Media Mentions
2011
“Asymmetry in the Ability to Communicate CER Findings”
States News Service, October 31, 2011
Paul Radensky was quoted by the National Pharmaceutical Council as saying that, while there are a number of health databases available, not all health care stakeholders have access to the information – even if it helps with patient care management. Dr. Radensky suggested that, with proper regulation, broader access to public databases could facilitate more informed decisions on health treatment.
Paul W. Radensky M.D., Health, Life Sciences & Medical Products Litigation, Life Sciences - Health
“Can the FDA Be a Catalyst for Innovation?”
Genetic Engineering & Biotechnology News, October 15, 2011
Paul Radensky called the development of therapeutic diagnostics “an area of great interest and concern” for the direction of FDA regulation, particularly for regulating in vitro diagnostics as medical devices. He cited as a challenge “the accuracy, reliability, and reproducibility of the test with respect to the information furnished by the test.”
Paul W. Radensky M.D., Health, Life Sciences & Medical Products Litigation, Life Sciences - Health
“In Information-Gathering Mode, CMS Undecided on Payment Structure for Genetic Tests”
Genome Web, July 19, 2011
Paul Radensky, assessing efforts by the Centers for Medicare & Medicaid Services (CMS) to determine payment policies for molecular diagnostics, said that new payment strategies beyond the existing physician fee schedules (PFS) are needed to capture the value of these tests for patient care. “Trying to convince everyone at CMS that everything has to fall under the PFS or that nothing should fall under the PFS would make no sense,” Mr. Radensky stated.
“Latest Draft of Hatch IVD Bill Contains New Regulatory Proposals”
GenomeWeb, July 6, 2011
Paul Radensky and Eric Zimmerman spoke about representing an industry coalition to clarify reimbursement reforms and incentives for innovative non-device diagnostic tests. “We’ve been looking at options to have a more predictable system in place to assign different payment rates and codes … so the payor actually knows what it is they’re paying for,” Mr. Radensky stated. Mr. Zimmerman added that “the current [reimbursement] system is not working well and that it does not appropriately incentivize the development of these tests.”
Paul W. Radensky M.D., Eric Zimmerman, Health
2010
Paul Radensky and T. Reed Stephens were interviewed on April 16 by BNA’s Daily Health Care Report concerning the impact of the health reform law on the life sciences industry. Mr. Radensky discussed the greater opportunities for drug and medical device makers through the bill’s national long-term care insurance program and its mandated coverage for routine care in clinical trials. However, he also cited cost pressures that the industry will face both from health care providers and from an independent advisory board that will set Medicare reimbursement rates. Mr. Stephens noted that fees and taxes in the bill also will have a negative impact on life sciences companies. He singled out as examples the pharmacy benefit manager provision on the pricing of generic drugs, the required annual fee on dispensing brand-name drugs, and the new tax on medical device manufacturers.
Paul W. Radensky M.D., T. Reed Stephens, Health, Life Sciences & Medical Products, Life Sciences - Health
2008
Robert Nicholas and Paul Radensky’s article "FDA and Drug Advertising: No Attention Deficit On Nooed For 'Substantial Evidence'" appeared in the November 7 issue of the Washington Legal Foundations' Legal Backgrounder.
Paul W. Radensky M.D., Health, Life Sciences & Medical Products, Life Sciences - Health
McDermott Will & Emery's White Paper entitled "FDA Challenges Implied Outcomes Claims for Several ADHD Products: An Analysis" was featured in the Guest Column on October 3 in Health Law360.
Paul W. Radensky M.D., Health, Life Sciences & Medical Products, Life Sciences - Health
McDermott was mentioned in the October 2 issue of FDA's Webview in an article regarding the Firm's On the Subject discussing the letters issued by the U.S. Food and Drug Administration's (FDA) Division of Drug Marketing, Advertising, and Communications alleging that promotional material for certain products intended for use in treating attention deficit hyperactivity disorder (ADHD) made implied claims about an effect on ADHD "outcomes" that were not supported by "substantial evidence." FDA Webview notes, "Attorneys at McDermott...say FDA's Warning Letters and notices of violation to several manufacturers of ADHD drugs mean that drug companies wanting to avoid a challenge from CDER's Division of Drug Marketing, Advertising, and Communications (DDMAC) should review ad and promotional materials in all therapeutic categories to determine whether they make implied outcomes claims of the kind alleged by DDMAC in the ADHD letters."
