Drugs

Mallinckrodt Paying $35 Million to Settle Opioid Allegations

The Justice Department says that Mallinckrodt will pay $35 million to resolve allegations that it failed to report suspicious orders of pharmaceutical drugs and for recordkeeping violations. A department news release says this is the first settlement of its magnitude with a manufacturer of pharmaceuticals resolving nationwide claims that the company failed to meet its obligations to detect and notify the Drug Enforcement Administration (DEA) of suspicious orders of controlled substances such as oxycodone. The settlement also addresses violations in the company’s manufacturing batch records at its plant in Hobart, NY, the release says.

The government alleged that Mallinckrodt failed to design and implement an effective system to detect and report suspicious orders for controlled substances, such as orders that are unusual in their frequency, size, or other patterns. The U.S. alleged that from 2008 to 2011, the company supplied distributors, and the distributors then supplied various U.S. pharmacies and pain clinics, an increasingly excessive quantity of oxycodone pills without notifying DEA of the suspicious orders.

During the investigation, the government says, it learned that drug manufacturers offer discounts, known as chargebacks, based on sales to certain downstream customers. Distributors provide information on the downstream customer purchases to obtain the discount. The Mallinckrodt settlement requires the manufacturer to use chargeback and similar data to monitor and report to DEA suspicious sales of its oxycodone at the next level in the supply chain, typically sales from distributors to independent and small chain pharmacy and pain clinic customers.

The government says the company’s recordkeeping violations created discrepancies between the actual number of tablets manufactured in a batch and the number of tablets Mallinckrodt reported on its records.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome