News

Washington, D.C.-House legislation that proposed to fund expanded coverage for children by cutting payments to Medicare Advantage (MA) plans was put on hold last month in an effort to reach a speedy compromise for reauthorizing the State Children's Health Insurance Program (SCHIP). The legislators agreed to adopt the less-costly Senate proposal, which increases tobacco taxes to expand SCHIP into a $60 billion program over five years. The House bill sought $75 billion for SCHIP and proposed to cut payments to MA plans to offset a lower increase in cigarette taxes. Both plans are much more costly than the $30 billion program proposed by the White House.

Washington, D.C.-House and Senate leaders finally agreed on compromise legislation to renew prescription user fees late last month, just a few days before the funding program was set to expire. The Food and Drug Administration legislation increases drug user fees by $225 million over five years, in addition to adopting user fee agreements negotiated with pharmaceutical, biotech and medical device companies that already raised fees considerably. There's also a new fee program to support FDA pre-review of DTC television ads.

Washington, D.C.-Democratic presidential hopeful Sen. Hillary Clinton scored points with the business community in pledging to retain the nation's public-private healthcare system while promising universal coverage, improved quality and lower costs. In an effort to distance herself from previous efforts to establish a single-payer system, Clinton offered a more centrist plan that touts the "share responsibility" of all parties and builds on the existing employer-based system. There is a mandate for large employers to provide health coverage, which most already do, along with a tax credit for small employers (fewer than 25 workers possibly) to offset premium costs.

Agents in late-stage development for the treatment of allergic rhinitis and sinusitis/rhinosinusitis

Telavancin is a novel semisynthetic lipoglycopeptide antibiotic undergoing FDA review for complicated skin and skin-structure infections; this agent is also in phase 3 clinical trials for the treatment of hospital-acquired pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA) or multidrug-resistant Streptococcus pneumoniae. Telavancin exerts its antibacterial action via a dual mode of action involving both inhibition of peptidoglycan synthesis and disruption of the bacterial cell membrane; the latter of these effects is believed to improve the rate of killing observed with telavancin compared with other glycopeptides. In vitro, telavancin exhibits good activity against a variety of gram-positive organisms, including drug-resistant S pneumoniae, MRSA, vancomycin intermediate-susceptible and vancomycin-resistant S aureus, and vancomycin-resistant enterococci. Clinical data have demonstrated that telavancin is at least as effective as comparator agents for a variety of infectious processes...

In response to the recent FDA warnings about an increased risk of suicidal ideation/suicide attempt among children and adolescents using antidepressants, investigators performed a meta-analysis to assess the efficacy and risk associated with antidepressants among pediatric patients.

Legislation to reauthorize the Prescription Drug User Fee Act (PDUFA) IV has been expanded, as expected, via a host of provisions designed to shape drug development and ensure the safe use of medications.

Initial combination therapy with sitagliptin and metformin is more effective than either agent alone in lowering glucose values in patients with type 2 diabetes, according to the results of a recently published study.

Splitting statin tablets does not negatively affect patient satisfaction, medication adherence, or lipid level control, according to the authors of a randomized, controlled study

Children who receive broad-spectrum antibiotics during their first year of life are at increased risk of developing childhood asthma.That was the conclusion of researchers who conducted a large, longitudinal, case-control study.

Proton-pump inhibitor (PPI) use moderately increases the risk of community-acquired pneumonia (CAP), particularly among younger patients and those who recently initiated treatment, according to the results of a population-based, case-control study.

Parkinson disease (PD) is a chronic progressive neurodegenerative disorder that affects >1 million people in the United States. PD causes both motor and nonmotor disturbances; common symptoms include resting tremor, rigidity, and bradykinesia. The current goals of treatment are to slow disease progression and to reduce disability without inducing long-term complications. The classes of agents currently approved for the treatment of PD include levodopa/carbidopa, dopamine agonists, catechol-O-methyl-transferase (COMT) inhibitors, monoamine-oxidase type B (MAO-B) inhibitors, anticholinergics, and agents/ combinations from other drug classes. Newer agents, such as rasagiline and rotigotine, offer additional treatment options to healthcare professionals. Despite these advances in the treatment of PD symptoms, current therapies do not prevent neuron degeneration. Research into new treatments is focused on neuroprotective drugs, new dopamine agonists, and nondopaminergic agents; the goal of these investigative..

