Drugs

FTC Targets Drug Rebate Schemes Affecting Formularies

The Federal Trade Commission says it is ramping up enforcement against any illegal bribes and rebate schemes that impede patients’ access to competing lower-cost drugs. Drug companies use rebates to have their drugs placed on formularies or on preferred tiers of formularies to ensure those drugs are covered. FTC issued an enforcement policy statement 6/14 that “puts drug companies and prescription drug middlemen on notice that paying rebates and fees to exclude competitors offering lower-cost drug alternatives can violate competition and consumer protection laws,” an FTC release says. “The agency will use its full range of legal authorities to combat illegal prescription drug practices that foreclose competition and harm patients.”

“These rebates are often conditioned on the drug staying in a preferred position on the formulary. Some rebates and fees are conditioned on the volume of sales of certain high list price prescription medicines,” FTC says. “In addition to other factors, some have suggested that high rebates and fees to PBMs and other intermediaries may incentivize higher list prices for drugs and discourage coverage of the lowest-cost products.” FTC also says it is concerned that rebate practices may be driving up the list price of insulin, which has jumped by over 300% over the past 20 years.

The enforcement policy also outlines the legal authorities that may apply when “dominant drug companies pay rebates and fees to middlemen” to block competition from less expensive generic and biosimilar alternatives.

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

Read more

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