Results for “FDA”
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A Pox on the FDA

Monkeypox isn’t in the same category of risk that COVID was before vaccines but it’s a significant risk, especially in some populations, and it’s a test of how much we have learned. The answer is not bloody much. Here’s James Walsh in NYMag:

As monkeypox cases have ticked up nationwide, the White House and federal agencies have repeatedly assured the public that millions of vaccine doses will be distributed to at-risk populations before the end of the year. Yet since the World Health Organization announced the global monkeypox outbreak in May, only tens of thousands of shots have been administered in the U.S. The slow start is due, at least in part, to the fact that 1.1 million doses have been stored in a Denmark pharmaceutical facility while the Food and Drug Administration has taken almost two months to approve their release here, according to people familiar with the situation. FDA officials only began to inspect the facility last week. The lag time, public-health experts say, is indicative of the federal government’s lackadaisical approach to a growing public-health emergency.

…It’s unclear why the FDA took so long to send inspectors to Denmark. The agency regularly conducted virtual inspections of drug facilities early in the COVID-19 pandemic, according to the agency’s guidance, and public-health activists are demanding answers. “Members of at risk communities are being turned away from monkeypox vaccination because these vaccines are not available in sufficient quantity in the U.S., but instead sitting in freezers in Denmark,” members of the advocacy group PrEP4All and Partners in Health wrote in a letter to federal officials overseeing the outbreak response last week.

Compounding their frustrations was the FDA’s refusal to accept an inspection done last year by its counterpart, the European Medicines Agency, which deemed the company’s facility in compliance with the FDA’s own standards.

“The FDA does not grant reciprocity for EMA authorization of any vaccines, for monkeypox or other diseases,” a spokesperson for the FDA said in a statement.

Is there anyone in the United States who is saying, “I am at risk of Monkeypox and I want the vaccine but I don’t trust the European Medicines Agency to run the inspection. I’d rather wait for the FDA!” I don’t think so. James Krellenstein, an activist on this issue, asks:

“Why were the Europeans able to inspect this plant a year ago, ensuring these doses can be used in Europe and the Biden Administration didn’t do the same,” he added. “The FDA is making a judgment that they’d rather let gay people remain unvaccinated for weeks and weeks and weeks than trust the European certification process.”

Many people want to be vaccinated:

New York City has received just 7,000 doses from the federal government amid the national vaccine shortage. Meanwhile, the city Department of Health and Mental Hygiene’s appointment booking system has failed to keep up with the high demand for the shots — most recently on Wednesday.

…The mounting frustrations left health officials and Mayor Eric Adams on the defensive, pushing back against comparisons to New York’s struggles during the early days of the coronavirus vaccine, which was beset by computer glitches and supply shortages.

This is a classic case for reciprocity. Any drug, vaccine, test or sunscreen (!) approved by a stringent regulatory authority ought to be conditionally approved in the United States.

Addendum: If you are not furious already–and you should be–remember that during COVID the FDA suspended factory inspections around the world creating shortages of life-saving cancer drugs and other pharmaceuticals. As I wrote then “Grocery store workers are working, meat packers are working, hell, bars and restaurants are open in many parts of the country but FDA inspectors aren’t inspecting. It boggles the mind.”

Hat tip: Josh Barro.

Photo Credit: Nigeria Centre for Disease Control.

The FDA is Increasing Skin Cancer

Americans who travel to the beaches in France, Spain, or Italy routinely do something that is illegal in the United States–they buy and use European sunscreens to protect themselves from sunburn and skin cancer. Suncreens in Europe and Asia are better than in the United States because more ingredients are allowed and these create more effective and more pleasing suncreens. I’ve been writing about this since 2013! My view hasn’t changed:

My rule is very simple. I don’t think the FDA is better than the EMA so if any drug or device is approved in Europe it ought to be available for purchase in the United States with a label saying “Approved by the EMA. Not approved by the FDA.” (By the way, we do have reciprocity type agreements with Canada and New Zealand for food so this would not be unprecedented.)

Here’s the latest from Amanda Mull writing in the Atlantic:

Newer, better UV-blocking agents have been in use in other countries for years. Why can’t we have them here?

In formal statements and position papers, doctors and cancer-prevention advocates express considerable interest in bringing new sunscreen ingredients to the American market, but not a lot of optimism that any will be available soon.

