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Focus on Regulation

U.S. Department of Justice’s Antitrust Division announces criminal penalties from cartel prosecutions

Last week, the U.S. Department of Justice’s Antitrust Division announced that criminal penalties from cartel prosecutions in fiscal year 2014 (ending September 30) reached $1.861 billion. This was, by far, the largest ever annual total for the Division. In addition, the Antitrust Division obtained jail terms for 21 individual defendants, with an average sentence of 26 months, the third-highest average ever. The DOJ’s full press release can be found here:  http://www.justice.gov/atr/public/press_releases/2015/311240.htm

So, what’s ahead for 2015? Recent changes in leadership and organizational structure plus the  influx of new talent should position the  Antitrust Division the for a very active 2015. Having emerged from a significant overhaul spanning several years and including the closing of four field offices, the creation of new criminal sections, changes in leadership at the highest levels, and the lifting of an extended hiring freeze, this leaner remodeled division should be primed to continue its aggressive anti-cartel campaign in 2015.

Here are a few of our expectations:

  • Auto parts prosecutions will continue, but they should wind down;
  • California real estate foreclosure auction prosecutions will show no sign of letting up, and trials are likely;
  • Capacitors investigation likely will lead to charges against major electronics companies;
  • Ocean shipping investigation will continue with additional pleas and/or indictments; and,
  • Generic pharmaceutical industry will continue to hold the Division’s interest.

For a more detailed assessment of what to expect in 2015, please check our article on Law360 available here:  http://www.law360.com/competition/articles/604830 (subscription required)

FDA Issues New Guidance on cGMP for Combination Products

On January 23, 2015, FDA issued its long-awaited guidance document on current good manufacturing practice (cGMP) requirements for combination products. The guidance, entitled Current Good Manufacturing Practice Requirements for Combination Products, comes two years after FDA’s January 22, 2013 final rule established specific combination product cGMP regulations (codified in 21 CFR Part 4).

The guidance provides an overview of FDA’s 2013 final rule and the role of the different agency components with respect to cGMP for combination products. The guidance also offers specific advice on applying certain cGMP requirements for drugs, devices, biological products, and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) to combination products. Perhaps most noteworthy in the guidance is FDA’s advice on cGMP compliance for specific types of combination products—namely, prefilled syringes, drug-coated mesh, and drug-eluting stents. This specific guidance includes hypothetical scenarios for the various product types, primarily focusing on how to streamline cGMP for those products.

Although FDA regulations permit comments to a draft guidance to be submitted at any time, the agency is requesting that interested parties submit comments on the draft guidance within 60 days of publication in the Federal Register, meaning comments will likely need to be submitted by late March 2015. We will continue to monitor future developments in this area, as FDA is likely to rely on this guidance as a tool for inspections and enforcement moving forward. The draft guidance can be found at the following link.

FTC seeks comments on proposed divestiture study

The Federal Trade Commission (FTC) recently announced that it is seeking public comments on a planned study to assess the effectiveness of divestiture remedies in mergers. This review would update and expand a divestiture study published in 1999.

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FTC Seeks Comments on Proposed Divestiture Study

The Federal Trade Commission (FTC) recently announced that it is seeking public comments on a planned study to assess the effectiveness of divestiture remedies in mergers. This review would update and expand a divestiture study published in 1999.

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Taking Another Step Into Modern Healthcare: FDA Proposes Rule to Require Electronic Distribution of Prescribing Information for Human Prescription Drugs

Last month, the Food and Drug Administration (FDA) published a proposed rule, 79 Fed. Reg. 75506, requiring manufacturers to distribute prescribing information (PI) electronically—in lieu of paper copies—to satisfy the regulatory requirement that a prescription drug bear adequate instructions for use on or within the drug’s package. Traditionally, manufacturers have met this requirement by providing a copy of the PI printed on thin paper in small font, and folded in an origami-like fashion so that the PI can fit in the drug carton or be attached to the drug’s packaging.

