Results for “regulatory state failing”
34 found

Our regulatory state is failing us, NIH edition

…the lawmakers pressed NIH leadership for answers about the mysterious disappearance of the Scientific Management Review Board, a committee that Congress empaneled in 2006 to ensure the agency was operating efficiently…

“There wasn’t any notification that we weren’t going to meet again — it was just that the meetings stopped getting called,” Nancy Andrews, a onetime board member and the former dean of the Duke University School of Medicine, told STAT in May.

She added: “I had the sense that we were asking questions in areas that they didn’t really want to get into, and I suppose Francis [Collins] in particular didn’t really want us working on.”

Here is the full StatNews piece.

Our regulatory state is failing us, monkeypox edition

Roy Gulick wants to give his monkeypox patients the best possible care. But he and his doctors simply don’t have enough hours in the day to complete dozens of pages of paperwork every time they need to pry medicine out of the Strategic National Stockpile.

And that’s just what has been required for a single patient. His team has treated more than a dozen.

“It’s been a very daunting task,” said Gulick, chief of the Division of Infectious Diseases at New York Presbyterian/Weill Cornell Medicine. “There’s a ton of paperwork, there’s a ton of assessments that are required, there’s a tremendous amount that one has to do to be able to administer this drug to someone.”

Physicians’ struggles to prescribe Tpoxx, an antiviral approved to treat smallpox, which is from the same family of viruses as monkeypox, are among a slew of obstacles related to testing, treatment and vaccination that experts say is contributing to a plodding national response that they fear is not keeping up with the virus’s spread. Some worry that the window is closing to prevent the virus from becoming permanently entrenched in this country, with more than 1,400 confirmed infections across 42 states — and hundreds or thousands of additional infections suspected, predominantly in the gay and bisexual community.

Here is more from The Washington Post.

Our regulatory state is failing us, edition #1637

The U.S. Food and Drug Administration (FDA) has authorized the SalivaDirect PCR COVID-19 test created by the Yale School of Public Health for use with pooled saliva samples.

Pooled testing allows labs to combine saliva samples from multiple individuals into a single tube and process the batch as a single test. This approach maintains the clinical sensitivity associated with the real-time reverse transcription polymerase chain reaction tests — the gold standard for detecting SARS-CoV-2, the virus that causes COVID-19 — and gives labs the ability to process the tests far more quickly. The FDA authorizes Yale-designated laboratories to use the SalivaDirect test to pool as many as five samples at a time for SARS-CoV-2 testing.

That is November 2021In July 2020, Alex wrote: “Tyler and I have been pushing pooled testing for months.”

Better to have nothing in the meantime I guess!  In the meantime, only a handful of pooled spit tests have been approved.

Here is the full piece, via DR.

How sad that our regulatory state is still failing us

When Pfizer representatives met with senior U.S. government health officials on July 12, they laid out why they thought booster shots would soon be necessary in the United States. Data from Israel showed the vaccine’s effectiveness waned over time, especially in older and immunocompromised people.

But officials from the Centers for Disease Control and Prevention disagreed, saying their own data showed something quite different, according to four people with direct knowledge of the meeting who spoke on the condition of anonymity.

Other senior health officials in the meeting were stunned. Why hadn’t the CDC looped other government officials on the data? Could the agency share it — at least with the Food and Drug Administration, which was responsible for deciding whether booster shots were necessary? But CDC officials demurred, saying they planned to publish it soon.

That episode, say senior administration officials and outside experts, illustrates the growing frustration with the CDC’s slow and siloed approach to sharing data, which prevented officials across the government from getting real-time information about how the delta variant was bearing down on the United States and behaving with greater ferocity than earlier variants — an information gap they say stymied the response…

“It’s not acceptable how long it takes for this data to be made available,” said a senior CDC official, who spoke on the condition of anonymity to discuss internal matters. “It’s done in a very academic way. Cross every ‘t,’ and dot every ‘i,’ and unfortunately, we don’t have that luxury in a global pandemic. There’s going to be a need to have a significant cultural shift in the agency.”

Here is the full Washington Post story by Yasmeen Abutaleb and Lena H. Sun.

Our regulatory state is still, still, still failing us

The U.S. agency leading the fight against Covid-19 gave up a crucial surveillance tool tracking the effectiveness of vaccines just as a troublesome new variant of the virus was emerging.

While the Centers for Disease Control and Prevention stopped comprehensively tracking what are known as vaccine breakthrough cases in May, the consequences of that choice are only now beginning to show.

Here is more from Bloomberg, tragic and stupid throughout.

