Reloxin Approval Delayed
Ipsen and its marketing partner Medicis announced in mid-April that its botulinum toxin type A, Reloxin, (known as Dysport in Europe) would not be approved at the expected time. Instead, the companies reported in a statement that they were "in active labeling and risk evaluation and mitigation strategy discussions" with the Food and Drug Administration for both the therapeutic—cervical dystonia—and the aesthetic indications. Galderma owns European marketing rights for aesthetic uses, and Medicis owns the U.S., Canadian, and Japanese rights. The companies did not say when they expected final approval.
QVC Settles Over Cellulite Cream
The megaretailer QVC Inc. has agreed to pay $7.5 million to settle Federal Trade Commission charges that it violated commission orders dating to 2000 and made false and unsubstantiated claims about an anticellulite cream as well as three dietary supplements. The company's TV-shopping network made unsubstantiated claims that Lipofactor lotion could reduce cellulite, said the FTC statement. "Simply put, we aren't going to let QVC get away with this," said the acting director of FTC's Bureau of Consumer Protection, Eileen Harrington. QVC will pay $6 million for consumer redress and a $1.5 million civil penalty. And the FTC extended the order prohibiting the claims.
NIAMS Touts Stimulus Funds
The government's economic stimulus package offers new opportunities for dermatologic research, Dr. Stephen Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), said on the agency's Web site. The stimulus funds are distinct from NIAMS's annual appropriation and will be managed separately, said Dr. Katz. Among the new programs is the Grand Opportunities initiative for projects requiring more than $500,000 per year. Other stimulus funds can be used to accelerate ongoing research. Application deadlines are in June and July, visit
www.niams.nih.gov/Recovery/directors_go_letter.asp
Lupus Research Gets Budget Boost
Congress has dedicated about $5 million to lupus research and education as part of the recently enacted fiscal year 2009 Omnibus Appropriations Act. The law, which was signed in March, includes $4 million to support the National Lupus Patient Registry, about $1 million more than in FY 2008. Congress provided another $1 million for health provider education aimed at improving early diagnosis and treatment of lupus and reducing health disparities. The Lupus Foundation of America specifically praised the health provider education initiative. Educational programs that improve the time to diagnosis are critical, the organization said, because more than half of individuals with lupus report that they had symptoms of the disease for at least 4 years and visited at least three physicians before receiving a diagnosis of lupus.
Path Outlined for Biosimilars
A bipartisan group of legislators has introduced a bill to promote approval of follow-on biologics, or biosimilars. The Pathway for Biosimilars Act (H.R. 1548) is designed to accomplish for follow-on biologics what the Hatch-Waxman Act of 1984 did for generic drugs. The legislation would set up a process within the FDA to expedite approval of new biologics that are based on existing products. However, the bill includes incentives for companies to continue to create innovative products, including 12 years of exclusivity for the original product.
Device Staff Decries FDA Politics
The FDA is a mess of politics, abuse, and misdeeds, according to members of the agency's Office of Device Evaluation, who sent a six-page letter to President Barack Obama in early April. The staff members called on the president to enact sweeping measures "to end the systemic corruption and wrongdoing that permeates all levels of FDA." They said that FDA managers have "abused their power and authority" and "engaged in illegal retaliation against those who speak out." The letter detailed a handful of events in the last few months but said that "the culture of wrongdoing is nothing new but is part of a long-standing pattern of behavior." The letter, with all of the signers' names redacted, was released at a congressional hearing.
Administration Posts Filling Up
The Obama administration has named officials to several top health care-related positions that do not require Senate confirmation, including the director of the White House Office of Health Reform, administrator of the Health Resources and Services Administration, and the new National Coordinator for Health Information Technology. Nancy-Ann DeParle, who ran Medicaid and Medicare under President Clinton, will now lead the White House office. Rural health expert Mary Wakefield, Ph.D., R.N., was selected to head HRSA, joining the agency from the University of North Dakota, Grand Forks. And internist David Blumenthal, former director of the Institute for Health Policy at Massachusetts General Hospital, Boston, will take the lead on creating a nationwide health information technology infrastructure.