MASSDEVICE ON CALL — The Institute of Medicine’s recommendations for the FDA’s medical device application fast-track are a nonstarter for the agency and for the industry.
The IOM released findings from its year-long audit of the 510(k) review process on Friday, concluding that the only way to fix the process was to replace it entirely.
"FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, said in a statement.
Wall street analysts agreed that the report was not a "game-changer," Reuters reported.
"The 510(k) process was established in 1976 and it was meant to be a temporary stop-gap," Thomas Gunderson, an analyst with Piper Jaffray, told the wire service. "The process can certainly be improved upon, but at the current pace, I don’t see this (IOM report) having any meaningful impact."
Al Franken (D-Minn.), a member of the Senate’s health committee and representative of the home state of med-tech goliath Medtronic Inc. (NYSE:MDT), was also wary of the report.
"Calling for the elimination of the 510(k) process could be very harmful to innovation," Franken said.
IOM investigators argued that the 510(k) review system, which relies on the premise that predicate devices are safe and effective and therefore devices that are found "substantially equivalent" are sufficiently safe and effective, operates under faulty assumptions and doesn’t protect patient safety.
Colon cleansing does harm and little good
Colon cleansing has little clinical benefit and poses grave risks, according to new research published in the Journal of Family Practice.
A Georgetown University Medical School review of 20 studies on colon cleansing found little evidence that the practice benefit health, but did find many cases of cramping, bloating, vomiting, electrolyte imbalance, renal failure and even death.
The theory behind colon cleansing is called "autointoxication," a largely discounted theory that food gets trapped in the colon and rots, releasing toxins that should be cleaned out, MSNBC reported.
Medicare prescription plan saves money
Medicare subsides on prescription drugs for seniors, implemented in 2006, led to improved medication adherence and lower out-of-pocket expenses for the elderly while reducing nondrug-related health care costs for the government program, researchers at Harvard Medical School and Brigham and Women’s Hospital found.
Researchers looked at data spanning 2004 to 2007 and compared nondrug health care spending before and after the subsidies were implemented, finding that lowered out-of-pocket drug costs for seniors lead to 10 percent less spending on other health care, the Boston Business Journal reported.
District Court dismisses attempt to ban embryonic stem cell research
A U.S. District Court backed President Barack Obama’s executive order expanding research on embryonic stem cells, dismissing a case brought by two scientists who work with adult stem cells, BioNews reported.
The two scientists, Dr. James Sherley and Dr. Theresa Deisher, argued that research using embryonic stem cells violates the Dickey-Wicker Amendment, which prohibits the use of federal funds for research that results in the destruction of human embryos. Prior courts have ruled that the amendment is ambiguous and does not prohibit research where human embryos are used, but only prohibits funding for the act of deriving stem cells from human embryos.
