The U.S. Food and Drug Administration has asked drug maker Merck & Co. for more information before it decides whether to expand approval for Gardasil, a human papillomavirus vaccine, Merck said Friday.
Gardasil is currently approved for females ages 9 to 26. Merck has asked the FDA to widen approval for its use in women aged 27 to 45, the Associated Press reported. The drug is designed to guard against HPV, which is responsible for most cases of cervical cancer.
The FDA wants additional data from an ongoing 48-month study of Gardasil, the wire service said. The agency's action does not affect currently approved uses or Merck's application to approve the drug for use in males ages 9 to 26.
The vaccine costs about $360 for the three required doses, and some experts have said it's not cost-effective for older women, Dow Jones news service reported. A Harvard study funded by the U.S. government and published last year, found the vaccine was cost-effective for girls, but not for females in their 20s, the AP said.
Consumers Union Urges Expanded Testing of Infant Formula
Consumers Union urged the U.S. Food and Drug Administration on Friday to expand testing of infant formula for melamine and related compounds, and to recall all contaminated products.
The request came after the FDA published two new reports of contamination on its Web site over the holidays, doubling the number cases previously reported last November. The FDA deemed melamine levels in the new cases extremely minute and safe for babies. Traces of the industrial chemical melamine and a byproduct, cyanuric acid, have now been found in four of 89 containers of infant formula made in the United States, the Associated Press reported.
The two new cases involved containers of Mead Johnson's Enfamil LIPIL with Iron that had traces of cyanuric acid, a weak acid used as a chlorine stabilizer in swimming pools. Previous tests had found traces of melamine in a can of milk-based liquid Nestle Good Start Supreme Infant Formula with Iron. A third major formula maker, Abbott Laboratories, whose brands include Similac, told the AP in November that in-house tests had detected traces of melamine in its formula, but far below levels the FDA found in the other formulas.
Consumers Union called the FDA risk assessment from November 2008 "flawed," saying it ignored important scientific data. The FDA now says that up to one part per million of melamine in formula is safe. Levels in the new cases were well below that standard, but an agency risk assessment issued as recently as October 2008 had said that no amount of melamine in formula could be considered safe.
Melamine-tainted formula has sickened tens of thousands of children in China, killing at least six. The melamine was apparently added to milk powder by manufacturers to make their watered-down formulas appear more nutritious. The FDA has said that domestic supplies are safe, however, because U.S. formula makers do not obtain ingredients for their products from China.
Abbott Laboratories, Nestle and Mead Johnson make more than 90 percent of the infant formula produced in the United States, the AP said.