Results for “FDA” 465 found
Google searches for inequality (from my email)
From Jared Sleeper:
I was surprised to see this magnitude of effect. Google searches for “inequality” are twice as high during the academic year as they are during the summer. They double in September vs. August and then collapse by 50% in June vs. May.
Speeding Up Pharmaceutical Approvals by Recognizing Other Stringent Regulators
New Zealand’s ACT party has proposed that New Zealand speed up pharmaceutical approvals by recognizing the decisions of other stringent regulators, an idea I have long promoted .
The average time for Medsafe to consent an application for a high risk medicine is 630 days. For intermediate risk, it is 661 days and for lower risk it is 830 days8. The average time taken just for processing some lower risk categories is 176-210 days. This is an unacceptable length of time, given there other regulatory bodies replicating that exact same work overseas.
ACT says if a drug or medical device has been approved by any two reputable foreign regulatory bodies (such as Australia, United States, United Kingdom), it should be automatically approved in NZ as well within one week unless Medsafe can show extraordinary reason why it shouldn’t be.
This simple change would significantly improve access to medicines that have already been subject to rigorous testing and analysis through other regulatory regimes.
The ACT party is small but it has some seats and surprisingly the much larger National party is proposing a similar rule:
New Zealand’s slow approval process for medicines means Kiwis wait much longer than people in other countries to access potentially life-saving treatments. While it is essential that medicines and other treatments are subject to stringent scrutiny to ensure they are safe, there is no reason why New Zealanders should have to wait for our domestic medicines regulatory body, Medsafe, to conduct its own cumbersome process from scratch, when countries with health systems we trust have already gone through this exercise.
National will:…• Require Medsafe to implement even faster approvals processes for any medicines for use in New Zealand that have already been approved by at least two regulatory bodies that we currently recognise, including Australia, the EU, Singapore, the UK, Switzerland and the US.
New Zealand, by the way, already has a reciprocity agreement with the United States for food and it’s mutual–the FDA also recognizes New Zealand as a stringent food regulator–so the idea is not unprecedented.
Moreover, all of this comes on the tail of the UK actually adopting the idea via the “reliance procedure” which recognizes the EU as a stringent regulator and guarantees approval in the UK within 67 days for ay drug approved in the EU.
In the United States, even AOC has flirted with the idea, at least for sunscreens!
Thus, the reciprocity or recognition idea is starting to be adopted.
Hat tip: Eric Crampton who has some further comments.
Pharmaceutical Externalities
In my view, pharmaceuticals are undervalued and underinvested in because, despite high prices, pharmaceutical innovations earn only a fraction of the value that they create (Nordhaus finds that in general that innovations reap only a small share of the gains that they create). In 2014, for example, we got Harvoni a new treatment that offered a complete cure for hepatitis C (HCV) infection. In 2014, Harvoni cost over $1000 a pill and between $60,000 and $100,000 for a full treatment. In 2015 Medicaid spent more on Harvoni than on any other drug and there were calls for regulation and price controls. Studies showed, however, that even at that high price, Harvoni was value/cost-effective. Today, with more competition, there are equivalent versions of Harvoni available from Amazon for $12,869 (and 64 cents) which is still expensive but cheap for a cure for an often debilitating and sometimes life-threatening disease (and the price is less for a private insurance buyer or Medicare/Medicaid). In 2030, Harvoni will go generic and prices will fall much more.
Writing at their new substack, Random Acts of Medicine (based on their book of the same name which I reviewed at the WSJ), Chris Worsham and Bapu Jena point us to another side-benefit of Harvoni and similar hep-C drugs. By curing hep-C these drugs results in fewer liver transplants but that means more livers are available for transplant to other people on the waiting list.
One simple statistic suggests that indeed, treatment of HCV is freeing up donor livers for patients with other diseases: in 2022, patients with chronic HCV infection represented only 11% of liver transplants (1,029 of 9,528)—down from the 38% in 2013 when the new HCV drugs were approved.