…In 2014, Congress passed a law attempting to speed access to sunscreen ingredients that have been in wide use in other countries for years, but it hasn’t really worked. “The FDA was supposed to be fast-tracking these ingredients for approval, because we have the safety data and safe history of usage from the European Union,” Dobos said. “But it seems to continually be stalled.” According to Courtney Rhodes, a spokesperson for the FDA, manufacturers have submitted eight new active ingredients for consideration. The agency has asked them to provide additional data in support of those applications, but none of them has yet satisfied the agency’s requirements.

“In the medical community, there is a significant frustration about the lack of availability of some of the sunscreen active ingredients,” Henry Lim, a dermatologist at Henry Ford Health, in Michigan, told me. The more filters are available to formulators, the more they can be mixed and matched in new ways, which stands to improve not just the efficacy of the final product, but how it feels and looks on your skin, and how easy it is to apply. On a very real level, making sunscreen less onerous to use can make it more effective. “The best sunscreen is going to be the one you’re going to use often and according to the directions,” Dobos said. Skin cancer is the most common type of cancer in the United States, and by one estimate, one in five Americans will develop it in their lifetime.

Hat tip: Joe.

The FDA should make Paxlovid easier to get

Pharmacists still cannot prescribe the medication themselves, a step that would cut the time it takes patients to secure the drug.

The Food and Drug Administration “is looking at this and thinking about it,” Dr. Jha said. “Whether they’re going to make a change, when and how, etc., is totally in their wheelhouse.”

Many patients are still handling the sometimes-cumbersome steps on their own: locating a virus test, then securing a Paxlovid prescription from a health provider, then finding a pharmacy that carries the pill, all within days of first showing symptoms.

Dr. Jha described being frustrated by physician colleagues who have told him they still limit Paxlovid to patients 65 years and older.

But no they still will not do this.  I repeat myself, but you need to keep in mind the only time panel members have resigned from the FDA is when the Biden administration pushed through the booster shots.

Here is the full NYT article, via Rich Berger.

ProPublica on the FDA and Rapid Tests

Lydia DePillis has written the best piece on the FDA that I have ever read in a mainstream news publication. It gets everything right and yes it frankly verifies everything that I have been saying about the FDA and rapid tests for the last year and a half. I wish it had been written earlier but I suppose that illustrates how difficult it is to radically change people’s mindset from the FDA as protector to the FDA as threat. The sub head is:

Irene Bosch developed a quick, inexpensive COVID-19 test in early 2020. The Harvard-trained scientist already had a factory set up. But she was stymied by an FDA process experts say made no sense.

The piece recounts how cheap, rapid tests could have been approved in March of 2020! Here’s the opening bit:

When COVID-19 started sweeping across America in the spring of 2020, Irene Bosch knew she was in a unique position to help.

The Harvard-trained scientist had just developed quick, inexpensive tests for several tropical diseases, and her method could be adapted for the novel coronavirus. So Bosch and the company she had co-founded two years earlier seemed well-suited to address an enormous testing shortage.

E25Bio — named after the massive red brick building at MIT that houses the lab where Bosch worked — already had support from the National Institutes of Health, along with a consortium of investors led by MIT.

Within a few weeks, Bosch and her colleagues had a test that would detect coronavirus in 15 minutes and produce a red line on a little chemical strip. The factory where they were planning to make tests for dengue fever could quickly retool to produce at least 100,000 COVID-19 tests per week, she said, priced at less than $10 apiece, or cheaper at a higher scale.

“We are excited about what E25Bio is capable of shipping in a short amount of time: a test that is significantly cheaper, more affordable, and available at-home,” said firm founder Vinod Khosla. (Disclosure: Khosla’s daughter Anu Khosla is on ProPublica’s board.)

On March 21 — when the U.S. had recorded only a few hundred COVID-19 deaths  Bosch submitted the test for emergency authorization, a process the Food and Drug Administration uses to expedite tests and treatments.

You know how the story ends but really READ the WHOLE THING.

ProPublica on FDA Delay

If you have been following MR for the last 18 months (or 18 years!) you won’t find much new in this ProPublica piece on FDA delay in approving rapid tests but, other than being late to the game, it’s a good piece. Two points are worth emphasizing. First, some of the problem has been simple bureaucratic delay and inefficiency.

