By Turna Ray
MOUNTAIN VIEW, Calif. — Diagnostics industry leaders are hoping that a much-anticipated bill that aims to create a separate regulatory division for so-called "advanced diagnostics" will be introduced in the US Congress some time this year.
"The Coalition for 21st Century Medicine and the Personalized Medicine Coalition … [are] working with Senator Orrin Hatch from Utah" on legislation that calls for a new division at the US Food and Drug Administration called the Center for Advanced Diagnostics Evaluation & Research, said venture capitalist Brook Byers at the Personalized Medicine World Conference here this week.
"It's a beautifully constructed bill that has been carefully put together. We hope it might get introduced this year," added Byers, who is the founder of the life science-focused venture capital firm KPCB.
Last year, PGx Reporter obtained a copy of the bill being drafted by the Republican Senator's office with significant input from the personalized medicine community and the diagnostics industry.
The "Better Evaluation and Treatment Through Essential Regulatory Reform for Patient Care Act," through the creation of CADER, aims to ensure the safety and efficacy of a new category of tests called "advanced personalized diagnostics," comprising both test kits and laboratory-developed tests. Specifically, the bill emphasizes that diagnostics should be regulated distinctly from devices, and thus should be reviewed by a division other than FDA's Center for Devices and Radiological Health (PGx Reporter 06/23/10).
"There's a historical reason that goes back decades as to why diagnostics are under CDRH. And, today, it really doesn't make any sense that it's under the device [center], especially with these advanced tests," Byers said at the meeting.
During another presentation at the conference, Carlos Peña, director of emerging technology programs at the FDA, was asked whether the concept of a separate diagnostic division has gained any traction within the agency. He noted that there has been quite a bit of discussion at FDA regarding coordination between existing centers, but said he's uncertain whether the idea of forming a new division has caught on.
Peña encouraged industry stakeholders to contact FDA staff regarding any concerns and to make recommendations at public meetings.
The draft version of the Hatch bill defined an advanced personalized diagnostic that would fall under CADER's purview as a regulated product "distinct from a device" that provides analysis of DNA, RNA, a chromosome, a protein, or a metabolite and that is used for diagnosing or treating disease.
Sheila Wolcoff, a legal consultant who works with the Coalition for 21st Century Medicine and is familiar with the Hatch bill, told PGx Reporter that the latest draft, while "substantially revised" to account for input from stakeholders, the FDA, and lawmakers, still establishes diagnostics as a "distinct medical product separate from devices."
The latest version of the bill "treats all in vitro diagnostic products as this new class (both LDT and IVD kits) and is technology neutral," Wolcoff said via e-mail. "It establishes a better-suited standard of evidence and standard of review … to more appropriately evaluate the test based on the impact of test information on care."
Wolcoff added that Senator Hatch "has told many stakeholders he is committed to introducing the bill early in the Congress," and that he intends to release a revised bipartisan discussion draft for additional stakeholder input.
"I'm optimistic [about] things like this bill and the awakening about the need for all these discussions," said Byers, who observed that despite the regulatory and reimbursement barriers to personalized medicine, "companies are moving ahead and prospering."
Byers discussed the Hatch bill within the context of an industry trend to educate policymakers about the value that diagnostics add to healthcare. "A lot of us are involved in this," Byers said. "It's going to be a movement, and [it's focused] on calling attention to the value of diagnostics, and things that surround it in its ecosystem."
Mara Aspinall, CEO of personalized cancer diagnostics firm On-Q-ity and former president of Genzyme Genetics, is at the head of this educational effort, according to Byers. Aspinall was also a key advisor in crafting the Hatch bill.
Last year, the genomics industry faced negative coverage from some media outlets that asserted that the promises life sciences leaders made 10 years ago about the downstream medical applications that would come out of the Human Genome Project remain unfulfilled. Personalized medicine advocates at this week's meeting took issue with this sentiment, pointing out that many of those conversations about the unfulfilled promise of the Human Genome Project only looked at how many new therapeutics had been launched and failed to consider how genomic advancements in the diagnostics field have impacted healthcare.
Quoting the oft-cited statistic that diagnostics account for 4 percent of healthcare spending but drive 80 percent of treatment decisions, Byers noted that if stakeholders can show how diagnostics can lower healthcare costs, then the barriers will be easier to lift.
"That means reduce drug [spending], reduce unnecessary surgeries, [fewer] hospitalizations. If you start with that, and work backwards to assembling the tools in order to build whatever product or service that you're offering, then the payors will love it," he noted.
Although there is still quite a bit of uncertainty around regulation and reimbursement, when it comes to molecular diagnostics, "don't let that freeze you," Byers encouraged stakeholders at the meeting. "Progress is being made."
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