FDA @ Ropes & Gray

News and Events

Quote Life Sciences Partner on Cosmetic Industry Reform BillsInside Health Policy  and FDA WeekFDA Week and Inside Health Policy quoted life sciences partner Paul Rubin (Washington, D.C.) in a Jan. 29 article on a split over cosmetic industry reform bills. (February 1, 2016)

Bloomberg BNA Health Care Daily Report Quotes Life Sciences Partner on FDA Medical Device Postmarket Cybersecurity Guidance - Bloomberg BNA Health Care Daily Report quoted life sciences partner Greg Levine (Washington, D.C.) in a Jan. 21 article on the FDA and Department of Homeland Security encouraging medical device makers to participate in public-private cybersecurity information sharing efforts. (January 27, 2016)

Bloomberg BNA Quotes Life Sciences Partner on 2016 Medical Device Law Trends - Bloomberg BNA Medical Devices Law & Industry Report quoted life sciences partner Gregory Levine (Washington, D.C.) in a column on 2016 medical device law trends. (January 12, 2016)

In Bloomberg BNA Medical Research Law & Policy Report, Litigators Review Corruption Risks Facing Sponsors and Service Providers in the Clinical Trial Industry - Health care partner Mark Barnes (Boston) business & securities litigation partner Nicholas Berg, and government enforcement associate Brendan Hanifin (both of Chicago) co-authored an article published by Bloomberg BNA’s Medical Research Law & Policy Report. (January 8, 2016)

Life Sciences Co-Chair Discusses Drug & Medical Device Good Manufacturing Practices on Food and Drug Law Institute Panel - Ropes & Gray partner Gregory Levine (Washington, D.C.), co-chair of the firm’s life sciences practice, discussed drug and medical device good manufacturing practices at the Food and Drug Law Institute’s Enforcement, Litigation & Compliance conference. (December 9, 2015)

Health Care Partner Features Extensively in Bloomberg BNA’s Medical Research Law & Policy Report - Health care partner Mark Barnes (Boston) is quoted extensively in the Nov. 18 issue of Bloomberg BNA’s Medical Research Law & Policy Report. (November 25, 2015)

Greg Levine Quoted in Institutional Investor Article on Biopharma Companies Facing Drug-Price Reckoning - Life sciences partner Greg Levine (Washington, D.C.) is quoted in an Institutional Investor (subscription required) article examining how biopharmaceutical companies are being forced to justify product value in the face of price gouging allegations in the specialty drug market. (October 9, 2015)

Al Cacozza Featured in Medical Marketing and Media Roundtable Discussion on Drug Promotion - Life sciences partner Al Cacozza (Washington, D.C.) is featured in a roundtable discussion published in the August 2015 edition of Medical Marketing & Media that includes commentary from regulatory affairs professionals, health policy experts and pharmaceutical marketing executives that touches on topics related to the promotion of pharmaceuticals. (August 3, 2015)

Health Care Partner and Associate Co-Author Bloomberg BNA Article on CLIA/HIPAA Privacy Provisions - In an article published by Bloomberg BNA’s Medical Research Law & Policy Report on July 15, health care partner Mark Barnes and health care associate David Peloquin (both of Boston) examine the CLIA/HIPAA conundrum of returning test results to research participants. (July 20, 2015)

Life Sciences Counsel Quoted in FDA Week Explaining Proposed New Model for Regulation of Drug Promotion - Life sciences counsel Alan Bennett and associate Josh Oyster (both of Washington, D.C.) co-authored, along with Johnson & Johnson’s Assistant General Counsel Freddie Jimenez and Janssen Pharmaceuticals Senior Director of Clinical Development Larry Fields, an article proposing a new model for the regulation of drug promotion published by The Journal of Law and the Biosciences on March 20. (July 8, 2015)

Life Sciences Partner Quoted in FDA Week Discussing Draft Proposal for Regulation of Laboratory Developed Tests - Life sciences partner Greg Levine (Washington, D.C.), co-chair of the firm’s life sciences practice, is quoted in an article that analyzes a draft proposal issued by the House Energy & Commerce Committee that would regulate laboratory developed tests and was published by FDA Week on July 2. (July 8, 2015)

Kellie Combs

Recent Developments

FDA Issues Draft Guidance on Postmarket Cybersecurity of Medical Devices - On January 15, 2016, the Food and Drug Administration (“FDA”) released a draft guidance entitled, “Postmarket Management of Cybersecurity in Medical Devices,” outlining recommendations that device manufacturers should implement to manage postmarket cybersecurity vulnerabilities. (January 20, 2016)

Ropes & Gray Advises Pacira Pharmaceuticals in Reaching Landmark Settlement Agreement with FDA - A cross-disciplinary team of Ropes & Gray attorneys advised Pacira Pharmaceuticals on its December 14 settlement agreement with FDA. (December 16, 2015)

HHS Grants 30-Day Extension on Comment Period for Common Rule Revisions - On November 25, 2015, the Department of Health and Human Services (“HHS”) published a Federal Register notice that extends the comment period for the Federal Policy for the Protection of Human Subjects (“Common Rule”) notice of proposed rulemaking (“NPRM”) by 30 days to January 6, 2016. (November 25, 2015)

China FDA Announces Implementation Scheme to Improve the Drug Approval System - Following the reform of the drug and device approval system by China’s State Council in August,1 the China Food and Drug Administration (“CFDA”) has finally unveiled its implementation policies. (November 19, 2015)

DOJ Issues Guidance on Individual Accountability for Corporate Misconduct - On September 9, 2015, U.S. Deputy Attorney General Sally Quillian Yates issued a memorandum outlining to U.S. Department of Justice (“DOJ”) personnel the importance of individual accountability for corporate wrongdoing (the “Yates Memorandum”). (September 11, 2015)

HHS Proposes Major Overhaul of the Common Rule - On September 8, 2015, the Department of Health and Human Services proposed significant revisions to the Federal Policy for the Protection of Human Subjects (“Common Rule”), the set of federal regulations governing the conduct of clinical research involving human subjects. (September 8, 2015)

FDA Issues Draft Guidance and Proposed Rule on the Nonproprietary Naming of Biological Products - On August 28, 2015, FDA issued a draft guidance document and a proposed rule addressing the nonproprietary naming of biological products. (September 8, 2015)

Amarin Court Holds Truthful Off-Label Speech Entitled to First Amendment Protection - On August 7, 2015, the U.S. District Court for the Southern District of New York issued an opinion in Amarin Pharma, Inc. v. FDA, granting Amarin preliminary relief to engage in truthful and non-misleading off-label speech about its triglyceride-lowering drug, Vascepa. (August 12, 2015)

Cures Are On the House: House Passes 21st Century Cures Act, But Senate Awaits - On July 10, 2015, the House of Representative passed H.R. 6, the 21st Century Cures Act (“Cures Act”), with strong bipartisan support, by a vote of 344-77. (July 23, 2015)

Medicare, Medicaid, and Enforcement Implications of the 21st Century Cures Act Recently Passed by the House - On July 10th, the U.S. House of Representatives passed the 21st Century Cures Act – medical innovation reform legislation that has been in the works for over a year – by a wide margin (344-77). (July 23, 2015)