In an effort to meet the administration's goal of expanded electronic government, FDA is requiring drug manufacturers to submit prescription drug label information to the agency in a new electronic format. This electronic format will allow healthcare providers and consumers to more easily access the product information found in package inserts for all approved medications in the United States.
The future leadership of FDA remains highly uncertain following the unexpected resignation of commissioner Lester M. Crawford, DVM, PhD, in September. Andrew C. von Eschenbach, MD, director of the National Cancer Institute (NCI) at the National Institutes of Health (NIH), was named acting FDA commissioner, but conflict arose initially because Dr von Eschenbach wanted to retain a leadership role at NCI while also taking the helm of FDA. Although he handed over day-to-day leadership of NCI to a deputy, that move failed to fully appease critics concerned about conflicts of interest in advocating for speedy access to new cancer treatments while overseeing the safety and effectiveness of those therapies. Department of Health & Human Services (HHS) secretary Michael Leavitt has indicated that Dr von Eschenbach is not likely to get the top job at FDA on a permanent basis.
Men who have used 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors to reduce their cholesterol levels may be at less risk of developing prostate cancer, according to a case-control study published in the American Journal of Epidemiology.
Results from a 6-month, phase 3b/4 study of eszopiclone (Lunesta, Sepracor) in adult patients with chronic insomnia demonstrated that nightly use of eszopiclone 3 mg resulted in statistically significant improvements (P<.0001) compared with placebo in patient-reported measures of sleep latency (onset of sleep), sleep maintenance, total sleep time, and sleep quality. These results were announced in late September at the American Neurological Association (ANA) Annual Meeting in San Diego, Calif.
Eszopiclone (Lunesta, Sepracor), a novel, non-benzodiazepine sleep aid, shows significant value in the treatment of insomnia associated with menopause, said Claudio N. Soares, MD, PhD, at the North American Menopause Society's 16th annual meeting in San Diego, Calif.
Results from a phase 3 clinical study demonstrate that a novel transdermal estradiol gel (Bio-E-Gel, BioSante) represents a major improvement in low-dose estrogen therapy, significantly reducing the frequency and severity of hot flashes in menopausal women in a dose-dependent manner at all 3 doses studied, with the low dose being identified as the lowest effective approach, stated James A. Simon, MD, at the North American Menopause Society's 16th annual meeting in San Diego.
Quetiapine (Seroquel, AstraZeneca), olanzapine (Zyprexa, Lilly), and risperidone (Risperdal, Janssen) are equally effective in patients experiencing first episode psychosis, according to data presented in late October during the Breaking News session at the European College of Neuropsychopharmacology (ECNP) Congress.
In a "real-world" setting, drug-eluting stents are clinically superior to bare metal stents, but their use is currently cost-effective only in high-risk subsets of patients, according to results from BASKET (Basel Stent Kosten Effektivit?ts Trial).
A single IV bolus of enoxaparin (Lovenox, Aventis) is just as effective as and associated with less bleeding than unfractionated heparin in patients undergoing elective PCI, said Gilles Montalescot, MD. Dr Montalescot was lead investigator of STEEPLE (Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention Patients), the results of which were announced during the the ESC Congress 2005 in Stockholm, Sweden.
USP has been awarded a cooperative agreement with the Centers for Medicare and Medicaid Services (CMS) to revise the Part D Prescription Drug Benefit Model Guidelines.
While Hurricane Katrina has disrupted healthcare for millions of people, one beneficial outcome may be more public and private efforts to develop a national electronic health records (EHR) system.
Children suffering from acute exacerbation of asthma can expect levalbuterol (Xopenex, Sepracor) (LEV) to produce results that are no better-yet are more costly-than racemic albuterol (RAC), according to a study published in Pediatric Emergency Care.
ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) possess a similar and significant ability to reduce the development of new-onset type 2 diabetes among patients with hypertension, coronary artery disease, and heart failure, according to a meta-analysis study published in Diabetes Care.
In other drug safety news, FDA has announced the selection of Gerald J. Dal Pan, MD, MHS, as director, Office of Drug Safety in the Center for Drug Evaluation and Research (CDER). Dr Dal Pan, selected from a strong field of candidates as part of a nationwide search, will lead the agency's post-marketing drug safety program.
