Q: Congress must act on FY 21 appropriations. What are the possible ways for Congress to address this? A: Congress must decide if they will do substantive work on the 12 appropriations bills with the goal of passing full-year funding bills before October 1. One alternative would be to fund the beginning of the fiscal year […]

Congress is starting to consider ways to address the budget cap problem that hangs over the entire FY 21 appropriations process for non-defense discretionary (NDD) programs. Last year, Congress broke a long-running stalemate by agreeing to budget caps for FY 20 and FY 21. They decided to front-load the increases, making spending decisions (relatively) easier […]

WASHINGTON, D.C. – Five lawmakers introduced a bipartisan bill giving a full range of medical services to families with children who have life-limiting illnesses and who qualify for Medicaid, which currently has gaps in such coverage.

The Children’s Program of All-Inclusive Coordinated Care (ChiPACC) Act (H.R. 6560) would let states create comprehensive care programs for these children. Its authors are the Co-Chairs of the Congressional Childhood Cancer Caucus: Representatives Michael McCaul (R-TX), Jackie Speier (D-CA), G.K. Butterfield (D-NC), and Mike Kelly (R-PA), together with Representative Diana DeGette (D-CO), a senior member of the House Energy and Commerce Committee.

“Families with children facing life-limiting illnesses need all the support they can get, and they should be empowered to seek out that support,” the bill’s sponsors said in a joint statement. “We owe it to these kids and their loved ones to help ensure more compassionate care in their most trying times.”

Gaps in Medicaid coverage of hospice and palliative services have deprived many beneficiaries of the care they need because the program does not cover some of children’s unique medical needs.

Under this bill, the family of every child who qualifies for Medicaid will receive a specialized care plan covering a range of services – palliative, counseling, respite, expressive therapy and bereavement – providing them and their families greater comfort and peace of mind.

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The company receives approval for MenQuadfi to prevent meningococcal disease.

Ajinomoto agrees partnership to manufacture leronlimab, which is currently undergoing clinical trials for the treatment of COVID-19.

The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading →

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading →

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading →

Posted by Roger Bate The Economic Times of India covered our new paper today (see here). The paper published by the National bureau of Economic Research and not AEI as claimed by the Economic Times (see here), shows that Indian firms send their worst quality medicines to Africa. It is a shame that Indian Industry hack DG Shah continues to trot out the same arguments attacking us rather than addressing the paper’s findings. For example, he asks why did it take so long to publish a study [...]

Posted by Roger Bate (on behalf of the authors of the paper) India’s pharmaceutical industry wants its government to sue us because of our “smear campaign” against it (Click here) and if today’s media in India are correct, India’s government is considering it (Click here). This so-called campaign is actually an academic study which identifies uncomfortable data that some Indian companies, or their distributors, seem to be sending inferior medicines to Africa (s [...]

Posted by Roger Bate India’s government is contemplating suing my coauthors and I for defamation for some research we published last month. In our National Bureau of Economic Research working paper on the quality of Indian medicines exported to Africa we concluded that poorer quality products were intentionally being sent to Africa because of the continents generally weak oversight of drug quality. Litigation is rarely an effective method of finding the truth, more often a process to li [...]

Posted by Roger Bate Cairo, Egypt – While its economy is still suffering from weak tourism, its new government is trying to do its best to bolster its modest regulatory structures to oversee medicines. With a population of approaching 90 million, Africa’s third most populous nation, is an important final destination for medicines, and a key transit point too. But it’s not just good medicines that Egypt needs to assess and ensure are procured, it has to prevent the bad &ndash [...]

Posted by Roger BateThe World Health Organization just posted its new report on inferior medicines (http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_33-en.pdf). It is called the member state mechanism (MSM) report on Substandard/spurious/falsely-labelled/falsified/counterfeit medical products - SSFFC for short. This report is the culmination of multiple meetings of health bureaucrats to finalize how to combat inferior medicines. Or rather that is what one hoped for when the SSFFC process began [...]

by Adriana Gallardo, ProPublica, and Ariel Goodman for ProPublica

They’ve gotten to know New York City in a way many have not, through the low-wage work of cleaning its skyscrapers, serving its restaurants and crisscrossing its streets on bicycles, through long subway rides very early in the morning and very late at night. The saying goes: You’re not a true New Yorker unless you’ve lived here for a decade. They’ve done their time and felt a deep sense of belonging in this city of immigrants.

But, in the epicenter of a pandemic, the undocumented have never felt more alone.

They are losing loved ones but do not qualify for city funding to help bury them. They are getting sick but hesitating to get tested or go to the hospital, balancing their fear of the virus with their fear of exposure to immigration authorities. They are worried about supporting their families abroad as well as those who live with them, weighing whether to keep working perilous jobs or to stay home and somehow keep food on the table.