In late May, WHPM head of international sales Chris Patterson said, the company got a confusing email from its FDA reviewer asking for information that had in fact already been provided. WHPM responded within two days. Months passed. In September, after a bit more back and forth, the FDA wrote to say it had identified other deficiencies, and wouldn’t review the rest of the application. Even if WHPM fixed the issues, the application would be “deprioritized,” or moved to the back of the line.

“We spent our own million dollars developing this thing, at their encouragement, and then they just treat you like a criminal,” said Patterson. Meanwhile, the WHPM rapid test has been approved in Mexico and the European Union, where the company has received large orders.

An FDA scientist who vetted COVID-19 test applications told ProPublica he became so frustrated by delays that he quit the agency earlier this year. “They’re neither denying the bad ones or approving the good ones,” he said, asking to remain anonymous because his current work requires dealing with the agency.

Recall my review of Joseph Gulfo’s Innovation Breakdown.

Second, the FDA has engaged in regulatory nationalism–refusing to look at trial data from patients in other countries. This is madness when India does it and madness when the US does it.

For example, the biopharmaceutical giant Roche told ProPublica that it submitted a home test in early 2021, but it was rejected by the FDA because the trials had been done partly in Europe. The test had compared favorably with Abbott’s rapid test, and received European Union approval in June. The company plans to resubmit an application by the end of the year.

A smaller company, which didn’t want to be named because it has other contracts with the U.S. government, withdrew its pre-application for a rapid antigen test with integrated smartphone-based reporting because it heard its trial data from India — collected as the delta variant was surging there — wouldn’t be accepted. Doing the trials in the U.S. would have cost millions.

Photo credit: MaxPixel.

Clement and Tribe Predicted the FDA Catastrophe

Paul Clement and Laurence Tribe

Laboratory developed tests are not FDA regulated–never have been–instead the labs are regulated under the Clinical Laboratory Improvement Amendments (CLIA) as overseen by the CMS. Laboratory developed tests are the kind your doctor orders, they are a service not a product and are not sold directly to patients. Labs develop new tests routinely and they do not apply to the FDA for approval. Despite this long history, the FDA has claimed that it has the right to regulate lab tests and they have merely chosen not to exercise this right for forty years. In 2015, Paul Clement the former US Solicitor General under George W. Bush and Laurence Tribe, considered by many to be the leading constitutional lawyer in the United States, wrote an article that rejected the FDA’s claims writing that the “FDA’s assertion of authority over laboratory-developed testing services is clearly foreclosed by the FDA’s own authorizing statute” and “by the broader statutory context.”

Despite lacking statutory authority, the FDA has continued to claim it is authorized to regulate laboratory tests. Indeed, a key failure in the pandemic happened when the FDA issued so-called “guidance documents” saying that any SARS-CoV-II test had to be pre-approved by the FDA. Thus, the FDA reversed the logic of emergency. In ordinary times, pre-approval was not necessary but when speed was of the essence it became necessary to get FDA pre-approval. The FDA’s pre-approval process slowed down testing in the United States and it wasn’t until after the FDA lifted its restrictions in March that tests from the big labs became available.

Clement and Tribe rejected the FDA claims of regulatory authority over laboratory developed tests on historical, statutory, and legal grounds but they also argued that letting the FDA regulate laboratory tests was a dangerous idea. In a remarkably prescient passage, Clement and Tribe (2015, p. 18) warned:

The FDA approval process is protracted and not designed for the rapid clearance of tests. Many clinical laboratories track world trends regarding infectious diseases ranging from SARS to H1N1 and Avian Influenza. In these fast-moving, life-or-death situations, awaiting the development of manufactured test kits and the completion of FDA’s clearance procedures could entail potentially catastrophic delays, with disastrous consequences for patient care.

Clement and Tribe nailed it. Catastrophic delays, with disastrous consequences for patient care is exactly what happened.

Addendum: See also my pre-pandemic piece on this issue, Our DNA, Our Selves.

FDA relents on mix and match for third dose

Here is the NYT account, they sound both confused and confusing.  How about “if you have had J&J, it is fine and probably preferable to get a further dose of Moderna or Pfizer”?  Yet suddenly it is fine.

