Bradley Merrill Thompson and James A. Boiani Mentioned in “Breaking Down the Regulation of LDTs: Moving Forward”Medical Design Technology August 4, 2014
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC office, and James A. Boiani, a Senior Counsel in the Health Care and Life Sciences practice, in the Washington, DC office, were mentioned in an article titled "Breaking Down the Regulation of LDTs: Moving Forward."
Following is an excerpt:
During the past few weeks, I've been reporting on a letter that Bradley M. Thompson, JD, and James A. Boiani, JD, attorneys at Epstein Becker Green (Washington, DC), recently sent to FDA Commissioner Margaret Hamburg. The attorneys sent this letter on behalf of the Combination Products Coalition, an association of drug, biologic, medical device, and IVD manufacturers dedicated to working with FDA to improve the regulation of combination products. In the letter, they discussed the regulation of laboratory-developed tests (LDT) and made the argument for creating a single regulatory framework for IVDs and LDTs. This week's blog presents further information from this letter.
According to the letter, although FDA has considerable discretion in how it administers the Food, Drug, and Cosmetic Act (FDCA), its discretion is not unlimited. Under the Administrative Procedure Act (APA), the agency must treat similarly situated parties and products in the same way. The current dual system of regulation for IVDs and LDTs violates this legal requirement. Non-lab companies that manufacture IVDs and labs that manufacture LDTs are both manufacturers for purposes of the APA. Both labs and non-labs offer products with similar technologies and similar uses that can help or harm patients. All IVDs, including LDTs, are run in CLIA-regulated clinical laboratories. However, laboratories and their LDTs go unregulated by FDA, while IVD manufacturers are required to comply with extensive and costly FDA standards.