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EPA Offers Clarity to Farmers in Light of Recent Court Vacatur of Dicamba Registrations

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The U.S. Environmental Protection Agency (EPA) issued a key order providing farmers with needed clarity following the Ninth Circuit Court of Appeals’ June 3, 2020 vacatur of three dicamba registrations. Today’s cancellation order outlines limited and specific circumstances under which existing stocks of the three affected dicamba products can be used for a limited period of time. EPA’s order will advance protection of public health and the environment by ensuring use of existing stocks follows important application procedures.

“At the height of the growing season, the Court’s decision has threatened the livelihood of our nation’s farmers and the global food supply,” said EPA Administrator Andrew Wheeler. “Today’s cancellation and existing stocks order is consistent with EPA’s standard practice following registration invalidation, and is designed to advance compliance, ensure regulatory certainty, and to prevent the misuse of existing stocks.”

EPA’s order will mitigate some of the devastating economic consequences of the Court’s decision for growers, and particularly rural communities, at a time they are experiencing great stress due to the COVID-19 public health emergency.

Details of the Order

EPA’s order addresses sale, distribution, and use of existing stocks of the three affected dicamba products – XtendiMax with vapor grip technology, Engenia, and FeXapan.

  1. Distribution or sale by any person is generally prohibited except for ensuring proper disposal or return to the registrant.
  2. Growers and commercial applicators may use existing stocks that were in their possession on June 3, 2020, the effective date of the Court decision. Such use must be consistent with the product’s previously-approved label, and may not continue after July 31, 2020.

Background

DOR’s Annual Public Hearing Set for June 26, Includes Online Access

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The Indiana Department of Revenue (DOR) will host this year’s annual public hearing on June 26, 2020, at 10 a.m. EST to provide customers with a general overview of the agency’s progress and allow direct feedback from the public.

“Giving Hoosiers a forum in which they can have their voices heard is just one of the ways DOR continuously improves and provides best-in-class service,” stated DOR Commissioner Bob Grennes who will provide updates on the agency’s successes, challenges and future. Chief Information Officer Kevin Gulley will also provide an update on Project NextDOR, the agency’s multi-year modernization initiative.

TO ATTEND:
To adhere to social distancing guidelines, interested customers and stakeholders may attend the hearing in-person and follow the required safety guidelines or watch online.

  • To attend in-person, customers will need to RSVP by emailing media@dor.in.gov by Thursday, June 25. Upon arrival, attendees are required to enter the public entrance and security checkpoint of Indiana Government Center North and then check-in at the first-floor lobby of DOR. All hearing attendees are encouraged to wear face masks.
  • To watch online, individuals can visit the annual public hearing section on DOR’s website at dor.in.gov/4877.htm for the meeting link. Online viewers can log into the meeting starting at 9:45 a.m. EST and the meeting will begin promptly at 10 a.m. EST.

TO PROVIDE COMMENT:

  • Individuals attending in-person or watching online may submit comments to DOR prior to the meeting by emailing media@dor.in.gov by Thursday, June 25. All comments will be read aloud and included in the meeting minutes posted online after the hearing.
  • Individuals wishing to attend in-person and speak during the hearing are, again, encouraged to email media@dor.in.gov to RSVP and reserve a speaker slot.

DOR will post a complete video of the hearing along with meeting minutes at dor.in.gov/4877.htm.

COMMENTARY: The Right To Assemble And To Seek Redress Of Grievances Is Enshrined In Our Constitution.

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CCO Supports The Right To Assemble And To Seek Redress Of Grievances Is Enshrined In Our Constitution.

We support those who have taken to the streets to exercise their First Amendment rights to peacefully express their anger and sorrow about George Floyd’s death.  We strongly opposed the discrimination and racial injustice of people of color.  We also oppose discrimination of people of all races, color, creed, and sexual orientation.

Over the last several weeks, we have witnessed peaceful and violent protests alike throughout America. The death of George Floyd caused by several Minneapolis law enforcement officers was the tipping point that has awakened America. The George Floyd tragedy has re-enforced the opinions that many in the minority community have felt for years, that they are unfairly treated by law enforcement and the courts.

It’s obvious that outside groups and agitators are attempting to foment lawlessness and unrest to advance their own objectives to cause anarchy in America. We are a nation born of the revolutionary spirit of protest, coupling expressions of grievances against injustice with the desire to be free.

We deplore the theft, lotting, and the burning of businesses and historical landmarks caused by the random acts of lawless anarchists and thugs. In fact, we believe that these lawless thugs should be arrested and thrown in jail.  Also if any members of law enforcement cause bodily harm or violate peaceful protester’s constitutional rights they should immediately be dealt with in the appropriate manner. We’re optimistic that in the future proper restraints will be practiced by both the protestors and police alike.