The CDC is broken, our regulatory state has been failing us

I was surprised by how good this NYT piece was, for instance here is one of the better diagnoses of the problem, or at least part of it:

Allen disputes the notion that she and her colleagues are doing work that the C.D.C. itself should be doing; in fact, she says, the task force and the federal agency have worked closely together. But she acknowledges that the interdisciplinary approach of the collaborative — it consists not only of doctors and public-health professionals but also of political scientists, economists, lawyers and M.B.A.s — enables it to spot problems that the federal institution can’t necessarily see. Infection control is a good example. “This is not a public-health problem, or even a medical one,” she says. “It’s an issue of organizational capacity.” The C.D.C. is not equipped to identify organizational issues, let alone resolve them.

And:

Around half of the agency’s domestic budget is funneled to the states, but only after passing through a bureaucratic thicket. There are nearly 200 separate line items in the C.D.C.’s budget. Neither the agency’s director nor any state official has the power to consolidate those line items or shift funds among them. “It ends up being extremely fragmented and beholden to different centers and advocacy groups,” says Tom Frieden, who led the C.D.C. during the Obama administration.

How about this?:

This funding system also hobbles emergency-response efforts, because there is no real budget for the unexpected.

Highly recommended, one of the best pieces of this year, here is the full article by Jeenen Interlandi.

The new version of “throwing away the key” — our prison regulatory state is failing us

According to Arizona Department of Corrections whistleblowers, hundreds of incarcerated people who should be eligible for release are being held in prison because the inmate management software cannot interpret current sentencing laws.

KJZZ is not naming the whistleblowers because they fear retaliation. The employees said they have been raising the issue internally for more than a year, but prison administrators have not acted to fix the software bug. The sources said Chief Information Officer Holly Greene and Deputy Director Joe Profiri have been aware of the problem since 2019.

The Arizona Department of Corrections confirmed there is a problem with the software.

As of 2019, the department had spent more than $24 million contracting with IT company Business & Decision, North America to build and maintain the software program, known as ACIS, that is used to manage the inmate population in state prisons.

One of the software modules within ACIS, designed to calculate release dates for inmates, is presently unable to account for an amendment to state law that was passed in 2019.

Senate Bill 1310, authored by former Sen. Eddie Farnsworth, amended the Arizona Revised Statutes so that certain inmates convicted of nonviolent offenses could earn additional release credits upon the completion of programming in state prisons. Gov. Ducey signed the bill in June of 2019.

But department sources say the ACIS software is not still able to identify inmates who qualify for SB 1310 programming, nor can it calculate their new release dates upon completion of the programming.

“We knew from day one this wasn’t going to work” a department source said. “When they approved that bill, we looked at it and said ‘Oh, s—.’”

Here is the full story, via Zach Valenta.

Our Virginia regulatory state is failing us

As of tomorrow, hospitals in Virginia will no longer be able to administer COVID-19 vaccines. Thousands of elderly people are having their vaccine appointments canceled. From now on, all COVID-19 vaccines will go to the local health departments and none directly to hospitals.

Virginia Hospital Center had been running clinics all day every day to give people the vaccine. Appointments there for all 1st dose vaccines have been canceled because the hospital will no longer be able to get the vaccines.

Northam’s health department has also forbidden people from crossing county lines to get the vaccine. If the county next to you has an abundance of the vaccine, you can’t get it. Only residents of that county may get their vaccine.

These new rules will result in many people either having their vaccination appointment canceled or delayed for months. Currently, 7.5 million people in Virginia, Maryland, and DC qualify to get the vaccine, if only they had access to it. The new rules limit the options citizens have for getting the shot. Everyone MUST go through their local health department to be vaccinated. That means in a county such as Loudoun, with a population of over 420,000, and two health department locations to receive the vaccine, will continue to inoculate 400 to 900 people a day. There are no other options. The Loudoun health department has said they are trying to open a third location for vaccinations (possibly at Dulles Town Center) but that could take months. If Loudoun continues at its current pace it will take well over a year for the local health department to inoculate all those who want vaccines. If Loudoun hospitals were allowed to open clinics for vaccines, many more people could be inoculated every day but the Northam administration will not permit it.

Here is the link, via Hans.  In general, Virginia is a fairly well-run state, but as of late it has not been cracking the top 40 for vaccine distribution.

Our regulatory state is failing us, FAA edition

The Federal Aviation Administration has for months been weighing whether to allow the nation’s more than 500 federally subsidized airports to spend their money on screening passengers for the coronavirus, an issue teed up by a plan developed by a fairly small airport in Iowa.