They’ve experienced separation, but not like this — out in the world, in a skeleton crew, wearing a mask to deliver food to closed doors; in cramped apartments, sectioned off, in an attempt to quarantine. They are divided across national borders as family members die, praying novenas on Google Hangouts. Their bodies cannot be buried, intact, where they were born; they move from hospital bed, to refrigerated truck, to incinerator.

ProPublica interviewed two dozen undocumented Latino immigrants and their families about their experiences with death, illness and survival. Some spoke on the condition of anonymity, afraid of being targeted. Others allowed us to use their first names or the full names of their family members who died.

One kitchen worker from the Bronx worked in the World Trade Center two decades ago. “We used to fill the back elevators of those towers,” he said. He lost friends on Sept. 11, 2001, who were not identified or acknowledged among the dead because their names did not match those on record or their families were unable to claim the bodies.

He and others spoke to ProPublica because this time they wanted their experiences to be counted as part of the story of their city, overtaken by a virus.

Barriers to a Proper Burial

Adrian Hernandez Lopez, 38, never planned to stay in New York City. His 15 year stint here was dotted with visits to his family in Mexico, for the baptism of his son, who is now almost a teen, and to check on the house he had been sending his paychecks to build.

He and brother worked at an Italian restaurant in Times Square. “We were always together,” his brother said. They crossed the border together and, years later, commuted together from Queens to midtown Manhattan.

The last time they spoke by phone, Lopez waited in agony in a hard chair at Elmhurst Hospital, breathing in oxygen from a machine. He was transferred to Woodhull Hospital in Brooklyn. One day later, the father of two wound up in a vegetative state.

He died on April 2. His mother, who lives in Allende, a small village in the state of Puebla, wants him buried there, alongside two babies she lost just after birth.

He can’t be traditionally buried, despite the strong Mexican custom. More than 400 Mexican migrants are known to have died of COVID-19 in the New York area, but for health reasons, Mexico will only accept their bodies if they are cremated.

In place of seeing the body one last time, Lopez’s brother was sent photos by the funeral home, which will hold the cremains while the family figures out how to get them to Mexico.

The Mexican Consulate pledged financial aid to the families of nationals who died of COVID-19 complications, but it has been slow to materialize. According to Lopez’s brother, they’ve been asked to follow guidelines to receive a reimbursement. The Consulate General’s office in New York said it was not authorized by the Mexican government to give interviews at the time of our request for comment.

The city of New York provides burial assistance, but it requires a Social Security number for both the deceased and the person requesting funds. City officials say they are limited by federal and state law in the help they can offer. “We are exploring every possible option to ensure that all New Yorkers, regardless of immigration status, are able to bury their loved ones in the way they feel is most fitting,” city spokesperson Avery Cohen said.

Two members of the City Council have called for an emergency fund to provide assistance to all low-income families, including the undocumented.

“One of the most devastating calls I’m regularly getting is from people who can’t afford to bury their loved ones and aren’t eligible for any assistance,” Council Member Francisco Moya said in a release. “That’s simply not acceptable.”

Lopez’s family is one of several raising money for the transport and burial of their loved one who died in the United States.

As he tries to figure out how to send Lopez home, his brother sits in the small apartment they shared in Queens, with his wife and 6-year-old daughter, listening to the sirens that have become a constant reminder of their loss. He and his wife have been out of work for a month. They don’t know how they will pay the rent.

Deterred From Seeking Care

More than a dozen undocumented people told ProPublica that when they got sick, they stayed home, deterred from seeking care by the worry that they would not get it if they tried. They faced the same obstacles as everyone else in New York, where hospitals were crowded and unsafe, and feared additional ones involving their immigration status.

Fani lives in East Harlem. Over the last 18 years, she’s worked at a laundromat and a factory, a restaurant and as a babysitter. When she and her husband got sick they called 311. She said the voice on the other end confirmed their COVID-19 symptoms and told them to stay home unless they couldn’t breathe.

“They said there were no beds, no respirators. We healed each other as best we could with soups, teas and Tylenol,” she said.

Sonia, who became ill with COVID-19 symptoms almost three weeks ago, was afraid to go to the hospital. “I knew several people who went into the hospital with symptoms and they never came back,” she said. “That was my fear and why I decided to not go in. I preferred to isolate myself at home, with a lot of home remedies and hot teas.”

Multiple people said they knew hospitals had limited resources and worried they would be placed last in line for care because they were undocumented. “They’re going to let us die,” one man told his brother. A woman named Yogi in the Bronx said, “It might not be that they don’t want to treat us, maybe there weren’t enough supplies.”

Stories rippled through the Latino community about those who had difficulty getting care and those who could not be saved. According to a recent poll of voters in New York City, more than half of Latinos there said they know someone who died, the highest percentage of any group asked.