In the large cohort study referred to as the "The Million Women Study," the use of hormone replacement therapy (HRT) in postmenopausal women was demonstrated to increase the risk of ovarian cancer and death from ovarian cancer by 20% and 23%, respectively, compared to nonuse of HRT.

Briefs of FDA actions/approvals of drugs, doses, and indications

First-time generic approvals: fosphenytoin for injection; pantoprazole delayed-release tablets; cefotetan for injection; cefepime for injection.

The latest FDA action (through September 2007) related to satraplatin, ropinirole (Requip CR), sumatriptan/naproxen (Trexima,) desvenlafaxine (Pristiq), eprodisate (Kiacta,) raloxifene (Evista), natalizumab (Tysabri), bifeprunox, fluticasone/salmeterol inhalation powder (Advair Diskus 500/50), LX211, TZP-101, Alferminogene tadenovec, Ad5FGF-4 (Generx), tramiprosate (Alzhemed), rilonacept, aripiprazole (Abilify), sapropterin (Kuvan), oral topotecan (Hycamtin), mifepristone (Corlux), vitiligo-derived IgG (VitiGam)

A new formulation for rivastigmine; a transdermal formulation of cholinesterase inhibitor approved for the treatment of mild-to-moderate dementia of the AD type and mild-to-moderate dementia associated with PD.

A new formulation for immune globulin intravenous (human), 10% liquid, a polyvalent human immunoglobulin G approved for the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura.

FDA has approved a new molecular entity for for use in combination with other antiretroviral agents for the treatment of adults with only CCR5-tropic HIV-1 who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

WASHINGTON, D.C.-Instead of going back to academia, former FDA Commissioner and Medicare Administrator Mark McClellan, MD, is setting up his own shop to tackle health reform and drug safety more actively. Dr. McClellan will head the Engelberg Center for Health Care Reform at the Brookings Institution, starting with $20 million in funding from Alfred Engelberg and Leonard Schaeffer.

Private fee-for-service (PFFS) plans are the fastest growing, and most controversial, aspect of the Medicare Advantage (MA) program. They account for approximately 18% of total enrollment, and according to MedPAC, they are receiving payments that average 19% more than payments to traditional Medicare.

Leaders of Medicare Advantage (MA) organizations are concerned about maintaining the profitability of their MA products. To be successful, organizations should develop internal profitability best practices.

Healthcare reform has surfaced as a national topic. Intel co-founder Andy Grove outlined some noteworthy ideas on healthcare reform during a national speaking tour, and California Governor Arnold Schwarzenegger recently proposed a plan to cover the citizens of his state. Getting a head start on the 2008 Presidential race, Mitt Rommey is weighing in with proposals based on his experience as former Governor of Massachusetts. While all these ideas are coming from different sources, they all share a few basic themes: healthcare should be easy to find, to buy, and to understand.

Preventable medication errors are resulting in $3.5 billion in drug-injury related healthcare costs. To address this crisis, the IoM recommends that the entire system move to electronic prescribing (e-prescribing) by 2010.

NATIONAL REPORTS-An opportunity for drug companies to voluntarily provide detailed evidence of their products' cost effectiveness to existing alternatives is showing progress-but is still far from successful, according to industry experts.

WASHINGTON, D.C.-Instead of going back to academia, former FDA Commissioner and Medicare Administrator Mark McClellan, MD, is setting up his own shop to tackle health reform and drug safety more actively. Dr. McClellan will head the Engelberg Center for Health Care Reform at the Brookings Institution, starting with $20 million in funding from Alfred Engelberg and Leonard Schaeffer.

SACRAMENTO-California's six largest preferred provider organizations (PPOs) have agreed to initiate quality-of-care measures to create a Health Insurance Report Card for the state, the first in the nation for PPOs.

PPOS are seeing a continued resurgence in some areas, and in others, are not able to compete effectively with HMOs, industry experts say.