FDA issues non-approvable letter for Jerini over icatibant
BERLIN The Food and Drug Administration has rejected Jerini’s experimental drug icatibant, which is used to treat hereditary angiodema, a life-threatening swelling disease, according to Bloomberg.
Hereditary angioedema is caused by a genetic defect that affects a protein called C1 inhibitor. The protein is normally responsible for regulating inflammation in the body, and malfunctions can lead to rapid swelling, abdominal pain or even death if the airways become blocked.
The agency sent a non-approvable letter to Jerini, but the company has not yet disclosed what the FDA was concerned with regarding the drug. Jerini does plan to review the decision with the FDA.
House votes overwhelmingly to block Medicaid cuts
WASHINGTON The full House of Representatives voted yesterday to block cuts aimed at Medicaid, which were proposed by the Bush administration, according to published reports. The spending cuts would have totaled $13 billion over the next five years.
The measure easily passed the mandatory two-thirds vote needed by a vote of 349-62. The vote will hopefully impose a one-year moratorium, through next March, on seven rules changes that the administration argues are needed to clean-up the waste and abuse in the program. The next step is for the vote to move to the Senate Finance Committee in hopes of moving to the Senate floor. President Bush, however, has threatened a veto, so it would be important for the Senate to be overwhelmingly in favor of the vote, as the House was.
The proposed rules would affect programs involving payment to public safety-net institutions, rehabilitation services for people with disabilities, coverage of hospital clinical services, graduate medical education payments and specialized medical transportation to school for children covered by Medicaid.
In 2007, some 48 million people participated in Medicaid programs. The total cost was about $352 billion, with the federal government paying almost $200 billion and states providing the rest.
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.