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All Reason.com articles with the "FDA" tag.



Published: Fri, 23 Jun 2017 00:00:00 -0400

Last Build Date: Fri, 23 Jun 2017 17:07:47 -0400

 



FDA's Gottlieb Hints at a Huge Overhaul of Health Tech Regulations

Fri, 16 Jun 2017 13:50:00 -0400

When Apple CEO Tim Cook was asked in 2015 if the forthcoming Apple Watch would feature cutting edge health technology, the answer was a very clear no. Making the Apple Watch more than just a really pricey fitness tracker would require approval from the Food and Drug Administration, and that, in turn, would "hold [Apple] back from innovating." In a blog post published this week, recently approved FDA Commissioner Scott Gottlieb acknowledged that "ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures." To that end, writes Gottlieb, FDA will provide guidance to clarify our position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not. In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements. Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA's compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher risk priorities. We don't yet know what the FDA's new guidelines will look like, but the tech industry is likely to get more clarity. Gottlieb wants the new guidelines to be transparent enough that developers can "apply them on their own, without having to seek out, on a case-by-case basis, FDA's position on every individual technological change or iterative software development." The timing for these reforms couldn't be better. Apple has been hiring medical tech engineers since early last year, and it is allegedly working on a blood glucose monitor for diabetes patients that doesn't require piercing the skin. Verily, meanwhile, is working with Dexcom, which manufactures a continuous glucose monitor that does pierce the skin, to make the device even less obtrusive. (All of Verily's projects look great, actually—and all, I suspect, will require some interaction with the FDA.) At the cheaper end of the market, we may just get better fitness and health apps for mobile devices. This software generally doesn't require FDA approval, but even device makers aren't sure when they should talk to the agency. In 2015, when he was still at the American Enterprise Institute, Gottlieb told NPR that bringing these apps under the FDA's purview would "create so much uncertainty for product developers that it's going to discourage a lot of investment and it's going to discourage a lot of programmers from getting into this space." "Hopefully this is a signal that the FDA is waking up to the realities of the Information Age and are willing to let consumers take advantage of the many life-enriching—and potentially even life-saving—technologies that could be at their disposal if not for excessive bureaucratic red tape," says Adam Thierer, a senior fellow at the Mercatus Center's Technology Policy Program. As soon as this fall, writes Gottlieb, the "FDA will pilot an entirely new approach toward regulating this technology."[...]



The FDA Commissioner's Novel Plan for Cutting Drug Prices: Competition

Wed, 07 Jun 2017 15:45:00 -0400

(image) Scott Gottlieb, the nation's new head of the Food and Drug Administration, wants to tame drug prices the old-fashioned way: by letting more companies compete.

Generic drugs are typically sold for far less than their chemically identical branded counterparts. Yet from 2010 to mid-2015, the prices of more than 300 of the 1,441 established generic drugs experienced at least one extraordinary price increase of 100 percent or more, according to a 2016 Government Accountability Office report. Lack of competition is one major reason why.

A stunning 2,640 generic drug applications are currently stuck in the FDA's approval process. (In 2006, by contrast, the agency's generic drug backlog stood at only 800 applications.) A 2016 article in the Journal of the American Medical Association pointedly noted that "none of the approximately 1500 generic drug submitted in fiscal year 2014 had been approved by the end of that year."

Lower-priced generic drugs saved the health care system an estimated $254 billion in 2014. An FDA study has found that as the number of competing manufacturers for a drug goes up, the price falls dramatically. When two companies compete, the price falls an average of just 6 percent; when there are nine competitors, the price drops by an average of 80 percent.

Gottlieb reportedly plans to prioritize the approval of additional generic competitors, and he hopes to eliminate the backlog of generic-drug applications within a year. It isn't surprising that he'd set such a goal: He wrote an op-ed last August arguing that excessive FDA regulation was stymieing the development and approval of generic drugs.

