Life Science Compliance Update

July

2018

Copay Assistance Lands Pfizer Another Corporate Integrity Agreement

Written by , Posted in Uncategorized

Kaitlin Fallon Wildoner, Esq.

Pfizer is the second company (of perhaps many) to find itself in a new corporate integrity agreement (CIA) over patient assistance programs and independent charities. The CIA entered between Pfizer and HHS-OIG, and the DOJ include some newer language and requirements centering around PAPs and give good insight into what other companies should be looking to do concerning their PAP arrangements.


   or   

  • Return to July 2018 LSC Update Table of Contents
  • Copy abstract URL
  • Order Reprints

  • July

    2018

    When “Free” Really Isn’t Free – A Look at the Abiomed Case

    Written by , Posted in Uncategorized

    Robert N. Wilkey, Esq.

    In March, the United State Department of Justice (DOJ) and U.S. Attorney’s Office for the District of Massachusetts announced a $3.1 million-dollar settlement with Abiomed to resolve allegations that the company was actively using illicit marketing tactics with physicians to increase sales in a manner that violated the AKS and FCA.  Such settlement highlights that there is no such as a free lunch.


       or   

  • Return to July 2018 LSC Update Table of Contents
  • Copy abstract URL
  • Order Reprints
  • Topic tags:

    July

    2018

    You Say Marketing Incentive; I Say Kickback – Former Valeant and Philidor Execs Convicted of Fraud in Kickback Scheme

    Written by , Posted in Uncategorized

    Carolyn Greene, Esq.

    Former executives of Valeant Pharmaceuticals and Philidor Rx Services, a specialty pharmacy, recently went on trial in Manhattan charged with fraud and conspiracy for allegedly engaging in a kickback scheme in which the Valeant executive encouraged Valeant to purchase an option agreement to acquire Philidor. The Philidor executive allegedly personally obtained $40 million from the deal and paid an almost $10 million kickback to the Valeant executive. Both were convicted, and each faces a potentially lengthy prison term at sentencing. In recent years, the DOJ has stepped up enforcement in holding company executives personally liable for corporate malfeasance. However, before this case, the DOJ had little success in obtaining convictions in these cases.


       or   

  • Return to July 2018 LSC Update Table of Contents
  • Copy abstract URL
  • Order Reprints

  • July

    2018

    Compliance Issues Can Scuttle A Deal – The Fresenius/Akorn Acquisition Seems to be the Latest Example

    Written by , Posted in Uncategorized

    Gwendolyn Ball

    Compliance issues seldom take center stage in major financial deals.  However, the Fresenius/Akorn merger may be collapsing because of Akorn’s deficiencies in complying with FDA data management rules.  While it is not guaranteed that the courts will allow Fresenius to withdraw from the deal, Akorn has already suffered a very public blow to its reputation and a severe hit to its stock price.  The case illustrates how deficiencies in regulatory compliance can not only impact a firm’s relationship with regulatory agencies, but also its long-term financial and strategic planning.


       or   

  • Return to July 2018 LSC Update Table of Contents
  • Copy abstract URL
  • Order Reprints
  • Topic tags:

    July

    2018

    The Sleeping Giant Awakens – Cantrell’s Consent Decree as a Study on How Not to Respond to FDA Enforcement Actions

    Written by , Posted in Uncategorized

    Carolyn Greene, Esq.

    Cantrell Drug Company, a 503B outsourcing facility in Little Rock, Arkansas, has been subject to multiple FDA inspections over a five-year period. Each inspection found numerous deficiencies, many in critical areas relating to the prevention of microbiological contamination and aseptic processing. Cantrell defied FDA instructions and shipped products in interstate commerce. As a result, FDA referred the matter to the DOJ, which filed a civil enforcement proceeding seeking to enjoin Cantrell from further distribution. Ultimately, Cantrell entered into a consent decree with the FDA. This case played out much more publicly than similar situations, as Cantrell executives were posting comments on Twitter about the process. Unfortunately, the tone of the comments suggested that Cantrell did not take the FDA’s supervision seriously.


       or   

  • Return to July 2018 LSC Update Table of Contents
  • Copy abstract URL
  • Order Reprints
  • Topic tags:

    July

    2018

    Swarming on the Opioid Crisis: Legislative Response Attacks Concerns from All Sides

    Written by , Posted in Uncategorized

    Katherine Norris

    This is the first article in a series exploring the major themes emerging from recent legislative efforts to combat the ‘opioid crisis’ and their potential impact on drug manufacturers’ compliance programs. Currently, there is a myriad of bills before the U.S. Congress attempting to address the growing epidemic of opioid abuse, misuse, and diversion throughout the United States.


       or   

  • Return to July 2018 LSC Update Table of Contents
  • Copy abstract URL
  • Order Reprints
  • Topic tags:

    July

    2018

    July

    2018

    LSCU Free Articles

    Written by , Posted in Uncategorized

    Thank you for your interest in our Life Science Compliance Updates publication.  Please fill in the form below and click on the send button.  Once you have done this, you will automatically be forwarded to the page where you can download and view our free articles.