Law enforcement officers are human and they make mistakes. We believe that the majority of the members of law enforcement understand that carrying a badge and gun has a responsibility and understand when to use force and when to use restraint.  They now understand what one bad decision will unleash. We also feel that there are some individuals currently in law enforcement that should be terminated because of their professional misconduct.  We also believe that the overwhelming majority of the members of our local law enforcement are professional, dedicated, ethical, and caring.

Last Saturday Mayor Winnecke and members of our law enforcement approved a plan that allowed protesters to stage a peaceful protest march starting at the Four Freedom Monuments and ended at the Ford Center.  To their credit, this event turned out to be a glorious day for the rights of people to peaceful protests and to excise their freedom of speech rights.

It’s time that our elected legislative bodies, judges, members of law enforcement, members of our criminal justice system, local clergy, community leaders and civil rights activists meet to discuss to look for ways to revise the outdated, unreasonable and discriminatory laws currently on the books in order to correct future racial injustice.

We are told that a peaceful protest is planned sometime during the next several weeks. It would be wonderful if Mayor Winnecke, City Council members, Vanderburgh County Commissioners and County Council members, Sheriff Dave Wedding, Police Chief Billy Bolin, Judges, local clergy, and civil rights activists march with the peaceful protesters to publically denounce prejudice and discrimination?  This march would show that “Evansville Is For Everone!”!

The right to assemble and to seek redress of grievances is enshrined in our Constitution. “No one is free when others are oppressed.”

 

 

 

 

Obituary Of Evansville Firefighter James “Jim” Scott Pfender

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Obituary Of Evansville Firefighter James “Jim” Scott Pfender

James “Jim” Scott Pfender, 48, of Newburgh, Indiana, passed away Monday, June 8, 2020.

Jim was born in Victorville, California on April 20, 1972, to Kathy A. (Paul) Barnett and Tom R. Pfender. He graduated from North High School in 1990 and went on to receive his Associate of Science in Nursing from the University of Southern Indiana.

Jim served his community as an ER trauma nurse for Deaconess Hospital and as a firefighter for the Evansville Fire Department for 20 years. He was a decorated captain and currently served at Hose House No. 9. Jim was very particular about everything in his life. In his free time, Jim enjoyed golfing, fishing, playing poker, and volunteering for the Court Appointed Special Advocate (CASA). Above all else, Jim loved being with his family, especially his twins, Dani, and Sam. He will be deeply missed by all who knew him.

Jim is survived by his twins, Dani and Sam Pfender, and their mother, Kim Haywood-Pfender, all of Newburgh, IN; mother, Kathy A. (Paul) Barnett (Steve A.) of Evansville, IN; father, Tom R. Pfender (Susan) of Evansville, IN; brother, Dave Pfender (Mandy) of Evansville, IN; step-sisters, Lisa Jarrell (Michelle) of Pendleton, IN and Laura Barnett of Austin, TX; nephew, Ryan Pfender of Evansville, IN; grandmother, Bernadette Paul of Evansville, IN; and many aunts, uncles, and cousins.

Jim was preceded in death by his grandparents, June and Melvin R. Pfender, and Marvin Paul.

Services will be held at 11:00 AM on Saturday, June 13, 2020, at Browning Funeral Home, 738 Diamond Ave., Evansville, IN 47711. Burial will follow at Sunset Memorial Park Cemetery.

Friends may visit from 2:00 PM until 8:00 PM on Friday, June 12, 2020, at Browning Funeral Home, and again from 10:00 AM until service time on Saturday, June 13, 2020, at the funeral home.

In lieu of flowers, memorial contributions may be made to Court Appointed Special Advocate (CASA), 600 SE 6th Street, Evansville, IN 47713, or the charity of your choice.

Condolences may be made online at www.browningfuneral.com.

Donatos Pizza to Open Evansville Location on June 9 th

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22􏰏􏰏nd restaurant in Indiana serving the brand􏰐s award-winning􏰒􏰑 Edge-to-Edge􏰓 pi􏰉􏰉zza

EVANSVILLE, Ind. (June 5, 2020)—Donatos Pizza is pleased to announce the opening of Donatos Pizza Evansville on Tuesday, June 􏰎. Tri-State Pizza, led by managing partners Sean Byrne and Mark Riney, look forward to bringing Donatos premium pizza, salads, subs, and wings to the community after successfully opening their first location in Owensboro, Kentucky three years ago.

“We are really excited about getting our second restaurant opened,” said Byrne. “We can’t wait to introduce the people of Evansville to this great pizza and to also find ways to partner in the community.”

The new location will offer online ordering at donatos.com for order-ahead pickup and delivery options. iPhone and Android users will also find the Donatos app extremely easy to order their favorite menu items. Donatos Pizza Evansville will feature seating for 􏰆0 people in its 2,􏰆00- square-foot store located at 􏰅10 S. Green River Road that will also feature a pickup window. This restaurant will employ approximately 45 full-time and part-time associates and will be open from 10:30 a.m. to 10 p.m. Sunday through Thursday and from 11 a.m. until 11 p.m. on Friday and Saturday.