They hear stories about people like Juan Leonardo Torres, a 65-year-old retired doorman who knew someone on every corner of Corona, Queens. Unlike the others, Torres, from the Dominican Republic, was a citizen. Even so, he grew discouraged when he tried to get care.

Within one week at the end of March, Torres had gone from feeling slightly ill to experiencing difficulty breathing and fevers that his wife Mindy tried to manage using herbs and other “remedios caseros,” or home remedies. She and her five sons who lived with them finally persuaded him to go to Long Island Jewish Medical Center Forest Hills, just a five-minute drive from the house.

When Torres arrived, he told his family there were not enough seats in the crowded emergency room. He gave his chair up to an older woman and stood for hours as staff connected and disconnected him to an oxygen tank.

Fifteen hours later, on a drizzly night, Torres appeared at the door of the family home. It was 2:30 a.m. He had made the walk alone and declared in Spanish, “For no reason do I want to go to the hospital to die like a dog.”

He spent the next three days quarantined in his son’s room, where he died.

As the family waited six hours for his body to be retrieved, his wife sat in the living room “like a statue.”

Calculating Survival

Unable to qualify for relief programs like unemployment and stimulus cash, undocumented people are faced with the difficult choice of working dangerous jobs or running out of the money they need for essentials like food and housing.

“The little we have goes to food,” said Berenice, who suffers from kidney problems and whose son struggles with asthma. She’s been home for weeks along with her husband Luis, who before the pandemic worked at a cab company.

“Yes, we need money, but there is also our health,” Berenice said. “We have family who are sick and friends who died. We are trying to survive.”

Luis has lived in New York for 18 years, working his way up from delivering pizza on a bicycle to owning a cab. He worries about exposing his wife and son. “I just want this to pass and we’ll see about starting over again,” he said.

Adan lives in the Bronx with his two teenage sons, who were born in New York City, and his wife. She cleaned homes. He worked in a restaurant in East Harlem. Neither are working and both overcame COVID-19. “The little money we had went to pay last month’s rent,” he said. “I don’t know what to do, we just want to work.”

He said his landlord always comes looking for the rent in person. He told “el señor” that he’s spending all his money on food. The man gave him flyers about unemployment, but Adan knows he won’t qualify. “Me las voy a ver duras,” he said. He’s going to see hard times. He said he has lived in the same building for 11 years and has never missed a payment. Even though he can’t be evicted now, he said, “the debt will be there.”

Adding to the pressure, for some, is that they also work to support family members in their home countries, who count on the money they send.

One delivery worker in Queens sends $400 to Mexico every two weeks to help his son, who studies biomedicine at a university in Puebla; that helps him cover what he needs for school, including rent and transportation. He sends another $300 each month to his elderly mother.

He said he remains one of only a few bicycle delivery workers at his diner who are still on the job, and he is seeing more orders than usual. He’s always worked six days a week, but this past month was so busy, he couldn’t stop to eat lunch or take breaks.

He would much rather be outside than at home, but the streets feel tense. “I feel strange not seeing anyone or saying hi anymore, but I think it’s much better this way,” he said. “I understand why people are afraid.”

Even though he doesn’t see them in the buildings he visits, customers have been conscious about leaving tips in envelopes. He feels grateful as he passes the long lines in Queens of those waiting for free food. It makes him sad to know how many need it now.

He rents a room in an apartment he shares with three other men who have all lost their jobs. One was in construction, the other two in restaurants. He takes precautions to keep them safe when he comes home, including changing his clothes before coming in. “It would be irresponsible not to,” he said.

He hopes the rules of social distancing, and his mask and gloves, will protect him. “I’m not scared,” he said. “If you are afraid all the time, you will get sick faster.”

by ProPublica

The Pulitzer Board announced Monday that two series published by ProPublica were awarded Pulitzer Prizes. “Lawless,” a ProPublica Local Reporting Network project by the Anchorage Daily News that revealed how indigenous people in Alaska are denied public safety services, was awarded the prize for public service. “Disaster in the Pacific,” an investigation on the staggering leadership failures that led to deadly accidents in the Navy and Marines, won a national reporting prize. The two designations are ProPublica’s 6th Pulitzer win in 12 years and the first Pulitzer awarded to a Local Reporting Network partner.

Led by Daily News reporter Kyle Hopkins, “Lawless” was the first comprehensive investigation to lay bare Alaska’s failing, two-tiered justice system in which Native villages are denied access to first responders. In much of rural Alaska, villages can only be reached by plane, and calling 911 to report an emergency often means waiting hours or days for help to arrive.

The series evolved from a string of stories that Hopkins reported in 2018 for the Daily News, recounting horrific incidents of sexual assault in Alaska — which has the nation’s highest rate of sexual violence — and policing failures that have allowed offenders to continue the abuse with impunity. To fully investigate issues of lawlessness and sexual assault in the most remote communities in the U.S., the Daily News applied to participate in ProPublica’s Local Reporting Network. The program partners with newsrooms across the country, paying the salary and a stipend for benefits for local reporters who spend a year tackling big investigative stories that are crucial to their communities. Participating reporters work with a ProPublica senior editor and receive support, including from ProPublica’s data, research and engagement teams.

