Health Law

The Wall Street Journal (3/11, B3, Armstrong) reports, "US Food and Drug Administration investigators found 'significant objectionable conditions' during an inspection of a Genzyme Corp. plant that makes expensive biotechnology drugs, according to a copy of an agency warning letter." The Feb. 27 missive "outlines a number of deficiencies in the manufacturing process at the Boston plant, which produces some of the company's best-selling products, including drugs such as Myozyme [alglucosidase alfa], Cerezyme [imiglucerase], and Fabrazyme [agalsidase beta]." Investigators for the agency "inspected the plant from Sept. 15 through Oct. 10 and 'documented significant deviations from current good manufacturing practice.' The problems fall into four areas involving maintenance of equipment, computerized systems, production controls, and the failure to follow procedures aimed at preventing microbiological contamination."

        FDA "inspectors cited a failure to properly maintain the stainless steel columns that drugmakers used during the purification process, which could cause cell cultures to be contaminated," the Boston Herald (3/10, McConville) added. In addition, the inspectors "found that the plant's computer systems had not been updated since 1999, which meant that a formula used to make Fabrazyme was out of date."

        "Genzyme responded to the FDA's initial concerns in two letters written Oct. 31 and Feb. 23," the Boston Business Journal (3/11, Douglas) reports. Genzyme "has 15 days from the issuance of the Feb. 27 warning letter to outline the steps that will be taken to correct the violations and prevent their recurrence." A spokesperson for the company said that "an 'action plan' has been submitted to the FDA and that 80 percent of those measures have already been addressed." But, "full compliance will be needed for the facility to remain open, according to the FDA."

The Wall Street Journal (3/11, Dooren) reports, "The Food and Drug Administration said Tuesday it would allow patients with Lou Gehrig's disease to have access to an experimental drug called Iplex" (mecasermin rinfabate). The agency "said Iplex, which is currently not on the US market, can be made available to certain ALS patients under the [FDA's] 'compassionate use' regulations, which allow individual patients to obtain access to experimental drugs. The FDA also said Iplex would be made available as part of a clinical trial for the drug in treating ALS." Additionally, the agency "said it first received requests about 10 weeks ago from physicians seeking access to Iplex for 'compassionate use.' The FDA said it initially denied those requests because it wasn't aware of data that suggested Iplex would be beneficial in the treatment of ALS." The drug "is available in Italy for Lou Gehrig's disease...under an expanded access program."

        Richmond, Virginia-based Insmed no longer markets the drug "because of a patent settlement with Paris-based Ipsen SA's Tercica subsidiary, which makes a competing drug to treat children with stunted growth," Bloomberg News (3/11, Larkin) adds. The drugmaker "sold its experimental biologic drugs and factory to Merck & Co., of Whitehouse Station, New Jersey, for $130 million last month to fund development of Iplex for other uses, including as a treatment for muscular dystrophy." The Virginian-Pilot (3/11, Simpson) also covers the story.

The Wall Street Journal (3/11, Whalen) reports, "GlaxoSmithKline PLC is preparing to launch its smoking-cessation products in as many as 20 new emerging markets," including Russia, China, and India. Aiming to keep the medications affordable, the company plans "to make its products available to 85 percent of the world's smokers within five years, up from about 20 percent today," according to Clive Addison, "vice president of smoking-control products." Data indicate that the majority "of the world's smokers live in emerging markets, but those countries haven't been a focus for Glaxo in the past because they haven't previously embraced antismoking campaigns, Mr. Addison said." But now, "that is...beginning to change." For instance, "India recently passed a ban on smoking in enclosed public spaces, and other countries such as Brazil are opening new clinics to help people quit smoking." In addition, Glaxo "plans to offer consumers in new markets the same 'behavioral support' programs it does in developed markets such as the US and Europe."

The Des Moines Register (3/10, Jacobs, Clayworth) reported, "Iowa employees would have the right to designate a doctor to treat them for workplace injuries under a controversial bill that will be the subject of a public hearing tonight." Advocates say the bill "would give employees better healthcare and lead to quicker recovery and lower costs for employers." However, opponents said, "Current law works because it's in a company's best interest to secure the best care possible."

        The AP (3/11, Glover) reports, "There's more emotion on the choice of doctor measure than many labor issues. Workers say it's all about their health and well-being, while businesses argue that it goes to the core of their rights as employers and would cost millions if workers could shop for doctors."

