Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Personalized Medicine Meeting – Discussion on FDA Regulation with Outgoing FDA Commissioner, Pharma and Investors

Reporter: Aviva Lev-Ari, PhD, RN

The agency has long felt that the current oversight provided by the Centers for Medicare & Medicaid Services under CLIA has critical gaps and is putting patients at risk. However, for more than two decades, the lab industry has aggressively fought against FDA regulation by threatening legal action and lobbying Congress. Despite industry objections, the FDA two years ago pushed ahead a draft guidance outlining a risk-based oversight plan for LDTs. However, following the November elections, the agency said it would hold off on finalizing those plans in order to consider input from other groups and await further input from the new administration.

Then, a week before Donald Trump was sworn into office, the agency released a discussion paper outlining a revised regulatory framework for LDTs based on more than 300 comments to its draft guidance, a public workshop, and meetings with stakeholders. The paper allowed the agency, without issuing enforceable regulations, to publicly respond to the lab industry’s concerns about burdensome requirements, demonstrate that it had listened to critics of the draft plan, and lay out the rationale, once again, for why FDA needed to step in to look at aspects of test development that CMS doesn’t.

“I think the community better take this really seriously,” Califf said discussing LDT regulation at the PMWC. While on the one hand regulation shouldn’t stifle innovation, he noted that doctors can’t be left to figure out which test they should order. “We’ve got to come up with some middle ground, so regardless of where you are in the US you can get a reproducible laboratory result,” he said, especially when patients’ treatment decisions depend on those results. “I think that’s upcoming work for this year,” Califf added.

Some industry observers have noted that in a crowded immunotherapy market, the availability of multiple PD-L1 tests, the availabilty of FDA approved kits and unapproved LDTs that seemingly gauge the same analyte, and the companion versus complementary diagnostic categories, are actually confusing physicians. This has led to some to suggest that drugmakers work with regulators to advance one test.

Additional Sources

• New Complementary Dx Category Provides Regulatory Flexibility, but Poses Real WorldChallenges

GenomeWeb , 2016

• At CDx Harmonization Meeting, Drugmakers Take First Step Toward Exploring Test Differences

GenomeWeb , 2015

• In Approving Opdivo With Dakos Complementary Test, FDA Advances Rx Personalization Option

GenomeWeb , 2015

• In 2016, Personalized Medicine Saw More CDx Deals, Flexible FDA, No LDT Guidance

GenomeWeb , 2017

• Agilents Dako Lands FDA Approval for Lung Cancer Complementary Dx

GenomeWeb , 2015

• In 2015, Precision Medicine Options Grew; FDA, Labs Still at Odds; Payment Remained Mostly Elusive

GenomeWeb , 2015

Outgoing FDA Commissioner, Pharma, Investors Discuss Regulation at Personalized Medicine Meeting

Jan 24, 2017 | Turna Ray

SOURCE

https://www.genomeweb.com/molecular-diagnostics/outgoing-fda-commissioner-pharma-investors-discuss-regulation-personalized?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Daily%20News:%20NSF,%20USDA%20Award%20Microbiome%20Research%20Grants%20-%2001/24/2017%2004:15:00%20PM