Daily on Healthcare: Generic drug to treat opioid addiction will hit the market


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Generic drug to treat opioid addiction will hit the market. The Food and Drug Administration has approved the first generic version of Suboxone, a drug used to treat opioid withdrawal symptoms. The medication comes in the form of a film strip that dissolves under the tongue. The brand name version of the drug carries a list price of about $200 a month. The drug is a combination of buprenorphine and naloxone. “The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them. That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access,” FDA Commissioner Scott Gottlieb said.  

Welcome to Philip Klein’s Daily on Healthcare, compiled by Washington Examiner Managing Editor Philip Klein (@philipaklein), Senior Healthcare Writer Kimberly Leonard (@LeonardKL) and Healthcare Reporter Robert King (@rking_19).  Email dailyonhealthcare@washingtonexaminer.com for tips, suggestions, calendar items and anything else. If a friend sent this to you and you’d like to sign up, click here. If signing up doesn’t work, shoot us an email and we’ll add you to our list.

Medicaid work requirements taken up in court. Plaintiffs argued this morning against the legality of the Trump administration allowing Kentucky to require certain Medicaid beneficiaries work or train for work as a condition of staying enrolled in the program. The case was argued in the U.S. District Court in Washington, D.C., this morning. The Trump administration has said that work ultimately gives people benefits that contribute to health, and that its intent is to encourage people to be able to be self-sufficient and have jobs that provide private medical coverage. The lawsuit was waged on behalf of 15 Medicaid beneficiaries in the commonwealth, who say that the requirements will cause people to become uninsured and that work requirements should not be part of Medicaid, saying that it is a healthcare program and not a welfare program. Forty health policy scholars wrote in an amicus brief that there is “zero evidence to suggest that depriving people of Medicaid will lead to greater levels of employer insurance.”

Ideological foes take aim at Texas anti-Obamacare suit. In a case of strange bedfellows, libertarian law professor Jonathan Adler, who was one of the intellectual architects of the King vs. Burwell Obamacare lawsuit, has teamed up with one of that lawsuit’s leading critics, law professor Nicholas Bagley. Bagley and Adler have joined forces along with an ideologically diverse group of legal minds to take aim at the reasoning behind the lawsuit in which states led by Texas and Wisconsin and the U.S. Department of Justice are arguing that the individual mandate was made unconstitutional by the 2017 tax law and thus other parts of the law have to be struck down. According to plaintiffs and the DOJ, without the penalties to purchase insurance that were repealed in the tax law, the Supreme Court justification of the mandate as a constitutional tax no longer holds, and thus it must be unconstitutional. Further, they argue that the mandate is a central part of the law that cannot be severed, meaning that other parts of Obamacare, particularly the insurance regulations, must be struck down as well. In their brief, Bagley and Adler do not take a position on the merits of the mandate claim. However, they argue against the idea that the mandate, if struck down, could not be severed from the rest of the law. The brief notes that courts must consider not the Congressional intent that existed when Obamacare passed in 2010, but the more recent actions of Congress in 2017. And with the tax law, Congress already decided that the mandate was severable, because it repealed the penalties while leaving the rest of the law intact. “If the Court finds that plaintiffs have standing and concludes that the individual mandate is unconstitutional, amici ask that it find the mandate severable from the rest of the ACA, including its guaranteed-issue and community-rating provisions,” the brief reads.

Texas’ effort to gut Obamacare would have ‘a devastating impact,’ health groups say. A collection of 17 states, healthcare groups, and experts made a last-minute plea to a federal judge to throw out a lawsuit that would eliminate Obamacare’s protections for people with pre-existing conditions, warning that wiping out the protections would have a “devastating impact” on the healthcare system. Major healthcare groups and mostly blue states on Thursday filed “friend of the court” briefs to argue against a lawsuit from Texas and several other states that says the healthcare law is unconstitutional. “The legal arguments in this case are a long shot and a real stretch,” said Virginia Attorney General Mark Herring on a call with reporters Thursday. “We feel confident we can defend the healthcare for millions and millions of Americans.” The American Medical Association led a group of five healthcare organizations in filing a brief opposing the lawsuit. “An unfavorable decision in this case would create further disruption, generate uncertainty, spark additional premium increases, and cause declines in coverage,” said Barbara L. McAneny, president of the doctors’ lobbying group. Another collection of groups led by the American Cancer Society’s Cancer Action Network, American Heart Association, and American Lung Association challenged Texas’ legal argument and said eliminating the protections for pre-existing conditions would have “a devastating impact on doctors, patients, and the American healthcare system as a whole.”