The collaboration’s first story, based on more than 750 public records requests and interviews, found that one in three rural Alaska communities has no local law enforcement of any kind. These indigenous communities are also among the country’s most vulnerable, with the highest rates of sexual assault, suicide and domestic violence. The series’ second major installment found that dozens of Alaska communities, desperate for police of any kind, hired officers convicted of felonies, domestic violence, assault and other offenses that would make them ineligible to work in law enforcement or even as security guards anywhere else in the country.

Next, Hopkins revealed how the state’s 40-year-old Village Public Safety Officer Program, designed to recruit villagers to work as life-saving first responders, has failed by every measure. Alaska had quietly denied funding for basic recruitment and equipment costs for these unarmed village officers while publicly claiming to prioritize public safety spending. “Lawless” also exposed how the Alaska State Troopers agency, created to protect Alaska Native villages, instead patrols mostly white suburbs surrounding cities on the road system like Wasilla. The series ended with a list of six practical solutions to Alaska’s law enforcement crisis, based on interviews with experts, village leaders, the Alaska congressional delegation and sexual assault survivors.

The Daily News and ProPublica faced a number of challenges in reporting the series. The first: No one knew which remote Alaska villages had police officers of any kind. So they built the first-ever statewide policing database by drawing on payroll, arrest and hiring records from communities spread across the state. They also contacted every village city government, sovereign tribal administrator and Alaska Native corporation in the state — more than 600 organizations.

The vastness of the state and the fact that 80% of communities aren’t on the road system posed another challenge. Journalists flew hundreds of miles, sleeping on the floors of schoolhouse libraries and riding in sleds and on snowmobiles. To aid the reporting, they also held a community meeting in Kotzebue, Alaska, where a 10-year-old girl had been raped and murdered in 2018, providing residents, advocates, tribal leaders and law enforcement their first chance for a public discussion on sexual violence. Throughout the year the reporters spoke to more than 300 people across the state.

Following publication of the first major story, U.S. Attorney General William Barr visited the state and declared the lack of law enforcement in rural Alaska to be a federal emergency. The declaration led the Department of Justice to promise more than $52 million in federal funding for public safety in Alaska villages. The U.S. Attorney’s Office in Anchorage announced the hiring of additional rural prosecutors, while Gov. Mike Dunleavy said the state will post 15 additional state troopers in rural Alaska. In addition, the Alaska Police Standards Council has proposed changing state regulations that govern the hiring and screening of village police officers, and Alaska legislators proposed legislation that would increase pay for VPSOs and overhaul funding of the program.

The Daily News’ Loren Holmes, Bill Roth, Marc Lester, David Hulen, Anne Raup, Vicky Ho, Alex Demarban, Jeff Parrott, Michelle Theriault Boots, Tess Williams, Tegan Hanlon, Zaz Hollander, Annie Zak, Shady Grove Oliver and Kevin Powell, as well as ProPublica’s Charles Ornstein, Adriana Gallardo, Alex Mierjeski, Beena Raghavendran, Nadia Sussman, Lylla Younes, Agnel Philip, Setareh Baig and David Sleight also contributed to the series.

“The ProPublica Local Reporting Network was started to give local newsrooms across America the resources and support they need to execute investigative journalism that digs deep and holds power to account,” Ornstein, a ProPublica deputy managing editor, said. “This powerful collaboration with the Anchorage Daily News investigation does exactly that, going far beyond reporting on isolated incidents to provide meticulous research and context on how the justice system has failed Alaska’s most remote and vulnerable communities. Most importantly, it has been a force for real change.”

In their “Disaster in the Pacific” series, ProPublica reporters T. Christian Miller, Megan Rose and Robert Faturechi centered on three deadly accidents in the Navy and Marines in 2017 and 2018. They exposed America’s vaunted 7th Fleet as being in crisis with broken ships and planes, poor training for and multiple warnings ignored by its commanders. The costs: 17 dead sailors in crashes involving Navy warships, and six Marines killed in a training accident.

The back-to-back accidents in 2017 and 2018 gained initial attention from Congress and the national media, but they had been told an incomplete, misleading and dangerous story of half-truths and cover-ups. ProPublica’s series provided the first full accounting of culpability, tracing responsibility to the highest uniformed and civilian ranks of the Navy. The reporting team spent 18 months on the investigation, obtaining more than 13,000 pages of confidential Navy records and interviewing hundreds of officials up and down the chain-of-command.