Beyond this simple figure, a new working paper by economists Kevin Callison, Michael Darden, and Keith Teltser has taken a new, rigorous look at data from 2014 to 2019 to understand how these new drugs for HCV have impacted liver transplants after their first 5 years of broad use. There were a number of encouraging findings:
- Waiting lists for liver transplants were being occupied by fewer HCV-positive patients and more HCV-negative patients; this shift can be explained by an estimated 45% reduction in the addition of new HCV-positive patients to waiting lists
- Patients on the waiting list were healthier, likely because waiting times for livers have decreased with less demand from HCV-positive patients
- Compared to what would have been expected without the introduction of new HCV treatments, the researchers estimated a 39% decrease in transplants to HCV-positive patients coupled with a 36% increase in transplants to HCV-negative patients.
- Over the five year period, researchers estimated 5,682 livers were transplanted to HCV-negative patients as a result of the new HCV drugs, corresponding to an economic value of $7.5 billion.
These kinds of external benefits from pharmaceuticals are often undercounted and they are one reason why I think the pharmaceutical price controls in the Inflation Reduction Act are a very bad idea.
Sunday assorted links
1. “Mobility indicators measuring voluntary decisions to socially distance, comprising measures of visitors/visits to recreational locations, and mobility proxy measuring duration of hours away from home show that a lower prevalence of long-term orientation traits explains persistent resistance to social distancing.” Link here, speculative.
2. Neanderthal genes and Covid risk? (WSJ)
3. “Masked ‘Boot Girls’ Are Freeing Booted Cars All Over Atlanta.”
4. Victor Fuchs has passed away.
5. Why it took the FDA so long to review the disputed cold remedy (NYT). And flying taxi executive to head the FAA.
6. “Japan’s Productivity Ranks Lowest Among G7 Nations for 50 Straight Years.” Why hasn’t YIMBY done more to fix that?
Diogo Costa on Brazil
From my email, via Gonzalo Schwartz:
The country ranks third globally in consuming information via digital platforms, a landscape that cultivates distrust in public institutions and ignites social unrest. This has fostered a rise in right-wing populism, including the election of former president Jair Bolsonaro, intensifying what Martin Gurri describes as a ‘crisis of authority.’ Efforts to counter this crisis, however, further destabilize Brazil’s democracy.
Supreme Court Justice Alexandre de Moraes exemplifies this turmoil with his controversial measures, including arbitrary digital content removal, ousting elected officials, and implementing unprecedented surveillance. Moraes and his peers have been criticized for investigating entrepreneurs and freezing assets over alleged anti-democratic private messages, probing executives from Google and Telegram for supposed disinformation campaigns, revoking passports of foreign-based journalists, and censoring a film about then-president Jair Bolsonaro.
The government’s endorsement of these measures amplifies the crisis. It has established a “National Attorney’s Office for the Defense of Democracy” to combat disinformation, while introducing a contested “fact-checking” platform. The Federal Prosecutor’s Office recently requested user data from followers of former President Jair Bolsonaro across major social media platforms to aid their investigation into anti-democratic activities.
Two key anti-corruption figures, Senator Sergio Moro, an ex-judge, and Representative Deltan Dallagnol, a former prosecutor, are under increased political assault. Accused of colluding in past investigations, they now face political retribution. Dallagnol has already been ousted from Congress by Brazil’s electoral court, and many speculate that Moro will follow suit. Their plight was summed up by President Lula’s statement, “I will only feel well when I f*ck with Moro”.
These high-profile cases are emblematic of a broader collapse of Brazil’s anti-corruption efforts. Initiatives like Operation Car Wash, which reclaimed R$3.28 billion out of R$6.2 billion in misappropriated funds, are now being undermined by political backlash. This underscores the urgent need for robust institutions that can effectively combat corruption without succumbing to political pressure.
Brazil’s circumstances resonate regionally due to its leadership role. As Ian Bremmer recently stated, commenting on the Supreme Court making former president Jair Bolsonaro ineligible for the next eight years, “Brazil [is] setting the standard for U.S. democracy”. This political meddling could influence other countries, potentially eroding the rule of law in other democracies.