House passes bill aimed at stemming shipments of illicit fentanyl. The House on Thursday passed a bill that aims to prevent the shipment of fentanyl through the international mail system. The House voted 353-52 to pass the Synthetics Trafficking and Overdose Prevention, or STOP, Act. It seeks to stem the tide of illicit and powerful drugs such as fentanyl, which is 100 times more powerful than morphine, from reaching addicts through the U.S. mail system. The bill requires the U.S. Postal Service to transmit electronic data on 70 percent of international packages to Customs and Border Protection by Dec. 31, 2018, and 100 percent by Dec. 31, 2020. A recent congressional probe found that it is extremely easy to buy fentanyl from overseas. Traffickers primarily use the U.S. postal system instead of private shippers such as FedEx because it is highly unlikely illegal drugs will be seized, according to the probe.

Kentucky sues Walgreens over opioid epidemic. Kentucky sued Walgreens Thursday for its role in flooding the state with opioids, the latest state lawsuit over the painkiller crisis. Democratic Attorney General Andy Beshear said the pharmacy chain engaged in “unfair, misleading and deceptive business practices … for excessively distributing and dispensing opioids in Kentucky.” He added the company also failed to report suspiciously large orders of opioids to state and federal authorities. “While Walgreens’ slogan was ‘at the corner of happy and healthy,’ they have significantly harmed the health of our families in fueling the opioid epidemic,” Beshear said. Other states and cities also have targeted drug distributors and manufacturers for helping to fuel the epidemic.

Abortion rights groups sue to undo dozens of Texas laws. Reproductive rights groups have filed a lawsuit challenging dozens of abortion restrictions in Texas, after a key 2016 Supreme Court win for the organizations. Some of the anti-abortion laws being challenged go back decades, include a requirement that parents are notified of an abortion, making women wait before they can have an abortion, and blocking patients from accessing abortion through telehealth. “For years, Texas politicians have done everything in their power to push abortion out of reach for Texans,” said Amy Hagstrom Miller, president of Whole Women’s Health Alliance, one of the plaintiffs in the case. “Today, we join communities and advocates across the state to send the message that we have had enough.” Defenders of the restrictions say they are intended to protect women during their pregnancies and ensure safer abortions, but critics charge they do not serve a medical purpose and instead cause clinics to shut down.

Health insurers lose lawsuit over Obamacare funds.The federal government does not need to pay health insurers hundreds of millions of dollars they say they are owed for an Obamacare program, a federal appellate court has ruled in a decision that sides with conservatives in Congress and the Trump administration. The three-judge panel of the Federal Circuit Court of Appeals decided 2-1 that the government does not have to pay for the risk-corridor program, which was meant to compensate health insurance companies for incurring losses because of enrolling sicker, more expensive customers. The panel said Congress had taken action that required the program to be budget neutral. Two insurers filed the lawsuit, and more than three dozen others have similar cases pending. Taken together, health insurance companies have asked for $12 billion in federal payments.

Teens engage in less risky behavior. The percentage of high school students who report that they have ever had sex declined from 47.8 percent in 2007 to 39.5 percent in 2017, according to data from the Centers for Disease Control and Prevention. The percentage of students who reported ever using illegal drugs, such as coke or heroin, fell from 22.6 percent in 2007 to 14 percent in 2017, though 14 percent reported they had misused prescription opioid painkillers. The results are the lowest they have been since the agency began the survey in 1991. CDC Director Robert Redfield said concerns remain despite the strides made in this area, and the agency said condom use among teens who are having sex needs to be higher. “We can’t yet declare success when so many young people are getting HIV and STDs, and experiencing disturbingly high rates of substance use, violence, and suicide,” he said.

Number of children without health insurance falls 38 percent. The number of children who didn’t have insurance fell by 2.2 million from 2013 to 2016, a 38 percent drop, according to a study from the Robert Wood Johnson Foundation. The study linked the drop to coverage gains from the Affordable Care Act, whose subsidized insurance exchanges went online in 2014. “When adults gain coverage, kids do too, as seen by these very positive trends between 2013 and 2016,” said Katherine Hempstead, senior adviser at the Robert Wood Johnson Foundation. “The process also works in reverse — so given the recent uptick in the uninsurance rate and the potential for more, we should be aware that this progress in kids’ coverage may be jeopardized.” The foundation relied on data from the U.S. Census to reach its conclusions on the uninsured rate for children.

RUNDOWN

NPR U.S. suicide rates are rising faster among women than men

Axios A $2.3 billion tax gain for the Blues

The Hill Lawmakers ask for increase in suicide prevention funding

Kaiser Health News As Medicaid costs soar, states try a new approach

Denver Post Coloradans protected from the comeback of pre-existing conditions in health insurance

Wall Street Journal Medicaid expansion gains popularity in red states

Associated Press FDA clears first generic film strip of addiction drug Suboxone

Reuters Kellogg issues massive Honey Smacks cereal recall over salmonella risk



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