerk's office. Express Scripts "lobbied on drug safety, online pharmacy regulations, and the creation of a regulatory pathway for generic versions of biologic drugs." In addition, the pharmacy benefits manager "lobbied on Medicare issues, including pay for pharmacies and changes to the Part D drug benefit, along with e-prescribing and changes to Medicare Part B." Agencies, besides Congress, that the company lobbied include: "the Centers for Medicare and Medicaid Services, the Federal Trade Commission, Food and Drug Administration, Congressional Budget Office," and "the Department of Health and Human Services."

Government Health IT (11/25, Foxhall) reported that the "complexity of the personalized medicine ecosystem makes the use of information technology critical, according to Kenneth Buetow, director of the National Cancer Institute's (NCI) Center of Biomedical Informatics and Information Technology." Still, "IT has been slow to develop in the biomedical enterprise, Buetow writes in a recent report," which was among "papers in the second report on personalized medicine from the Department of Health and Human Services (HHS)." Beutow added that "systems are rarely connected among the laboratories of one institution, much less different institutions." Echoing Buetow's sentiments HHS Secretary Mike Leavitt has also "stressed, as a part of the American Health Information Community process, the need for links between IT and personalized medicine."

The New York Times (11/26, A21, Nossiter) reports that "local and federal officials on Tuesday announced plans for a 70-acre medical campus in the heart of New Orleans to replace two hospitals damaged during Hurricane Katrina, a $2 billion investment that supporters say will create thousands of jobs and begin to rebuild the city's shattered healthcare system." One facility "would replace the city's landmark Charity Hospital, a lifeline for generations of the city's poor," while "the other would replace the vacant Department of Veterans Affairs hospital." The move could lay "the foundation for a new economy for New Orleans, and" it is "the largest investment in the area since Katrina." But "the plan...has drawn strong criticism from preservationists and neighborhood activists because it will lead to the destruction of dozens of old houses and buildings" in a registered historic district. Although officials stated that "steps would be taken to mitigate the loss, including moving some houses in the way of the proposed development," a number of "residents are mystified by this logic, in a city with vast stretches of underused, unused, and downright derelict property."

In the Washington Post (11/26, D3) Federal Diary column, Joe Davidson wrote that under the Blue Cross Blue Shield standard option for federal employees, next year beneficiaries "will pay 100 percent for an operation by an out-of-network physician, up to a maximum of $7,500, 'per surgeon, per surgical day,' according to the Service Benefit Plan." Patients currently pay "25 percent of what the company sets for a procedure, plus any difference between that and the billed amount." Now, in an effort to "make their case" about the fee change, "opponents have engaged Dezenhall Resources, a Connecticut Avenue public relations firm." One expert, Walt Francis, principal author of Checkbook's 2009 Guide to Health Plans for Federal Employees, "doubts the fee change will reduce the firm's expenses very much, while costing the company in the customer and public relations department."

The Boston Globe (11/26) reports, "The number of American children without health insurance declined by about six percent last year, according to a new report by Families USA, a nonpartisan organization representing healthcare consumers." The decline, however, is "largely because the child poverty rate increased, so more children qualified for government-sponsored insurance," the report said. The latest U.S. Census Bureau estimates indicate that over "11 percent of children nationwide -- about one in nine -- still lacked health insurance in 2007."

        Modern Healthcare (11/25, Lubell) added that the report "does not reflect the worsening economic situation this year." Still, data indicated that "most of the 8.6 million uninsured children in the U.S. come from working families," and "89 percent of uninsured children come from families where at least one parent works." Notably, over "two-thirds of uninsured children live in households where at least one family member works full-time, year-round." The report also said that over "60 percent of the nation's uninsured children come from low-income families." Combined, data for Texas, California, Florida, New York, and Georgia showed that these states had "the largest number of uninsured children," accounting for "nearly half of all uninsured children in the country."

