Roche’s proposed draft guidance to the US Food and Drug Administration (see above), co-signed by IVD colleagues BD and Gen-Probe, is the latest cobble in a path that might eventually lead to additional regulations guiding the development and sale of microarray-based diagnostics.
But will it have impact on Roche’s new AmpliChip product?
The draft guidance by the three companies suggests a novel diagnostic category that may in turn absorb existing guidelines governing the regulation of analyte-specific reagents — regulations that the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety is currently rewriting.
Yet for Roche Diagnostics — not to mention others angling to stake claims in the competitive ASR space — the suggested draft might free the AmpliChip, or future similar diagnostics, from regulatory scrutiny, even though the suggested draft draws no link between the AmpliChip and IVATs, according to interviews with industry insiders. Indeed, the draft in its current form, is adopted in toto by the FDA, may benefit Roche more than BD or Gen-Probe as the Swiss giant prepares to meet with OIVD director Steven Gutman to determine whether its AmpliChip can be marketed as an ASR.
Could the suggested guidance affect the way the AmpliChip product is marketed? Ron Eisenwinter, an IVD specialist for Boston Healthcare-Expertech, a Boston-based life-sciences consultancy, said: “It may. They do go over [in the draft] that type of system that detects the presence of a genetic marker.”
On the surface, the draft guiideance can be viewed in the context of the recent events illustrating the molecular-diagnostic industry’s regulatory nascence.
“This is sometimes what happens,” said Greg Glover, an attorney with the Washington, DC-based law firm Ropes & Gray, which focuses on FDA-regulatory issues for big biopharma. According to Glover, it is not uncommon for drug or diagnostic companies, facing FDA scrutiny for a product launched without FDA approval, to say: “‘Well, [the existing regulation] was all ambiguous [so] we went on the market, and when FDA banged us, we were good citizens. We went in and talked with them, and we asked them not to take us off the market until we get all our information together.”
This is not unheard of. In early 1995, Genzyme began selling a novel orthopedic therapeutic called Carticel. Genzyme brought the product to market without undergoing FDA approval.
“The FDA finds out about [Carticel] in the newspaper and says, ‘Hmmm. Why did you guys really think you could do this?’” said Glover, who did not read the suggested guidance. “Then, Genzyme follows with meetings with the FDA where they then propose the regulatory scheme for this.”
During the following year, Genzyme and the FDA went on to co-develop a set of regulations that more closely defined the company’s orthopedic product. That policy became the agency’s framework for regulating cellular and tissue-based products and Carticel was the first product of its kind to be approved under the new regulation.
“My guess is [Roche Diagnostics] took the business risk going out without a regulatory approval to see what would happen, knowing that, generally speaking, FDA doesn’t yank you off the market unless you’ve done something really, really bad,” said Glover.
Of course, the draft guidance might suggest a larger strategy by Roche Diagnostics ahead of the AmpliChip launch — enlisting BD and Gen-Probe to compose the draft as an insurance policy against an unfavorable FDA communiqué. “Roche may very well have had this [guidance] before they went to market,” Glover said.
A close look at the sequence of events shows that the suggested guidance, stamped June 17, was submitted well before the FDA’s letter to Roche questioning the ASR status of the AmpliChip — July 8 — and even before the AmpliChip itself was launched — June 25.
“Now, is FDA likely to buy this? I don’t know,” said Glover. Roche “would have to make a good case for how this is going to be relatively segregated ... in the marketplace, how it could not be used, and why it makes sense to do it this way.
“I’m not sure they’re really going to win [and create] a new regulatory category. Most of the device regulatory structure is done by statute,” he went on. I’m not sure how much discretion FDA has.”