FDA slammed for slow action on digital mammo approval

April 6, 2010
Rebekah Moan

Angry mammographers and vendors gave the FDA a tongue-lashing at a hearing, arguing restrictive policies are jeopardizing patients and keeping U.S. screening mammography behind what’s available in Europe.

The comments came at a Center for Devices and Radiological Health Medical Devices Advisory Committee meeting held in November to consider reclassifying full-field digital mammography (FFDM) from class III to class II, which would allow vendors to bypass the premarket approval process and would open the market to more of them.

Of the 20 million women screened for breast cancer in the past five years, approximately 20,000 had breast cancer, and radiologists could have found those tumors earlier but for the FDA’s lack of action, said Morgan Nields, chair of Bioptics.

“Some of these women will die. What happened at FDA?” he said.

Many of the speakers at the meeting said there is already enough clinical evidence to support reclassification of FFDM. Dr. Etta Pisano, principal investigator of the American College of Radiology Imaging Network’s Digital Mammography Imaging Screening Trial (DMIST), said the study clearly showed digital is better than screen-film.

The time for skepticism on whether digital is better than film has passed, the University of North Carolina professor said.

In fact, DMIST was designed to provide enough definitive data to reclassify FFDM from class III to class II. It would be unethical to carry out any further studies on whether digital is better than film, Pisano said.

“Why should any wo-man be double-exposed to film and digital to justify FDA approval?” she said. “That study’s been done already, 50,000 times. It was called DMIST.”

Limiting the entrance of more FFDM devices into the market forces people who own radiology departments to triage their patients into screen-film mammography, said Dr. Margarita Zuley, an associate professor and director of breast imaging at the University of Pittsburgh.

“It causes access barriers to underserved patients, where people cannot afford to buy high-cost digital equipment. And it’s increasing the average glandular dose for mammography because digital mammography is providing a lower dose to our patients than screen-film,” she said.

Stalling on reclassification also limits vendors’ ability to produce better processing algorithms, such as differentiations between fatty and dense breasts, she said.

“It is limiting our ability in breast imaging to improve detection beyond the current standards,” Zuley said.

There are only four companies selling FFDM in the U.S. There are 12 in the European Union. If the FDA reclassified FFDM, then Kodak, Agfa, Konica, Giotto USA, and Carestream would all likely enter the market.

In 2006 the FDA drafted a guideline on what it takes for a company to meet the agency’s criteria to manufacture an FFDM device without premarket approval. Drafting of the document, which the FDA calls a guidance, was followed by a public comment period and then a panel meeting. Three years later, the FDA is still debating what should be in the class II guidance.

“I’m beginning to wonder if I will live long enough to finally sell digital mammography in the U.S.,” said Robert Rusk, of Giotto USA. “Why can’t the guidance be finished quickly?”

An FDA official admits the process to reclassify FFDM has taken longer than the agency had hoped. But they want to make sure they promote and protect the public’s health, he said.

“There was some frustration at the meeting, that was clear,” said Dr. Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA. “But the devil is really in the details.”

The agency is still figuring out the level of evidence and the clinical requirements necessary to reclassify FFDM, he said.

As the agency down-classifies, it has to decide how high to set the bar so that devices can come into the market but with enough protections to ensure they’re safe and effective, Gutierrez said.

“The process has been slower than even the agency wishes it was,” he said. “It’s just part of the way our government works. I don’t think it’s a matter of the agency not understanding what it needs, [but] when you have difficult issues, it takes a while to resolve them.”

The FDA hopes after airing the issues at the last public meeting, the agency can move forward and get the guidance out quickly, Gutierrez said.