|Katherine Siggerud, GAO's managing director for congressional relations|
The FDA has been getting it from all sides lately for its oversight of power morcellator devices, with lawmakers last month urging the U.S. Government Accountability Office (GAO) to probe the agency's regulation of the products. Now, the GAO is planning to take on the charge and launch an investigation into the devices.
"We've agreed to do the work," Katherine Siggerud, managing director for congressional relations at the GAO, told The Wall Street Journal. Last month, a bipartisan group of 12 lawmakers including Rep. Mike Fitzpatrick (R-PA) and Rep. Louise Slaughter (D-NY) sent a letter to the agency asking it to look into the FDA's morcellator regulation. Regulators have cleared at least 10 power morcellators for sale since the first one launched 24 years ago, the lawmakers said in their note.
And even though the FDA has flagged morcellators' risk of spreading undetected cancer, its warning came "decades after some studies were already pointing to a serious problem," lawmakers said, as quoted by the WSJ.
The GAO is staying mum on details of the probe, with Siggerud telling the newspaper that it is too soon to tell how long the investigation will take. An FDA spokesman said the agency will cooperate with any GAO review but that it does not comment on pending or ongoing investigations, the WSJ reports.
The probe turns up the heat on the FDA, which is facing its fair share of scrutiny over power morcellator devices. Last year, the agency issued a warning against using laparoscopic power morcellator tools in minimally invasive surgeries to remove uterine fibroids, saying there was a one in 350 risk of uterine sarcoma in women undergoing procedures with the tools. Before regulators issued their warning, the device was used in about 50,000 U.S. uterine surgeries each year.
|Ethicon's Morcellex Sigma Tissue Morcellator--Courtesy of Johnson & Johnson|
The FDA warning prompted backlash, with Johnson & Johnson ($JNJ)--the world's largest maker of the devices--pulling its product from the global market in July 2014. In November, the FDA stepped up its oversight of the products, slapping the devices with a black box and recommending against using them in the "majority" of women undergoing a hysterectomy or uterine fibroid removal.
Still, the move has not done much to appease industry groups and patients. Private health insurers including Aetna ($AET) and UnitedHealth ($UNH)--the largest insurer in the U.S.--have curtailed coverage for power morcellator devices since the FDA released its warning. And some experts argue that the fallout points to a bigger problem, as the agency approves too many moderate- and high-risk devices without proper evidence.
But the FDA is standing by its regulation, saying that 510(k) clearance allows it to balance "innovation and safety," Dr. William Maisel, the agency's chief scientist, told the WSJ last year. The agency has stopped short of banning power morcellators altogether, saying the devices' benefits may outweigh the risks in some women.
- read the WSJ story (sub. req.)