Waxman asks Obama to look for alternative pathway for biosimilars
NEW YORK Support for a regulatory pathway for biosimilars has grown rapidly, and even a few branded companies, such as Merck & Co. and Pfizer, have expressed interest. But Rep. Henry Waxman’s, D-Calif., request that the Obama administration look for legal means to let the FDA approve biosimilars before his bill, its companion in the Senate or fellow California Democratic Rep. Anna Eshoo’s competing bill is put to a vote, is a strong signal that biogenerics are going to be a reality in American health care — and sooner rather than later.
The Federal Trade Commission released a report Wednesday concluding that giving the Food and Drug Administration authority to approve biosimilars would be an efficient way to get them to market and lower consumers’ healthcare costs.
Immediately, the Generic Pharmaceutical Association praised the report, while the Biotechnology Industry Organization criticized it, particularly over the assertion that allowing market exclusivity periods of 12 to 14 years would be “too long to promote innovation.”
But the report also drew applause from CVS Caremark, whose EVP specialty pharmacy services, Dave Golding, participated in an FTC roundtable event on the issue last fall. CVS’ support is significant because of its stake – through its Caremark Pharmacy Services division – in the growing specialty pharmacy industry, which relies heavily on biotech drugs. In its 2009 Drug Trend report, pharmacy benefit manager Medco, which operates a significant specialty pharmacy business of its own, noted that a pathway for biosimilars could generate “a significant new wave of cost savings opportunities.”
American Dietetic Association survey: Healthcare system should focus on nutrition
WASHINGTON Nearly 96% of primary care physicians believe the nation’s healthcare system should place more emphasis on nutrition to treat and manage chronic disease, according to a new survey.
Based on the 400 physicians surveyed, primary care physicians were almost unanimous in their belief that nutrition is a key role in chronic disease.
“Nutrition is more than just eating a healthy diet; for patients with chronic disease nutrition acts as therapy to help them heal faster, respond better to medical care and control their disease,” said Jane V. White, PhD, LDN, RD, FADA, with the department of Family Medicine at the University of Tennessee Graduate School of Medicine, who partnered with the American Dietetic Association on the survey.
Nearly half of all adults in the United States have at least one chronic disease and survey showed that physicians believed two-in-three of their adult patients who have chronic disease would benefit from nutrition services. Nevertheless, 80% of physicians admit they refrain from addressing nutrition more frequently as part of chronic disease prevention and management due to the lack of direct reimbursement for nutrition services.
As the focus on healthcare reform and preventative care becomes more concentrated, physicians are pushing for governmental action.
“Registered dietitians and doctors have long known the intrinsic value of nutrition services for their patients,” said registered dietitian Martin Yadrick, MS, MBA, RD, FADA, previous president of the ADA. “It is now important for lawmakers to recognize the benefits as well and include them as covered benefits in health care reform.”
Stayhealthy presents wireless body-fat analyzer; final product to be HealthVault-friendly
BELLEVUE, Wash. Following a two-year clinical study at the University of Southern California, Stayhealthy on Thursday introduced their next generation body composition analysis technology at Microsoft’s Connected Health Conference.
The technology accurately measures body composition in various forms depending on the need – from a home use individual device that will retail for less than $100 to a commercial grade device for physicians, fitness and nutrition professionals.
The devices will be able to upload the data directly into Microsoft HealthVault. “Stayhealthy’s body composition analysis is an example of inexpensive and innovative technology that connects with HealthVault to really make a difference in improving healthcare,” stated David Cerino, general manager of the Consumer Health Solutions Group at Microsoft. “Through our cooperative efforts, we are creating technology that brings together the power of the web, server-based processing and medical grade devices to deliver a revolutionary means of helping people better understand and measure their weight-related health risks.”
“At a time when our nation faces a healthcare crisis driven by excess weight and obesity, we are excited to introduce the Stayhealthy Body
Composition Analysis technology,” stated John Collins, CEO of Stayhealthy. “By providing this technology we hope to help millions of people track their body compositions and make positive adjustments as necessary.”
Stayhealthy’s Body Composition Analysis technology incorporates two elements – a physical data collection device that utilizes bio-impedance technology, and a proprietary server-based algorithm that analyzes the data collected at the device and provides a precise body composition reading via the Internet back to the user’s computer.