And it is the usual story — people have been doing this for months, and the FDA would not say it is terrible.  Because they knew it wasn’t.  But they wouldn’t say so.  And now the status quo has shifted, and so everyone will treat it as fine, as if the supposed fears of yesterday never ever existed.

Maybe I should insult people more often?

FDA Approves American Rapid Antigen Test

I wrote earlier:

What makes the FDAs failure to approve more rapid antigen tests even more galling is that the test being sold cheaply in the Amsterdam supermarket is the Flowflex, an American test made by Acon Labs in San Diego.

Well the FDA has finally approved the Acon test! Apparently it is good enough for the Germans and for US citizens. Hoorah! USA Today notes:

ACON expects to make 100 million tests per month by the end of this year. Production could double to 200 million monthly tests by February, according to the FDA.

…The United Kingdom and Germany have made significant purchases of home tests and widely distributed them to their residents to slow the spread of coronavirus. Such large government purchases allowed manufacturers to continue making tests even when demand softened as cases dropped.

The Biden administration will spend nearly $1.2 billion to purchase up to 187 million home tests from Abbott Laboratories and Celltrion Inc., company officials confirmed. The Department of Defense announced additional contracts totaling $647 million to buy 60 million kits from Abbott and three other testing vendors: OraSure Technologies, Quidel and Intrivio Holdings.

The FDA has authorized seven antigen-based tests that can be used at home without a prescription. The EU has authorized 21 tests beginning with the letter A (I am not sure all of these are authorized for home use but you get the idea.) Turtle slow. Still this is a big improvement.

Frankly, I think all the pressure from people like Michael Mina amplified by myself and others over 18 months and culminating in David Leonhartd’s NYTimes article Where Are the Tests? finally pushed them over the edge.

The NYTimes on the FDA and Rapid Tests

In July of 2020 I wrote in Frequent, Fast, and Cheap is Better than Sensitive:

A number of firms have developed cheap, paper-strip tests for coronavirus that report results at-home in about 15 minutes but they have yet to be approved for use by the FDA because the FDA appears to be demanding that all tests reach accuracy levels similar to the PCR test. This is another deadly FDA mistake.

…The PCR tests can discover virus at significantly lower concentration levels than the cheap tests but that extra sensitivity doesn’t matter much in practice. Why not? First, at the lowest levels that the PCR test can detect, the person tested probably isn’t infectious. The cheap test is better at telling whether you are infectious than whether you are infected but the former is what we need to know to open schools and workplaces.

It’s great that other people including the NYTimes are now understanding the problem. Here is the excellent David Leonhardt in Where are the Tests?

Other experts are also criticizing the Biden administration for its failure to expand rapid testing. Even as President Biden has followed a Covid policy much better aligned with scientific evidence than Donald Trump’s, Biden has not broken through some of the bureaucratic rigidity that has hampered the U.S. virus response.

In the case of rapid tests, the F.D.A. has loosened its rules somewhat over the past year, allowing the sale of some antigen tests (which often cost about $12 each). But drugstores, Amazon and other sellers have now largely run out of them. I tried to buy rapid tests this weekend and couldn’t find any.

The F.D.A.’s process for approving rapid tests is “onerous” and “inappropriate,” Daniel Oran and Dr. Eric Topol of Scripps Research wrote in Stat News.

For the most part, the F.D.A. still uses the same cumbersome process for approving Covid tests that it uses for high-tech medical devices. To survive that process, the rapid tests must demonstrate that they are nearly as sensitive as P.C.R. tests, which they are not.

But rapid tests do not need to be so sensitive to be effective, experts point out. P.C.R. tests often identify small amounts of the Covid virus in people who had been infected weeks earlier and are no longer contagious. Rapid tests can miss these cases while still identifying about 98 percent of cases in which a person is infectious, according to Dr. Michael Mina, a Harvard epidemiologist who has been advocating for more testing

Identifying anywhere close to 98 percent of infectious cases would sharply curb Covid’s spread. An analysis in the journal Science Advances found that test frequency matters more for reducing Covid cases than test sensitivity.

As I said on twitter what makes the FDA’s failure to approve more rapid antigen tests especially galling is that some of the tests being sold cheaply in Europe are American tests just ones not approved in the United States. If it’s good enough for the Germans it’s good enough for me!

