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The Food and Drug Administration is asking manufacturers of over-the-counter anti-diarrhea treatments to change the way they package their products to curb abuse by people with drug addictions. Commissioner Scott Gottlieb said in a statement Tuesday that the agency was taking the “novel” action because of growing concerns that abuse of Imodium A-D and similar medications was adding to the death toll of the nation's opioid epidemic. (McGinley, 1/30)

FDA Commissioner Scott Gottlieb called the agency request “fairly unprecedented” in a statement on Tuesday and said those restrictions could constitute a two-day supply, or a maximum of eight two-milligram pills. J&J was noncommittal. The steps to limit Imodium are part of a broader FDA effort to stem the tide of overdose deaths. More than 42,000 Americans died from opioid overdoses in 2016, according to the Centers for Disease Control and Prevention. (Edney, 1/30)

The key ingredient in anti-diarrhea medications like Imodium is part of the opioid family, an addictive drug class that includes morphine and oxycodone. At low doses, the medicine, known generically as loperamide, helps control diarrhea. But recent statistics show a rise in abuse of the drug, including massive doses that can cause heart problems and death. (1/30)

Now, after years of research and perseverance, a handful of biopharma companies believe they’ve found a safe way to relieve pain with NGF treatments, pressing through late-stage trials that will determine whether the old drugs can finally pass FDA muster and provide a much-needed alternative to opioids. ...Regeneron, which is studying its drug in osteoarthritis and chronic lower back pain, expects to disclose results of a late-stage trial this year. Pfizer and Eli Lilly, which have partnered on an NGF drug, plan to release data in osteoarthritis on the same timetable. (Garde, 1/31)

The Drug Enforcement Agency (DEA) plans to target the nation's pharmacies and prescribers in a nationwide crackdown against opioid abuse, Attorney General Jeff Sessions announced Tuesday. Sessions told agents in Louisville, Ky., that over the next six weeks the DEA will begin a nationwide investigation of pharmacies and drug prescribers that are issuing "unusual or disproportionate" numbers of opioid prescriptions. (Bowden, 1/30)

Three senators are urging the Trump administration to quickly issue a new rule that would aim to increase access to opioid addiction treatment in rural areas. Sens. Claire McCaskill (D-Mo.) and Alaska’s two Republican senators — Lisa Murkowski and Dan Sullivan — are requesting the Drug Enforcement Administration (DEA) issue a new regulation that would let certain health-care providers obtain a special registration letting them use telemedicine to prescribe medication for an opioid addiction. (Roubein, 1/30)

The House Energy and Commerce Committee announced Tuesday that it will begin holding legislative hearings on measures to fight the opioid crisis the week of Feb. 26, a step forward in addressing the epidemic. The panel said that there will be multiple hearings to consider legislation aimed at fighting opioid abuse, an issue that has received bipartisan attention amid a rising number of deaths. (Sullivan, 1/30)

Drug distributors poured 20.8 million pain pills into a West Virginia town of 3,000 people over a 10-year period, according to information released Tuesday as part of a congressional probe into the opioid crisis. The out-of-state companies shipped the painkillers to two pharmacies four blocks apart in Williamson, W.Va., from 2006 to 2016. (Hellmann, 1/30)

Williamson, W.Va., sits right across the Tug Fork river from Kentucky.  ...But despite its small size, drug wholesalers sent more than 20.8 million prescription painkillers to the town from 2008 and 2015, according to an investigation by the House Committee on Energy and Commerce. (Wamsley, 1/30)

Franklin County officially joined a national lawsuit Tuesday that accuses prescription opioid makers and distributors of being a public nuisance by improperly fueling the national epidemic of opioid addiction and overdose deaths. The suit accuses dozens of opioid manufacturers and distributors, including Dublin-based Cardinal Health, of being hazards to public health by flooding the market with painkillers and other opioids that have fueled the deadly epidemic. (Perry, 1/30)