    First Name (required)

    Last Name (required)

    Your Email (required)

    Organization/Institution (required)

    Telephone Number (required)

    Please enter the code below: captcha

     

    June

    2018

    Test Ad

    Written by , Posted in Uncategorized

    June

    2018

    Solving The Problems With Drug Compounding – Sparse Data And An Inconsistent Regulatory Framework Muddy The Waters

    Written by , Posted in Uncategorized

    Carolyn Greene

    At least partly in response to the 2012 fungal meningitis outbreak, Congress passed the DQSA to increase federal regulatory authority over compound pharmacies. Many states also joined in the increased FDA regulatory oversight, strengthening their quality requirements. Data on compound drug quality is limited, but the data that does exist depicts an industry with a substantial number of quality and safety problems, potentially endangering the health of millions of Americans. The compound pharmacy industry isn’t helping matters – instead, they insist that compound drugs are safe. Since the passage of the DQSA, significant improvements have been made in the quality and safety of compound drugs, but much work remains.


       or   

    Topic tags:

    June

    2018

    Where In The World Is OPDP? Where In The World Is OPDP?

    Written by , Posted in Uncategorized

    Kaitlin Fallon Wildoner, Esq. and Seth B. Whitelaw, J.D., LL.M, S.J.D.

    OPDP enforcement activities have sharply declined over the past several years. That trend continues in 2018 as OPDP has only issued one letter involving opioids and a conference booth. This article looks at the trend, reviews the most recent letter and tries to determine what this means for compliance and regulatory professionals.


       or   

    Topic tags:

    June

    2018

    Maryland Loses Rx Price Gouging Law But Not The Debate

    Written by , Posted in Uncategorized

    Nicodemo (Nico) Fiorentino, Esq.

    Recently the United States Court of Appeals for the Fourth Circuit overturned Maryland’s law prohibiting price gouging for essential off–patent or generic drugs. This article highlights Maryland’s first-in-the-nation prescription drug price gouging legislation, key points to the commerce clause, and the impact the court’s ruling has on similarly proposed legislation throughout the country.


       or   

    Topic tags:

    June

    2018

    Looking Back – Reviewing OIG’S Report On The Top Management & Performance Challenges For HHS

    Written by , Posted in Uncategorized

    Gwendolyn Ball

    Greg Demske’s recent keynote address at Mitchell Hamline’s Health Law Institute Symposium and the OIG’s report on the top management challenges facing HHS published in 2017 provide a remarkably consistent picture of the OIG’s focus and direction. As this article highlights there are no magic bullets to address those challenges.


       or   

    Topic tags:

    June

    2018

    Finding The Golden Nuggets – OIG-HCCA Recommendations For Smaller Life Science Companies

    Written by , Posted in Uncategorized

    Carla-Marie Ulerie, Eric Davis, and Jon Wilkenfeld

    Recently the OIG and the HCCA published a resource guide with recommendations for determining if a compliance program is effective. Since small to mid-sized pharma and medical device companies typically operate with limited compliance staff and financial resources, we identified recommendations that were relatively easy or low cost to implement but were rarely adopted. Based on our review we have determined the “golden nuggets” from that guide.


       or   

    Topic tags:

    June

    2018

    Everything Old is New Again – McKesson Accused of Skimming Cancer Meds in FCA Suit

    Written by , Posted in Uncategorized

    Carolyn Greene, Esq.

    In response to concerns about the provenance of cancer drugs its providers received from McKesson, Omni has filed an FCA suit alleging that McKesson engaged in a scheme to increase profits illegally on cancer drugs. Specifically, Omni asserts that McKesson harvested and pooled overfill from single-use vials of cancer medications. McKesson then re-packaged these cancer drugs into pre-filled syringes. By collecting the overfill, Omni alleges that McKesson increased the number of doses of the cancer medications. This practice led to adulteration of the drugs themselves, as well as the submission of fraudulent claims to various government agencies for reimbursement on these extra doses of drugs created from the overfill. This case is yet another example of the re-occurring themes of overfill harvesting and “playing the spread” in conjunction with submission of fraudulent claims to the federal government for pharmaceutical reimbursement.


       or   

    Topic tags:

    Menu Title