The first article in the series, “Fight the Ship,” reconstructed a 2017 crash involving the USS Fitzgerald, one of the deadliest accidents in the history of the Navy. The story showed that the accident was entirely preventable, and that the Navy’s senior leadership had endangered the warship by sending a shorthanded and undertrained crew to sea with outdated and poorly maintained equipment. To show readers what happened, ProPublica hired designer Xaquín G.V. Working with investigations producer Lucas Waldron, Xaquín used geodata on the ships’ locations, mapped the path of each vessel and created a graphic that simulated the crash, down to the moment the Fitzgerald was sent spinning out of control, rotating 360 degrees. The team also collected radar images, ship blueprints, hand-drawn images made by surviving sailors and video taken inside the ship, which allowed them to portray the disaster from the perspective of the sailors onboard.

A second story, “Years of Warnings, Then Death and Disaster,” detailed how the fatal crash of the USS Fitzgerald, and of the USS McCain weeks later, were the result of a congressional gutting of the Navy and the Navy’s prioritization of building new ships. Top Navy officials gave urgent, repeated warnings to Navy Secretary Ray Mabus about the deadly risks facing its fleet, including being short of sailors, sailors poorly trained and worked to exhaustion, warships physically coming apart, and ships routinely failing tests to see if they were prepared to handle warfighting duties. They were ignored, told to be quiet or even ordered to resign.

Another story captured the Marine Corps multiple failures that were responsible for the deaths of six men in a nighttime training exercise 15,000 feet above the Pacific — an accident that senior leaders had been warned was possible, even likely. ProPublica created an animated short documentary, using a combination of an on-camera interview, 3D animation, 2D illustration and atmospheric footage to bring the excruciating hours of a needless tragedy to light. Through extensive interviews with eyewitnesses, the team reconstructed the moments leading up to the crash, the crash itself and the botched search and rescue effort.

The series also illuminated how the Navy’s reckless management of the 7th Fleet was measured not only in fatalities, but also in the hurt and shame of the rank-and-file sailors whom the Navy blamed and prosecuted for the accidents. The Navy’s prosecution of Navy Cmdr. Bryce Benson for what were clearly systemic shortcomings, traceable all the way to the Pentagon, left many of its own furious and demoralized.

Weeks after the first story’s publication, the House Armed Services Committee convened a panel to challenge senior Navy leaders over their claims that they had been fully truthful about its failings and its efforts at reform. The reporting forced the Navy to admit to Congress that its claims about its rate of progress on reform were misleading. In light of ProPublica’s reporting on the improper role that the Navy’s top commander played in the prosecution of Benson, one of captains on the USS Fitzgerald, the Navy dropped all criminal charges. U.S. and NATO Navy commands throughout the world have ordered sailors and officers to read the ProPublica accounts as part of training and education.

Joseph Sexton, Tracy Weber, Agnes Chang, Katie Campbell, Joe Singer, Kengo Tsutsumi, Ruth Baron, David Sleight, Sisi Wei, Claire Perlman, Joshua Hunt and Nate Schweber also contributed to this series.

“The Navy actively blocked reporting at every step, with communications officers attempting to dissuade officials from conducting interviews with ProPublica and leaking positive stories to competing media outlets in an attempt to front-run our stories,” ProPublica Managing Editor Robin Fields said. “The military even threatened that we could be criminally prosecuted for publishing the material we obtained. This tour de force of investigative journalism is a testament to the unflinching tenacity of the reporters and the innovation of ProPublica’s data, graphics, research and design teams. Their essential work laid bare the avoidance of responsibility by the military’s most senior leaders.”

by Joshua Kaplan and Benjamin Hardy

On April 17 in Toledo, Ohio, a 19-year-old black man was arrested for violating the state stay-at-home order. In court filings, police say he took a bus from Detroit to Toledo “without a valid reason.” Six young black men were arrested in Toledo last Saturday while hanging out on a front lawn; police allege they were “seen standing within 6 feet of each other.” In Cincinnati, a black man was charged with violating stay-at-home orders after he was shot in the ankle on April 7; according to a police affidavit, he was talking to a friend in the street when he was shot and was “clearly not engaged in essential activities.”

Ohio’s health director, Dr. Amy Acton, issued the state’s stay-at-home order on March 22, prohibiting people from leaving their home except for essential activities and requiring them to maintain social distancing “at all times.” A violation of the order is a misdemeanor, punishable by up to 90 days in jail and a $750 fine. Since the order, hundreds of people have been charged with violations across Ohio.

The state has also seen some of the most prominent protests against state stay-at-home orders, as large crowds gather on the statehouse steps to flout the directives. But the protesters, most of them white, have not faced arrest. Rather, in three large Ohio jurisdictions ProPublica examined, charges of violating the order appear to have fallen disproportionately on black people.

ProPublica analyzed court records for the city of Toledo and for the counties that include Columbus and Cincinnati, three of the most populous jurisdictions in Ohio. In all of them, ProPublica found, black people were at least four times as likely to be charged with violating the stay-at-home order as white people.