One of the hallmarks of Donatos Pizza has also been giving back in the community where they serve. Tri-State Pizza has already proven to be very active in the Owensboro community with its first restaurant and they plan to partner with schools, businesses, and charities in the Evansville community.

“We are excited to open this new location in Evansville,” said Donatos CEO Tom Krouse. “Our franchise partners, Sean and Mark, have done a tremendous job with their first restaurant and we are looking forward to more great things as they now have the opportunity to give a good thing in a new community.”

The menu features Donatos’ famous Edge-to-Edge􏰓 pizza, with toppings loaded from one edge to the other, all atop a layer of aged provolone cheese. Each large pepperoni pizza boasts 100 pieces of pepperoni, and customers can mix and match from a variety of 25 toppings including fresh vegetables that are hand-cut daily. Donatos Pizza Evansville will also serve fresh salads, oven-baked subs, and boneless or traditional baked chicken wings that are available naked, sauced or dry-rubbed.

HEALTH DEPARTMENT UPDATES STATEWIDE COVID-19 CASE COUNTS

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The Indiana State Department of Health (ISDH) today announced that 430 additional Hoosiers have been diagnosed with COVID-19 through testing at ISDH, the Centers for Disease Control and Prevention (CDC) and private laboratories. That brings to 38,033 the total number of Indiana residents known to have the novel coronavirus following corrections to the previous day’s total.

Intensive care unit and ventilator capacity remain steady. As of today, nearly 39 percent of ICU beds and more than 82 percent of ventilators are available.

A total of 2,158 Hoosiers are confirmed to have died from COVID-19, an increase of 23 over the previous day. Another 181 probable deaths have been reported based on clinical diagnoses in patients for whom no positive test is on record. Deaths are reported based on when data are received by ISDH and occurred over multiple days.

To date, 315,390 tests have been reported to ISDH, up from 309,503 on Monday.

Hoosiers who have symptoms of COVID-19 and those who have been exposed and need a test to return to work are encouraged to visit a state-sponsored testing site for free testing. Individuals without symptoms who are at high risk because they are over age 65, have diabetes, obesity, high blood pressure or another underlying condition, as well as those who are pregnant, live with a high-risk individual or are a member of a minority population that is at greater risk for severe illness, also are encouraged to get tested.

To find testing locations around the state, visit www.coronavirus.in.gov and click on the COVID-19 testing information link. More than 200 locations are available around the state.

 

Vanderburgh County Board of Commissioners Agenda

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AGENDA of the  Vanderburgh County Board of Commissioners

Old National Events Plaza Ballroom B, C

June 9, 2020, at 10:00 am

  1. Reconvene Emergency Meeting
  2. Attendance
  3. Pledge of Allegiance
  4. Action Items 
    1. County Treasurer: LawMan Security and Consulting Contract
    2. Continuation of Public Hearing and Final Reading of Vacation Ordinance CO.V-05-20-001: Petition to Vacate a 12’ Public Utility and Drainage Easement at 2140 West Haven Drive
    3. Public Hearing and Final Reading of Vacation Ordinance CO.V-06-20-003: Petition to Vacate a Portion of a 12’ Alley at 500 N. Woods Avenue
    4. Computer Services: 
      1. Granicus Agreement Extension 
      2. AT&T Contract for FirstNet Services
    5. Sheriff’s Office: Memorandum of Understanding with LexisNexis
    6. Superior Court: Contract for Professional Services with David Taylor Nellis
  5. Department Head Reports
  6. New Business
  7. Old Business
    1. St. Joseph Avenue July 6th Road Closure
  8. Consent Items
    1. Approval of May 26, 2020 Emergency Meeting Minutes
    2. Employment Changes 
    3. County Treasurer April 2020 Monthly Report
    4. County Auditor: Claims Voucher Reports 5/25-5/29/2020 & 6/1-6/5/2020
    5. Surveyor’s Office Surplus Request
  9. Public Comment
  10. Recess Meeting

Capital One and Other Debt Collectors Are Still Coming for Millions of Americans

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Capital One and Other Debt Collectors Are Still Coming for Millions of Americans

As the COVID-19 pandemic hit, Americans got protection from evictions, foreclosures and student debt. But debt collectors have continued to siphon off their share of paychecks from those who still have jobs.

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published.

Since 2018, Capital One has been a looming presence in Julio Lugo’s life, ever since the company sued him, as it did 29,000 other New Yorkers that year, over an unpaid credit card. But when the coronavirus hit the city this March, it wasn’t on his mind.

At Mount Sinai in Manhattan, where he works, he’d been drafted into the hospital’s frenzied effort against the virus. He normally gathered patient information at the front desk of a radiology clinic in orderly shifts, 9 to 5. Now he was working 16-hour days, often overnight. At one moment he might be enlisted to help a team of doctors or nurses put on their full-body protective equipment and then he would rush to disinfect another team. He lost track of the days, only orienting himself by the need to juggle care with his ex-wife of their two young children who were now out of school.

