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|OIG Advisory Opinion Approves Drug Discount Program|
Tara Swenson Dwyer; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
July 22, 2016, previously published on July 5, 2016Last week, the OIG posted favorable advisory opinion (16-07) regarding a proposed discount program for Part D beneficiaries who are prescribed a statutorily excluded erectile dysfunction drug. The OIG concluded that while the proposed discount program could potentially generate prohibited...
|FDA Solidifies Its Position on Certain Compounding Issues in New Guidance Documents|
Duane Morris LLP;
July 22, 2016, previously published on June 20, 2016On June 9, 2016, the U.S. Food and Drug Administration (“FDA”) published two final guidance documents on drug compounding under Sections 503A and 503B of the Food, Drug, and Cosmetic Act (“FDCA”). These guidance documents cover two topics:
|Congress Proposes Legislative “Fixes” to Drug Industry Rules Believed to Be Contributing to High Costs|
Eli Greenspan, Joanne S. Hawana; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
July 21, 2016, previously published on June 30, 2016We spend a lot of time covering prescription drug costs on this blog, and even convened a Pharmacy Industry Summit earlier this year focusing on the various pressures that are contributing to higher drug prices. Although Congress has not been sitting on the sidelines of the drug pricing debate -...
|Texas Medical Board Seeks State Action Immunity Protection in Fifth Circuit Brief|
Helen J. Kim, Dionne C. Lomax, Carrie A. Roll; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
July 21, 2016, previously published on June 30, 2016On June 17, the Texas Medical Board (“Board”) filed a brief with the Fifth Circuit Court of Appeals reiterating that the Board’s rulemaking processes are protected under the state action immunity doctrine, noting that the case could significantly impair state agencies in carrying...
|FTC Suffers Another Hospital Merger Loss in Advocate-NorthShore|
Dionne C. Lomax; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
July 20, 2016, previously published on June 15, 2016On Tuesday, June 14, 2016, the U.S. District Court for the Northern District of Illinois declined to temporarily block the proposed merger of Advocate Health Care Network and NorthShore University HealthSystem in the Chicago area, handing the FTC its second hospital merger loss this year. The FTC...
|Parts Supplier Settles Price-Fixing Claims for more than $250M|
Sutherland Asbill Brennan LLP;
July 19, 2016, previously published on July 15, 2016Auto parts supplier Denso Corp. has agreed to pay more than $250 million to settle price-fixing claims in a multi-district litigation. According to settlement documents filed in the District Court for the Eastern District of Michigan, Denso will pay approximately $193.8 million to car buyers and...
|The Last Set of Major FSMA Regulations Are Done!|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
July 15, 2016, previously published on June 17, 2016The last of FDA’s seven “foundational” rules mandated under the Food Safety Modernization Act of 2011 (FSMA) was published at the end of last month, just a few days before the May 31, 2016 deadline agreed to by the Agency when it settled a lawsuit related to its implementation of...
|Harmonized Discretionary Relief for New Trading Rules|
Mark S. Powell; Bennett Jones LLP;
July 12, 2016, previously published on June 19, 2016On June 17, 2016, pursuant to Multilateral CSA Staff Notice 96-301 (the "Notice"), the securities regulators of each Alberta, New Brunswick, Nova Scotia and Saskatchewan (the "Announcing Jurisdictions") announced that they were providing harmonized discretionary relief with...
|Authorities Increasing Scrutiny of Employee Noncompete Agreements|
Kathryn M. (Kathy) Fenton, Margaret A. (Peggy) Ward; Jones Day;
July 10, 2016, previously published on June 2016U.S. authorities are increasingly scrutinizing noncompete provisions made part of employment agreements, with close focus on provisions restricting junior-level and low-wage employees. Common in technology firms, which frequently deal with proprietary information, noncompetes are becoming more...
|Summary of FSMA Intentional Adulteration Final Rule|
Melvin S. Drozen, Alissa D. Jijon, Leslie T. Krasny, Evangelia C. Pelonis; Keller and Heckman LLP;
July 7, 2016, previously published on May 31, 2016We have reviewed and analyzed FDA's recently-issued final rule to implement the intentional adulteration provisions of the FDA Food Safety Modernization Act (FSMA). The final rule was published in the Federal Register on May 27, 2016. See Mitigation Strategies to Protect Food Against Intentional...