As states across the country attempt to curb the spread of COVID-19, stay-at-home orders have proven instrumental in the fight against the novel coronavirus; experts credit aggressive restrictions with flattening the curve in the nation’s hotbeds. Many states’ orders carry criminal penalties for violations of the stay-at-home mandates. But as the weather warms up and people spend more time outside, defense lawyers and criminal justice reform advocates fear that black communities long subjected to overly aggressive policing will face similarly aggressive enforcement of stay-at-home mandates.

In Ohio, ProPublica found, the disparities are already pronounced.

As of Thursday night in Hamilton County, which is 27% black and home to Cincinnati, there were 107 charges for violating the order; 61% of defendants are black. The majority of arrests came from towns surrounding Cincinnati, which is 43% black. Of the 29 people charged by the city’s Police Department, 79% were black, according to data provided to ProPublica by the Hamilton County Public Defender.

In Toledo, where black people make up 27% of the population, 18 of the 23 people charged thus far were black.

Lt. Kellie Lenhardt, a spokeswoman for the Toledo Police Department, said that in enforcing the stay-at-home order, the department’s goal is not to arrest people and that officers are primarily responding to calls from people complaining about violations of the order. She told ProPublica that if the police arrested someone, the officers believed they had probable cause, and that while biased policing would be “wrong,” it would also be wrong to arrest more white people simply “to balance the numbers.”

In Franklin County, which is 23.5% black, 129 people were arrested between the beginning of the stay-at-home order and May 4; 57% of the people arrested were black.

In Cleveland, which is 50% black and is the state’s second-largest city, the Municipal Court’s public records do not include race data. The court and the Cleveland Police Department were unable to readily provide demographic information about arrests to ProPublica, though on Friday, the police said they have issued eight charges so far.

In the three jurisdictions, about half of those charged with violating the order were also charged with other offenses, such as drug possession and disorderly conduct. The rest were charged only with violating the order; among that group, the percentage of defendants who were black was even higher.

Franklin Country is home to Columbus, where enforcement of the stay-at-home order has made national headlines for a very different reason. Columbus is the state capital and Ohio’s largest city with a population of almost 900,000. In recent weeks, groups of mostly white protesters have campaigned against the stay-at-home order on the Statehouse steps and outside the health director’s home. Some protesters have come armed, and images have circulated of crowds of demonstrators huddled close, chanting, many without masks.

No protesters have been arrested for violating the stay-at-home order, a spokesperson for the Columbus mayor’s office told ProPublica. Thomas Hach, an organizer of a group called Free Ohio Now, said in an email that he was not aware of any arrests associated with protests in the entire state. The Columbus Division of Police did not respond to ProPublica’s request for comment.

Ohio legislators are contemplating reducing the criminal penalties for violating the order. On Wednesday, the state House passed legislation that would eliminate the possibility of jail time for stay-at-home violators. A first offense would result in a warning, and further violations would result in a small fine. The bill is pending in the state Senate.

Penalties for violating stay-at-home orders vary across the country. In many states, including California, Florida, Michigan and Washington, violations can land someone behind bars. In New York state, violations can only result in fines. In Baltimore, police told local media they had only charged two people with violations; police have reportedly relied on a recording played over the loudspeakers of squad cars: “Even if you aren’t showing symptoms, you could still have coronavirus and accidentally spread it to a relative or neighbor. Being home is being safe. We are all in this together.”

Enforcement has often resulted in controversy. In New York City, a viral video showed police pull out a Taser and punch a black man after they approached a group of people who weren’t wearing masks. Police say the man who was punched took a “fighting stance” when ordered to disperse. In Orlando, police arrested a homeless man walking a bicycle because he was not obeying curfew. In Hawaii, charges against a man accused of stealing a car battery, normally a misdemeanor punishable by up to 30 days in jail, were enhanced to a felony, which can result in 10 years in prison, because police and prosecutors said he was in violation of the state order.

The orders are generally broad, and decisions about which violations to treat as acceptable and which ones to penalize have largely been left to local police departments’ discretion.

Kristen Clarke, president of the Lawyers’ Committee for Civil Rights Under Law, a legal organization focused on racial justice, said such discretion has opened the door to police abuse, and she said the U.S. Department of Justice or state governments should issue detailed guidelines about when to make arrests. That discretion “is what’s given rise to these rogue practices,” she told ProPublica, “that are putting black communities and communities of color with a target on their backs.”

In jails and prisons around the country, inmates have fallen ill or died from COVID-19 as the virus spreads rapidly through the facilities. Many local governments have released some inmates from jail and ordered police to reduce arrests for minor crimes. But in Hamilton County, some people charged with failing to maintain social distancing have been kept in jail for at least one night, even without any other charges. Recently, two sheriff’s deputies who work in the jail tested positive for COVID-19. “The cops put their hands on them, they cram them in the car, they take them to the [jail], which has 800 to 1400 people, depending on the night,” said Sean Vicente, director of the Hamilton County Public Defender’s misdemeanor division. “It’s often so crowded everyone’s just sitting on the floor.”

