News

Andrew von Eschenbach, MD, has faced a number of tough issues since he was sworn in as FDA's commissioner in December 2006, not the least of which is drug safety. Fewer new drugs have been coming to market, and pressure continues to mount for FDA to do more with limited resources. Legislation to reauthorize user fees for pharmaceutical and medical device manufacturers has to be approved by Congress by September 30, 2007, or FDA will have to lay off hundreds of staff members. The need for speedy legislative action has focused public attention on agency operations and policies, a trend likely to continue as the nation's healthcare system and prescription drug costs become a central issue in next year's presidential elections.

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

First-time generic approvals, August 2007

The latest FDA action (through August 2007) related to rimonabant (Zimulti), guanfacine extended-release (Intuniv), risperidone (Risperdal), maraviroc, sitaxsentan (Thelin), HCV-796, docetaxel (Taxotere Injection Concentrate), raltegravir (Isentress), topotecan (Hycamtin), ixabepilone, cetuximab (Erbitux), leukocyte interleukin (Multikine), pafuramidine, ALTU-135

Amlodipine/valsartan, a combination of calcium-channel blocker and angiotensin II receptor antagonist is now approved by FDA for the treatment of hypertension

Pregabalin, an anticonvulsant agent, is now approved by FDA for the management of fibromyalgia.

Ambrisentan, an endothelin-receptor antagonist is now approved by FDA for the treatment of PAH

Rising use of digital technologies and the Internet in the past decade has led to a dramatic explosion in the collection and use of personal data. While electronic use of information provides numerous benefits, it also poses various risks, such as identity theft and security breaches.

Employers are looking for ways to improve quality and affordability. Early identification and consumer engagement strategies help minimize an employer's risk of an employee becoming a high-risk and unproductive employee.

For years, surgeons and other specialists working at hospitals were at the financial mercy of administrators. While it was true that these physicians were the ultimate authority on clinical care, the decisions about equipment, more staff and other important aspects of treating patients were often out of their hands. With departments wrestling each other for precious few dollars, their requests were frequently denied.

Roughly 150,000 Americans traveled abroad for care in 2005, and many more are expected to follow suit in the next few years. Medical tourism, once associated mainly with cosmetic procedures, now represents an attractive alternative for consumers to obtain hip replacement, heart procedures and other surgical interventions at a lower cost than what the United States can offer.

Newly diagnosed patients with chronic conditions wait an average of 105 days until someone reaches out to them with disease management support. Precious time is lost, affecting their health, attitude and openness to change.

Providing patients with safe, effective and affordable prescription drugs is a continuous challenge for health plans and insurers. These efforts rely heavily on the decisions made by the Food and Drug Administration (FDA) in determining which new drugs come to market and how those medicines perform when used in real-world healthcare settings.

Ahearing before a federal district court this summer will most likely conclude the 14-year Texas class action case of Frew v. Hawkins. This class action suit was filed in 1993 by a group of mothers who were dissatisfied with the medical treatment that their children received-children who qualified for, but allegedly did not receive, full preventive care and treatment under Medicaid laws. As states enact changes to ensure full compliance with these laws, MCOs will see the effects on Medicaid provider networks, reimbursement rates and reporting requirements.

Recently, there has been a slight decline in HMO enrollment, according to industry experts. PPOs are gaining share.

NATIONAL REPORTS-For chronically ill patients, increased cost sharing can be associated with lower rates of drug treatment, less adherence among existing users and more frequent d iscontinuation of therapy, according to research published in a recent issue of the Journal of the American Medical Assn.

WASHINGTON, D.C.-As expected, the Centers for Medicare and Medicaid Services (CMS) has proposed a nearly 10% reduction in Medicare physician fees for 2008. The cut reflects the physician payment formula approved by Congress in 1998 that has long been the subject of criticism and debate.

Get your Power Point ready because the annual season of strategic planning is upon us. There are quite a few givens that we know we'll have to work with for 2008 in spite of the fact that the year still has several good months left in it.

A significant barrier to the productivity of physicians and other clinicians is gaining access to the information needed to administer patient care. In many cases, the process of granting access to information starts on the day a caregiver is credentialed with the organization and could drag on up to two months.

First-time generic drug approval: amlodipine/benazepril capsules

A review of agents in late-stage development for the treatment of asthma (July 2007).

In a nested case-control study, the use of low-to-moderate doses of aspirin (ASA) in women was associated with a significant reduction in all-cause mortality.

New research presented at the Digestive Disease Week 2007 regarding the effect of statins on hepatitis C infection.

In the Avoiding Cardiovascular Events Through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) study, initial treatment of hypertension with a fixed-dose, dual-drug combination demonstrated "unprecedented" levels of control at 18 months.

Nebivolol is associated with long-term control of blood pressure and is as effective in obese patients as in nonobese patients with hypertension, according to the results of a 9-month extension study and a post-hoc analysis that were presented at the American Society of Hypertension 22nd Annual Scientific Meeting and Exposition.

In a randomized, controlled trial, telmisartan demonstrated a greater antiproteinuric effect than losartan in hypertensive patients with type 2 diabetes and chronic kidney disease.

Rituximab, which is currently FDA-approved for the treatment of certain B-cell lymphomas and moderate-to-severe rheumatoid arthritis, demonstrated benefit in the treatment of relapsing-remitting multiple sclerosis (RRMS) in 2 early-phase experimental trials.

Hemostatic treatment with recombinant activated factor vIIa (rFVIIa) failed to reduce death or disability in a phase 3 trial of patients with intracerebral hemorrhage (ICH), according to results presented during the AAN 59th annual meeting.