For example, the Obama administration abruptly imposed higher manufacturing standards on generic makers in 2009, forcing many to leave the market. Gottlieb's op-ed also noted that the average cost to file a generic drug application with the agency had risen from about $1 million in 2003 to $5 million in 2016—and that sometimes it was as high as $15 million. As a result, a company would have to expect to earn considerably more revenue from a generic product for it to be worth its while to consider competing against companies already in the market.

Last year Gottlieb called for changing that; this year he'll get a chance to try.




Mandating Menu Labeling is Foolish, Not 'Easy'

Sat, 27 May 2017 08:00:00 -0400

This week, New York City—the first place in America to require chain restaurants to post calorie information on their menus—expanded the reach of its menu-labeling law. The city is now "the first municipality to require grocery and convenience stores with more than 15 outlets nationwide to clearly display calorie counts for prepared foods and beverages and have additional nutritional information available upon request," reports New York's Fox 5. "The rules will apply to about 1,500 food retailers." This expansion is a microcosm of a larger, ongoing debate in Washington over the fate of federal menu-labeling rules. In a column last month, I correctly predicted the agency responsible for implementing the rules, the FDA, was likely to delay—once again—implementing enforcement of its menu-labeling rules. The agency delayed enforcing the rules—which were mandated by Congress under 2010's Affordable Care Act—for one year, just days before enforcement was set to begin. I oppose mandatory menu labeling for many reasons. For one: it's ineffective. Research has shown that posting mandatory calorie counts on restaurant menus doesn't help people make better choices. One key sticking point in Washington is whether the federal rules should apply (as they now do in New York City) to grocery and convenience stores, along with pizza chains. This week, the USA Today editorial board weighed in on the issue. Apparently, the USA Today editors have never seen a less intractable problem than devising and complying with menu-labeling rules. "It's not rocket science," the USA Today editors note. It's "so seemingly simple." Isn't it even a little bit difficult? Nope. "[H]ow hard can it be to post a small sign over each offering with a calorie count?" they ask. "Not very." The alleged simplicity of devising and complying with menu-labeling rules is a common argument in support of them. If it's so easy to provide calorie information, then certainly one place that must have figured it out is the Breaking News Café, located inside USA Today's Mclean, Va. headquarters. I called this week to ask. The woman who answered the switchboard at Gannett (USA Today's parent company) at noon on Thursday said she could not connect me with the cafe because she did not have their updated number. But she volunteered to me that she has not seen calorie information during the times she has been in the Breaking News Café. (She then connected me with catering, where the phone rang a few times before I was disconnected.) I did a bit more poking around. While many of the two-dozen or so photos of the cafe show food on sale, I did not see any calorie counts displayed. Maybe this is because the calorie information just isn't there. Or it could be because the information is present but goes unnoticed (which would track with research that most people don't even see calorie counts on menus, hence defeating their very purpose). Or maybe there's a long, sad trail of unanswered internal memos from USA Today's editors demanding calorie counts be displayed at the Breaking News Café. I don't know. (No one responded to my Thursday email to the editorial board.) One thing I do know, though, is that the USA Today editorial gets at least one key fact wrong about menu labeling when it argues the FDA rules place "no burdens on small business, as the law applies only to chains with 20 or more outlets." As I've written time and again, that's not how it actually works. Franchisees—small-businesspeople who own one or more restaurants that USA Today argues should be subject to the rules, such as your local Domino's franchisee—could be forced to comply with the rules. A small businesswoman who owns one Pizza Hut location, for example, would have to pay perhaps thousands of dollars to buy one or more new menu boards if the FDA applies its rules to small businesses like hers. Ultimately, despite the claims of menu-labeling supporters, it's neither easy nor cost-free nor effective to force food sellers to add calorie counts [...]