The proposed rule would require manufacturers to:

  • Submit electronic copies of PIs to be uploaded to FDA’s labeling repository (www.labels.fda.gov), including updated PIs within 2 business days after approval of a labeling change by prior approval supplement and on the same day that a changes being effected supplement is submitted to the agency;
  • Verify that the versions of the PIs posted on FDA’s labeling repository are correct and current, and notify FDA promptly if a PI posted in the labeling repository is not a correct or current version;
  • Maintain a toll-free number on a 24/7 basis that health care practitioners (HCPs) can call to request that a copy of a PI be emailed, faxed, or mailed; and
  • Affix a statement on the immediate container label and outside package of a prescription drug product that directs HCPs to the labeling repository and provides the toll-free number.

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The EMA Publishes New Biosimilars Guideline on Non-Clinical and Clinical Issues

Following its adoption by the Committee for Medicinal Products for Human Use (“CHMP”) on 18 December 2014, the European Medicines Agency (“EMA”) recently published a finalised version of its Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (hereafter “EMA Guideline”). The revised EMA Guideline is expected to come into force in July 2015 and will replace the current guideline which came into effect in June 2006.

The EMA Guideline outlines the following non-clinical and clinical requirements for demonstrating a biosimilar’s comparability with the reference biological medicinal product:

  • design of non-clinical studies;
  • the use of pharmacodynamic markers;
  • clinical study design;
  • choice of appropriate patient population;
  • choice of surrogate and clinical endpoints in efficacy trials;
  • clinical safety (including design of immunogenicity studies);
  • risk management plans;
  • pharmacovigilance; and
  • extrapolation of safety and efficacy data.

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SBA Releases Proposed Rule Implementing Substantial Changes to the Limitations on Subcontracting Restriction

Ogechi C. Achuko, an Associate in Hogan Lovells’ Government Contracts Practice, contributed to this post.

On December 29, 2014, the Small Business Administration (SBA) released a proposed rule implementing the National Defense Authorization Act (NDAA) of 2013, which reforms numerous aspects of the SBA regulations, including the limitations on subcontracting rule, affiliation principles, and the eligibility of small business joint ventures. Continue Reading

Law360′s Government Contracts Group of the Year Award Goes to Hogan Lovells

Law360, New York (January 13, 2015, 6:24 PM ET) — Hogan Lovells’ government contracts practice once again showed its knack for helping clients dominate tough litigation, as it guided Lockheed Martin Corp. through contentious fee litigation with Goodyear Tire & Rubber Co. and successfully maintained a concession contract for the Grand Canyon’s primary resort manager, placing it among Law360’s Government Contracts Groups of the Year.

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EPA Continues to Regulate Disposed Coal Ash as Nonhazardous Waste but Greatly Upgrades Impoundment and Landfill Standards

On 19 December 2014, the EPA placed on its website a controversial new rule on how coal ash is regulated when disposed in wet surface impoundments and dry landfills. The final rule is in direct response to a retaining wall that failed at a coal ash impoundment at the Tennessee Valley Authority Kingston, Tennessee power plant in 2009, and more recently, a coal ash impoundment release at a Duke Energy power plant in North Carolina, both allowing tons of coal ash to run across neighboring property and into waterways.

Read More: EPA Continues to Regulate Disposed Coal Ash as Nonhazardous Waste but Greatly Upgrades Impoundment and Landfill Standards

Congress Agrees on Six-Year Reauthorization of Terrorism Risk Insurance Act (TRIA)

After failing to pass a TRIA reauthorization during the lame duck session last Congress, on January 7, 2015, the House passed H.R. 26, the Terrorism Risk Insurance Program Reauthorization Act of 2015, by a vote of 416-5. Shortly after on January 8, 2015, the Senate passed H.R. 26 by a 93-4 vote. Upon the President’s signature, TRIA will be reauthorized until December 31, 2020.

Link: Congress Agrees on Six-Year Reauthorization of Terrorism Risk Insurance Act (TRIA)