But despite a global pandemic, Capital One didn’t forget about him. The company began in late March to seize a portion of his wages to collect on that debt — one that he says wasn’t even his.

Federal, state, and local officials have all taken some steps to protect Americans from the ravages of the economic crash due to COVID-19. Congress halted a substantial portion of evictions, foreclosures, and collection on student loans. And when it sent $300 billion in stimulus checks out to families, many states took steps to make sure that debt collectors didn’t grab the money. But one of the most aggressive and common forms of debt collection has generally been allowed to continue: the seizure of wages for old consumer debts.

The main protection Americans have gotten from debt collectors has been inadvertent, a byproduct of state courts being closed to most hearings, including those pushed by debt collectors. But this didn’t help people like Lugo who were the target of actions that began before the closures. Wage garnishments can run indefinitely once begun. As a result, essential workers and others who were lucky enough to keep their jobs have still been at risk of forfeiting a portion of their paychecks.

No one tracks wage garnishments either federally or at the state level, and that’s a key reason they get little public attention. But ProPublica has found that it hits workers earning $40,000 or less the hardest and is particularly common in predominantly black communities. Because garnishments are set at a percentage of income (25% in most states) regardless of whether someone can afford it or not, they often provoke a financial emergency and cause the debtor to let other bills go unpaid.

While new collection activity has dropped off, some major debt collectors have been laying the groundwork for a return to normal by filing suits by the thousands, according to a ProPublica review of online court records from county and state court websites. For example, in Maryland, two major debt collectors alone filed over 2,000 suits in April.

When the courts fully reopen, as they already have in some states, these companies will be first in line to win new court judgments. Those debtors who still have jobs will be forced to either make payments or risk their wages being seized. With 48% of American households have experienced a loss of employment income in the past few months, many will have no wages to take. But debt collectors can be patient and wait until they do.

Even more worrying to consumer advocates is what lies ahead. Households often rely on credit cards during moments of financial stress. In recent months, more have been paying the rent with their cards. Eventually, the bill will come due, which could lead to a wave of collection suits as the nation attempts to recover.

“There’s going to be a whole swath of people who never thought they’d be in a position to default,” said Pamela Foohey, a law professor at Indiana University who argues in a recent paper with two colleagues that Congress should impose a debt collection moratorium to allow for recovery. “It’s not productive to be garnishing people’s wages when they need to pay for food and get back on track financially,” she said.

Over the past couple of decades, Capital One, Lugo’s pursuer, helped lead the way in transforming the nation’s local courts into collection machines. As recently as the 1990s, these courts conformed to the picture most people have in their heads, primarily working as a venue where a judge resolved disputes between two sides represented by a lawyer. Now the most common type of case is debt collection, a recent Pew Charitable Trusts report found. Lining up against debtors who are almost never represented by an attorney, debt collection companies win millions of court judgments each year, which then allow them to seize debtors’ wages for years into the future. An old unpaid bill will fall off a credit report after seven years, but a court judgment can haunt someone forever.

While different types of plaintiffs may flood the courts in different areas (from payday lenders to nonprofit hospitals), those collecting on credit card debt have driven this trend over time, according to ProPublica’s review of court data from several states.

The change has been obvious in courts everywhere, from New York to Las Vegas (where the local court decided to give such cases their own category, “Civil – Credit Card Collection”) to rural Iowa.

“It does bother me that courts have become a sort of a tool for credit card companies. We’ve just become part of their business machinery,” said Judge Chris Foy, who presides over the district court in the small town of Waverly, Iowa.

The most common plaintiffs don’t tend to be household names that advertise with bold TV campaigns: Most are debt buyers, companies that buy up bad debts in bulk. The exception is Capital One.

Aggressive debt collection is key to Capital One’s profitability. Last year, the same year the company reported $5.5 billion in net income, it recovered $1.4 billion from its card accounts that had been previously charged-off, or recognized as losses. It was a haul hundreds of millions of dollars beyond any other card issuer, even much larger ones like JPMorgan Chase.

In a statement, a Capital One spokeswoman said the bank files more suits than other banks because it makes riskier loans. According to public filings, as of the end of this year, one-third of Capital One’s cardholders had a credit score under 660, generally considered the threshold that identifies those most likely to have trouble paying debts back. The bank’s current card offers for such customers carry an annual interest rate of 27%.

“Most regional, community, and especially large banks retreated from the subprime segment to focus on more affluent customers, resulting in a growing population of people with less access to the banking system,” the spokeswoman said. “Capital One remains a full spectrum lender.”

“Debt collection for us is about helping customers resolve their delinquent debt and reducing losses, not making money,” she said, and the bank always attempts to work with borrowers before suing. As for Lugo’s case, the company said it couldn’t comment because it was currently in litigation.