MDMA Moves One Step Closer to Phase 3 Clinical Trial

Wed, 17 May 2017 16:45:00 -0400

(image) The Food and Drug Administration is likely to approve a phase three clinical trial of MDMA-assisted psychotherapy, according to the Multidisciplinary Association for Psychedelic Studies (MAPS), which met with the agency on May 11. A successful phase three trial--i.e., a randomly controlled, double-blinded study that demonstrates both efficacy and safety in a large patient population--would all but guarantee the drug's eventual removal from schedule I of the Controlled Substances Act.

"At the meeting, all of the FDA's concerns were addressed and no outstanding questions remain," MAPS reported after its sit-down with the FDA earlier this month. "There are no roadblocks to moving forward with Phase 3 as the FDA gave favorable feedback to MAPS and [MAPS Public Benefit Corporation's] responses to FDA questions."

The FDA will share official minutes with MAPS in mid-June, after which the group will re-submit its protocol and Statistical Analysis Plan. It expects both will be approved without objection.

The phase three trial for MDMA-assisted psychotherapy as a treatment for PTSD is expected to cost approximately $25 million, of which MAPS has already raised $10 million (none of it from government agencies or pharmaceutical companies.)

There's a lot at stake here. In addition to the outrageous criminal penalties associated with schedule I substances, MDMA has incredible potential as a treatment for a range of central nervous system disorders:

src="https://www.youtube.com/embed/RdHCfq2jn_c" allowfullscreen="allowfullscreen" width="560" height="340" frameborder="0">




Will Donald Trump Be the Most Deregulatory President Ever? New at Reason

Tue, 16 May 2017 09:53:00 -0400

(image) If it is a day ending with the letter "y," there is probably some all-consuming media controversy involving President Donald Trump. But underneath the headlines and tweetstorms, the Trump administration, and even a normally reluctant Congress (at least to some degree), has already teamed up make the biggest dent in the federal regulatory state we've seen during the 21st century. And if the GOP manages to follow through with other planned reforms, Trump may challenge the deregulatory records of even Ronald Reagan and Jimmy Carter

This threatened deconstruction of the administrative state has put many libertarian think tankers in the dissonant position of rooting hard for one aspect of a presidency they otherwise root against, and dusting off their knowledge of how much the executive branch can do on its own to peel back agencies that Congress willed into existence. As Matt Welch writes in Reason's June cover story, "Washington's regulatory reformers, largely sidelined for the past quarter-century, are infiltrating the halls of federal power and attempting to engineer the most ambitious executive-branch overhaul in at least three decades."

On the day of Trump's [address to a joint session of Congress], I paid a visit to the Competitive Enterprise Institute (CEI), a libertarian nonprofit focusing on regulatory issues, to speak with Myron Ebell, director of the institute's Center for Energy and Environment. Ebell had been the Trump transition team's point man at the EPA, a personnel selection witheringly characterized by former League of Conservation Voters official Daniel Weiss as "like picking Colonel Sanders to protect your chickens." So what can libertarians expect from the Trump administration? "I think," Ebell says, "he could be the most serious deregulatory president ever."




Scott Gottlieb Confirmed as New FDA Commissioner

Tue, 09 May 2017 18:05:00 -0400

(image) Physician, venture investor, and drug industry consultant Scott Gottlieb has been confirmed by the Senate as the new Commissioner of the Food and Drug Administration. Gottlieb takes the helm of the agency that regulates products accounting for about 20 cents of every dollar of annual spending by U.S. consumers, that is, about $2.4 trillion in annual consumption that includes medical products, food and tobacco. The agency regulates medicines, diagnostic tests, medical devices, food safety including those made from modern biotech crops and livestock, food labeling, and tobacco and nicotine products. What the agency's bureaucrats decide has signifcant impact on U.S. economic growth and the livelihoods of Americans.

Gottlieb has long been a critic of the FDA's slow and protracted drug and medical device approval processes. Researchers at the Tufts University Center for the Study of Drug Development have estimated that in 1991 it cost $412 million (2013 dollars) to develop and obtain approval for a new pharmaceutical. Last year, they calculated that it now takes more than $2.5 billion, a six-fold increase.

