Drugs

Bill to Fight Illegal Opioid Imports

Rep. Frank Pallone (D-NJ) has introduced HR 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now (SCREEN) Act, to increase funding to and expand FDA authority to prevent illegally manufactured opioids, including heroin and fentanyl, from arriving through the mail from overseas.In a statement (includes link to bill text), Pallone says that one of the many ways synthetic opioids reach the U.S. is through international mail facilities (IMFs) that he says receive millions of parcels containing illegal or unapproved drugs.

“The SCREEN Act would strengthen FDA’s authority to detain, refuse, and destroy illegal substances identified in IMFs, improve enforcement mechanisms, and provide funding to better combat the influx of illegally manufactured opioids into the country,” Pallone says. The legislation reportedly would:

grant FDA authority to refuse importation and destroy drugs on the basis that they have been identified as ‘articles of concern’;
allow FDA to destroy more than $2,500 worth of drugs (the maximum under current law) if it determines that doing so would be in the best interest of the public health;
authorize FDA to place an emergency recall order and to cease distribution of drugs that may pose an imminent threat of adverse health effects or death;
give FDA authority to debar individuals or companies that exhibit recidivist activity; and
authorize $110 million to FDA for Fiscal Years 2019 through 2023 to support innovation in non-opioid and non-addictive pain treatment, programs to increase access to opioid use disorder treatment, and to reduce illicit importation of opioids, including increasing staff capacity at IMFs.

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