The Las Vegas Journal-Review (3/10, Wells) reported that the Nevada Assembly's Committee on Commerce and Labor heard testimony on Assembly Bill 162 Monday, which would "require certain insurance plans to cover treatments and therapies for autism." The bill would also prohibit "insurance companies from refusing other medical care to children because of their autism. The law, however, doesn't apply to individuals or companies that are self-insured." Jan Crandy, of the Autism Coalition of Nevada, argued that "each child with autism can accrue millions of dollars in costs to society over their lifetime, which is a reason early intervention is key." Opponents of the bill, however, said "the mandate could prove too costly during Nevada's economic downturn. Some said the bill would disproportionately affect small businesses and could lead to a rise in premiums."

On the front page of its Business Day section, the New York Times (3/11, B1, Lohr) reports, "Wal-Mart Stores is striding into the market for electronic health records [EHRs], seeking to bring the technology into the mainstream for physicians in small offices, where most of America's doctors practice medicine." Partnering "its Sam's Club division with Dell for computers and eClinicalWorks, a fast-growing private company, for software," Wal-Mart aims to "make the technology more accessible and affordable, undercutting rival health information technology suppliers by as much as half." In doing so, the company will offer a "package deal of hardware, software, installation, maintenance and training." The package will "be made available this spring" for "under $25,000 for the first physician in a practice, and about $10,000 for each additional doctor." According to experts, "traditional health technology suppliers...have tended to shun the small physician offices because it has been costly to sell to them." But, "Wal-Mart...has the potential to bring not only lower costs but also an efficient distribution channel" through the "200,000 healthcare providers" among its Sam's Club members.

        Physicians consider healthcare IT unresponsive to their needs, survey indicates. Healthcare IT News (3/10, Merrill) reported, a survey conducted by the American College of Physician Executives found "that although more physician leaders are using healthcare information technology, they still find it clunky and unresponsive to their needs." The survey of 1,000 ACPE members "revealed that the biggest source of frustration is a lack of input from physicians when designing and implementing healthcare information technology systems. Many said involving clinicians at the planning stages would pre-empt many of the problems that crop up later." One respondent noted that "systems are chosen according to administrative criteria rather than what physicians need." Other "findings include: More than 64 percent of respondents said they use electronic medical records, up from 33 percent in 2004; about 44 percent said their organization uses computerized order entry, while only about 33 percent used CPOE five years ago;" and "more than 38 percent said they use pharmaceutical bar coding, up from 20 percent in 2004."

        "The survey findings were released a few weeks after approval of a federal $787 billion economic stimulus that includes $19 billion for health information technology, including $17 billion for incentives and penalties to encourage doctors and hospitals to abandon paper record-keeping and go high-tech beginning in 2011," the Washington Business Journal (3/11) added.

        Analysis suggests new stimulus incentives may not increase EHR adoption. Government Health IT (3/10, Ferris) reported, "A new analysis by a Washington healthcare consultancy suggests that despite the incentives for adopting e-health records (EHRs) in the stimulus legislation, some doctors may be better off financially sticking with pen and paper." Under the stimulus bill, Medicare providers would receive "up to $44,000 apiece for adopting EHRs," and their payments would be reduced "by up to five percent if they fail to use them by 2015." An analysis conducted by Avalere Health, however, indicates that "a doctor still will have to shell out $70,000 over five years for an EHR system, or about $14,000 a year, beyond the incentive payments." And, according to Jon Glaudemans, a senior vice president of Avalere, "the gap between the cost of EHRs and the incentives will be felt most acutely in practices with one to three physicians -- the same practices that so far have been most resistant to using health IT."

        The researchers noted that after adoption, "the resulting financial deficit" would represent "about eight percent of a physician's annual Medicare receipts, contrasted with the legislation's provisions to impose an $8,500 penalty on non-adopters," Healthcare IT News (3/10, Manos) added. Glaudemans noted that "for many physicians, the level of the incentive may not reflect current financial realities."

The AP (3/11) reports, "A major New York City health plan has agreed to stop using a faulty database that charges patients more for seeing doctors outside their insurance networks, making it the last health insurer in the state to discontinue a process that cost customers money." According to "a spokeswoman for the combined Group Health Inc. and HIP Health Plan...the insurer will use a new, independent database being created under the auspices of New York Attorney General Andrew Cuomo." The new database is expected to eliminate the "conflict of interest" that Cuomo claimed existed in the Ingenix database, "a subsidiary of...UnitedHealth Group Inc." He noted that the unit "had a vested interest in helping set rates low, so companies could underpay patients for out-of-network services."

