Drugs

Grassley Promotes Bill Addressing REMS ‘Gaming’

Sen. Charles Grassley (R-IA) says he and several colleagues have introduced the Creating and Restoring Access to Equivalent Samples (CREATES) Act (S. 974) to help FDA address REMS program abuse in which brand drug manufacturers restrict generic manufacturer access to samples for product testing and refuse to enter into single, shared distribution system protocols with generic manufacturers. Grassley wrote to FDA commissioner Scott Gottlieb on the day the commissioner announced a 7/18 public meeting on the subject.

According to Grassley, the bill would deter drug companies from denying samples to generic companies, so they can conduct testing to produce cheaper generic alternatives. It also would give FDA more flexibility in making single, shared distribution system determinations.

The letter says the senator also is concerned about situations in which innovator and generic drug companies enter into agreements in which the innovator pays the generic not to compete as part of a settlement. He says that another bill, the Preserve Access to Affordable Generics Act (S. 124) , would crack down on such anti-competitive payoffs.

“I hope you will take a close look at these two bills as you formulate your strategy to address accessibility and the high cost of prescription drugs,” Grassley concludes. “Your support for these bills will help in our shared goal of increasing access and lowering the price of drugs.”

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