Drugs

California Sues Abbvie Over ‘Illegal’ Kickbacks

California has filed a lawsut against AbbVie alleging that it gave illegal kickbacks to health care providers to prescribe Humira (adalimumab), indicated for multiple inflammatory diseases. The whistleblower-based suit, which was filed under the Insurance Frauds Prevention Act, alleges that private insurers have paid out $1.2 billion in Humira-related pharmacy claims.

According to the complaint, AbbVie allegedly engaged in classic kickback efforts (cash, meals, drinks, gifts, trips, and patient referrals) and “more sophisticated ones — free and valuable professional goods and services to physicians to induce and reward Humira prescriptions,” the state says. “These professional goods and services included free insurance processing and prior authorizations, gifts of medical practice management hardware and software, and even marketing assistance, all of which save physicians valuable staff time and resources.”

The state says that the most dubious part of Abbott’s alleged scheme was that it inserted its own personnel directly into patient homes. “When doctors prescribe Humira, AbbVie sends its registered nurses — which AbbVie calls ‘ambassadors’ — into patients’ homes, representing them to be an extension of the doctor’s office. The system AbbVie established takes advantage of the ambassadors’ nursing background and direct access to patients to serve the biopharma giant’s financial interest in getting patients to take Humira by downplaying its risks. Ambassadors are trained to send patient complaints directly to AbbVie and not the patients’ treating physicians. Ambassadors also provide unbalanced information, as they are trained to tout the drug while at the same time also instructed on methods to avoid directly answering patient questions about risks of the medication, including those pertaining to Humira’s serious and important side effects.”

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