The best estimate of the national scope of garnishments comes from ADP, the nation’s largest payroll services provider. At the request of ProPublica, ADP first undertook a study of payroll records six years ago. It followed up with a second survey in 2017. Both times, it found that 2.9% of workers had their wages garnished for consumer debts in the previous year. That works out to about 4 million nationally. Notably, both surveys were done during a period of economic expansion. In the Great Recession, between 2007 and 2009, the number of suits skyrocketed, according to ProPublica’s review of filings from several states.

Court judgments also allow collectors to seize money from bank accounts, often emptying them. But taking a portion of a paycheck is far more common, according to a ProPublica review of court data in Missouri and Georgia.

When the coronavirus outbreak hit, New York, like many other states, took several steps to protect vulnerable people, such as halting evictions or new garnishment orders. But the state let existing wage garnishments continue. Consumer advocates and the New York City Bar called on Gov. Andrew Cuomo to fill that gap and suspend all garnishments. So far, he has not, despite moves by some other states, such as Nevada, to do so. In New York, plaintiffs can take up to a tenth of a debtor’s pay.

Cuomo’s office did not respond to a request for comment.

Lucian Chalfen, a spokesman for the New York State Courts, told ProPublica that garnishments were allowed to continue because “existing orders were considered essential matters.”

Those burdened with a garnishment amid the pandemic could request an emergency court hearing to have it suspended, according to guidance given to the city’s marshals, who administer garnishments. Michael Wolz, a spokesman for the marshals, said they “do everything they can to accommodate” people with hardships.

Susan Shin, legal director of the New Economy Project, a legal aid organization in New York City, said her group has been getting calls since March from New Yorkers asking for help with ongoing wage seizures. Capital One was often the plaintiff. People were afraid of risking their health to go out and seek help from the courts. “Why to put someone in that position?” she said. Relatively few people who need help find their way to legal aid.

ProPublica spoke with three New Yorkers who struggled to address seizures of their pay after the pandemic hit. Although all three managed to eventually halt the garnishments with the help of a legal aid attorney, the cases show how such suits can hang over people’s lives for decades. Two of them asked ProPublica not to use their last names out of fear it would displease their employers.

Capital One, asked about the cases, said, “Our policy is to work with any customer who needs help and is impacted by COVID-19.”

Capital One sued Robert in 2007 for about $1,900. He is HIV positive and fell behind because of health issues, he said, and has been in and out of work over the years. For almost a decade, he said, he didn’t hear from Capital One. But last fall, soon after Robert began a new job, he received a notice telling him to arrange payment on the debtor he would be at risk of garnishment.

He eventually struck a settlement to pay Capital One a total of $300 on a payment plan of $20 a month. But shortly after he made his first payment, he was shocked to find that his wages had been garnished anyway. The seizures continued for weeks, well into March of this year. Both Capital One and the marshal’s office told ProPublica that Robert’s employer had been sent notice not to execute the garnishment, but that it had done so anyway in error and that the checks had been promptly mailed back to the employer.

Capital One sued Grace, a social worker in Queens, in 2013 after she lost her job and fell behind on her payments. Like Robert, she said she hadn’t heard from Capital One for years. In February, she received a letter from the marshal warning her that her pay would be garnished if she did not make other arrangements to pay off her debt of $2,800.

When the virus hit and the courts largely shut down, she assumed it was a problem that could wait. “I was just trying to get by,” she said. After the garnishment started, she searched online for help and found her way to Shin, the legal aid lawyer. The money has since been returned, but Grace knows the seizures could start again when the courts reopen.

Given Lugo’s hectic days and nights working at the hospital, it wasn’t until mid-April, when 500 New Yorkers were still dying every day from the virus, that he discovered $168 missing from his latest paycheck. Although he was sued in 2018, he didn’t find out about the suit until his wages began to be garnished last year, he said. One reason is that the debt is not his, he said.

In a legal filing, with the help of a legal aid attorney, he argued that his now-deceased father likely stole his identity to take out the card. A process server falsely claimed to have served his mother with notice of the suit, he said.

The filing stopped the garnishments last year, but in early March, he missed a court hearing because it conflicted with a parent-teacher conference at his child’s school, he said. He thought the hearing would be rescheduled, but unbeknownst to him, it triggered a new garnishment.

“Being that the courts were closed, I couldn’t understand how they could just start taking out money again without letting me know,” he said.

Eventually, again with help from a legal aid attorney, he was able to stop the garnishment and get a new court date, currently set for August.

After the virus hit in March, Capital One largely suspended filing any new debt-collection lawsuits. But other big debt collectors did not, including Encore Capital, the nation’s largest debt buyer. ProPublica reviewed online court filings in eight states where courts had largely stopped hearing new cases and found that Encore still filed over 1,600 lawsuits in April.

Encore reported collecting $1.3 billion in old debt in the U.S. last year and was looking forward to another good year when March came.