Strengthening Brazil’s commitment to the rule of law transcends national borders — it’s a regional imperative. The advantages span from curbing corruption to advancing large infrastructure projects unimpeded by interference, as well as bolstering economic relationships given Brazil’s significant role in regional trade.
Diego on gas station drugs
From my email:
The average gas station is now packed to the brim with drugs. This place had a Whip-it stand near the checkout, that I imagine is for recreational nitrous oxide users rather than whipped cream enjoyers, as well as a massive selection of kratom. ‘Whippets’ can cause irreversible brain damage and kratom has opiate-like effects, binding to the same receptors as morphine. There were also 3 stands near the checkout dedicated to weed-adjacent things including a mix of gummies, vapes, and flower bud containers. Unsure exactly what the weed-adjacent stuff was, some of it was Delta-8. Seems like a lot of these weed derivatives stemmed from the 2018 farm bill. The kratom proliferation has been insane. One of the main kratom brands, Botanic Tonics, sells super-popular small blue vials under the name ‘Feel Free’ that merely say ‘Plant-based herbal supplement’ on the front. Despite the FDA recently seizing $3M of kratom from Botanic Tonics as well as endless stories of addiction on the subreddit r/Quittingfeelfree, Botanic Tonics is an official sponsor of UT Austin and Florida State University and gives out free vials to students.
I do not personally have data on this question, but I thought this content was worth passing along.
How the NSF Moved Faster than the NIH During COVID-19
The NSF is a much smaller organization than the NIH but during the pandemic it moved more quickly. Why? Maxwell Tabarrok explains:
The NSF relied on its special congressional authority to skip peer review to bootstrap its pandemic-related granting. Two pre-existing programs which use this authority enabled the NSF’s speedy response. The RAPID (Rapid Response Research) and EAGER (EArly-concept Grants for Exploratory Research) programs focus on “proposals having a severe urgency,” and “exploratory work in its early stages on untested, but potentially transformative, research ideas,” respectively. Both turn applications around quickly: while typical federal science grants take 9-12 months of review, RAPID and EAGER grants usually provide funding to researchers in less than a month.
…The NSF funded valuable research through its RAPID grants program, including the development of the first COVID-19 test to get FDA approval, the Johns Hopkins COVID-19 data dashboard, and both inhaled and micro-needle patch vaccines, the latter of which is currently being scaled up for use in HPV vaccines. These examples don’t conclusively show that the NSF avoided sacrificing quality control for speed, but they suggest that the NSF’s internal team of reviewers funded multiple effective projects that benefited from faster turnarounds. The benefits of speeding up these big successes when they were urgently needed outweighed the hypothetical costs of approving some below-average projects.
In crises generally, the success of a science funder is determined by its biggest wins, not by the average quality of the projects it approves. Science’s impact on the pandemic was dominated by a single technology: the mRNA vaccine. The next most important contributions, likely testing or pharmaceutical treatments, were less important than the vaccine, and the average COVID-19 research project may have had minimal impact. External peer review slows down the funding of all projects to make sure that low-quality research is not funded. This kind of bottom-end quality control is less important in a crisis environment. At crisis-response margins, it’s probably better for science funding agencies to anchor less on quality control and instead take more shots on goal.
The NIH, to be fair, also responded more rapidly than usual and it used some special “shark-tank” like programs to do so which also worked well.
Read the whole thing for more recommendations.
Why I am not entirely bullish on brain-computer interface
I agree that miracles may well be possible for disabled individuals, but I am less certain about their more general applicability. Here is one excerpt from my latest Bloomberg column:
Another vision for this technology is that the owners of computers will want to “rent out” the powers of human brains, much the way companies rent out space today in the cloud. Software programs are not good at some skills, such as identifying unacceptable speech or images. In this scenario, the connected brains come largely from low-wage laborers, just as both social media companies and OpenAI have used low-wage labor in Kenya to grade the quality of output or to help make content decisions.