In an email, Union of Concerned Scientists spokesperson Seth Michaels warned that Gottlieb's confirmation is "yet another example of an appointee whose record raises questions about whether they'll respect science and the public interest." On the other hand, Paul Howard, Senior Fellow and Director, Health Policy at the market-friendly Manhattan Institute issued a statement applauding the appointment. "At a time of both unprecedented scientific opportunity and rapidly evolving public health challenges, Dr. Gottlieb provides the FDA with principled and pragmatic leadership," declared Howard. "His experience as a regulator, practicing physician, cancer survivor, and innovator will help the agency navigate the scientific challenges surrounding drug and medical device development and approval without losing sight of the real-world implications of the agency's decisions for patients struggling with potentially life threatening conditions."

I earlier noted, "While not a radical reformer, Gottlieb clearly has a good understanding of how over-regulation has been slowing down innovation in medicines and foods." Good luck to him as he tries to reform the agency's excessively cautious regulatory culture.




CRISPR and the Dawn of the New Biotech Revolution

Wed, 03 May 2017 12:15:00 -0400

(image) CRISPR genome editing will transform biotechnology and our lives in the next decade making possible (and cheap*) all kinds of new cures, new crops, new livestock, new industrial processes, and new ways to manage the environmental commons. Just two years ago, Science hailed CRISPR as the scientific breakthrough of 2015 noting, "It's only slightly hyperbolic to say that if scientists can dream of a genetic manipulation, CRISPR can now make it happen." Researchers have tweaked CRISPR so that it can find and cut and, if desired, replace essentially any DNA sequence in an organism's set of genes, including those in human beings.

With regard to new cures, researchers at the Lewis Katz School of Medicine at Temple University and the University of Pittsburgh have just published results in which they used CRISPR to almost entirely eliminate HIV, the virus that causes AIDS, from living experimental animals. Basically, the researchers targeted segments of HIV genes using CRISPR loaded into a viral delivery system that inactivated the HIV genes. Temple University researcher Kamel Khalili said, "Our eventual goal is a clinical trial in human patients."

(image)

Another group of researchers announced last week that they are developing a pill that would use CRISPR to target specific microbial pathogens. The idea is that a CRISPR antibiotic pill would instruct harmful bacteria to shred their own genes to bits. The researchers have engineered CRISPR to contain bits of genomic DNA of Clostridium difficile into bacteria-killing viruses called bacteriophages. The next step is to package the engineered phages into Lactobacillus bacteria. Found in yogurt, Lactobacillus would survive passage through the human digestive tract while shedding CRISPR phages that infect and then destroy the targeted pathogens. Unlike current antibiotics, CRISPR pills would kill only the targeted pathogens, leaving benign microorganisms alone.

*Cheap, if the Food and Drug Administration regulators don't stand in the way. The initial signs are not good.




Is the World Finally Ready for a Female-Orgasm Machine? [Reason Podcast]