Marty Lenss, director of Eastern Iowa Airport in Cedar Rapids, began working on the plan in the spring, when the spread of the virus and lockdown orders brought air travel to a near standstill.

Lenss worked with a local hospital to craft a plan to quickly screen travelers before they passed through security. He figured he could cover the $800,000 cost by using some of the $23 million the airport received under the $2 trillion coronavirus relief package known as the Cares Act.

The local airport commission signed off on the plan in July, agreeing to make the screening mandatory. At a public meeting shortly before the vote, Lenss predicted he would have the program up and running by September.

But months after Lenss started work, no passengers have been screened. Airport funds are tightly controlled by federal rules, so Lenss started asking the Federal Aviation Administration (FAA) in May if his plan qualified. He’s still waiting for an answer.

“We would have started the FAA conversation much earlier if we’d anticipated the time it’s been taking,” Lenss said. “At this point, I really don’t have a timeline when we might hear. We’re in limbo.”

Here is the full story, outrages throughout.

Our regulatory state is failing us, antibodies edition

It might be the next best thing to a coronavirus vaccine.

Scientists have devised a way to use the antibody-rich blood plasma of COVID-19 survivors for an upper-arm injection that they say could inoculate people against the virus for months.

Using technology that’s been proven effective in preventing other diseases such as hepatitis A, the injections would be administered to high-risk healthcare workers, nursing home patients, or even at public drive-through sites — potentially protecting millions of lives, the doctors and other experts say.

The two scientists who spearheaded the proposal — an 83-year-old shingles researcher and his counterpart, an HIV gene therapy expert — have garnered widespread support from leading blood and immunology specialists, including those at the center of the nation’s COVID-19 plasma research.

But the idea exists only on paper. Federal officials have twice rejected requests to discuss the proposal, and pharmaceutical companies — even acknowledging the likely efficacy of the plan — have declined to design or manufacture the shots, according to a Times investigation. The lack of interest in launching development of immunity shots comes amid heightened scrutiny of the federal government’s sluggish pandemic response.

Here is more from the LA Times, substantive throughout, via Anecdotal.

Our regulatory state is failing us

The Transportation Security Administration withheld N-95 masks from staff and exhibited “gross mismanagement” in its response to the Coronavirus crisis – leaving employees and travelers vulnerable during the most urgent days of the pandemic, a senior TSA official alleges in a new whistleblower complaint.

On Thursday evening the Office of Special Counsel, an independent federal agency that handles whistleblower complaints, said they had found “substantial likelihood of wrongdoing” in the complaint and ordered the Department of Homeland Security to open an investigation…

TSA Federal Security Director Jay Brainard is an official in charge of transportation security in the state of Kansas, and has been with the TSA since the agency’s inception in 2003.

He told NPR that the leadership of his agency failed to protect its staff from the pandemic, and as a result, allowed TSA employees to be “a significant carrier” for the spread of the Coronavirus to airport travelers.

Here is the full NPR story.

Our regulatory state is failing us

You don’t think airlines can just provide hand sanitizer to passengers, do you? On Tuesday the FAA wrote to American Airlines granting permission, and the letter they sent (.pdf) offers a window into process the airline had to go to in order to secure the government’s blessing.

Tuesday’s correspondence came from the FAA’s American Airlines Certificate Management Office in Irving, Texas. Imagine having a local office of a federal agency dedicated to your business, with its own letterhead.

American wanted permission to provide “personal use quantities of hand sanitizer gel and sanitizing wipes to customers prior to boarding and/or distributed during flight.” That means there would be hand sanitizer on the aircraft, and that falls within the FAA’s jurisdiction.

Before writing for permission, a team from American Airlines held two separate meetings with FAA inspectors, from two separate FAA offices – the airline’s direct regulators in their certificate management office, and also with the Office of Hazardous Materials Safety. The purpose of these meetings was “to discuss the 14 CFR part 5 required safety risk assessment” required to have hand sanitizer on board.

Passengers and crew are permitted to carry hand sanitizer, consistent with 49 CFR §175.10. And shippers can carry hand sanitizer, consistent with 49 CFR §173.150(g). For the airline to carry and distribute it, though, 49 CFR §175.8 (a)(4) requires permission of the Administrator of the FAA.

And:

The FAA issued a finding that American’s proffered plan to offer hand sanitizer to passengers “meets conditions for FAA approval allowed in 49 CFR §175.8 (a)(4).” Even so, the specific products that the airline sources for use must be “approved by the AA Chemical Review Board (CRB) to meet the above CFR limitations and will be tracked on an internal reference list.”

