FDA Reopens Comment Period to Address Oversight of Laboratory-Developed Tests

Global Life Sciences: US - FDA Update

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Last week the U.S. Food and Drug Administration (FDA or the Agency) announced that it would reopen the comment period until September 15, 2010 to provide additional time for stakeholders to submit comments—and to update already-submitted comments—regarding the Agency’s oversight of laboratory developed tests (LDTs) (75 FR 5120).

FDA first requested comments in a June 17 Federal Register notice (75 FR 34463). In that notice, FDA also announced that it was revisiting its longstanding policy of “enforcement discretion” for LDTs, and stated that it would hold a meeting on July 19 - 20 to discuss issues and stakeholder concerns surrounding LDT oversight.

At the July 19-20 meeting, FDA again signaled its intention to reverse its longstanding enforcement discretion policy, but provided little detail regarding how the agency plans to regulate LDTs or its timeframe for implementing its new policy. Notably, Center for Devices and Radiological Health Director, Jeffrey Shuren, stated that the Agency was not required to engage in rulemaking in order to implement new requirements for LDTs, but could instead proceed through the issuance of guidance.

On July 19 FDA sent untitled letters to more than a dozen genetic testing companies alleging that their tests were medical devices within the meaning of the Federal Food, Drug, and Cosmetic Act.

FDA’s plan to end enforcement discretion for LDTs could have a significant impact on the business models of pharmaceutical and diagnostic companies as well as clinical laboratories. Sidley’s Global Life Science practice will be following the issue closely keep its clients and contacts updated.

If you have any questions regarding this update, please contact Gail Javitt (+1.202.736.8980, gjavitt@sidley.com) or the Sidley lawyer with whom you usually work.

The Food, Drug and Medical Device Compliance and Enforcement Practice of Sidley Austin LLP

Sidley Austin LLP has an internationally recognized food and drug practice, representing major pharmaceutical, biological, medical device and food clients on matters relating to the development, manufacture and marketing of products regulated by the Food and Drug Administration (FDA) and other related government authorities.

The Global Life Sciences Practice of Sidley Austin LLP

On three continents, Sidley’s Global Life Sciences Practice team offers coordinated cross-border and national advice on Food, Drug and Medical Device laws, Healthcare, Intellectual Property, Products Liability, International Trade and Arbitration, FCPA Enforcement, Environmental/Nanotechnology, Antitrust/Competition, Corporate M&A, Licensing and Joint Ventures. Globally rated as one of the top life sciences practices, our team includes former government officials, medical doctors, and leaders in various life sciences fields.

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