Thu, 27 Apr 2017 12:30:00 -0400

When Brent Reider, a 58-year-old medical-device inventor from Oxford, Ohio, set out to develop a fix for the suprisingly widespread problem of female urinary incontinence, one of the last things on his mind was building a better orgasm. He was just trying to use a neuromuscular electrical stimulator (NMES) device to strenghten women's pelvic floor muscles so that they could better control their bodies in the face of changes wrought by aging, childbirth, and other life experiences. Yet by the time he brought his newest contraption, the Yarlap, to market last year, he'd discovered something that only a very few (and almost always female) researchers had ever seriously thought about: A woman's pelvic floor is almost unfathomably complicated, designed by evolution to control and influence all sorts of bodily functions from bladder control to posture to sexual functioning. The pelvic floor's health and strength affects not just obvious parts of a woman's anatomy but also her lower back, hips, and knees. As important, Reider found that his device, which uses low-level electrtical stimulation to strengthen the pelvic floor muscles, not only helps cure incontinence but often heightens a woman's ability for sexual satisfaction in a way that the most-dedicated Kegel practitioner could only dream about. Reider's findings, which draw on work by academic researchers such as Beverly Whipple and Elisabeth Lloyd, has been published in The Journal of Women's Health, Issues and Care, and crosses boundaries between sex and medicine that are rarely acknowledged, let alone traversed. Unsurprinsingly, then, when it came time to start certifying the device through the Food and Drug Administration (which has been tasked with "clearing" medical devices for safety and efficacy since the 1970s) and marketing it through sites such as Amazon and Facebook, Reider and his business partner, his 24-year-old daughter MaryEllen, ran into a different but equally knotty set of issues. It turns out that neither the government nor social media are quite ready for a medical device that transcends the traditionally separate categories of sex and medicine. In the latest Reason podcast, I talk with the entrepreneurs about the difficulties in launching a device that not only promises to help the one-in-three women (including many high-performance female athletes) who experience incontinence but also reconfigures the way we think about personal health and well-being. The Yarlap, says MaryEllen Reider, can be bought without a prescription and is an example of a medical technology that's "about improving your lives and taking your health into your own hands." As such, it joins a growing roster of "electroceuticals" and other devices, drugs, and techniques that empower individuals to improve their lives in very specific and personalized ways. Subscribe, rate, and review the Reason Podcast at iTunes. Listen at SoundCloud below: src="https://w.soundcloud.com/player/?url=https%3A//api.soundcloud.com/tracks/319607721%3Fsecret_token%3Ds-XYBGP&auto_play=false&hide_related=false&show_comments=true&show_user=true&show_reposts=false&visual=true" width="100%" height="450" frameborder="0"> Don't miss a single Reason podcast! (Archive here.) Subscribe at iTunes. Follow us at SoundCloud. Subscribe at YouTube. Like us on Facebook. Follow us on Twitter. This is a rush transcript—check all quotes against the audio for accuracy. Nick Gillespie: Brent, what is the problem that the Yarlap was designed to address originally? Brent Reider: The Yarlap is designed to treat female urinary incontinence, both stress and urge incontinence, and of course incontinence. Nick Gillespie: Now we are talking, we're all in Oxford, Ohio, where Brent and Mary Ellen or Brent lives and they work out of. I live their part time. Brent is a friend of mine, I want to say that upfront, and that's how I learned about hi[...]



