Drugs

Attorneys Explain Antikickback Rule

The HHS Inspector General finalized 12/7 a rule amending the safe harbor regulations under the federal healthcare program antikickback law and established exceptions to the civil monetary penalty prohibiting remuneration to Medicare and Medicaid beneficiaries. Attorneys Alan Kirschenbaum and David Gibbons (Hyman, Phelps & McNamara) write in their firm’s FDA Law Blog that the final rule changes existing safe harbors and adds new ones, while also adding new exceptions to the beneficiary inducement civil monetary penalty. The final rule is effective 1/6/17. The attorneys explain key provisions of interest to drug and medical device companies, including:

cost-sharing waivers by pharmacies;
Medicare coverage gap discount program;
local transportation;
other safe harbors;
access to care/low risk of harm
coupons or rewards from a retailer;
free or discounted items or services where financial need exists; and
other civil monetary penalty provisions.

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