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FDA wants to boost use of software that goes along with prescription drugs. The Food and Drug Administration is seeking public comments on a way to modernize its method for approving software products like apps alongside prescription drugs. The agency said in an announcement Monday that it wants to take into account the presence of such software products when considering drug approvals. Some examples the agency gave of such products include an app to help patients be aware of a drug’s treatment effects or an app to promote adherence to the recommended dose. Another example is a sensor that collects data to track a drug as it moves through the body to help monitor how a drug is working, the FDA said. “The FDA expects these circumstances to be limited and, under the efficient framework that we’re proposing, we would treat the majority of prescription drug apps that may help patients, including dose calculators, symptom trackers and medication reminders, as promotional labeling,” FDA Commissioner Scott Gottlieb said in a statement. “This would provide a more efficient path to market for these kinds of tools that can help patients be better informed about their medical care.”

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Pregnant women face reprieve in Trump-backed criminal justice bill. The criminal justice reform bill known as the First Step Act would prohibit pregnant women from being shackled and would ensure all people who are incarcerated are placed closer to family, a help to women who give birth and are separated from their newborns. Some estimates show that roughly 2,000 women give birth while in custody every year. When females in custody are moved from one place to another, they are often tied up the same way that men are, wearing handcuffs, ankle irons, and a waist chain. Women who are pregnant have tripped, been unable to break their falls, and suffered miscarriages. Advocacy groups devoted to criminal justice reform have for years tried to reduce the number of people who are serving lengthy sentences for nonviolent crimes, and discussing the treatment of pregnant women has provided one of the avenues for proceeding in a bipartisan manner on Capitol Hill. “Talking about how women are being treated inside has built a lot of consensus,” said Jessica Jackson Sloan, national director and co-founder at #cut50, a bipartisan advocacy group. “It’s instant common ground. Neither party thinks we should be shackling pregnant women in prisons and jail. That’s just barbaric.”

Proponents of the bill are hopeful it will pass before the end of the year. Advocates say the bill provides a strong first step and they hope eventually to enact reforms to allow pregnant women to receive proper nutrition and to keep them from being placed in solitary confinement. President Trump has told Senate Majority Leader Mitch McConnell, R-Ky., that passing the criminal justice bill is a priority for the lame-duck session before the new Congress meets in January, but not everyone shares the president’s enthusiasm for the bill. The divisions aren’t over the aspects addressing pregnancy, but over the sentencing reforms. Sen. Tom Cotton, R-Ark., has been among the bill’s most vocal critics, calling it in a “misguided effort to let serious felons out of prison” in a USA Today opinion piece. But Sen. Lindsey Graham, R-S.C., who is in good position to be the next chairman of the Judiciary Committee, said he believed the bill had widespread support in the upper chamber, saying he thought as many as 90 senators would support it. Asked whether it would get a vote before the end of the year, he said, “I hope so. I’m doing everything I can.”

Chuck Grassley to take Senate Finance Committee chairmanship. Sen. Chuck Grassley, R-Iowa, will be the next chairman of the Senate Finance Committee, the chamber’s lead panel on taxes and trade. Grassley previously served as the committee’s chairman twice, once for a six-month stint in 2001, then from January 2003 to January 2007. He’s also twice served as the committee’s ranking member. Grassley gives up his chairmanship of the Senate Judiciary Committee, where he oversaw the nomination processes for Supreme Court Justices Neil Gorsuch and Brett Kavanaugh, among a number of other judges nominated by the Trump administration, in order to take the top slot at the Finance Committee.  Prescription drug prices may be one area where Grassley might find common ground with his counterparts across the aisle. Grassley will likely be more critical of the pharmaceutical industry than was his predecessor. He was a co-sponsor of the Sunshine Act, which called for pharmaceutical companies to disclose the payments they make to doctors for travel to events or for meals and other items. Grassley has also sought to fight for more drug price transparency. For instance, he and Sen. Dick Durbin, D-Ill., fought to add to a September spending deal a provision to require drugmakers to add list prices on TV ads.

