Life Sciences Legal Update

Analysis & commentary by Reed Smith on trends & developments in life sciences & health care law

Blog Authors

Latest from Life Sciences Legal Update

Just prior to departing the FDA (U.S. Food and Drug Administration) Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram issued a statement (the “Statement”) on the Agency’s 2019 goals to improve the quality of compounded drugs. While the change of leadership at the Agency may affect how these efforts will be managed and implemented, the Statement provides helpful insight into the timing of Agency action in the compounding space, including: Maintaining Quality and Compliance…
The Supreme Court of the United States heard oral argument on March 27, 2019 concerning a case (Kisor v. Wilkie, No. 18-15) involving the Department of Veteran Affairs (VA). The case asks the Supreme Court to consider overruling the current doctrine which allows an agency to interpret its own regulation unless it is clearly incorrect. A merits brief has been filed by the Solicitor General of the United States (SG) in Kisor on behalf of…
The Advanced Medical Technology Association (AdvaMed) – the national industry association of medical technology manufacturers – recently issued an updated Code of Ethics on Interactions with Health Care Professionals (HCPs) (the AdvaMed Code or Code). Last revised in 2009, AdvaMed’s updated Code will go into effect January 1, 2020. The Code speaks to the evolving regulatory risk landscape in relation to manufacturers’ interactions with the modern medical technology marketplace. A select committee of AdvaMed members,…
In-house counsel at pharmaceutical, medical device, and health companies are invited to join their peers and leading Reed Smith life sciences lawyers for a roundtable discussion on how to identify and mitigate risk. The event will be held on 5 March in Reed Smith’s London office. A networking breakfast will be provided at 8:30 a.m., with the program itself starting at 9 a.m. and ending at 11:30 a.m. Panels will cover “The Intersection of…
In accordance with the United States Food & Drug Administration’s (“FDA”) 2018 Compounding Policy Priorities Plan, on December 11, 2018, FDA published its revised draft guidance regarding human drug compounding by outsourcing facilities entitled, “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry,” (the Revised Draft Guidance). FDA released this Revised Draft Guidance to describe FDA’s current thinking on what FDA has described as…
Reed Smith’s Life Sciences Health Industry Group will be hosting an upcoming CLE webinar, “The Good, the Bad and the Ugly: The Best and Worst Drug/Medical Device Decisions of 2018” on Wednesday, January 16, 2019 at 12 p.m. ET. Each year since 2007, Reed Smith’s Drug and Device Law blog contributors have compiled and posted lists of the 10 best and 10 worst drug and medical device court decisions for that year. Starting…
On November 26, 2018, the Food & Drug Administration (FDA) announced its intent “to modernize the FDA’s 510(k) clearance pathway”1 by encouraging manufacturers to rely on newer (that is, 10 years old or less) medical devices as predicate devices in 510(k) notifications, and providing an alternative 510(k) pathway that allows manufacturers to rely on objective safety and performance criteria, at least for certain well-known devices. This revised approach comes at a time when advances in…
The Office of the Inspector General (OIG) published a report in September 2018 after a review of the Food and Drug Administration’s (FDA) policies, procedures, and guidance relating to cybersecurity reviews of networked medical1 devices. In its findings, covered in our recent client alert, the OIG determined that while the FDA has started to include cybersecurity concerns in its review process, the FDA should take steps to ensure their cybersecurity review is systematic and…
The Office of Inspector General (OIG) recently gave the green-light on a medical device manufacturer’s proposed warranty program, wherein the company would provide a refund to the hospital at which a patient underwent joint replacement surgery using the company’s knee or hip implant and related products, if the patient was readmitted within 90 days because of a surgical site infection or need for implant replacement surgery. Advisory Opinion No. 18-10 concluded that although the suggested…
The Office of Inspector General (OIG) of the Department of Health Human Services (HHS) is seeking input on Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP. The OIG describes this request for information (RFI) as part of HHS’s endeavor “to transform the health care system into one that better pays for value.” The RFI looks to identify ways to amend or add…