Lilly Settles Zyprexa Charges
As anticipated, Eli Lilly & Co. has agreed to settle various federal complaints about off-label promotion of its antipsychotic Zyprexa (olanzapine). Lilly pleaded guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act for illegal promotion of Zyprexa for dementia from 1999 to 2001. The company will pay $615 million in that plea. Lilly did not admit to civil allegations against it, but will pay $800 million to settle those charges. Of that, $438 million will go to the federal government and $362 million will be set aside for ongoing state investigations. The company also entered into a corporate integrity agreement with the government that requires Lilly to submit to third-party review of its policies and procedures.
Most Favor Family Consent
University of Michigan health researchers say that a nationally representative survey of older adults shows that most believe it's okay for a family surrogate to give consent for a cognitively impaired person to be a research subject. The surveyors queried 1,515 people aged 51 years and older who were randomly selected from the government-funded National Health and Retirement Survey. Group members responded to questions about a family member's consenting to a patient's joining one of four research scenarios: a lumbar puncture study; a randomized, controlled trial of a new drug; a similar trial of a vaccine; or a gene-transfer study. In all, 82% said that consent by a surrogate was allowable for a drug trial, 72% for a lumbar puncture, 70% for a vaccine trial, and 67% for gene transfer. The federal government defers to states on when surrogate consent may be authorized, but the states' rules are far from clear, said the authors. Their survey results are in the Jan. 13 issue of Neurology.
Mixed Grades on Tobacco Control
In 23 states, smoking in workplaces and public spaces has been banned, but the pace of adoption of those life-saving prohibitions has slowed, according to the American Lung Association's annual State of Tobacco Control report. Only two states passed such laws in 2008, compared with five in 2007 and six states and Washington, D.C., in 2006. Similarly, only three states and Washington, D.C., increased tobacco taxes in 2008. New York tops the list at $2.75 in taxes per pack, whereas South Carolina exacts only 7 cents per pack. In 2008, Arizona, Nebraska, and Washington state increased Medicaid beneficiaries' access to smoking cessation benefits–important because the Medicaid population smokes at a rate 50% higher than the national average, according to the association. The group's state-by-state report card on various tobacco-control measures is available at its Web site.
Jump in Singulair Psych Reports
Surging reports of aggressive and suicidal behavior associated with the asthma drug Singulair (montelukast) contributed to another high number of serious adverse events reported to the Food and Drug Administration in the second quarter of 2008, according to the nonprofit Institute for Safe Medicine Practices. The group said that a sevenfold increase in Singulair reports (to 644) was driven by the FDA's announcement in March 2008 that it was taking a closer look at the drug's side effects. For all drugs, 22,980 reports of drug-related serious injuries included 2,968 deaths. Digoxin accounted for 650 deaths, and the institute's analysis linked most of those to the recalled Digitek brand. After digoxin, the smoking-cessation drug Chantix (varenicline) accounted for the greatest number of reports: 910 cases of serious injury or death.
FDA Posts Guidance on Handouts
The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements that are funded even partially by a manufacturer. In its presentation to practitioners, an article shouldn't be highlighted, otherwise marked up, or attached to promotional materials.
FDA Approvals Increase
The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 NMEs and 2 biologics in 2007. Four of the 2008 approvals came in December. In 2006, the FDA approved 22 new drugs and biologics. Although the agency has increased the annual number of novel therapies approved in the recent years, it is still not meeting statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits set by law. Many of the delays were attributable to resource constraints, the agency said. The FDA has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009, according to analyst Ira Loss at the firm Washington Analysis Corp. However, delays may persist for new diabetes therapies and opioids, Mr. Loss said, noting that the potential for cardiac toxicity and abuse hangs over those products.