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FDA Life

News and Trends Impacting the FDA and Life Science Industry

FDA Revisits Nutty Definition of “Healthy” Food

Posted in FDA Organization, Foods, Regulation, Uncategorized

Food and BeverageOn May 10, the Food and Drug Administration announced it will be reevaluating how it defines “healthy” food. The move constitutes a reversal of an FDA warning letter issued in March 2015 to Kind, LLC (“Kind”), accusing the snack bar company of misbranding its KIND products as “healthy,” and falsely labeling some of its fruit and nut snacks as low-fat or rich in antioxidants. Continue Reading

McGuireWoods’ Brian Malkin to Conduct Off-Label Promotion Discussion at FDLI’s Annual Meeting on May 5 in Washington, D.C.

Posted in Advertising and Promotion, Meetings

FDLILogoOn May 5, 2016, McGuireWoods LLP’s Brian Malkin will conduct an exclusive discussion at the Food and Drug Law Institute’s (FDLI’s) Annual Meeting in Washington, D.C.  New this year to the Annual Meeting, FDLI will conduct a variety of lunch table discussions from 12:30-1:30 p.m.  Malkin will host a table called “Amarin” to discuss off-label communications in view of the recent cases Caronia, Amarin, Pacira and more.  Following the Amarin decision, Malkin moderated a FDLI Webinar, “Amarin and the Future of Off-Label Promotion“.  Malkin has followed the issue for not only drug products, but also for medical devices, where he later spoke on “Off-Label Promotion in the Wake of the Amarin Decision” at McGuireWoods LLP’s own 7th Annual Medical Device and Life Sciences Conference. Continue Reading

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Advertising Claims for Over-the-Counter, Cosmetic, and Dietary Supplements in NYC on May 26, 2016

Posted in Advertising and Promotion, Cosmetics, Dietary/Nutritional Supplements, Drugs, Meetings

New York CityOn May 26, 2016, the Cosmetic Law Committee and Food Law Committee of the Food, Drug and Cosmetic Law Section of the New York State Bar Association will present an expert panel of private practitioners, in-house counsel, and staff attorneys of the ASRC National Advertising Division (NAD) program administered by the Council of Better Business Bureaus to discuss the NAD’s self-regulatory program for challenging deceptive and unsubstantiated advertising claims, and analyze recent and noteworthy NAD challenges and decisions regarding advertising claims for over-the-counter (OTC) drugs, cosmetics, and dietary supplement products. Continue Reading

Danish Biotech Conference at McGuireWoods LLP’s New York City Office on April 12-13, 2016

Posted in Biological Products, Meetings

ThinkstockPhotos-178705804On April 12-13, 2016, McGuireWoods LLP‘s New York City Office will host a special Danish Biotech Conference featuring nationally-renowned speakers on topics concerning investors in Danish biotechnology companies, as well as one-on-one sessions with Danish biotechnology companies.  McGuireWoods LLP’s Seth Goldsamt, Stephen Older, and Brian Malkin will speak on or introduce the following panels:  “Welcome and Introduction” (Goldsamt), “Demystifying the US IPO Process” (Older), and “Navigating the FDA: Positioning for Orphan Drugs, Special Assessments, and Breakthrough Designations” (Malkin).  McGuireWoods Consulting’s Stephanie Kennan and Charlie Iovino will speak on the panel “Understanding Pricing and Reimbursement; Building a Strategy”.  Other panels feature speakers from Avalere Health, NASDAQ, Citibank, BDO USA, LLP, FBR Capital Markets & Co., Venrock, Aisling Capital, Omega Funds, 5AM Ventures, Pfizer, Inc., DYAX Corp., Johnson & Johnson Innovation LLC, and Pharmakon Advisors and include:

  • Fireside Chat with Ole Larsen, CFO, Bavarian Nordic
  • NASDAQ: Ringing of Marketing Opening Bell
  • Investor Prospectives Through the Lifecycle
  • Working with Pharma: Collaborations to Buyout.

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McGuireWoods LLP’s Brian Malkin Quoted in Law360 Article on FDA’s New Stance on Opioid Drugs

Posted in Drugs, Risk Management

antibioticsOn March 28, 2016, McGuireWoods LLP’s Senior Counsel Brian J. Malkin was quoted in a La360 article, “New FDA Rules Put Onus On Doctors To Curb Opioid Abuse.”  discusses the U.S. Food and Drug Administration’s new requirement for “black box” warnings on immediate-release opioids, intended to alert patients to potential risks of “misuse, abuse, addiction, overdose and death.” Malkin was quoted indicating that a black box warning is perceived as the “kiss of death” because it means drug companies must bring up the subject of the warning almost immediately when discussing the drugs. The full text of this article is available to subscribers online.

Antitrust Fines for Pharma Pay-for-Delay: the UK Gets in on the Act

Posted in Antitrust, Litigation

Money186216778On February 12, 2016, the United Kingdom (UK) Competition and Markets Authority (CMA), the UK’s antitrust regulator, handed out a huge fine for a pay-for-delay antitrust law infringement in the UK. Although the CMA has been investigating this case for a while, it was announced at a very convenient moment for the CMA, just days after the body was criticized by the UK National Audit Office for not taking enough antitrust infringement decisions or handing out high enough fines (see here).  The fines amount to GBP 45 million for illegal pay-for-delay agreements entered into between originator GlaxoSmithKline plc (GSK) and several generic companies in the UK, see here. Continue Reading

More on Patent Settlements Including Litigation at the European Courts

Posted in Antitrust, Litigation, Patents

EU building (vertical)Last week I posted on the European Commission’s (EC) latest report into patent settlement agreements between originator and generic companies in the European Union (EU). The EC says each time it produces these reports that the limited number of prima facie unproblematic settlements entered into by companies active in the EU shows that they have a good awareness of potentially problematic practices and generally do not feel hindered from concluding patent settlements due to EU antitrust/competition law concerns. Continue Reading

Patent Settlement Update for Pharmaceutical Cases in Europe

Posted in Antitrust, Drugs, Litigation

EU building (vertical)Ever since the publication in July 2009 of the report on its antitrust inquiry into the pharmaceutical sector, the European Commission (EC) has been monitoring patent settlement agreements between originator and generic companies in the EU (plus Norway, Iceland and Liechtenstein, thus making up the European Economic Area or EEA). This monitoring was started because the inquiry identified settlements that limit generic entry and provide at the same time for a value transfer from the originator to the generic company (“pay-for-delay”) as potentially raising antitrust concerns in the EU/EEA.

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Food Check 2016 – Ideas to Mitigate Adulterated and Misbranded Food Products

Posted in Enforcement, Foods

Food and BeverageFor 2016, we expect adulterated food-related investigations to continue to lead the headlines, inspiring food and beverage companies to ask what they can do to prevent and prepare for a potential outbreak on their watch or in their supply chain. A recent spate of significant adulterated food outbreaks and related criminal investigations and prosecutions ranging from ice cream to eggs, and melons to Mexican food, have highlighted the need for food companies to be increasingly vigilant in identifying and mitigating risks relating to food-borne illness at every step of the process. Continue Reading

Turkey’s “Additional Customs Duties” – Will Medical Devices Be Next?

Posted in Medical Devices, Trade

iStock_000009370987MediumIn 2011, Turkey imposed for the first time “additional customs duties.”  These are duties as high as 50% imposed on top of normal customs duties on certain goods entering the Turkish territory.  These additional customs duties affect goods originating in (i.e., made in) the United States, as well as all countries with which Turkey has no preferential trade agreement (e.g., China and India).  Continue Reading