Data suggests FDA approving drugs despite delayed studies
WASHINGTON Almost two-thirds of the time, pharmaceutical manufacturers are not even beginning studies that they promised to the Food and Drug Administration upon receiving approval for their drugs, according to Bloomberg. To receive FDA approval, drugmakers often agree to perform additional studies of safety, dosing and other matters after medications come to the market. The research is usually voluntary.
The data released yesterday showed that 1,044, or 62 percent, of incomplete studies for both biotech and conventional medications had yet to begin as of Sept. 30. This is an increase compared to the 1,026 studies that had not begun by the same date in 2006.
“Drugs often come on the market with an expectation that studies will be conducted,” said Peter Lurie, deputy director of the Health Research Group at Public Citizen, an advocacy organization. “In fact, many of these studies begin late or do not begin at all.”
Doctors say post-approval studies may be needed to fully assess the risks of medications because some dangers don’t emerge until products are in widespread use.
Some research has been pending for years. Of the 1,044 studies that hadn’t begun, drugmakers committed before Oct. 1, 2004 to undertake 444 of them, according to the FDA.
The FDA statistics show 271 studies, or 16 percent, were on or ahead of schedule, and 242, or 14 percent, had been submitted for FDA review or terminated before completion. The FDA described 125 studies as “delayed.”
The FDA does not consider all of the uninitiated studies late. Many of them don’t have deadlines, at least not ones imposed by regulators. The agency didn’t specify the number of drugs covered by the studies. Drugmakers sometimes agree to complete multiple studies for a single product.
Schering-Plough posts quarterly loss from purchase of Organon
KENILWORTH, N.J. Schering-Plough today released its first-quarter results for 2008, according to published reports. The drugmaker reported a net income of $253 million, down from $543 million during the first quarter of 2007, mostly due to the acquisition of the biotech company Organon BioSciences.
Sales though rose by 56 percent to $4.66 billion. Its rheumatoid arthritis drug Remicade’s sales rose by 36 percent to $507 million.
Vytorin and another cholesterol treatment drug Zetia, which Schering markets through a joint venture with Merck saw sales of both drugs combined rise 6 percent to $1.2 billion during the quarter. But they fell 5 percent in the United States amid the widely publicized failure of Vytorin to cut plaque in neck arteries in a study for which results were presented in January.
Merck said Monday it expects its revenue from the drugs to drop by $700 million over the rest of 2008.
Chief executive officer Fred Hassan said the company is on track with its plan to cut annual costs by $1.5 billion by 2012, announced earlier this month. About 10 percent of its 55,000 jobs are to be cut.
Genzyme plans expansion in China
CAMBRIDGE, Mass. Genzyme has announced that it will build a research and development center in Beijing as part of its global expansion, according to published reports.
The company expects the facility to open in 2010 and cost them about $90 million. It will be a 200,000 square-foot facility, which will be able to accommodate 350 employees.
Genzyme said it already has 25 employees working in offices in Beijing and Shanghai and has a pilot program for its cell therapy MACI at Beijing Wujing Hospital.