Policy News Roundup: November 10, 2022

Key reads

CDC issues new opioid prescribing guidelines

The Centers for Disease Control and Prevention (CDC) released new recommendations as an update to the 2016 guidelines on opioid prescribing. The previous guidance succeeded in reducing inappropriate and dangerous prescribing, but it was also seen as a barrier to care. The new guidelines are designed to ensure that patients get compassionate and safe pain care. The CDC no longer suggests trying to limit opioid treatment for acute pain to three days, dropped the specific recommendation that doctors avoid increasing dosage to a level equivalent to 90 milligrams of morphine per day and is urging doctors not to abruptly halt treatment for patients receiving higher doses of opioids unless there are indications of a life-threatening danger.

Source: CDC softens guidelines for doctors prescribing opioid painkillers (NBC)

Maryland and Missouri legalize recreational marijuana, while Arkansas, North Dakota and South Dakota reject it

More than 155 million Americans will now live in states with legal marijuana after Maryland and Missouri passed legalization referendums yesterday. Twenty-one states now have legalized recreational marijuana, marking a seismic shift since Colorado and Washington became the first a decade ago. Still, voters in Arkansas, North Dakota and South Dakota rejected recreational marijuana measures, marking the first time that multiple states have defeated marijuana referendums. None of the referendums were particularly close. Four years ago, North Dakota voters also defeated a recreational legalization referendum, while South Dakota backed a referendum in 2020 that was later thrown out by the state Supreme Court. Medical marijuana businesses donated heavily to the campaigns in Arkansas and Missouri, while in the past, advocates have struggled to raise money from industry interests. Most advocates on both sides of the legalization debate do not believe yesterday’s results on legalization will fundamentally alter the calculus of federal lawmakers.

Source: Nearly half of Americans to reside in states where marijuana is legal (Politico)

FDA issues alert on xylazine in illicit substances

The Food and Drug Administration (FDA) issued an alert to health care professionals suggesting they be cautious of possible xylazine inclusion in fentanyl, heroin and other illicit substance overdoses, as naloxone may not be able to reverse its effects. Health care professionals should continue to administer naloxone and consider xylazine exposure if patients are not responding it or when there are signs/symptoms of xylazine exposure (such as severe necrotic skin ulcerations). Health care professionals should provide appropriate supportive measures to patients who do not respond to naloxone. The FDA issued a letter to stakeholders providing clinical information about the risks of severe necrotic skin ulcerations from repeated xylazine exposure, possible withdrawal symptoms and xylazine’s interference with successful treatment of opioid overdoses. The FDA encourages health care professionals and patients to report adverse events associated with possible illicit xylazine exposure.

Source: FDA alerts health care professionals of risks to patients exposed to xylazine in illicit drugs (Food and Drug Administration)

Election results will impact health efforts in new Congress and lame-duck session

Tuesday’s election results will determine how Washington approaches health care and pharma policy from January until the 2024 presidential contest, but the fallout will also seep into the lame-duck session, set to culminate in omnibus spending by December 16. A mental health package could be in the lame-duck mix or could easily slip into next Congress. Senator Bernie Sanders is expected to lead Democrats on the Senate Health, Education, Labor, and Pensions (HELP) Committee next Congress, as current chair Patty Murray is expected to take the top slot on Senate Appropriations. Senator Rand Paul is next in line to lead HELP Republicans. Should he opt instead for the top spot on the Homeland Security and Government Affairs Committee, Senator Bill Cassidy is a leading contender for HELP. With several provisions in a 2018 law addressing the opioid crisis up for reauthorization at the end of FY 2023, that could be another avenue for mental health legislation.

Source: Lame-duck, new Congress face pharma reforms (Politico)

California approves ballot measure to ban flavored tobacco products

California overwhelmingly voted to ban all flavored tobacco products in the state through a ballot measure on Tuesday. The fate of the ban, however, could ultimately be determined by a legal fight over a previously enacted ban in Los Angeles County. R.J. Reynolds is currently challenging the initiative on the grounds that federal tobacco law does not allow states and localities to prohibit the sale of tobacco products. A federal appeals court ruled in March that states and municipalities do have the power to ban flavored products, but the company asked the Supreme Court to review that decision in October. If the Supreme Court agrees to take the case and sides with R.J. Reynolds, it could torpedo California’s ban, as well as the bans in other states and localities.

