FDA: Reform at the Federal Agency
While the Food and Drug Administration has made noteworthy improvements in its approval process for new drugs and medical devices since the days when the "honest rap on [the agency] was that its regulatory delays effectively killed people waiting for treatment," much still needs to be reformed, according to an article last week in Investor's Business Daily. The agency has "made big strides in recent years," boosted in part by passage of The Food and Drug Administration Modernization Act in 1997, which helped decrease approval time for new drugs to 11.7 months, a "20-month drop from a decade earlier." And soon, "the FDA will have only a month to explain why it decides to put a company's candidate drug on 'clinical hold,'" changing a system that currently places no time limit on such a decision. But one provision in the 1997 act -- requiring the agency to set up expert panels to referee scientific disputes -- is causing dissension among both the agency and the pharmaceutical industry. The FDA is "loathe to lose control of this chunk of the regulatory process," while the business side says "getting the government out of the review process could speed up approvals without compromising safety."
Not Soon Enough?
Meanwhile, the experience of one medical device manufacturer attempting to get approval for a new hysterectomy surgical tool symbolizes the FDA's slow pace of reform. Although San Diego, CA-based CryoGen Inc. received clearance from the agency in 1997 to market its First Option probe -- a device to "remove fibroids and polyps from the uterus ... without forcing a woman to undergo general anesthesia and full-blown surgery -- it still can't get approval for its request to label the device as usable for endometrial ablations, a virtually identical procedure. An FDA spokesperson said the matter is "still being reviewed by the agency." Observers say the semantic spat -- the FDA is steadfast in its approval of the device for intrauterine ablation only -- could "delay the application for years" (Murphy, 8/30).