SHalasey BBB_1136_crop100x100pFor many companies, the approach of a new year offers an opportunity to take stock of past performance, and to plan for the anticipated business conditions of the coming year. But for clinical laboratories, planning for business in 2015 has become even more difficult than usual as a result of regulatory disputes that seem destined to drag on throughout the coming year—and beyond.

At the center of the dispute is FDA’s proposal to implement a risk-based system of regulatory oversight for laboratory-developed tests (LDTs), as defined in two guidance documents issued on October 3, 2014 (79 FR 59776; 79 FR 59779). During November, associations aligned in favor and against the proposal jockeyed for position with policymakers, hoping to force FDA to alter its course.

On November 18, the American Cancer Society Cancer Action Network, the American Heart Association, and the Ovarian Cancer National Alliance, in cooperation with Rep Louise M. Slaughter (D–NY), held a roundtable discussion in which a panel of doctors, scientists, and academics expressed support for increased FDA oversight over LDTs. “FDA’s recently proposed draft oversight framework will ultimately ensure that diagnostic and genetic tests will yield the safe, effective, and reliable results that patients and their doctors can trust,” said Elliott Antman, MD, AHA president.

Not to be outdone, on the same date opponents of FDA’s proposal sent a letter to FDA Commissioner Margaret Hamburg, MD, requesting that FDA withdraw its guidance and arguing that “the draft guidance documents conflict with existing regulations and would impose substantial new requirements on clinical laboratories, hospitals, physicians, and other healthcare providers without complying with notice-and-comment rulemaking as required under the Administrative Procedures Act.”

Meanwhile, the American Clinical Laboratory Association announced that it had retained prominent litigators Paul D. Clement, a partner with Bancroft PLLC, and Laurence H. Tribe, professor of constitutional law at Harvard University, for representation relating to FDA’s draft guidances. “FDA’s proposal is bad for patients and bad for the healthcare industry,” said Stephen H. Rusckowski, president and CEO of Quest Diagnostics and ACLA chairman. “We are pleased that Laurence Tribe and Paul Clement, two of the nation’s most pre-eminent experts in constitutional law and administrative procedure, will advise ACLA in its opposition to the FDA proposal.”

At the end of November, FDA released details of its much-anticipated public workshop, “Framework for Regulatory Oversight of Laboratory-Developed Tests,” which will be held January 8–9, 2015 on the National Institutes of Health campus in Bethesda, Md. According to the agency’s notice in the Federal Register, the workshop will be structured around six themes, with opportunities for public comment in each of six corresponding sessions:

  1. Components of a test and LDT labeling considerations;
  2. Clinical validity and intended use;
  3. Categories for continued enforcement discretion, including rare diseases;
  4. Notification and adverse event reporting (medical device reports);
  5. Public process for classification and prioritization of tests for enforcement of premarket review requirements; and
  6. Quality System Regulation.

To register for the workshop or its webcast version, visit FDA’s workshops and conferences calendar at www.fda.gov/medicaldevices/newsevents/workshopsconferences/default.htm.

Steve Halasey
Chief Editor, CLP
[email protected]
(626) 219-0199