The FDA and CDC Standards on the J&J Vaccine and the Immunocompromised are Unintelligible

Last week the FDA authorized and the CDC now recommends a third mRNA booster for the immunocomprimised. The CDC says:

Who Needs an Additional COVID-19 Vaccine?

Currently, CDC is recommending that moderately to severely immunocompromised people receive an additional dose. This includes people who have:

  • Been receiving active cancer treatment for tumors or cancers of the blood
  • Received an organ transplant and are taking medicine to suppress the immune system
  • Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
  • Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection
  • Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response

That’s very reasonable but the headline is inaccurate because the CDC then goes on to say:

The FDA’s recent EUA amendment only applies to mRNA COVID-19 vaccines, as does CDC’s recommendation.

Emerging data have demonstrated that immunocompromised people who have low or no protection following two doses of mRNA COVID-19 vaccines may have an improved response after an additional dose of the same vaccine. There is not enough data at this time to determine whether immunocompromised people who received the Johnson & Johnson’s Janssen COVID-19 vaccine also have an improved antibody response following an additional dose of the same vaccine.

So if you got one dose of J&J and are immunocompromised then you can’t get a second dose. But if you got two doses of an mRNA (which is already more effective than one dose of J&J) and are immunocompromised then the CDC recommends a third dose. None of this makes any sense. The weasel words there ‘isn’t enough data to determine’ indicate a typical failure to think in Bayesian terms and use all the information available and a typical failure to think in terms of patient welfare and expected cost and benefits.

Notice also the illiberal default. Instead of saying ‘we don’t have data on the J&J vaccine and the immunocompromised so we are not at this time recommending or not recommending boosters but leaving this decision in the hands of patients and their physicians’ they say ‘we don’t have data and so we are forbidding patients and their physicians from making a decision using their own judgment.’

Hat tip: Pharmacist CB.

The TGA is Worse than the FDA, and the Australian Lockdown

I have been highly critical of the FDA but in Australia the FDA is almost a model to be emulated. Steven Hamilton and Richard Holden do not mince words:

At the end of 2020, as vaccines were rolling out en masse in the Northern Hemisphere, the TGA [Therapeutic Goods Administration, AT] flatly refused to issue the emergency authorisations other regulators did. As a result, the TGA didn’t approve the Pfizer vaccine until January 25, more than six weeks after the US Food and Drug Administration (FDA), itself not exactly the poster child of expeditiousness.

Similarly, the TGA didn’t approve the AstraZeneca vaccine until February 16, almost seven weeks after the UK.

In case you’re wondering “what difference does six weeks make?“, think again. Were our rollout six weeks faster, the current Sydney outbreak would likely never have exploded, saving many lives and livelihoods. In the face of an exponentially spreading virus that has become twice as infectious, six weeks is an eternity. And, indeed, nothing has changed. The TGA approved the Moderna vaccine this week, eight months after the FDA.

It approved looser cold storage requirements for the Pfizer vaccine, which would allow the vaccine to be more widely distributed and reduce wastage, on April 8, six weeks after the FDA. And it approved the Pfizer vaccine for use by 12 to 15-year-olds on July 23, more than 10 weeks after the FDA.

And then there’s the TGA’s staggering decision not to approve in-home rapid tests over reliability concerns despite their widespread approval and use overseas.

Where’s the approval of the mix-and-match vaccine regimen, used to great effect in Canada, where AstraZeneca is combined with Pfizer to expand supply and increase efficacy? Where’s the guidance for those who’ve received two doses of AstraZeneca that they’ll be able to receive a Pfizer booster later?

In the aftermath of the pandemic, when almost all of us should be fully vaccinated,there will be ample opportunity to figure out exactly who is to blame for what.

But the slow, insular, and excessively cautious advice of our medical regulatory complex, which comprehensively failed to grasp the massive consequences of delay and inaction, must be right at the top of that list.

You might be tempted to argued that the TGA can afford to take its time since COVID hasn’t been as bad in Australia as in the United States but that would be to ignore the costs of the Australian lockdown.

Article 13 of the Universal Declaration of Human Rights states that

  1. Everyone has the right to freedom of movement and residence within the borders of each state.
  2. Everyone has the right to leave any country, including his own, and to return to his country.