Clarke said the enforcement push is sometimes undercutting the public health effort: “Protecting people’s health is in direct conflict with putting people in overcrowded jails and prisons that have been hotbeds for the virus.”

Court records show that the Cincinnati Police Department has adopted some surprising applications of the law.

Six people were charged with violations of the order after they were shot. Only one was charged with another crime as well, but police affidavits state that when they were shot, they were or likely were in violation of the order. One man was shot in the ankle while talking to a friend, according to court filings, and “was clearly not engaged in essential activities.” Another was arrested with the same explanation; police wrote that he had gone to the hospital with a gunshot wound. The Cincinnati Police Department did not respond to ProPublica’s requests for comment.

In Springfield Township, a small, mostly white Cincinnati suburb, nine people have been arrested for violating the order thus far. All of them are black.

Springfield Township Police Chief Robert Browder told ProPublica in an email that the department is “an internationally accredited law enforcement organization” and has “strict policies ... to ensure that our zero tolerance policy prohibiting bias-based profiling is adhered to.”

Browder said race had not played a role in his department’s enforcement of the order and that he was “appalled if that is the insinuation.”

Several of the black people arrested in Springfield Township were working for a company that sells books and magazine subscriptions door to door. One of the workers, Carl Brown, 50, said he and five colleagues were working in Springfield Township when two members of the team were arrested while going door to door. Police called the other sales people, and when they arrived at the scene, they too were arrested. Five of them, including Brown, were charged only with violating the stay-at-home order; the sixth sales person had an arrest warrant in another state, according to Browder, and police also charged her for giving them false identification.

Brown said one of the officers had left the group with a warning: They should never come back, and if they do, it’s “going to be worse.”

Browder denied that the officers made such a threat, and he said the police had received calls from residents about the sales people and their tactics and that the sales people had failed to register with the Police Department, as required for door-to-door solicitation.

Other violations in Hamilton County have been more egregious, but even in some of those cases, the law enforcement response has stirred controversy. On April 4, a man who had streamed a party on Facebook Live, saying, “We don’t give a fuck about this coronavirus,” was arrested in Cincinnati’s Over-the-Rhine neighborhood, the setting of a 2001 riot after police fatally shot an unarmed black man.

The man who streamed the party, Rashaan Davis, was charged with violating the stay-at-home order and inciting violence, and his bond was set at $350,000.

After Judge Alan Triggs said he would release Davis from jail pretrial because the offense charged was nonviolent, local media reported, prosecutors dropped the misdemeanor and said they would focus on the charge of inciting violence, a felony.

The Hamilton County prosecutor’s office declined to comment on Davis’ case.

In Toledo, there’s been public controversy around perceived differences in the application of the law. On April 21, debate at the Toledo City Council meeting centered around a food truck. Local politicians discussed recent arrests of young black people at house parties, some contrasting them with a large, white crowd standing close together in line outside a BBQ stand, undisturbed by police. Councilmember Gary Johnson told ProPublica he’s asked the police chief to investigate why no one was arrested at a party he’d heard about, where white people were congregating on docks. “I don’t know the circumstances of the arrests,” he said. But “if you feel you need to go into poor neighborhoods and African American neighborhoods, you better be going into white neighborhoods too. … You have to say we’re going to be heavy-handed with the stay-at-home order or we’re going to be light with it. It has to be one or the other.”

Toledo police enforcement has not been confined to partygoers. Armani Thomas, 20, is one of the six young men arrested for not social distancing on a lawn. He told ProPublica he was sitting there with nine friends “doing nothing” when the police pulled up. Two kids ran off, and the police made the rest stay, eventually arresting “all the dudes” and letting the girls go. He was taken to the county jail, where several inmates have tested positive, for booking and released after several hours. The men’s cases are pending.

“When police see black people gathered in public, I think there’s this looming belief that they must be doing something illegal,” RaShya Ghee, a criminal defense attorney and lecturer at the University of Toledo, told ProPublica. “They’re hanging out in a yard — something illegal must have happened. Or, something illegal is about to happen.”

Lenhardt, the police lieutenant, said the six men were arrested after police received 911 calls reporting “a group gathering and flashing guns.” None of the six men were arrested on gun charges. As for the 19-year-old charged for taking the bus without reason, she said police asked him on consecutive days to not loiter at a bus station.

With more than 70,000 Americans dead from the coronavirus, government officials have not figured out how to balance the threat of COVID-19 with the harms of over policing, Clarke said. “On the one hand, we want to beat back the pandemic. That’s critical. That’s the end goal,” she told ProPublica. “On the other hand, we’re seeing social distancing being used as a pretext to arrest the very communities that have been hit hardest by the virus.”