Source: California bans flavored tobacco products, including vapes (STAT)

South Dakota votes to expand Medicaid

South Dakota approved a ballot initiative to expand Medicaid. This is the seventh time a state has passed a ballot initiative to expand Medicaid, and such initiatives remain undefeated. South Dakota approved a constitutional amendment that would extend Medicaid eligibility to anyone making less than 133% of the federal poverty level. Right now, 5% of South Dakota residents are uninsured. Childless adults of working age cannot qualify for coverage at all. Pregnant women, children and the elderly can receive Medicaid benefits, but working parents must have a very low income (less than 63% of the federal poverty level, about $17,500 for a family of four) to enroll. An estimated 45,000 South Dakotans would be covered by the expansion, including about 14,000 American Indians currently ineligible for coverage.

Source: South Dakota voters decide to extend Medicaid coverage to 45,000 people +(Vox)

Pennsylvania decriminalizes fentanyl test strips

Pennsylvania Governor Tom Wolf signed into law HB 1393, which decriminalizes fentanyl test strips. The bill amends the Controlled Substance, Drug, Device, and Cosmetic Act to no longer define fentanyl test strips as drug paraphernalia.

Source: Gov. Wolf signs bill to decriminalize fentanyl test strips (WHTM)

New York attorney general secures opioid settlement with Teva

The New York attorney general secured up to $523 million from Teva for its role in fueling the opioid crisis. The settlement is the largest reached with an individual opioid defendant by the attorney general and raises the total amount secured from opioid manufacturers and distributors to more than $2 billion to combat the opioid crisis. Teva was the final remaining defendant not currently in bankruptcy and concludes the attorney general’s litigation against opioid manufacturers and distributors. The $523 million comes from two separate settlement agreements with Teva – $210.5 million from New York’s share of the nationwide settlement and $313.3 million announced today as the remedy following a liability verdict reached in a jury trial in New York against Teva last year. The settlement would also resolve lawsuits against Teva by Nassau and Suffolk Counties if the county legislatures approve it. The funds will be paid out over 18 years.

Source: Attorney General James Secures $523 Million from Top Opioid Manufacturer Teva, Bringing Total Funds for New Yorkers to More Than $2 Billion (New York State Office of the Attorney General)

Alabama attorney general reaches opioid settlement with Walmart

The Alabama attorney general announced a $44 million statewide agreement with Walmart to fund opioid abatement in Alabama’s cities and counties. This is the fifth opioid settlement negotiated by the attorney general. According to the terms of the agreement, Walmart will pay $35.7 million to Alabama’s local governments for opioid abatement, while $3 million will be dedicated to improving the connectivity and integration of the state’s local court systems. The State of Alabama was not a plaintiff in the case; the attorney general negotiated the statewide deal on behalf of local entities, many of which sued Walmart.

Source: Attorney General Steve Marshall Reaches $44 Million Agreement with Walmart to Fund Opioid Abatement Statewide (Alabama Office of the Attorney General)

Classifying fentanyl as a weapon of mass destruction could be counterproductive

Members of Congress and state attorneys general have recently made calls for the federal government to treat illicitly manufactured fentanyl as a weapon of mass destruction (WMD). While this has some intuitive and emotional appeal, it is ultimately counterproductive in efforts to stem overdose deaths. Proposed legislation to do this would not get us closer to ending the overdose crisis for several reasons. Declaring illicitly manufactured fentanyl a WMD would distract from the Department of Homeland Security’s Countering Weapons of Mass Destruction Office’s mission of preventing a nuclear attack and would duplicate and needlessly increase punitive and ineffective criminal consequences for people who use substances, and existing law and regulations allow appropriate action against weaponized fentanyl. Instead of declaring illicitly manufactured fentanyl a WMD, we need to boost evidence-based resources to combat overdose deaths, using a public health approach to substance use across the continuum of care.

Source: Illicitly Manufactured Fentanyl As A Weapon of Mass Destruction: Rhetoric And Reality (O’Neill Institute)

Big Tobacco supports smoking alternatives but still fights restrictions

Government proposals would ban menthol-flavored cigarettes and limit nicotine levels to make traditional smoking less addictive. At the same time, the government is slowly embracing vaping as an alternative by authorizing the sale of some e-cigarettes. Big Tobacco companies acknowledge that cigarettes are dangerous, and they are heralding their investments in e-cigarettes and other less harmful alternatives to cigarettes. However, they are also taking steps to slow the smokeless future they claim to want, submitting letters protesting the proposed menthol ban and signaling that they will resist efforts to lower nicotine levels. Big Tobacco is also fighting local initiatives. Industry critics say the goal is to maintain the lucrative share of the cigarette market at all costs. The industry has also persistently sued to stop graphic warning requirements and has continued to poach former Food and Drug Administration employees.

Source: Big Tobacco Heralds a Healthier World While Fighting Its Arrival (New York Times)