Australia has now violated each and every clause of this universal human right and seemingly without much debate or objection. It is deeply troubling to see people prevented from leaving or entering their own country and soldiers in the street making sure people do not travel beyond a perimeter surrounding their homes. The costs of lockdown are very high and thus so is any delay in ending these unprecedented infringements on liberty.

The American Academy of Pediatrics Tells the FDA to Speed Up and Stop Endangering Patients

The American Academy of Pediatrics has written a stunning letter to the FDA:

We understand that the FDA has recently worked with Pfizer and Moderna to double the number of children ages 5-11 years included in clinical trials of their COVID-19 vaccines. While we appreciate this prudent step to gather more safety data, we urge FDA to carefully consider the impact of this decision on the timeline for authorizing a vaccine for this age group. In our view, the rise of the Delta variant changes the risk-benefit analysis for authorizing vaccines in children. The FDA should strongly consider authorizing these vaccines for children ages 5-11 years based on data from the initial enrolled cohort, which are already available, while continuing to follow safety data from the expanded cohort in the post-market setting. This approach would not slow down the time to authorization of these critically needed vaccines in the 5–11-year age group.

In addition, as FDA continues to evaluate clinical trial requirements for children under 5 years, we similarly urge FDA to carefully consider the impact of its regulatory decisions on further delays in the availability of vaccines for this age group. Based on scientific data currently available on COVID-19 vaccines, as well as on 70 years of vaccinology knowledge in the pediatric population, the Academy believes that clinical trials in these children can be safely conducted with a 2-month safety follow-up for participants. Assuming that the 2-month safety data does not raise any new safety concerns and that immunogenicity data are supportive of use, we believe that this is sufficient for authorization in this and any other age group. Waiting on a 6-month follow-up will significantly hinder the ability to reduce the spread of the hyper infectious COVID-19 Delta variant among this age group, since it would add 4 additional months before an authorization decision can be considered. Based on the evidence from the over 340 million doses of COVID-19 doses administered to adults and adolescents aged 12-17,as well as among adults 18 and older, there is no biological plausibility for serious adverse immunological or inflammatory events to occur more than two months after COVID-19 vaccine administration.

In my many years of writing about the FDA, I can’t recall a single instance in which a major medical organization told the FDA to use a smaller trial and speed up the process because FDA delay was endangering the safety of their patients. Wow.

The invisible graveyard is invisible no more.

The FDA Is Still Much Too Strict

Here is just one bit from a superb post on the FDA by psychiatrist Scott Alexander at Astral Codex Ten.

I worry that people are going to come away from this with some conclusion like “wow, the FDA seemed really unprepared to handle COVID.” No. It’s not that specific. Every single thing the FDA does is like this. Every single hour of every single day the FDA does things exactly this stupid and destructive, and the only reason you never hear about the others is because they’re about some disease with a name like Schmoe’s Syndrome and a few hundred cases nationwide instead of something big and media-worthy like coronavirus. I am a doctor and sometimes I have to deal with the Schmoe’s Syndromes of the world and every [email protected]$king time there is some story about the FDA doing something exactly this awful and counterproductive.

A while back I learned about Infant Short Bowel Syndrome, a rare condition with only a few hundred cases nationwide. Babies cannot digest food effectively, but you can save their lives by using an IV line to direct nutrients directly into their veins. But you need to use the right nutrient fluid. The FDA approved an early draft of the nutrient fluid, but it didn’t have enough fish oil, which is necessary for development, so a lot of the babies still died or ended up with permanent neurological damage. Around the late 90s/early 00s, researchers figured out what was going on and recommended adding fish oil to the IV fluid. The FDA responded that they had only approved the non-fish-oil version, it would take them a while to approve the new version, and until they did that adding fish oil was illegal. A bunch of babies kept dying and getting permanent neurological damage, and everyone knew exactly how to stop it, but if anyone did the FDA would take away their licenses and shut them down. Around 2010, Boston Children’s Hospital found some loophole that let them add fish oil to their nutrient fluid on site, and infants with short bowel syndrome at that one hospital stopped dying or ending up permanently disabled, and the FDA grudgingly agreed to permit it but banned them from distributing their formulation or letting it cross state lines – so for a while if you wanted your baby not to die you had to have them spend their infancy in one specific hospital in Massachusetts. Around 2015 the FDA said that if your doctor applied for a special exemption, they would let you import the correct nutritional fluid from Europe (where, lacking the FDA, they had just added fish oil to the fluid as soon as researchers discovered it was necessary), but you were only able to apply after your baby had already sustained serious damage, and the FDA might just say no. Finally in 2018 the FDA got around to approving the corrected nutritional fluid and now babies with short bowel syndrome do fine, after twenty years of easily preventable state-mandated deaths. And it’s not just this and coronavirus, I CANNOT STRESS ENOUGH HOW TYPICAL THIS IS OF EVERYTHING THE FDA DOES ALL THE TIME.