The COVID-19 pandemic has brought to the fore some issues of ad-promo for FDA-regulated products. I'm posting here to highlight some developments and correct some of the discussion.

Snake Oil & Enforcement

Off-Label Promotion & Outbreaks

A manufacturer has announced plans to move production of hydroxychloroquine — currently being trialled as a COVID-19 treatment — to the UK from abroad to combat potential shortages.

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All the most important developments in the COVID-19 pandemic for pharmacists and their teams, as they happen.

To read the whole article click on the headline

March 16, 2020 – Amid rising concerns over “Novel Coronavirus Disease 2019” (COVID-19), the Food and Drug Administration and the Federal Trade Commission took action last week against seven companies for selling fraudulent COVID-19 products. The regulators sent Warning Letters to the companies because these products “are unapproved drugs that pose significant risks to patient […]

March 23, 2020 – As the United States grapples with the COVID-19 outbreak and its ongoing fallout, there is another pressing issue that is crucial to the American public: ensuring safe and fair elections between now and Nov. 3. “The Coalition believes it is important for all Americans to be active in the political process […]

April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […]

April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […]

May 4, 2020 – An important part of protecting the public health during the COVID-19 pandemic is making sure that the marketing of treatments or remedies that are not approved by the Food and Drug Administration (FDA) to treat the virus is stopped before consumers waste their money or potentially are harmed by these products. […]

The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients.

Newron will terminate work on its experimental Rett syndrome drug sarizotan after a complete failure in its pivotal STARS trial.

Temple University researchers discovered that boosting levels of a protein called Lin28 in injured spinal cords of mice prompts the regrowth of axons and repairs communication between the brain and body. They believe the discovery could be used to develop new treatments for both spinal cord and optic nerve injuries.

The FDA has delayed its decision on whether to approve Bristol Myers Squibb’s CAR-T cell therapy by three months. Bristol Myers attributed the delay to its submission of additional information upon the request of the FDA.

Following in the footsteps of an increasing number of biopharmas that want to use data to get more bang for their buck in R&D, J&J has promoted Najat Khan, Ph.D., to the role of chief data science officer.

The recommended daily allowance of protein may be inadequate to support maintenance of muscle in young women and eating protein from the humble potato can help to maintain muscle, according to research from McMaster University funded by the Alliance for Potato Research & Education.

A novel combination of two Lactobacillus paracasei strains may increase absorption of key amino acids in plant proteins, according to a new placebo-controlled, randomized, double-blind, multicenter, crossover study.

The unpredictable spikes in demand that are distorting the supply chain in the current crisis has created another opportunity, in this case for herbal ingredients that help adults deal with urinary incontinence issues.

Combining exercise with a bacterial strain isolated from an Olympic weightlifting gold medalist may synergistically increase endurance compared to training or the probiotic alone, suggests data from a mouse study.

Today I had the chance for a panel conversation with Geeta Vemuri from Baxter Ventures and Ed Silverman from Pharmalot blog (Wall Street Journal) at the Midwest Healthcare Venture Forum. Our general topic was how we (an entrepreneur and a corporate venture capitalist) look at bringing drugs/devices to market. Here are a couple of takeaways from our

Among those rallying against state shutdown orders are anti-vaccination activists. They see these protests as a way to form political alliances that promote their movement.

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1]  The en banc opinion...… Continue Reading

After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon: Here is what I think about this development. Work on a proposal ongoing The Commission announced that ‘work on a proposal to postpone the date of application’. This tells […]

On Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in the works for some time was finally published. As I have heard from many directions immediately after the announcement of the proposal being […]

It’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR amendment proposal. Recent development seem to confirm that I was right in assuming that not touching the two dates of application of 26 […]

Protesters of California's stay-at-home orders returned for another unsanctioned rally Thursday, telling law enforcement officers they are forgiven for arresting them last week.

The idea that old people are worth something because they contribute significantly to society puts us on a slippery slope.

Trump admits that he's putting Americans at grave risk by encouraging economices to reopen. He should protect us with testing.

Coronavirus pandemic widens racial and political divisions

The NFL is operating under the assumption that the season will be played as scheduled, but COVID-19 has created many challenges for the league.

The NFL is operating under the assumption that the season will be played as scheduled, but COVID-19 has created many challenges for the league.

A looming recession due to the coronavirus imperils Champagne, buffalo mozzarella and other European delicacies. They're luxuries, but also livelihoods.

Three members of the group Indivisible OC 48 staged an hourlong protest to bring attention to the people who are following Gov. Gavin Newsom's stay-at-home orders during the COVID-19 pandemic.

Older people who are more at risk of dying from COVID-19 contribute immeasurably to society, but they should not have to prove their worth.