Furthermore, permission is contingent on “mitigations and procedures included in the AA RWM ‘Corp SMS and Team – 200512- 01 / Hand Sanitizer in Amenity Kits and Snack Bags’ [being] “completed and complied with.” Any deviations require advance coordination with the dedicated FAA Certificate Management Office for American Airlines “prior to any further flights that provide personal use quantities of hand sanitizer gel and sanitizing wipes to customers.”

A small matter, yes, but indicative of the larger whole.  Here is the full post from Air Genius Gary Leff, via Lama.

“Our regulatory state is failing us”

A number of commentators suggest that the real problem is President Trump, rich people overly concerned with tax cuts, a Republican Party with a deregulatory ideology, and so on.

Instead I have been repeating insistently that “our regulatory state is failing us.”  The FDA and CDC, for instance, have through their regulations made it harder for testing and also widespread mask supply to get off the ground.

I don’t see how you can blame (supposed) deregulatory fervor for the presence of too many regulations, as we have been observing in these instances.

I do think you can blame President Trump, along multiple dimensions, for a poor response to the pandemic, see my grades here.  (If there were a separate risk communication grade, Trump would get an F minus for that.)  Nonetheless a regulatory state cannot be said to work well if it requires such extraordinary attention from a sitting president.

It can be the case that both Trump and the permanent bureaucracy are at fault.  If something takes a long time to get done for reasons relating to preexisting rules, regulations, and laws, usually the current president is not directly at fault for that particular problem.  Was it only Trump’s fault, for instance, that the permits to build a mask factory can take months to acquire?  Or that the HHS did not respond to inquiries about gearing up mask production in Texas?  Or that a law had to be changed to allow industrial companies to sell quality masks to hospitals?  Or that so many a-legal or extra-legal activities (e.g., rich people arranging deliveries by plane, etc.) had to occur to sneak masks into this country?  That the trade barriers on masks persisted for so long? (And yes likely the Trump administration is at fault for de facto toughening restrictions on masks from China.)

It is fine to say “the buck stops here,” and to criticize Trump for not having erected processes to be more aware of these problems and to dissolve them more quickly.  I would agree with some of those criticisms, while noting the Trump administration also has tried to ease many of the regulations hampering adjustment.

This is more something on the horizon, but how do these apples make you feel?  Comforted?  The fault of plutocratic Republicans most of all?

And in both cases, vials and stoppers, a vaccine manufacturer cannot just switch to a slightly different product or another brand. They typically have to run manufacturing changes by FDA first, which could make quick supplier changes to curb shortages a difficult prospect.

The FDA can decide how flexible it will be about this type of change, says Sklamberg. The agency said in a December 2017 draft guidance that companies could note some changes in their annual reports rather than waiting for approval, but it has not finalized the policy.

The ability to switch products could be crucial as the entire world readies for a possible vaccine and vies to secure their supplies.

If you wish, consider a simple question.  When the CDC pooh-poohed masks early on, or botched their testing kit thereby delaying U.S. testing by weeks or maybe months, did the permanent staff of the CDC rise up and rebel and leak howling protests to the media, realizing that thousands of lives were at stake?  That is surely what would happen if say the current FDA announced it was going to approve thalidomide.

Those are still cases of our regulatory state failing us.

Our regulatory state is failing us, installment #1437

The Trump administration has stumbled in its initial push to implement the $2 trillion coronavirus aid package, with confusion and fear mounting among small businesses, workers and the newly unemployed since the bill was signed into law late last month.

Small-business owners have reported delays in getting approved for loans without which they will close their doors, while others say they have been denied altogether by their lenders and do not understand why. The law’s provision to boost unemployment benefits has become tangled in dated and overwhelmed state bureaucracies, as an unprecedented avalanche of jobless Americans seeks aid.

Officials at the Internal Revenue Service have warned that $1,200 relief checks may not reach many Americans until August or September if they haven’t already given their direct-deposit information to the government. Taxpayers in need of answers from the IRS amid a rapidly changing job market are encountering dysfunctional government websites and unresponsive call centers that have become understaffed as federal workers stay home.

Here is the full piece by Jeff Stein.  And here is me in WaPo:

Cowen said it’s inexplicable why the federal government, given all the warnings and evidence from China of a spreading pandemic, did not move more rapidly.

“You know, Trump was terrible, but you can’t just pin it on him. It’s far more systemic than that. The NBA [which suspended its season on March 11] really gets so much credit. I would put the NBA in charge of fighting climate change at this point.”

The piece there is by Dan Balz.