Encore CEO Ashish Masih told analysts last month that the company is still optimistic. Widespread unemployment and the courts closing hurt the company’s near term prospects, but Masih said this would only cause a “delay, not a permanent loss” in what the company hoped to collect in 2020. Eventually, he said, “the court processes will start working,” and “we hope to recoup about 90% of collections over time.”

In response to questions from ProPublica, Encore said that according to its company policy, “We’ve suspended collections for any consumer who lets us know they’ve been directly impacted by COVID-19.”

Across the country, courts are taking steps to resume full function. In Arkansas, where the virus did not initially hit hard but has been spreading faster lately, the state supreme court announced in early May that all courts could reopen to hearing any type of case starting May 18. How exactly to do this is up to local courts, and solutions range from video hearings to in-person hearings with a limited number of people in the courtroom and temperature checks before entering.

Wage garnishments in the state never stopped, said Susan Purtle, an attorney with Legal Aid of Arkansas, which serves almost half the state. That’s partly due to a large number of meat processing plants there, she said. “Those clients have continued to work,” she said, and so had wages to take.

But recently, she said, calls about new suits have been coming in. Typically, she’s seeing court hearings scheduled for July or August. Once they begin again, collectors will resume winning judgments that can be used to collect on the debtors who still have jobs. For the ones who don’t, the companies will wait until they do.

FOOTNOTE: Ellis Simani contributed reporting.

Senator Braun Introduce Promising Pathway Act For Patients With Serious And Life-Threatening Illnesses

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Senator Braun Introduces Promising Pathway Act for Patients With Life-Threatening Illnesses

WASHINGTON, D.C. – Today, Senator Mike Braun (R-IN), Senator Lisa Murkowski (R-AK), and Senator Martha McSally (R-AZ) introduced the Promising Pathway Act (S. 3872) to give those struggling with serious and life-threatening illnesses a fighting chance at receiving meaningful treatments.

The Promising Pathway Act requires the U.S. Food and Drug Administration (FDA) to establish a rolling, real-time, priority review pathway to evaluate provisional approval applications for drugs intended to treat, prevent, or diagnose serious or life-threatening diseases or conditions, including those that pose a threat of epidemic or pandemic.

Under this pathway, provisional approval would be granted by the FDA to drugs demonstrating substantial evidence of safety and relevant early evidence of positive therapeutic outcome(s).

“There are things we can do right now to help those fighting for their lives every day against terminal illnesses that will also better prepare us for pandemics like the coronavirus,” said Senator Mike Braun. “The current system doesn’t work for those with a serious and life-threatening illnesses. A provisional drug approval pathway—designed to promote efficient access to effective treatments for patients with progressive diseases—will bring us closer to fixing the system for those who don’t have time to wait.”  

“In the current environment, Americans are all too familiar with the devastating impact of deadly, fast-moving diseases with no known cure. Unfortunately, many have been living with this reality for far too long, as they and their families deal with tragic diseases such as ALS. Accelerating and clarifying FDA approval pathways for promising new treatments is more important now than ever.” said Senator Murkowski.“We know that ALS is a tragic disease, but with advances in research, treatment, and advances in clinical trials, my hope is that we are closer to a cure for ALS. Our legislative effort recognizes that patients suffering from life-threatening, fast-moving diseases may benefit from access to promising treatments earlier. While we work towards the day we have promising cures, anything we can do to accelerate pathways to treatment is a step in the right direction.”

“Americans suffering from terminal conditions do not have time to wait months on end for the approval of potentially life-saving treatments,” said Senator McSally. “Our legislation allows access to more 21st century therapies by creating another pathway at the FDA that will safely accelerate its approval process for drugs meant to treat chronic or life-threatening diseases for patients battling critical conditions like ALS or advanced stages of cancer.”

“The FDA must be an innovation-enabler.  A provisional approval pathway is consistent with the FDA’s goal of advancing 21st-century patient-focused medicine regulation.  The Promising Pathway Act is a public health triple play—Good for patients, good for innovation, good for the broader public health.” – Peter J. Pitts, Former FDA Associate Commissioner, President and Co-Founder of the Center for Medicine in the Public Interest

“Every year thousands of Americans are diagnosed with ALS and told to get their affairs in order. This legislation gets us ever closer to a place where we can say, ‘you have ALS, here is an effective therapy that will allow you to see your children and grandchildren grow up.’ We fight every day to make that day real,” says Danielle Carnival, CEO of I AM ALS.

“We are grateful for Senator Braun’s commitment to and leadership in the fight to end ALS and to make real treatments for so many now. This critical legislation provides the opportunity to dramatically speed up the race for treatments for ALS patients and so many others by providing a real, long-overdue pathway access to promising therapies,” says Brian Wallach, ALS patient and co-founder of I AM ALS.

“The ALS Association strongly supports the Promising Pathway Act to create a faster pathway for new therapies,” said Calaneet Balas, president and CEO of The ALS Association.“This bill advances efforts to bring effective treatments to everyone with ALS as soon as possible. We look forward to working together to ensure Congress passes this bill quickly.”