Those investments may be good for raising the wages of those people. Many observers may object, however, that a new and more insidious class distinction will have been created — between those who have to hook up to machines to make a living, and those who do not.
Might there be scenarios where higher-wage workers wish to be hooked up to the machine? Wouldn’t it be helpful for a spy or a corporate negotiator to receive computer intelligence in real time while making decisions? Would professional sports allow such brain-computer interfaces? They might be useful in telling a baseball player when to swing and when not to.
The more I ponder these options, the more skeptical I become about large-scale uses of brain-computer interface for the non-disabled. Artificial intelligence has been progressing at an amazing pace, and it doesn’t require any intrusion into our bodies, much less our brains. There are always earplugs and some future version of Google Glass.
The main advantage of the direct brain-computer interface seems to be speed. But extreme speed is important in only a limited class of circumstances, many of them competitions and zero-sum endeavors, such as sports and games.
Nonetheless I am glad to the FDA is allowing Neuralink’s human trials to proceed — I would gladly be proven wrong.
The Promising Pathway Act
The evident failures of the FDA and CDC during COVID have opened up new opportunities for reform. One of the most interesting is the Promising Pathway Act, sponsored by Sens. Mike Braun (R-Ind.) and Kirsten Gillibrand (D-N.Y.). As Bart Madden and I write, the Act would create a new form of approval, provisional approval.
The Hill: Here’s how the current version of the bill works: A new drug could secure provisional approval for serious or life-threatening health conditions via early-stage clinical investigations indicating that the new drug’s safety and efficacy compare favorably to approved drugs.
Importantly, provisional approval requires establishing patient registries for all such treatments and is not simply a matter of faster approval. Third-party, independent entities would manage these registries, tracking safety and effectiveness.
In order to speed up the use of this new knowledge, the de-identified, disaggregated databases would be accessible to approved researchers, medical professionals for public health research and biopharmaceutical industry researchers. Drug sponsors or the government would fund the registries, and the FDA would submit an annual report to Congress on provisionally approved drugs.
Thus, provisional approval would allow earlier access to not yet approved drugs but would require the creation of a patient registry and database that could be used by anyone to evaluate the drug. An interesting and important idea.
Emergent Ventures Africa and Caribbean, third cohort
Dr. Keabetswe Ncube is a Geneticist from South Africa. Her EV grant is for her work in using statistical and genetic inferences to help rural farmers maximize yields.
Frida Andalu is a petroleum engineer by training from Tanzania and a Ph.D. candidate. Her EV grant is to assist in her research of developing plant-based volatile corrosion inhibitors to mitigate top-of-line corrosion in natural gas pipelines.
Desta Gebeyehu is a biochemical researcher from Kenya. Her EV grant is to assist in her research of developing bioethanol-gel fuel from organic waste.
Bobson Rugambwa is a software engineer from Rwanda. After graduating with a master’s from Carnegie Mellon University he co-founded MVend to tackle the problem of financial inclusion in Rwanda.
Sylvia Mutinda is a Chemist and Ph.D. researcher from Kenya. Her EV grant is to assist with her search on strigolactone biosynthesis focusing on countering striga parasites in sorghum farms in Kenya.
Dr. Lamin Sonko, born in the Gambia and raised in the U.S., is an Emergency Medicine physician and recent Wharton MBA graduate. He is the founder of Diaspora Health, an asynchronous telemedicine platform focused on patients in the Gambia and Senegal.
Cynthia Umuhire is an astronomer from Rwanda and Ph.D. researcher. She works as a space science analyst at the Rwanda Space Agency. Her EV grant is to assist her in establishing a knowledge hub for junior African researchers in space science.
Brian Kaaya is a social entrepreneur from Uganda. He is the founder of Rural Solars Uganda, a social enterprise enabling rural households in Uganda to access electricity through affordable solar panels.
Shem Best is a designer and urban planning enthusiast from Barbados. His EV grant is to start a blog and podcast on urban planning in the Caribbean to spur discourse on the built environment in the Caribbean and its impact on regional integration.