Why LSD Trips Last Forever, What Happens When You Inject Psilocybin

Wed, 26 Apr 2017 17:25:00 -0400

The world's leading researchers of psychedelic drugs met in Oakland, Calif., this past weekend at Psychedelic Science 2017, sponsored by the Multidisciplinary Association of Psychedelic Science (MAPS). I attended for for a story I'm working on about MDMA-assisted therapy, and thought I'd share some items from my notebook. Why do LSD trips last so long? Psilocybin and MDMA are both active in the body for two to three hours when administered in tens of milligrams. LSD, meanwhile, is administered in micrograms (1 mcg is .001 mg) and yet the drug experience can exceed eight hours. UNC-Chapel Hill's Dave Nichols, a medicinal chemist who's been studying psychedelics for decades, shared some new research that explains why. Imagine a carnivorous pitcher plant. That's the 5-HT2B serotonin receptor. Lysergic acid diethylamide, LSD, is a fly. Instead of attaching to the top of the receptor, the LSD molecule gets pulled inside and the top of the receptor closes around it. Basically, LSD trips last forever because the drug gets trapped in a brain cage. (Nichols' team published their findings in January. You can read more about them here.) What happens when you inject psilocybin? The psilocybin-assisted therapy study conducted by Johns Hopkins University--which found that moderate and high doses of psilocybin, in conjunction with psychotherapy, reduced anxiety and depression in cancer patients--used gel caps as the method of administration. Most recreational users just eat the mushrooms or brew them into tea. Over in Europe, however, researchers have experimented with intravenous administration. Apparently, it's like "rocketing [someone] out of a cannon"; the come-up takes place over roughly a minute, rather than half an hour. Well, duh. Except, at a Q&A later in the day, Nichols revealed LSD doesn't work any quicker when administered via IV. It truly is the Good Friday mass of psychedelic drugs. Prohibition makes this kind of research stupidly expensive: The Imperial College of London pays 1,500 British Pounds per dose of UK Home Office-approved psilocybin, according to researcher Leor Roseman, who noted that street prices are a fraction of that. (The ICL is currently doing a ton of interesting psychedlelic research right now.) I'm not sure how easy it is to obtain isolated psilocybin on the black market, but the mushrooms themselves grow on cow shit and dead plant matter. Stateside, dried psilocybin shrooms go for about $5-$10 per gram, according to various mycophile message boards and my own independent research. The most common (and cheapest) strains contain about .6 mg of psilocybin per gram of dry weight, and more exotic (read: expensive) strains have as much as 1.6 mg per gram. The Home Office essentially charged the ICL a penalty for studying a drug that should never have been banned. This kind of oblique research penalty is not unique to psilocybin, or to the UK. Cannabis researchers in the U.S. have to buy their bud from NIDA's monopoly operation, and it is not quality stuff. Psychedelic researchers are cautiously optimistic about Scott Gottlieb at FDA: Gottlieb, Trump's nominee for head of the Food and Drug Administration, has said he'd like to speed up the drug approval process, perhaps using more flexible clinical trial designs. What does this mean for MAPS, currently sponsoring clinical trials for MDMA-assisted psychotherapy? MAPS clinical sites recently completed stage two trials, and the group is now negotiating stage three protocols with the FDA. All they really need is for the agency to treat them like it would any other sponsor of a new drug application. That may sound like a small ask, but the FDA's history with psychedelic researchers is replete with periods of capricious obstructionism. The agency environment changed in the mid 2000s, leading to the current research boon. MAPS Founder Rick Doblin e[...]



Eating Less Salt Does Not Lower Blood Pressure for Most Americans, Says Yet Another Study

Tue, 25 Apr 2017 15:10:00 -0400

(image) The Centers for Disease Control and Prevention states that "most Americans should consume less sodium." The CDC asserts, "Your body needs a small amount of sodium to work properly, but too much sodium is bad for your health. Excess sodium can increase your blood pressure and your risk for a heart disease and stroke. Together, heart disease and stroke kill more Americans each year than any other cause."

Yet, evidence has been gathering for years that the amount of salt consumed by most Americans is not causing them appreciable harm. A new study that followed more than 2,600 people for 16 years in the Framingham Offspring Study, once again, debunks the Federal nutrition nannies' dire claims about salt. The new results are being reported by at the American Society for Nutrition Scientific Sessions during the Experimental Biology 2017 meeting in Chicago.

"We saw no evidence that a diet lower in sodium had any long-term beneficial effects on blood pressure," said Boston University School of Medicine lead researcher Lynn Moore. "Our findings add to growing evidence that current recommendations for sodium intake may be misguided."

The press release announcing the results noted:

The 2015-2020 Dietary Guidelines for Americans recommends limiting sodium intake to 2,300 micromilligrams* a day for healthy people. For the study, the researchers followed 2,632 men and women ages 30 to 64 years old who were part of the Framingham Offspring Study. The participants had normal blood pressure at the study's start. However, over the next 16 years, the researchers found that the study participants who consumed less than 2500 milligrams of sodium a day had higher blood pressure than participants who consumed higher amounts of sodium.

Other large studies published in the past few years have found what researchers call a J-shaped relationship between sodium and cardiovascular risk--that means people with low-sodium diets (as recommended by the Dietary Guidelines for Americans) and people with a very high sodium intake (above the usual intake of the average American) had higher risks of heart disease. Those with the lowest risk had sodium intakes in the middle, which is the range consumed by most Americans.

