FDA's release of draft guidance in a congressional notice officially put down a marker on the agency's plans for a risk-based framework for regulating laboratory-developed tests. Some stakeholders think the proposed oversight could better align regulatory requirements and the needs of payers. It could also give a competitive advantage to companies that have already generated the necessary data on clinical utility.
Others think the draft does little to alleviate the regulatory uncertainty that has dogged the sector for years. These critics note a slew of questions remain to be answered before investors and companies can be confident that the paradigm of laboratory-developed tests (LDTs) - which straddles a blurry line between device manufacturing and clinical practice - can be slotted into FDA's regulatory stable.
Coupled with concerns about how FDA will find sufficient resources for such an undertaking, some stakeholders told BioCentury the guidance could spur Congress to legislate on the regulation of LDTs in PDUFA VI in 2017.
"I think this guidance basically tells you what the ceiling looks like," NEA's Scott Gottlieb said. "It tells you what the most onerous architecture that FDA, if it had its own way, would impose. Then from here we might see Congress dial this back."
On July 31, FDA included anticipated details - and what appears to be a copy of the draft guidance itself - in a letter of notification to Congress on the agency's intent to release draft guidance on LDTs.
On a conference call, Jeffrey Shuren, director of the Center for Devices and Radiological Health, said the agency has exercised enforcement discretion, meaning the agency has chosen not to enforce premarket review and other requirements for labs developing LDTs since it was granted authority to regulate all in vitro diagnostics (IVDs) as devices in 1976.
According to Shuren, this was because "LDTs were relatively simple tests that tended to be low risk, often for rare diseases, and typically were used by a laboratory in a healthcare facility responsible for the care of a patient and intended to meet the needs of the local patient population."
LDTs have been regulated by the Centers for Medicare & Medicaid Services (CMS) since 1988 under the Clinical Laboratory Improvement Amendments (CLIA), which governs the accreditation, inspection and