National News
Amid Push For Lower Drug Prices, Antibiotics Makers Want More
Even as lawmakers debate policies to lower drug prices and curtail Big Pharma profits, manufacturers that specialize in new antibiotics are begging Congress for help in staying afloat. Investors don't see the same moneymaking potential in antibiotics as with cancer and other chronic disease drugs. That's despite a clear public health need for new antibiotics, since many don't work as well due to years of overuse.
By Siddons, Published in CQ
CDC: Most People Who Died From Vaping-Linked Disease Used Products Containing THC
Most people who died from vaping-related injuries used products containing THC, the psychoactive ingredient in marijuana, federal health officials said Friday, offering another data point tying the outbreak of lung illnesses to products made with that compound. Based on data available from 860 of the 1,604 patients who have fallen ill with the disease, about 85 percent reported using THC-containing products, compared to about 10 percent who reported exclusively vaping nicotine-containing products, officials said. Many sick patients said they bought THC vape products on the black market, and those have come under increased scrutiny.
By Sun, Published in The Washington Post
Drugs Most Involved In Overdose Deaths Vary By Region
Fentanyl remains the drug most associated with deaths in the United States, but methamphetamine is linked to more deaths in some parts of the country, according to federal drug overdose data released Friday. Fentanyl, a highly potent opioid, is the drug most involved in overdose deaths in all regions east of the Mississippi River. In western parts of the country, methamphetamine is the leading drug associated with overdose deaths.
By Raman, Published in CQ
FDA Awards Grant to the NABP to Establish an Information-sharing System and Research Interstate Distribution of Compounded Drugs
The U.S. Food and Drug Administration is announcing that it has awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP) to establish an information-sharing system for drug compounding activities that are primarily overseen by states. The roughly three-year pilot project undertaken through this grant will work to improve the information available to state regulators and the FDA about state-licensed entities, primarily pharmacies, that engage in drug compounding and distribute compounded drugs interstate. The overall goal is to help provide more targeted regulation and oversight of compounded drugs, while ultimately reducing risk to patients.
The agency's goal for the system developed through this grant is to help enable states to enter into memorandum of understanding (MOU) agreements, once finalized, with the FDA that will reduce the potential resource burden associated with collecting and sharing information on interstate distribution. The FDA plans to finalize the MOU later this year. At the conclusion of the grant, a final pilot project assessment report will be provided to the agency, including recommendations for future collaboration.
FDA Generic Approvals Hit a New Record, but the Effort's Not Paying Off Yet
Under former commissioner Scott Gottlieb, the FDA pledged to approve more low-cost generics to compete with pricey branded meds. And that it did in fiscal 2019, signing off on a whopping 1,171 of them-a new record. But new research found the approvals haven't necessarily delivered the hoped-for savings.
Despite efforts by the FDA and others to take on high drug prices, U.S. prices remain higher than any other country. President Donald Trump has made the issue a priority, but some of the administration's efforts have faced setbacks. Gottlieb resigned earlier this year, and the administration walked back its proposal to take on drug rebates after a Congressional Budget Office review. HHS still hopes to force drugmakers to include prices in TV ads.
By Eric Sagonowsky, Published in Fierce Healthcare (edited) 
States Try A Gentler Approach To Getting Medicaid Enrollees To Work
Under pressure from the Republican-controlled Pennsylvania legislature to require Medicaid recipients to work as a condition for coverage, state health officials have devised a gentler approach to getting beneficiaries into jobs. Starting early next year, the Pennsylvania Medicaid agency under Democratic Gov. Tom Wolf will ask people when they enroll if they want job training assistance. It will then require its private Medicaid managed-care organizations to connect those who want help to local employment specialists and follow up to make sure they got it.
Pennsylvania's effort to assess enrollees about their job training interest comes after the governor has twice vetoed legislation to enact work requirements. The legislature will take up the same bill this year.
The Trump administration has approved requiring work in nine states, with requests from nine others pending. Arkansas is the only state to implement the requirements, and more than 18,000 enrollees there lost coverage from June 2018 to March 2019 - with little sign many found jobs.
Since then, a federal judge struck down the work requirements in Arkansas, Kentucky and New Hampshire. The Trump administration and the states are appealing the decision.
A handful of states are offering alternatives to get more enrollees into jobs to lift them out of poverty and off Medicaid, the federal-state health program for low-income residents.
In Montana, about 32,000 of the 95,000 adult enrollees who gained coverage when the state expanded Medicaid in 2016 have received employment services from the state, including 4,200 who received one-on-one employment training services.
In August, Louisiana began a pilot program to train Medicaid enrollees for jobs such as a nursing assistant, commercial driver and forklift operator. It expects 50 people to complete the training this year at a community college.
Conservatives nationwide have pushed for work requirements since Medicaid expanded dramatically under the Affordable Care Act. That law allows states to use federal funds to provide coverage to all adults with incomes below 138% of the federal poverty level, or $17,230 for an individual. Before that, many states limited adult enrollment to pregnant women, parents and people with extremely low incomes.
Despite the focus on getting Medicaid enrollees into jobs, studies show most people on Medicaid already work, and many of the rest have some disability, go to school or are caring for a family member.
By Phil Galewitz, Published in Kaiser Health News (edited)
State News