In a front-page story, the Los Angeles Times (3/11, Hennessy-Fiske) reports, "Young military wives make popular surrogates, especially in California where, unlike other states, surrogacy is legal and case law protects parents' rights to hire women to carry their babies." And, because "military wives have access to military medical insurance called Tricare, which includes comprehensive prenatal care worth as much as $10,000," some agencies "offer surrogates who have it a $5,000 bonus." And although Tricare "requires paid surrogates to pay for prenatal care" it "has had a hard time getting women to admit it" under "medical privacy laws," which "prevent the company from compelling women to disclose that information." Surrogacy among military wives has met criticism "in recent years for" the use of "military insurance to make money," but efforts "to end the practice have had little success." In fact, when "Pentagon officials dismissed surrogacy as an 'income-producing enterprise,' they failed to eliminate surrogate medical coverage from recent defense spending bills." Some military wives, however, believe that because they "pay their premiums," they "should be able to do what [they] want with [their] insurance."

Life Sciences Law

Boston Globe /Bloomberg News (3/11) reports that "Stryker Corp. said its biotech unit is being investigated by a US grand jury over illegal product promotion, the sale of misbranded medical devices, and the submission of false reports to US regulators." According to the company, it "was informed of the probe in a March 5 letter from the US attorney's office for the district of Massachusetts." Stryker "said the investigation relates to its OP-1 products, a protein that promotes bone growth, and Calstrux bone filler."

In the Wall Street Journal (3/10) Health Blog, Alicia Mundy wrote, "Sen. Chuck Grassley (R-IA) is busy again, asking for information about the FDA's approval last fall of a knee implant made by ReGen Biologics." Sen. Grassley has requested "documents about" the interactions between the FDA and ReGen, "particularly those leading up to an FDA advisory committee meeting about the device held Nov. 14." He stated that his inquiry is in response to "emails that 'make it look like the device maker was calling the shots and the FDA was going out of its way to accommodate the company." Sen. Grassley also inquired about a study "that ReGen sponsored to support approval of its device," published in the Journal of Bone and Joint Surgery, which he claims "didn't mention" two of the authors' "company connections." In addition, "slides prepared by the agency for its advisory committee meeting 'did not mention that these two authors were affiliated with ReGen,'" he noted. For its part, ReGen claims the "medical journal's disclosure policies had been followed."

The AP (3/11, Chase) reports, "Attorneys for drugmaker AstraZeneca are challenging the findings of medical experts who claim the company's anti-psychotic drug Seroquel [quetiapine] causes diabetes." A Delaware judge will decide "whether to allow testimony from three doctors in a case brought by a Kansas woman who claims that Seroquel caused her to develop diabetes." AstraZeneca's attorneys contend "that the reports submitted by the medical experts are scientifically and legally insufficient to justify" the plaintiff's claims. Meanwhile, attorneys for the plaintiff argue "that their expert witnesses are qualified to testify, and that their opinions are supported by scientific literature." AstraZeneca's attorneys are aiming for a decision similar to that of "a federal judge in Florida presiding over a consolidated case involving thousands of Seroquel lawsuits. The judge ruled that...the plaintiffs' experts had failed to establish triable issues regarding a specific causal link between Seroquel and diabetes." Jane Thorpe, an attorney for AstraZeneca, states that "the plaintiff has to prove causation...and she has to prove it with expert testimony."

The AP (3/10) reported, "Eli Lilly & Co. said Monday a US district court granted its request to temporarily halt generic drugmaker Teva Pharmaceutical Industries Ltd. from launching a version of the osteoporosis drug Evista" (raloxifene HCl). Teva announced "that it is ready to launch a generic version of the Eli Lilly drug."

        "However, Judge Sarah Barker of the US District Court for the Southern District of Indiana put a stop to Teva's plan by issuing a 10 calendar-day temporary restraining order against it," Forbes (3/11, LaMotta) adds. "The trial is expected to last 12 working days, but analysts believe the judge will have it expedited." The drug "is a treatment for post-menopausal women with osteoporosis that reduces the risk of breast cancer."

The AP (3/11) reports, "Sepracor Inc. said Tuesday it will allow Teva Pharmaceutical Industries Ltd. to launch generic versions of its respiratory drug Xopenex [levalbuterol] in 2013 under terms of a patent lawsuit settlement." The company "had sued Barr Pharmaceuticals now a unit of Teva, to prevent the company from" selling a generic version of the drug. "The patents supporting Xopenex, or levalbuterol, begin to expire in March 2013."

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