Drugs

PhRMA Lays Out Opposition to Drug Importation Rule

Laying out opposition to an FDA proposed rule on the importation of prescription drugs, Pharmaceutical Research and Manufacturers of America (PhRMA) says “importation is not the solution to lowering patient costs. PhRMA supports fundamental policy changes to achieve solutions that will help patients and produce better and more efficient care. Although the current drug distribution and payment system has constrained overall spending on medicines, the underlying mechanics could work better for patients.”

In its 3/9 comment letter, the trade group says that providing patients with access to negotiated rebates, addressing affordability challenges in patient deductibles, and giving patients information on out-of-pocket costs and healthcare quality would empower consumers and lower out-of-pocket costs.

The 81-page comment letter summarizes and explains these concerns over the proposed rule:

the proposed importation scheme would jeopardize the health and safety of patients and fail to reduce patient costs;
HHS’ proposed certification and the FDA proposed rule would exceed their authorities under the Federal Food, Drug, and Cosmetic Act and other laws;
the proposed rule raises constitutional concerns and is inconsistent with U.S. treaty obligations;
FDA promulgated the proposed rule without effective statutory authority and failed to adhere to other procedural requirements; and
other aspects of the rule are impermissible or would lead to significant public health risks.

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