Approving Follow-On Biologics
Creating a regulatory pathway for approving generic or “follow-on” versions of biologic therapies would improve competition and curb rising biotech prices, according to an analysis from the Competitive Enterprise Institute. Congress is considering legislation that would allow an abbreviated approval process for so-called follow-on biologics. This pathway would be similar to the process currently in place for approving generic pharmaceuticals. Whether this regulatory pathway is created through legislation or out of the Food and Drug Administration's existing authority, the report maintains that the process could be done safely. Generic manufacturers have the capability to create safe follow-on biologics, and the FDA has the tools to recognize products that are comparable with existing drugs or interchangeable, wrote study author Gregory Conko, a senior fellow at the Competitive Enterprise Institute. “Consumers would see tremendous benefits from an abbreviated approval process for generic biotech prescription drugs,” Mr. Conko said in a statement. “In addition to the cost savings, the competition that these approvals would generate could spur even more improvements in the quality of biopharmaceuticals.” Find the report online at
www.cei.org/gencon/025,05933.cfm
Lupus Grants Awarded
The Department of Defense's Congressionally Directed Medical Research Program awarded over $2 million in the form of two grants for research on lupus and lupus biomarkers. The grants will fund investigations in mouse models, but the findings could lead to human advances. Researchers at the Medical University of South Carolina in Charleston will experiment with targeting a certain cascade of proteins in a mouse model to target certain areas where lupus causes tissue damage and to minimize immune suppression in other areas of the body. Grant recipients at the Feinstein Institute for Medical Research at the North Shore Medical Center in Manhasset, N.Y., will examine the estrogen's role in triggering lupus activity in certain mouse models but not in others. That research could have long-term implications for testing patients with lupus for hormonal disorders.
AMA Fights Medicare Cuts
Physicians report they will severely limit the numbers of Medicare patients they treat if Congress won't avert planned Medicare physician payment cuts, which will total 10% on Jan. 1, 2008, and will reach about 40% over the next 9 years, according to an American Medical Association survey of nearly 9,000 physicians. If Medicare payment rates are cut by 10% in January, 60% of physicians report they will limit new Medicare patients and 40% will limit established Medicare patients, the AMA survey found. “As physicians brace for 9 years of steep payment cuts, it will be extremely difficult for them to continue accepting new Medicare patients,” said Dr. Cecil Wilson, AMA board chair. “The baby boomers begin entering the program in 2010, and the Medicare cuts increase the likelihood that there may not be enough doctors to care for the huge influx.” MedPAC, Congress' advisory committee on Medicare, has recommended Congress halt next year's 10% cut and update payments 1.7% in line with practice cost increases.
State Variations in Care Cost, Quality
Cost, quality, and access to care vary widely depending on where you live, according to a report from the Commonwealth Fund. The report ranks states based on 32 indicators of access, quality, avoidable hospital use and costs, equity, and healthy lives. While no state ranked first across all indicators, in general states in the Northeast and Upper Midwest performed better, while southern states tended to score the lowest. “The differences we found between the top and bottom states were shocking, often a two- to threefold variation or greater,” study coauthor Cathy Schoen said in a statement. “Where you live clearly matters for access to care when you need it, the quality of care you receive, and opportunities to live healthier lives.”
New FDA Risk Panel
Following an Institute of Medicine recommendation, the FDA has created an advisory committee charged with helping the agency communicate the risks and benefits of pharmaceuticals and other products. In 2006, the IOM's report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, urged Congress to establish a new advisory panel that would weigh in on the FDA's communications about safety and efficacy to health care providers and the public. The agency found an administrative process that let it establish the committee without congressional action. The FDA is now seeking 15 members to serve on the Risk Communication Advisory Committee, including experts on risk communication, social marketing, health literacy, journalism, bioethics, and cultural competency.