Susan Ling is an undergraduate researcher from Canada. Her EV grant is to continue her research on biodegradable, long-acting contraceptive implants with a focus on Africa, and general career development
Elizabeth Mutua is a computer scientist and Ph.D. researcher from Kenya. Her EV grant is to assist in her research on an efficient deep learning system with the capacity to diagnose retinopathy of prematurity disease.
Youhana Nassif is the founder and director of Animatex, the biggest animation festival in Cairo, Egypt. His EV grant is for the expansion of the festival and general career development.
Esther Matendo is a Ph.D. candidate in food science from the Democratic Republic of the Congo. Her EV grant is to assist in her research on plant-based treatments of mycotoxin contamination on maize in South Kivu (one of the main maize production zones in the DRC).
Alex Kyabarongo is a recent graduate of veterinary medicine from Uganda. He is now a political affairs intern at the Implementation Support Unit of the Biological Weapons Convention at the United Nations Office for Disarmament Affairs in Geneva. His EV grant is for general career development.
Margaret Murage is a Ph.D. researcher from Kenya. Her EV grant is to assist in her research of developing new photosensitizing agents for photodynamic therapy for cancer treatment.
Kwesiga Pather, for design and development of low-cost drones for agricultural uses in Uganda and general career development.
Dr. Sidy Ndao is a materials engineer by training from Senegal. He is the founder and President of the Dakar American University of Science and Technology (DAUST). The university provides a rigorous American-style English-based engineering education to African students.
Chiamaka Mangut is a Ph.D. candidate at Columbia University from Nigeria. Her EV grant is to fund new field research using archaeobotanical methods to study ancient populations in the Jos Plateau.
Dr. Yabebal Fantaye is Cosmologist by training from Ethiopia. He is the co-founder of 10 Academy, a training bootcamp to assist recent graduates of quant fields to acquire remote data science-related jobs.
For his very good work on these award I wish to heartily than Rasheed Griffith. And here is a link to the previous cohort of Africa winners.
The return of American immigration
Over the past two and a half years, immigration into the American labour market has increased by 4mn workers, and the working age immigrant population has now finally reached its pre-pandemic trend level.
More than 900,000 immigrants became US citizens during 2022 — the third highest level on record and the most in any fiscal year since 2008, according to Pew. The largest numbers came from Mexico, India, the Philippines and Cuba, and the highest growth in flows were from Cuba, Jamaica, the Philippines, India and Vietnam.
Bottom line — the US seems to be returning to pre-Trump, pre-pandemic rates of immigration.
Here is more from Rana Foroohart at the FT.
Peltzman Revisited
Casey Mulligan has an excellent new paper, Peltzman Revisited: Quantifying 21st-Century Opportunity Costs of Food and Drug Administration Regulation. What are the costs of delaying a new drug or a vaccine? Longer and bigger clinical trials increase safety but I’ve often made the point that the people who would have lived had a good drug been approved sooner are buried in an invisible graveyard and thus these costs are typically undercounted–the failure to see the invisible graveyard biases decisions in favor of delay. Mulligan makes a different and rarely considered point about substitution effects. If a vaccine isn’t available there are substitutes but these substitutes are themselves potentially unsafe and ineffective. But who is testing the substitures?
Many of these substitute interventions, such as remote work, closing schools, and canceling normal medical appointments, are beyond the jurisdiction of the FDA and can be utilized without any attempt to demonstrate their safety or efficacy.
If the substitutes work, the costs of delay are reduced. The FDA, for example, is right to prioritize drugs for which there are few alternative treatments. But the standards for many vaccine or drug substitutes are completely different than those used to approve a vaccine:
Closing schools to in-person learning is an important example of a prevention activity that was available, was applied to tens of millions of children in the United States, and was outside the FDA’s jurisdiction…Obviously the FDA’s effectiveness standard for vaccines differs from the effectiveness standard (if any) that school districts applied in deciding to close schools.
