FDA Tries To Fill The Gap For Smoking-Cessation Drug Chantix

CIDRAP: FDA Works To Mitigate Shortage Of Quit-Smoking Drug 
In July and August Pfizer voluntarily recalled a total of 16 lots of its smoking-cessation drug, Chantix (varenicline), due to unacceptably high levels of the carcinogen N-nitroso-varenicline, and the Food and Drug Administration (FDA) has taken steps to address the shortage. The company still hasn't publicly announced any resolution timeline for its shortage, and a company representative was not available for interviews on the matter. However, in the interim, the US Food and Drug Administration (FDA) has relaxed regulations and turned to drug companies Apotex and Par Pharmaceuticals to help fill the gap. (McLernon, 8/27)

ScienceDaily: Subscription-Based Payment Models May Improve Access To Hepatitis C Medications 
Subscription-based payment models (SBPM), a novel approach in which states contract exclusively with a single manufacturer to supply prescriptions at a reduced price, could increase access to these life-saving treatments, according to a new study. In a SBPM, states pay reduced per prescription prices for medications until a certain utilization threshold. After this threshold, the cost of additional prescriptions is essentially zero. (Boston University School of Medicine, 9/3)

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Stat: Would Letting Medicare Negotiate Drug Prices Make Others Pay More?
As Democrats design a way to use the government’s leverage to lower drug prices for seniors, they are facing the possibility that drug makers could try to make up their profits by hiking prices for private insurers instead. Lawmakers in both the House and Senate are eyeing drug pricing reforms as part of a major legislative push to deliver on President Biden’s agenda this fall. A key pillar of that platform is allowing Medicare to negotiate prices with drug makers — but exactly how meaningful that policy will be is still being hammered out, according to House and Senate aides and lobbyists working on the policy. (Cohrs, 9/3)

Axios: Pharma's Uphill Messaging Battle Over Drug Prices 
The success of Democrats' attempt to allow Medicare to negotiate prescription drug prices hinges on whether the drug industry can persuade voters — particularly seniors — that the policy would result in fewer new drugs, an endeavor that experts say is an uphill battle. Why it matters: Seniors are both directly impacted by the policy and disproportionately likely to vote in midterm elections, meaning what they think is incredibly influential. (Owens, 9/8)

Forbes: Political Preoccupation With Prescription Drug Costs May Distract From Larger Problem Of Hospital Costs
It’s no secret that per capita healthcare costs are very high in the U.S. This wouldn’t be as much of a problem if the system produced correspondingly excellent health outcomes. But, overall, it doesn’t. The U.S. ranks at or near the bottom among peer nations. To address healthcare costs, politicians on both sides of the aisle have been crafting legislation that mostly targets prescription drugs, while generally ignoring other healthcare sectors. Whether it’s the Elijah E. Cummings Lower Drug Costs Now Act, H.R. 3, the Biden Administration’s July executive order, or the prescription drug expenditure component contained in the budget reconciliation blueprint, the almost exclusive focus is on reducing drug spending. (Cohen, 9/1)

CNBC: Here's How Pharmacies Set Drug Prices, And What Consumers Can Do To Save Money
Americans are having a tough time paying for medications despite bipartisan efforts to drive down prescription drug prices. Nearly 1 in 4 Americans say it’s difficult to afford their medications, according to a March 2019 poll by the Kaiser Family Foundation. This comes as pharmacies raked in a record $465 billion from prescriptions. Lawmakers from both parties support lowering drug prices, but they haven’t had much success regulating the industry. In September 2019, U.S. Rep. Frank Pallone, D-N.J., introduced the Elijah E. Cummings Lower Drug Costs Now Act. The House passed the bill in December 2019, but it died in the Senate. (Morabito, 8/26)

Politico: Drug Industry Banks On Its Covid Clout To Halt Dems’ Push On Prices 
As Democrats prepare a massive overhaul of prescription drug policy, major pharmaceutical companies are mounting a lobbying campaign against it, arguing that the effort could undermine a Covid fight likely to last far longer than originally expected. In meetings with lawmakers, lobbyists for the pharmaceutical industry have issued warnings about the reconciliation package now moving through both chambers of Congress that is set to include language allowing Medicare to negotiate the price of some drugs, which could generate billions of dollars in savings. (Fuchs, Ollstein and Wilson, 9/2)