Drugs

Stakeholders’ Comments on Drug Shortage Causes, Solutions

Pharmaceutical Research and Manufacturers of America (PhRMA) says it embraces the collaborative approach FDA has taken towards identifying and mitigating drug shortages, including the open communication that the agency has fostered. In a comment on an agency 11/27/18 public meeting on drug shortages, PhRMA says it and its members “strongly believe that retaining a flexible framework that allows FDA and manufacturers to interact and discuss potential drug shortages is the best way to serve patients.”

The Healthcare Supply Chain Association recommends that FDA should (1) encourage early drug shortage alerts and ongoing multi-stakeholder communications; (2) enhance transparency requirements for drug shortage information; (3) strengthen drug shortage disclosures; (4) improve and standardize review processes for manufacturers; (5) require manufacturers to develop drug shortage action plans; and (6) expand its drug shortage list.

The American Association of Physicians and Surgeons says FDA should continue progress toward lowering counterproductive barriers that impede innovation and deter the abundant supply of lifesaving care and cures. It also calls on the agency to work to remedy group purchasing organization and pharmacy benefit manager abuse of safe harbors by encouraging Congress to repeal specific legislation and amplifying HHS Office of Inspector General efforts to stop exploitation of the law and related regulations.

In its comment, the American Pharmacists Association says that as FDA develop its drug shortage report, its task force should consider which definition of shortage is being used and to recognize there are often circumstances where patient access to medications is limited even when a product is not recognized by FDA as in shortage. The association says it encourages the agency to also consider developing recommendations to improve patient access to products that are unattainable for other reasons, including manufacturer-imposed limited distribution policies, excessive price fluctuations, minimum order requirements and payer policies where coverage is limited to products dispensed from specific pharmacies.

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