Paul W. Radensky M.D., Conflicts of Interest - Health, Health, Life Sciences & Medical Products, Life Sciences - Health
McDermott Will & Emery was mentioned in the July 2008 issue of DTC Insights – DTC Forecast in an article summarizing McDermott's recent White Paper on Merck settling the Vioxx Litigation with State Attorneys General.
Paul W. Radensky M.D., T. Reed Stephens, Health, Health Care Litigation, Life Sciences - Health
Jennifer Geetter, Robert Nicholas and Paul Radensky had their On the Subject published in the May 30 edition of Health Law 360 regarding the FDA Draft Guidance on certification of compliance with the new FDAAA clinical trial registration and posting regime.
Jennifer S. Geetter, Paul W. Radensky M.D., Health, Life Sciences - Health
Robert Nicholas, Paul Radensky and T. Reed Stephens were mentioned in a May 29 article in FDA Webview regarding the recent White Paper they had authored regarding Merck’s $58 million settlement of consumer fraud claims by state attorneys general.
Paul W. Radensky M.D., T. Reed Stephens, Health, Life Sciences - Health
2007
Paul W. Radensky was quoted in the December 2007 issue of Biotechnology Healthcare in an article regarding IVDMIA guidance. "Assays are not defined in the Food, Drug and Cosmetic Act or any other regulation. In effect, the guidance is being promulgated as if it were a rule, even though guidances are not supposed to be binding. The Health and Human Services secretary has reportedly stated that the FDA would not enforce the IVDMIA guidance before any policy," Mr. Radensky said.
Paul Radensky was quoted in the July 2007 issue of Clinical Lab Products Magazine in an article regarding the new FDA draft guidance regarding in vitro diagnostic multivariate index assays (IVDMIAs). "I think you get universal agreement, including the FDA, that what was put in the September draft guidance was not clear,"Mr. Radensky said.
Paul W. Radensky M.D., Health, Life Sciences - Health
Paul Radensky was quoted in the March 9 issue of the Silicon Valley/San Jose Business Journal in an article regarding the draft regulations from the FDA on genetic testing laboratories. "This is a major, substantive change in the rules and it should go through regular rule-making procedures. There are a number of provisions, when you have rule-making, in which the FDA has to explain the impact on small businesses. These are important protections that you don’t have from a draft guidance," Mr. Radensky said.
Paul Radensky was quoted in the February 14 issue of Pharmacogenomics Reporter in an article regarding the U.S. Food and Drug Administration's proposition to regulate a subset or complex laboratory-developed genetic tests. "The draft guidance raises ‘concerns over FDA's legal authority to regulate clinical laboratories,' is unclear over the definition of in vitro diagnostic multivariate index assays, and does not clearly identify the elements of an IVDMIA that comprise a medical device subject to FDA regulation versus those regulated under CLIA," Mr. Radensky said.
Paul Radensky was quoted in the February 12 issue of The Gray Sheet in an article regarding laboratory stakeholders urging the FDA to ditch in vitro diagnostic multivariate index assays. "It's not all clear what an IVDMIA is. It begs the question to simply says, 'It's different,'" said Mr. Radensky.
Paul Radensky was quoted in the February 12 issue of Medical Device Week in an article regarding published guidance for in vitro diagnostic multivariate index assays (IVDMIAs or MIAs). "Guidance has raised a large number of issues, including FDA's authority to regulate these assays. Other issues include how the quality system regulations (QSRs) mesh with the Clinical Laboratory Improvement Amendments (CLIA) standards, which are overseen by the CMS," Mr. Radensky said.
2004
Global Counsel 3000 (Practical Law), a law-related resource site, recently recommended MWE's Miami office as a top firm for Company and Corporate Transactions, where the office is a leader in health care transactions. In addition, Paul Radensky was recommended nationally for his work in the Life Sciences/Regulatory area.
Paul W. Radensky M.D., Corporate, Life Sciences & Medical Products