“The Promising Pathway Act may serve a critical need we have for accelerated drug approval for children facing terminal brain cancers.  For years we’ve watched promising treatments languish at bureaucratic hurdles set to consider side effects when the alternative for these children was almost certain death.  We are hopeful that now these options can be offered as they develop and lives will be saved.” –Keith Desserich, Co-Founder of The Cure Starts Now International Cancer Foundation, Founder of the DIPG/DMG Collaborative, President of the Pediatric Brain Tumor Consortium Foundation.

Read more about the Promising Pathway Act

Read a section by section summary of the Promising Pathway Act

Read the full text of the Promising Pathway Act

The Promising Pathway Act

A Bill to Expedite Positive Patient Outcomes

SUMMARY: 

Expediting beneficial outcomes for patients is the sole purpose of this Act.  For individuals with life-threatening, serious diseases, timely access to treatment is an essential element in the battle between life and death.  The FDA drug approval pathways must be continually rethought and redesigned to promote efficient access to effective treatments for patients with progressive diseases that, if left untreated, may significantly affect their daily lives or lead to premature death.

SUPPLEMENTARY INFORMATION:

The Promising Pathway Act (PPA) requires the FDA to establish a rolling, real-time, priority review pathway to evaluate provisional approval applications for drugs intended to treat, prevent, or diagnose serious or life-threatening diseases or conditions—including those that pose a threat of epidemic or pandemic (e.g., COVID-19).  Under this pathway, provisional approval would be granted by the FDA to drugs demonstrating substantial evidence of safety and relevant early evidence of positive therapeutic outcome(s).  The FDA currently has the legal authorities to establish such a pathway—in fact, they did so in the 1990s with the parallel track system—but creating a clearly defined, modernized pathway under PPA ensures such a pathway exists for the benefit of patients and can be reliably utilized by drug sponsors.

I. Background

On December 21, 2019, to make good on the government’s promise to allow those with life-threatening illnesses better access potentially meaningful treatments, a first draft of PPA was introduced and interested parties were encouraged to submit questions, comments, and suggestions to be considered for a subsequent revision of PPA.

II. Comments on First Draft and Responses

Hundreds of Americans submitted feedback and proposed revisions—including personal stories, expert opinion, and stakeholder input.  The great majority of comments either suggested changes to specific elements of PPA or requested clarification on certain elements of PPA.

A. Standard of review and how PPA differs from other FDA pathways and programs

(Comment 1)  We received several comments seeking clarification on the standard of review for provisional approval and how it differs from the substantial evidence of safety and effectiveness standard utilized by the FDA in existing drug review pathways.

(Response 1)  For a drug to be eligible for provisional approval status under PPA, it must be intended for the treatment, prevention, or medical diagnosis or serious or life-threatening diseases or conditions in which there is a reasonable likelihood that premature death or disability will occur without early medical intervention, a disease or condition that poses a threat of epidemic or pandemic, or a disease or condition that is associated with morbidity that substantially impacts day to day functioning.  Additionally, to receive provisional approval status, a drug must demonstrate substantial evidence of safety and relevant early evidence of positive therapeutic outcome(s).

(Comment 2)  Many comments requested clarification on how a new provisional FDA drug review pathway would differ from already established and utilized FDA drug review pathways—specifically, the Accelerated Approval pathway.

(Response 2)  Several critical features distinguish provisional approval from accelerated approval.  For instance, drugs being reviewed under the accelerated approval pathway are only accessible by patients enrolled in the drug’s clinical trial, restricting widespread patient access to beneficial drugs until granted full approval.  Encouraging the FDA to accept rolling applications for the time-limited provisional approval status for drugs that are safe and demonstrate relevant early evidence of positive therapeutic outcome(s) will facilitate access to promising drugs for a broader patient population faster than accelerated approval.  Additionally, the accelerated approval pathway requires the use of validated surrogates, or endpoints, to measure the efficacy of a drug—which limits clinical trial design for rare or lesser-studied diseases.  The provisional approval pathway, however, allows drug sponsors to incorporate the use of scientifically substantiated surrogates—surrogate endpoints other than those previously validated by the FDA—to predict a drug’s clinical benefit based on epidemiological, therapeutic, pathophysiologic, or other evidence for provisional approval.  This difference in pathway requirements will increase innovation in clinical trial design and encourage sponsors to use real world data to ascertain the benefits of the drug without reducing the standard of effectiveness.

(Comment 3)  Additionally, several commenters requested clarification on how a provisional approval pathway would impact clinical trial designs and enrollment.