Where were the randomized controlled trials for closing schools, shutting the parks and beaches, and delaying medical appointments? Thus, it’s quite possible that greater safety of vaccines comes at the expense of greater time under less safe and possibly unsafe substitutes. As Mulligan concludes:
Approval delays for pandemic tests and vaccines pushed tens of millions of individuals and businesses into preventions and treatments that were both outside FDA jurisdiction and hardly safe or effective. The pandemic experience raises the question of whether, on the whole, consumers engage in more unsafe and ineffective practices than they would if FDA approval were not a prerequisite for pharmaceutical sales.
Addendum: Much else of interest in the paper including a calculation of the value of the vaccines in the hundreds of billions and trillions very much in line with work done by the AHT team, including myself ,in the AER PP (especially the appendix) and Science.
UK to Adopt Pharmaceutical Reciprocity!
More than twenty years ago I wrote:
If the United States and, say, Great Britain had drug-approval reciprocity, then drugs approved in Britain would gain immediate approval in the United States, and drugs approved in the United States would gain immediate approval in Great Britain. Some countries such as Australia and New Zealand already take into account U.S. approvals when making their own approval decisions. The U.S. government should establish reciprocity with countries that have a proven record of approving safe drugs—including most west European countries, Canada, Japan, and Australia. Such an arrangement would reduce delay and eliminate duplication and wasted resources. By relieving itself of having to review drugs already approved in partner countries, the FDA could review and investigate NDAs more quickly and thoroughly.
Well, it’s happening! After Brexit, there were concerns that drugs would take longer to get approved in the UK because the EU was a much larger market. To address this, the UK introduced the “reliance procedure” which recognized the EU as a stringent regulator and guaranteed approval in the UK within 67 days for any drug approved in the EU. The Reliance Procedure essentially kept the UK in the pre-Brexit situation, and was supposed to be temporary. However, recognizing the logic of recognizing the EU, the UK is now saying that it will recognize other countries.
Our aim is to extend the countries whose assessments we will take account of, increasing routes to market in the UK. We will communicate who these additional regulators are and publish detailed guidance about this new framework in due course, including any transition arrangements for applications received under existing frameworks.
The UK is already participating in a mutual recognition agreement with the FDA over some cancer drugs. Therefore, it seems likely that the FDA will be among the regulatory authorities that the UK recognizes. If the UK does recognize the FDA, then we only need the FDA to recognize the UK for my scenario from more than 20 years ago to be fulfilled.
It’s thus time to revisit the Lee-Cruz bill of 2015, which proposed the Result Act (I was an influence).
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act (S. 2388), or the RESULT Act,” which would amend the Food, Drug and Cosmetic Act to allow for reciprocal approval of drugs.
Addendum: Many previous posts on FDA reciprocity.
Yglesias on Operation Warp Speed and the Republicans
Here’s Yglesias on Operation Warp Speed and the Republicans:
The debate over Operation Warp Speed wasn’t just a one-off policy dispute. Long before the pandemic, there was a conservative critique that the Food and Drug Administration is too slow and too risk-averse when it comes to authorizing new medications. Alex Tabarrok, a George Mason University economist, wrote about the “invisible graveyard” that could have been avoided if the FDA took expected value more seriously and considered the cost of delay in its authorization decisions.
The pandemic experience validated this criticism, which came to be embraced by some on the left as well — and it was about more than just vaccines. When it came to home Covid tests, Ezra Klein noted in the New York Times in 2021, “the problem here is the Food and Drug Administration. They have been disastrously slow in approving these tests and have held them to a standard more appropriate to doctor’s offices than home testing.”
And yet, just as the invisible graveyard was becoming seen and the debate was being won and just as a historical public-private partnership had sped vaccines to the public and saved millions, the Republicans abandoned the high ground:
…it’s not surprising that Democrats are comfortable with the bureaucratic status quo and hesitant to ruffle feathers at federal regulatory agencies. What’s shocking is that Republicans — the traditional party of deregulation, the party that argued for years that the FDA is too slow-footed, the party that saved untold lives by accelerating vaccine development under Trump — have abandoned these positions.