Read the whole thing! I actually had to read it in several sessions, it’s not that long but bouts of anger interspersed with moments of laughter made me have to put it down momentarily to recover. There is a lot more in the post on reforms.

Best quick intro to my views on the FDA is this post (follow the links) and my paper on off-label prescribing.

Addendum: Scott updates the infant fish oil story and provides much more detail. He got some things wrong and the FDA as an agency ends up looking better but the broad outline about the FDA system looks right. I am leaving the post up for posterity but this specific part isn’t correct.

My Conversation with Daniel Carpenter, on regulation and also the FDA

Here is the audio, video, and transcript, I found it a very substantive and also illuminating episode.  Carpenter is very, very smart and also very well-informed historically.  Here is part of the summary:

Daniel Carpenter is one of the world’s leading experts on regulation and the foremost expert on the US Food and Drug Administration. A professor of Government at Harvard University, he’s conducted extensive research on regulation and government organizations, as well as on the development of political institutions in the United States. His latest book Democracy by Petition: Popular Politics in Transformation, details the crucial role petitions played in expanding the franchise and shaping modern America.

Here is an excerpt from the non-FDA section, much of which focuses on (non-FDA) regulation:

COWEN: What kinds of records should the Postal Service keep about itself?

CARPENTER: [laughs] Great question. There’s a whole set of things that they don’t since the Griswold decision and since the First Amendment decisions. They don’t keep as much records of what goes through the mail. They can’t prohibit things like pornography, contraception.

I guess it depends on what you mean by “itself.” I would start with the idea that basic privacy restrictions, which governed the postal system as much through norm as by law in the 19th century and early 20th century, should govern the system.

It’s a crime if I were to walk past your mailbox and open your letter. I’m committing a federal crime, but there were also norms that seals were not to be broken, things like that. I do think whichever way the Postal Service goes — and it’s quite possible that you could imagine an electronic platform for the US postal system — I think basic privacy restrictions have to be guaranteed.

Actually, in some respects, I think we need to know a fair amount about what postal workers do without, say, calling for Amazon tracking. But if we think that postal workers are misplacing ballots or not providing birth control pills or something like that, then we should probably have some way of picking up on that kind of nefarious behavior.

In the FDA section I got mad at him, the first (but not last?) time that has happened in a CWT, do read or listen to the whole section, the two of us really had at it!  Here is a tiny sliver from it:

COWEN: But shouldn’t there be a button within the FDA that can be pushed, where the FDA goes into a kind of wartime mode?

I don’t want to misrepresent Carpenter by an ill-chosen excerpt, so please do digest his full set of replies.  Recommended.

From the comments, on FDA credibility

This maybe a violation of Cowen’s second law, but my cursory examination turns up no useful hits in PubMed about FDA credibility. We have the odd op-ed, some drivel about people thinking the FDA is more credible about cigarettes when they learn that FDA regulates cigarette manufacture, and precious little else of remote utility.

Almost as though senior FDA leadership have not bothered, after over a year of pandemic to even commission a rigorous survey of which action(s) the public would view as credible. Certainly what they are doing is not coherent with any of the effective medical communication techniques I was taught nor with any of my training for dealing with public responses to calamity.

But maybe I’m wrong. Maybe somewhere the FDA dumped a couple of grand into even a Mechanical Turk survey to justify actions that will have billions in cost implications and might lead to the death of thousands of folks (particularly overseas).

I mean, the civil servants at the FDA surely are not just LARPing as pop psychologists, somewhere I’ve missed they have actual peer reviewed literature guiding any of their moves regarding communication, credibility, and risk management, right?

That is from Sure.  So what is the best piece on FDA credibility?  (Yes, I know the work of Daniel Carpenter and have a CWT with him coming out and we do address this directly.)  And what has the FDA itself done to study the issue of its own credibility?