Judith Cahill, executive director of the Academy of Managed Care Pharmacy (AMCP), gave testimony in early November during FDA's public hearing on direct-to-consumer advertising (DTC) of pharmaceutical products.
Evaluation of newly released medications for potential formulary inclusion should focus on clinical benefit over product price or rebate. Dossiers are invaluable to the evaluation process, but it's important to note that dossiers obtained from pharmaceutical manufacturers are often incomplete, according to presenters at AMCP's 2005 Educational Conference last month in Nashville, Tenn.
Incremental cost-effectiveness ratios produced by pharmacoeconomic modeling are the gold standard for evaluating drug alternatives, but the result of such an analysis often requires a value judgment on the part of the managed care organization (MCO), Daniel C. Malone, PhD, RPh, said at the Academy of Managed Care Pharmacy's (AMCP's) 2005 Educational Conference last month in Nashville, Tenn.
Accumulating data have demonstrated that the endothelin axis plays a role in the progression of many malignancies. Endothelin-1, which is produced by prostate cancer cells, can stimulate new bone formation. It can also act synergistically with a number of growth factors promoting cancer cells growth and proliferation. Over-expression of endothelin-1 and diminished capacity for its clearance have been seen in prostate cancer cell lines. The highest concentration of endothelin-1 is found in patients with hormone refractory metastatic disease. Atrasentan (Xinlay, Abbott) is a member of a new class of drugs called the selective endothelin-A receptor antagonists (SERAs). The safety and efficacy of atrasentan in hormone refractory prostate cancer (HRPC) have been evaluated in several clinical trials. Atrasentan demonstrated some efficacy in delaying the progression of disease and improving patients' quality of life while having an acceptable safety profile. An NDA for atrasentan was submitted in December 2004 for..
FDA extended the Prescription Drug User Fee Act action date to January 7, 2006, for lenalidomide (Revlimid, Celgene). The drug is intended to treat patients with transfusion-dependent anemia resulting from low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality.
Amlodipine tablets 2.5, 5, and 10 mg (equiv to Norvasc tablets).
Muraglitazar (Pargluva, Bristol-Myers Squibb, Merck) for the treatment of type 2 diabetes.
This tablet formulation of lopinavir and ritonavir provides several advantages over the capsule formulation.
This recombinant IgG1 monoclonal antibody exerts its therapeutic effect through inhibition of human tumor necrosis factor (TNF).
The prodrug of a cytotoxic deoxyguanosine analogue, nelarabine inhibits DNA synthesis and leads to cell death.
In each issue, Formulary's "Focus on" article reviews a newly approved or investigational drug of interest to pharmacy and therapeutics committee members. Because so many readers have told the editors of Formulary that they reference this column frequently when making formulary decisions for their hospitals, health systems, or managed care organizations, the editors have compiled this review of all the "Focus on" articles published so far in 2005, along with updates on the status of each agent.
Inhaled insulin (Exubera, Pfizer/Sanofi-Aventis) could be an effective therapy and alternative to rosiglitazone (Avandia, GlaxoSmithKline) for individuals who are early into the course of type 2 diabetes, according to a study published in Diabetes Care.
HEPATITIS B AND C are serious viral diseases that can lead to lifelong infection, cirrhosis, liver cancer, liver failure and death. They often produce chronic, hidden infections. An estimated 1.25 million Americans are infected with hepatitis B, and about 30% of them have no signs or symptoms. An estimated 2.7 million Americans have chronic hepatitis C, and about 80% of them have no signs or symptoms. Both diseases are transmitted through blood and other bodily fluids.
Medicare Part D is the first large scale example of a true consumer healthcare product
As a result of the Medicare Modernization Act (MMA), Medicare HMOs are well positioned. As MA-PDs gain traction, the increased publicity will drive awareness among the senior population, further increasing enrollment, according to industry experts.
Companies in service industries are busy trying to please their customers, but do they pay the same attention to their own employees? A resounding "yes" is the answer from health plans, many of which claim they spend time and energy on attracting and retaining their employees. In a labor market where available jobs outnumber potential employees, healthcare organizations and other companies are vying for top-notch people.