Governor's Bill-Signing Marathon Offers Glimpse Of 2020 Issues


Newsom signed SB-276 and an accompanying measure, which will give state public health officials authority to review and, in some cases, revoke questionable medical exemptions for childhood vaccinations.


AB-824 will give the state attorney general more power to go after pharmaceutical companies that engage in "pay for delay," a practice in which makers of brand-name drugs pay off generic manufacturers to keep the lower-cost generic versions of their medications off the market.


And legislation adopted as part of the state budget this year will require Californians to have health insurance next year or face a penalty. The budget also funded new state-based tax credits for Californians who purchase health insurance through Covered California, including some who earn too much to qualify for federal financial aid.


Also starting next year, young adults in the country illegally will be eligible for Medi-Cal if their incomes qualify.


An additional bill of interest to pharmacies is SB-159 by state Sen. Scott Wiener (D-San Francisco) which will allow pharmacists to dispense a 60-day supply of PrEP, a once-a-day pill for HIV-negative people that may keep them from becoming infected or a 28-day course of PEP a medication that can help prevent the virus from taking hold if they have been exposed to it.. Patients will need to see a physician to obtain more medication. The bill prohibits insurance companies from requiring patients to obtain prior authorization before obtaining the medication.

Kaiser Health News (edited)




Hepatitis A Infections Rising 

The number of hepatitis A infections in Minnesota has been consistently climbing since spring, and state health officials are urging people at risk to get vaccinated. Infections were initially reported mostly in the north-central part of the state but have recently moved into the Twin Cities, said Kris Ehresmann, director for infectious disease at the Minnesota Department of Health.

By Collins Published by MPR




Appeals Court Overturns $110 Million Talc Verdict

A Missouri appeals court has overturned a $110 million verdict in a case alleging that Johnson & Johnson products containing talcum powder caused a Virginia woman's ovarian cancer. The appeals court ruling Tuesday reversed a 2017 judgment on behalf of Lois Slemp. She is among many women whose lawsuits have claimed that Johnson & Johnson's talcum powder contributed to their cancer. Johnson & Johnson says its Baby Powder is safe and does not cause cancer.

            Published By The Associated Press




Four companies reach $260M opioid settlement with Ohio counties 


Four large drug companies reportedly reached a $260 million legal settlement over their role in the U.S. opioid addiction epidemic, striking a deal with two Ohio counties just before the first trial concerning the opioid crisis was set to begin Monday.

Drug distributors AmerisourceBergen, Cardinal Health and McKesson will contribute $215 million toward the settlement, according to Hunter Shkolnik, an attorney for the counties.

Teva is paying $20 million in cash and will contribute $25 million worth of Suboxone, an opioid addiction treatment, according to Shkolnik. The deal settles claims brought by Ohio's Cuyahoga and Summit counties, which had accused the companies of fueling a nationwide opioid crisis. Some 400,000 U.S. overdose deaths between 1997 and 2017 were linked to opioids, according to government data.


According to the report, a new trial date for the remaining defendant. Walgreens Boots Alliance has not been determined.

WBA said in a statement to CNBC on Monday that it only sold opioids to fill a valid prescription written by a licensed physician. It said it was diligent to prevent the diversion of controlled substances. 

By Sandra Levy, Published in Drug Store News




Ohio's Largest Medicaid Provider Cuts Ties With Walgreens 
More than half of Ohio's Medicaid recipients will lose access to Walgreens pharmacies on Jan 1. CareSource, Ohio's largest Medicaid provider, is cutting ties with the state's second-largest pharmacy retailer. Walgreens, Ohio's second-largest pharmacy retailer, will no longer service the state's largest Medicaid provider as of Jan 1, raising concerns about creating pharmacy "deserts" in parts of Ohio.

By Schladen, Published in Columbus Dispatch

PFOA Board of Directors
Todd Pendergraft

Dirk Andrepont
David Spence
Doug Coyle

Gabriel Guijarro
Ty Stout
Phil Rigsby

Gaye Moseman
John Zuzak

Larry McIntosh

Eric Pusey 

PFOA-MS Board of Directors
Doug Coyle
David Cole

Phil Rigsby

PFOA-MC Board of Directors

Eric Pusey
Gene Windom
Bobbie Barbrey

For Board of Directors contact information, please call 314-843-5977