Originally Published IVD Technology May 2005
INDUSTRY NEWS
IVD industry mulls an FDA
under Crawford
Matt Grebow
 |
| Lester M. Crawford |
The year-long vacancy at the helm of FDA came one step closer to being filled in March when acting commissioner Lester M. Crawford, DVM, PhD, following his nomination by President George W. Bush, appeared before the Senate Health, Education, Labor, and Pensions Committee to make his case for the position. “My vision for the future of FDA is one of transformation,” he said, referring to the enormous technological advances that have been generated and embraced by the scientific community.
Crawford’s nomination comes at a time when FDA is struggling to address industry concerns about expediting product approvals while also reassuring the public that the agency’s drug and medical device approvals are safe. During his nomination hearing, Crawford reaffirmed his commitment to postmarket safety of FDA-regulated products. He also said that he would go ahead with plans to create a drug-safety oversight board, although he did not rule out making the Office of Drug Safety a separate entity. What was less clear was how expectations of FDA reform in the wake of scandals surrounding COX-2 drugs will spill over to IVDs, and to what extent Crawford’s own concerns about the current approval process will affect IVD manufacturers.
“I think that the single most important issue in IVDs for a new commissioner is coming up with appropriate regulation,” says Jeff Gibbs, a director at Hyman, Phelps & McNamara, a Washington, DC–based law firm. Gibbs points out that many companies today are seeking to introduce IVDs by different means. As technology continues to advance, he says, FDA will need to decide appropriate ways to classify these new products. “I think FDA has been slow to respond, but that is in part due to the extraordinary rapidity of change in industry. For example, when the ASR regulation was adopted just eight years ago, nobody foresaw the kinds of technological and biochemical changes that would take place. Regulatory practice, by its nature, cannot move as quickly as science and technology. I think that pattern is exacerbated for IVDs for a variety of reasons.”
Crawford is no stranger to the demands of and expectations for the agency, having served as deputy commissioner from 2002 to 2004 and as director of FDA’s Center for Veterinary Medicine from 1982 to 1985, as well as holding other FDA positions. Still, many in the IVD industry are unsure what his current stint as acting FDA chief might say about his actions if confirmed.
The Senate committee was scheduled to decide on April 13 whether to approve Crawford’s nomination, but the vote was postponed after some Senators questioned his support to delay decision on the approval of nonprescription sales of the Plan B contraceptive. As this issue went to print, a new election date had not been set. FDA and Crawford said they would decline requests to comment during the confirmation process.
Copyright ©2005 IVD Technology