Pfizer plans price hikes on 41 drugs despite pressure from Trump, Democrats. Pfizer will raise the prices of 41 drugs in January, amid escalating Trump administration efforts to lower prescription drug prices and months after Trump’s intervention forced the largest U.S. drugmaker to postpone planned cost increases. The hikes, first reported by the Wall Street Journal, will affect 5 percent of the company’s total drug portfolio and will be offset with higher rebates and discounts, Pfizer said in a statement. The Trump administration is expected to try to overhaul the drug rebate program, an effort departing CEO Ian Read previously told investors would advance in 2018. “We believe the best means to address affordability of medicines is to reduce the growing out-of-pocket costs that consumers are facing due to high deductibles and co-insurance, and ensure that patients receive the benefit of rebates at the pharmacy counter,” Read said in a statement.

Discharged veterans with war-related mental illnesses can sue, judge rules. Veterans with mental health issues related to their service will be able to pursue a class-action lawsuit against the military. A federal court judge in Connecticut ruled Thursday in favor of Navy and Marine Corps veterans who received a less-than-honorable discharge due to incidents related to untreated mental illnesses. As a result of their discharge status, these veterans were subsequently denied VA benefits to receive healthcare for their war-related mental health issues. Veterans argue that they might still be serving today if their mental ailments, such as post-traumatic stress disorder and traumatic brain injuries, had been treated properly. But without access to medical benefits, the veterans say it was difficult for them to get care for issues that occurred as a result of their service.

FDA unveils new study to avoid testing drugs on dogs. The Food and Drug Administration unveiled a new study Friday designed to lead to fewer dogs used in later trials for veterinary medicine. And, all the dogs in the study will be adopted out as pets at its end. “In short, our goal is to do one single study involving a small number of dogs — where the dogs will only be subject to minimally invasive blood sampling, and adopted as pets at the completion of the short trial — to eliminate the need for the use of dogs in certain types of future studies, somewhere they might have been euthanized,” FDA Commissioner Scott Gottlieb said in a statement Friday. The single study will help researchers replace the canine test subjects with new informatics tools that will model how drugs are absorbed in dogs’ blood rather than testing them on live dogs. The study will employ “bioequivalence” trials that compare pharmaceutical products already approved to a proposed generic version to determine whether the drugs are equally safe and effective. Such drug tests commonly euthanize dogs so that their bodies can undergo a necropsy to evaluate the impact of the medicine on the dogs’ bodies. But the new study intends to use the data gathered to “validate a research model” that would “establish a clear benchmark for how these drugs are absorbed in the dogs’ blood.” Gottlieb said the 27 dogs that will participate in the study will receive proper medical attention “so that they remain happy, well-socialized, and healthy.”

Jennie-O recalls 91,338 pounds of turkey ahead of Thanksgiving. The second-largest U.S. turkey producer has recalled more than 91,000 pounds of raw turkey meat ahead of the Thanksgiving holiday due to a Salmonella outbreak, according to the Agriculture Department’s Food Safety and Inspection Service. Jennie-O Turkey Store Sales, LLC will pull 91,338 pounds of ground and seasoned turkey that was produced on Sept. 11 after 164 people in 35 states became sick after eating it. No whole turkeys have been compromised by the illness outbreak, according to the government news release issued Thursday. FSIS is worried that because the product was sold a few months ago, many people may have it in their freezers and not be aware they have food that has been compromised in their kitchen.

Congressional report details price hike of naloxone. A new report detailed how the drugmaker Kaleo increased the price of vital overdose antidote naloxone product called Evzio by more than 600 percent by 2016. The report from the Senate Permanent Subcommittee on Investigations found that the initial price of Evzio was $575 per unit and now to $3,750 and $1,400 about 11 months later, according to a release. “The fact that one company dramatically raised the price of its naloxone drug and cost taxpayers tens of millions of dollars in increased drug costs, all during a national opioid crisis no less, is simply outrageous,” said Sen. Rob Portman, R-Ohio, chairman of the committee.

RUNDOWN

Axios Pharma dreads Chuck Grassley as Senate Finance Committee chair

Associated Press Florida sues Walgreens, CVS over opioid sales

CNN One-third of U.S. patients plan to skip flu shots for their child this season

The Hill GOP lawmaker pushes back on Trump’s drug pricing proposal

Politico Medicaid expansion supporters already looking towards 2020

Governing During Obamacare enrollment in the Trump era, states face greater challenges

Kaiser Health News Playing on fear and fun, hospitals follow pharma on direct-to-consumer advertising