Life Science Compliance Update

April 26, 2018

FDA Issues Order Restricting Sales of Contraception Device


On April 9, 2018, the United States Food and Drug Administration issued an order restricting the sale and distribution of the Essure permanent contraception device. The FDA took this step once it became aware that some women were not “adequately informed” of the risks that come with the device prior to its implantation, despite “previous significant efforts to educate patients and doctors” about the risks associated with the device. Essure is the only permanently implanted birth control device for women on the market that does not require a surgical incision. Some patients implanted with Essure have experienced adverse events, including perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity reactions. In addition, women have also reported experiencing headache, fatigue, weight changes, hair loss and mood changes, such as depression. It is unknown whether these symptoms are related to Essure.

Here, the FDA is requiring a unique restriction by using its authority to restrict the sale and distribution of a device to impose additional requirements needed to provide a reasonable assurance of its safety and effectiveness.

The new Essure labeling will now be required when this product is offered to a patient, including a review and acceptance of the patient brochure, Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement. The labeling will now restrict the sale and distribution of the device only to healthcare providers and facilities that provide the required information to the patient. The patient must also be given the chance to review and sign the acknowledgement, as well as the physician implanting the device.

Bayer, the device manufacturer, is required to implement the restrictions immediately and ensure that the process going forward results in health care provider compliance with the sales restriction. The FDA will review and monitor Bayer’s plan to ensure the company complies with the restriction. The FDA plans to enforce these requirements and will take appropriate action for a failure to comply, including applicable criminal and civil penalties.

FDA Commissioner Scott Gottlieb, M.D., stated,

“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option. We take the concerns of all women affected by Essure very seriously. I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”

“Ensuring informed decision making is just one important step in our ongoing efforts to monitor this device. We remain committed to carefully and thoroughly considering all new data and evidence and will continue to work with patients affected by this device as part of our process,” said Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health. “While some women may continue to choose Essure as their birth control option based on current information, as new information becomes available, the FDA will continue to keep the public informed of the agency’s evaluation and findings, and consider regulatory options that appropriately balance benefits and risks for Essure.”

April 25, 2018

McKesson Accused of Illegally Handling Cancer Medications

Drug Distribution
On April 4, 2018, a lawsuit was unsealed that shows McKesson Corporation – America’s largest drug distributor and one of the top five largest public companies of any kind in America – is being accused of illegally pooling leftover cancer medication from single-dose vials and selling it to healthcare providers. Those healthcare providers then in turn treated patients with it and typically billed the cost to government programs for reimbursement.

The lawsuit, brought by a private company, Omni Healthcare, seeks unspecified damages from McKesson for violating the federal False Claims Act by selling the medication and providing kickbacks by offering the pooled drugs at a discount and repackaging them under non-sterile conditions, from 2001 until at least 2010. The lawsuit was brought under the qui tam  provisions and the federal government, thirty states, Washington, D.C., New York City, and Chicago all joined as plaintiffs.

Allegedly, McKesson produced and sold pre-filled syringes containing drugs for cancer and its side effects to oncology centers, hospitals, and physicians. To ensure that each syringe could be properly filled, each vial contained up to ten percent more than would be necessary to fill the syringe. Additionally, since the vials did not contain any preservatives, once the vial was punctured, the medication was out in the open, available to be contaminated. Because of the possibility of contamination, the distributor is supposed to dispose of the partially-used vials.

However, instead of disposing of the partially-used vials, McKesson allegedly “harvested” them, producing roughly one extra syringe per every ten legitimate ones. Further complicating the situation, In some cases, the company put false FDA identification numbers on the unlawfully produced syringes. Some health-care providers billed Medicare and Medicaid for the treatment they gave patients, an action the lawsuit described as defrauding the government.

The lawsuit further contends that McKesson encouraged providers to purchase the pre-filled syringes (using the leftover vials) by offering them at a discount. For example, in September 2007, a syringe cost $327.42, compared to the $346.99 cost of the vials.

McKesson responded in a statement saying, “patient safety, compliance with the law and maintaining the trust of our customers are top priorities for us. While we have not yet formally received the complaint, we reject the allegations as they’ve been reported and plan to vigorously defend the company in court if this case moves forward.”

One of McKesson’s competitors, AmerisourceBergen, pled guilty last year to similar actions and made a payment of roughly $900 million in fines - $625 million in the form of a settlement to resolve FCA allegations and $260 million in fines and forfeitures as part of a criminal suit. Time will tell if the same cards will play out for McKesson. 

The End of Guidance Documents or Simply a Reminder of Well-Established Administrative Law Principles?


As discussed in several news outlets, the Trump Administration recently announced that it would begin to enforce long-standing administrative law principles and limit the weight guidance documents carry in government actions against private companies and individuals. While the ramifications of this decision are still months away from realization, this article outlines the principles and the possible effects we will see in the future from this decision.

Chaos and controversy seem to be synonymous with Trump Administration activities. This was certainly the case a few weeks ago when the United States Department of Justice (“DOJ”), with the support of the White House, recently announced that it would begin limiting the use of “guidance documents” and that non-compliance with guidance documents did not constitute a punishable violation.

The announcement, quickly picked up by several news outlets, had the predictable effect of having the pundits take sides on whether this announcement was simply a reminder of the proper role of guidance documents, a domino effect that may have vast implications for the government’s ability to sue companies accused of violating those document or something more nefarious such as Trump was trying to dismantle Executive Branch agencies.

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