FDA Gives Clearance to Home Laser
The Food and Drug Administration has given 510(k) clearance to Palomar Medical Technologies' home laser system for periorbital wrinkles. Palomar received FDA approval for a light-emitting, over-the-counter hair removal device in 2006. The company said the newest approval gives it entrée into "the multibillion dollar consumer skin care market." In a statement, Palomar Chief Executive Officer Joseph P. Caruso said, "The professional treatment of fine lines and wrinkles using lasers has been well established and proven to be safe and effective for years in the doctors' office using large and expensive lasers. With this breakthrough, consumers will be able to use similar technology in the privacy of their own home for a fraction of the cost." Johnson & Johnson is collaborating with Palomar.
Boasting About Botox
Nine in 10 people surveyed recently about aesthetic treatments said that they openly discuss their Botox injections and filler treatments. The survey was conducted by the Aesthetic Surgery Education & Research Foundation and supported in part by Botox maker Allergan. Survey forms were distributed to patients by physicians. From 687 analyzed responses, the typical Botox and filler patient was 4055 years old and a working, married, mother of one to three children. Top reasons for getting Botox included patients feeling that they looked stressed or angry and that a family member or friend recommended it. Twenty-five percent said that a physician had recommended the injections. Among patients receiving fillers, 61% had gotten Juvéderm, 59% Restylane, and 13% Perlane. Nearly two-thirds of patients getting fillers said they sought to remove facial wrinkles and folds.
Evolence Gets 12-Month Okay
The dermal filler Evolence is safe and effective up to 1 year after its injection, according to the FDA in granting supplemental approval to Ortho Dermatologics. The Johnson & Johnson unit submitted data on moderate to deep facial wrinkles. Evolence is now the only collagen-based filler approved for 12-month duration, said Ortho.
Increased Vitamin D Urged
The Skin Cancer Foundation is urging adult Americans who get limited sun to increase their vitamin D intake from 400 IU daily to 1,000 IU. The vitamin D should come from both diet and supplements, said the foundation. The 1,000 IU intake is well within safety limits established by the U.S. Food and Nutrition Board, Warwick Morison, chairman of the foundation's Photobiology Committee, said in a statement. The foundation said children under 18 years old should continue to get 400 IU.
Obama: Give MedPAC More Clout
The Obama Administration wants to give the Medicare Payment Advisory Commission (MedPAC) greater influence. In a June 2 letter to Sen. Ted Kennedy (D-Mass.) and Sen. Max Baucus (D-Mont.), President Obama said he supported giving each MedPAC recommendation the force of law unless it's opposed by a joint resolution of Congress. This appeared to embrace the approach in the MedPAC Reform Act of 2009, which Sen. Jay Rockefeller (D-W.Va.) introduced in May. Currently, MedPAC advises Congress, which then decides whether to act on the recommendations. At a Brookings Institution conference in mid-June, White House Office of Management and Budget Director Peter Orszag reiterated support for giving MedPAC more teeth. Mr. Orszag said the administration wanted to "take the MedPAC recommendations and, rather than having them sit on a shelf somewhere, have them protected in a fast track procedure, voted up or down as a package, and considered within a limited period of time so they become much more relevant."
Feds Launch Disease Program
The National Institutes of Health has launched a $24 million drug development program to produce new treatments for rare and neglected diseases. The Therapeutics for Rare and Neglected Diseases program, funded by Congress this spring, creates a drug development pipeline within NIH and is intended to stimulate research collaborations with academic scientists researching these diseases, NIH said. The NIH Office of Rare Diseases Research will oversee the program. NIH estimates that more than 6,800 rare diseases affect more than 25 million Americans but that effective pharmacologic treatments exist for only about 200 of these illnesses. In addition, many neglected diseasesuncommon in the United States but more common in parts of the world where people cannot afford expensive therapiesalso lack treatments, NIH said.
Funds for Rheumatic Research
The Obama administration's fiscal year 2010 budget request includes $531 million for the National Institute of Arthritis and Musculoskeletal and Skin Diseases, about $6 million more than Congress budgeted this year. The FY 2010 funds would be used to continue the agency's support for pain research related to arthritis and rheumatic diseases. NIAMS will also be part of the administration's push to accelerate cancer research by doubling NIH-wide cancer research spending by 2017. NIAMS plans to support investigator-initiated research that focuses on the effects of anticancer therapies on bone quality and muscle strength, as well as the cellular mechanisms associated with autoimmune diseases and cancer.