The Dallas Morning News (11/26, Roberson) reports, "With healthcare costs steadily rising and family budgets contracting, financial and healthcare experts recommend that consumers take control over their medical costs." Most experts are "asking questions, searching for alternatives, and maintaining self-discipline." According to one expert, Devon Herrick, a healthcare economist at the National Center for Policy Analysis, to save on prescription drug costs, patients can take advantage of "free samples of drugs" from physicians "that pharmaceutical companies are promoting." In addition, physicians are increasingly "distributing coupons for discounts on a particular medication," Herrick noted. Patients should also call "at least two labs to get test prices in advance," if lab work is needed, Herrick said. He added that "cutting hospital visits altogether" will also cut costs. In fact, "doctors say many chronic conditions...can be prevented or managed through free health fairs and diagnostic facilities to avoid hospitalization."

Life Sciences Law

The Wall Street Journal (11/26, Rubenstein) reports, "AstraZeneca PLC and Teva Pharmaceutical Industries Ltd. said Tuesday they reached an agreement allowing Teva to launch a generic version of AstraZeneca's asthma treatment Pulmicort Respules (Budesonide) in late 2009." Under terms of the agreement, "Teva will be able to launch the generic on Dec. 15, 2009, under an exclusive license from AstraZeneca, in exchange for giving a 'significant undisclosed royalty' on sales to AstraZeneca, according to AstraZeneca."

        The AP (11/26) adds that Teva launched a generic version "Nov. 18, following a favorable ruling from the Food and Drug Administration." But, "two days after Teva launched its generic version of Pulmicort...AstraZeneca received a temporary restraining order in a ruling by the U.S. District Court in New Jersey. The ruling halted the supply and distribution of Teva's version." The generic drugmaker's "launch was 'at-risk,' because the two companies were in the midst of patent litigation over the drug." In other words, the company "may have had to pay triple damages if it lost the case." The company "will be able to sell what it has already shipped, but it won't ship any more of the drug until Dec. 15, 2009." The Wall Street Journal (11/25, Rubenstein) Health Blog and the Philadelphia Business Journal (11/26) also cover the story.

In the Chicago Tribune (11/25) Julie's Health Club blog, Julie Deardorff wrote, "Risperidone (Risperdal) is one of 14 widely-prescribed medications...that needs more evidence for off-label use, according to a study published in the journal Pharmacotherapy." The drugs are: quetiapine (Seroquel), warfarin (Coumadin), escitalopram (Lexapro), montelukast (Singular), bupropion (Wellbutrin), sertraline (Zoloft), venlafaxine (Effexor), celecoxib (Celebrex), lisinopril (Prinivil, Zestril), duloxetine (Cymbalta), trazodone (Desyrel), olanzapine (Zyprexa), and epoetin alfa (Procrit, Epogen).

        In the Los Angeles Times (11/25) Booster Shots blog, Tami Dennis wrote that "the researchers at the University of Illinois-Chicago, Stanford University, and elsewhere explain their selection of the [14] drugs as the ones most deserving of further study. They considered how often the drugs were prescribed off-label without much evidence, the potential safety problems and the costs." Notably, "many drugs used off-label are antipsychotics or antidepressants (six on the list are being used to treat bipolar disorder)."

In the Wall Street Journal (11/26) Career column, Niraj Sheth and Nathan Koppel write, "As the economic crisis deepens in the U.S., some lawyers are making out well -- in India." Under pressure from clients "to trim fees," law firms are sending "more routine work like legal research, due diligence, and document review," to "India at roughly half the cost as in the U.S.," according to outsourcers. In one estimate, from Forrester Research Inc., Cambridge, Mass., about "35,000 U.S. legal jobs will be moved offshore by 2010 and 79,000 will move by 2015." Furthermore, "hiring is down now for junior lawyers in the U.S. as firms struggle with declining demand," Michael Short, a law-firm consultant with Hildebrandt International Inc. said. Although some are not "convinced legal outsourcers will meet [their] firm's standards or that outsourcers, which are subject to high turnover, can adequately guard against disclosing confidential client information," outsourcers claim that "they take measures to ensure security, like using security badges to control access and making sure computers stay put."

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