At the cusp of what should have been a huge policy victory, Republicans don’t brag about their success, and they have no FDA reform legislation to offer. Instead, they’ve taken up the old mantle of hard-left skepticism of modern science and the pharmaceutical industry.
It’s been painful to see all that has been gained now being lost. Libertarian economists and conservatives argued for decades that the FDA worried more about approving a drug that later turns out to be unsafe than about failing to approve a drug that could save lives; thus producing a deadly caution. But now the FDA is being attacked for what they did right, quickly approving safe vaccines. I hope that he is wrong but I fear that Yglesias is correct that the FDA may now get even slower and more cautious.
The irony of the present moment is that there is substantial backlash to the FDA’s approval of vaccines that haven’t turned out to be dangerous at all.
That’s only going to make regulators even more cautious. Right now the entire US regulatory state is taking essentially no heat for the slow progress on the next generation of vaccines, and an enormous amount of heat for the perfectly safe vaccines that it already approved. And the ex-president who pushed them to speed up their work on those vaccines is not only no longer defending them, he’s embarrassed to have ever been associated with the project.
Like I said, it’s a comical moment of Republican infighting. But it’s a very grim one for anyone concerned with the pace of scientific progress in America.
Testing Freedom
In the latest Discourse Magazine I discuss the FDA’s long-standing fear and antipathy toward personalized medical tests and how this violates the 1st Amendment.
In 1972, the FDA confiscated thousands of home pregnancy tests, declaring that they were “drugs” meant to diagnose a “disease” and thus fell under the FDA’s regulatory dominion. The case went to the U.S. District Court for the District of New Jersey, and Judge Vincent P. Biunno ruled that the FDA had overstepped. “Pregnancy,” he said, “is a normal physiological function of all mammals and cannot be considered a disease … a test for pregnancy, then, is not a test for the diagnosis of disease. It is no more than a test for news….” As a result of Judge Biunno’s ruling, home pregnancy tests are easily available today from pharmacies, grocery stores and online shops without a prescription.
These days, debates over home pregnancy tests from the 1970s seem anachronistic and paternalistic. Yet the same paternalistic arguments appear again and again with every new testing technology. In the late 1980s, for example, the FDA simply declared that it would not approve at-home HIV tests, regardless of their safety or efficacy. As with pregnancy tests, the concern was that people could not be trusted with information about their own bodies…the first rapid at-home HIV test was developed and submitted to the FDA in 1987 [but] it took 25 years before the FDA would approve these tests. (Now, you can easily buy such a test on Amazon.)
…The FDA has a vital role in ensuring that tests are clinically accurate—tests should do what they say they do. Tests don’t need to be perfectly accurate to be useful (think of thermometers, personality tests and tire pressure gauges), but if a test advertises that it measures HDL cholesterol, it should do that within the tolerances the firm promises. The FDA has the technical knowledge to ensure that tests work, and that’s a skill that Americans value from the agency.
What Americans don’t want is to be told they can’t handle the truth. Yet when it came to at-home tests such as pregnancy tests, HIV tests and genetic tests, that’s exactly the reasoning the FDA used—and continues to use—to suppress information. The FDA should ensure that tests are safe, but “safety” means physical safety. The FDA may not declare a product unsafe because it might produce dangerous knowledge. Patients have a right to know about their own bodies. Our antibodies, ourselves. The FDA has authority over drugs and devices but not over patients.
Judge Biunno had it right back in 1972 when he said that diagnostic tests produce “news.” Test results, therefore, are a type of speech that fall under the First Amendment right to freedom of speech. The Supreme Court has repeatedly rejected restrictions on freedom of speech based on “a fear that people would make bad decisions if given truthful information”; thus, FDA restrictions on tests based on such fears are unconstitutional. The question of whether consumers will respond “safely” to test results is no more relevant to the FDA’s regulatory authority than the question of whether readers will respond safely to political news published in The New York Times. The FDA does not have the constitutional authority to regulate news.