(Response 3)  PPA includes an important provision that requires the FDA to issue guidance that establishes clear protocols for enabling sponsors to submit rolling, real-time, mid-trial provisional approval applications.  Importantly, this provision preserves the integrity of ongoing clinical trial design, development, and enrollment, as well as prohibits sponsors from being penalized for utilizing this pathway mid-trial—further promoting expedited and broad patient access to provisionally approved drugs.  PPA is distinct from programs such as Right-to-Try and Expanded Access, also referred to as Compassionate Use, because under this pathway, patients will receive timely access to provisionally approved drugs.  Whereas Right-to-Try and Expanded Access grant patients access to experimental, unapproved drugs.

B. Transparency and Patient Monitoring Requirements

(Comment 4)  Many commenters, rightly, raised concerns with overall transparency relating to the new provisional approval pathway and questioned how patients and prescribers would receive timely information from the FDA and drug sponsors on provisionally approved drugs.

(Response 4)  PPA establishes the requirement of patient registries for all provisionally approved drugs.  Under PPA,the sponsor of a provisionally approved drug must ensure that all patients who use the drug participate in an observational registry and consent to the collection of, and submission of, data related to the patient’s use of the drug until the drug receives full approval.  Importantly, the registries must be readily accessible to patients—as well as allow approved researchers and medical professionals to access the aggregated and de-identified data for public health research.  Additionally, patients will be immediately notified of any FDA decisions or adverse drug effects brought to light by review of any registry related to a provisionally approved drug—as the FDA is required under PPA to conduct an annual review of applicable patient registries.  These registries can be run by third party governmental, for-profit, or nonprofit entities—but must track the effect of provisionally approved drugs on patients, including patient treatments, uses, length of use, side effects, scan results, and adverse drug effects.  Finally, under PPA, any scientific, medical, academic, or health care journal publishing an article explaining, releasing, conveying or announcing research findings which were funded by the federal government shall be prohibited from publishing such research unless the article conveying the research findings is made publicly available on the journal’s website without a paywall or charge three (3) months after it was first made available to subscribers or for purchase.

C. Post Market Controls

(Comment 5)  A few commenters raised the issue of compliance with post-market approval requirements.  Specifically, these commenters sought clarity about how the FDA would ensure drug sponsors met post-market approval requirements under the pathway.

(Response 5)  Under PPA, the period of provisional approval is time-limited and effective for a two-year period.  Drug sponsors may request provisional approval status renewal for subsequent two-year periods, up to a total of six years.  The FDA will review the drug and renew provisional approval status based on real-world data collected in the patient registries—which track patient usage of provisionally approved drugs—until the drug receives full approval or provisional approval expires.  Additionally, under PPA, the FDA will review registry data as a part of the approval for a sponsor’s application for full approval or withdraw a drug’s provisional approval status.  Sponsors may apply for full approval for a drug at any time under the pathway.  The FDA may also withdraw provisional approval of a drug with a significant number of reported adverse effects.  Importantly, PPA establishes the position of Patient Advocate General within the Office of the Commissioner at the FDA to increase transparency and provide assistance to patients, as well as their families and caregivers.

Time-limited provisional approval incentivizes drug sponsors to collect diligently and submit drug data to the registries to renew their drug’s provisional approval status.  If a sponsor fails to meet post-approval requirements, the FDA will issue penalties and, in certain cases, withdraw provisional approval for the drug.  For example, under PPA, if a drug sponsor has less than 90 percent of patients using a provisionally approved drug participating in the required registry—they will receive a $100,000 penalty, and if the violation is not corrected within 30 days the sponsor will be issued a $10,000 penalty every day the violation is not corrected.  If patient participation is not at or above 90 percent within 6 months, provisional approval will be withdrawn.

D. Payment

(Comment 6)  A great number of commenters—including patients and caregivers—raised the issue of payment in their comments.  Specifically, commenters sought clarity on how patients would ultimately be able to afford drugs provisionally approved.

(Response 6)  This issue is vitally important.  Indeed, we cannot expect to expedite beneficial and positive patient outcomes if patients are ultimately unable to afford treatments provisionally approved under this pathway.  Although there is no easy solution to this issue, PPA seeks to ensure better and greater access to provisionally approved treatments for patients.  Specifically, PPA prohibits any group health plans, health insurance coverage providers and federal health care programs (e.g., Medicare) from denying coverage of a provisionally approved drug on the basis of it being experimental and mandates that provisionally approved drugs be treated in the same manner as drugs fully approved by the FDA under other review pathways.

E. Priority Review and Evaluation Process

(Comment 7)  Several commenters specifically asked how drug sponsors would request provisional approval under the provisional approval pathway and whether they would be required to pay user fees.

(Response 7)  PPA allows for rolling, real-time FDA review of provisional approval applications, where the FDA may review various portions of new product applications as they become available, instead of waiting for a completed dossier.  Under PPA, the FDA must evaluate provisional approval applications within 90 days of receiving a completed application.  If the drug submitted for review under this pathway qualifies for FDA special designations, including but not limited to, designations for a rare disease or condition under the “Orphan Drug Act,” all benefits of that designation shall be available for use under provisional approval, including any tax credits and waiving of FDA fees.