"Our new results support these other studies that have questioned the wisdom of low dietary sodium intakes in the general population," said Moore.

The researchers suggest that some subset of Americans may be especially salt sensitive and would benefit from consuming less. Better tests should be devised to identify such people so that the rest of us can consume our sodium in peace. As always folks, if your goal is to protect your health strive for moderation in what you eat and drink.

For more background on the ongoing collapse of dietary puritanism, see my article "The Red Meat, Eggs, Fat and Salt Diet."

*Press release said "grams," but as astute readers noted, it's really micromilligrams**. Fixed. **Haste makes mistakes.




Enforcement Looms of FDA's Menu Labeling Regulations

Sat, 22 Apr 2017 08:00:00 -0400

FDA enforcement of its absurd rules governing mandatory calorie menu labeling, passed in 2010 as part of Obamacare, is set to begin on May 5, after years of delays. In 2015, the FDA delayed implementing the rules until December 2016, after the presidential election. At the time, The Hill speculated that a new "Republican president could choose to scrap the rule altogether." That hasn't happened. Yet. But in December 2016 the FDA delayed enforcing the rules until May 5, 2017, which is the deadline that now looms. The FDA interprets its menu-labeling rules as requiring mandatory calorie labeling of most foods sold by "restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, offering for sale substantially the same menu items and offering for sale restaurant-type foods." Owners of more than twenty vending machines must also comply with the rules. The rules would be a disaster. They'll cost at least $1 billion. And if they're grounded in science, that science is shoddy. The purpose of menu-labeling rules in general is to help consumers make smarter (read: lower-calorie) choices. But the very premise that mandatory menu labeling accomplishes this is flawed. Research demonstrates that menu labeling doesn't improve consumer food choices. That's something I first noted here in 2011, and which subsequent reports have also shown (see, for example, here, here, here, and here). So can the rules be stopped? Yes. Congress could act by repealing or amending the menu-labeling rules. Or food sellers whose First Amendment rights would be violated by rules that compel speech for no constitutionally supported reason could ask a court to halt implementation of the rules. Or the FDA could delay the rules from taking effect. Each of these is possible. But how likely are these outcomes? While the clock is ticking, furious efforts are underway to halt the rules. Earlier this year, Congress introduced a bill supported by the American Pizza Community, an advocacy group that includes pizza companies like Domino's and Pizza Hut. The bill, the Common Sense Nutrition Disclosure Act, would exempt most pizza-delivery companies and delay implementation of the menu-labeling rules by at least two years. A comparable bill passed out of the House last year but died in the Senate. While pizza makers are working in Congress, two other groups that oppose the law, the National Grocers Association and National Association of Convenience Stores, petitioned the FDA this month in an effort to delay or halt implementation of the rules. The petitioners argue compliance with the "unworkable" rules is impossible; that the costs of complying are exorbitant and far exceed FDA estimates; that the FDA exceeded its authority in adopting the rules; that the rules run afoul of the First Amendment; and that the rules are "inconsistent with the [Trump] Administration's agenda to alleviate unnecessary regulatory burdens on business." Pushing back against these efforts is the voice of the restaurant industry—the National Restaurant Association—a staunch supporter of the FDA menu-labeling rules. That stance might surprise some—if for no other reason than that it's got some basis beyond rent-seeking. "With more and more states adopting their own menu-labeling rules, the National Restaurant Association... sought a shield against this death by 1,000 cuts by pushing for one uniform national menu-labeling rule," I explained in a 2013 column. Will one or more of the aforementioned approaches succeed in stymying the rules from taking effect on May 5? Repeal seems like something Congress won't stomach. Consider that the GOP's ham-fisted attempts to repeal, replace, or rename (or whatever) the Affordable Care Act completely ignored th[...]



Premature Babies Are Struggling to Breathe. Why Are Regulators Dragging Their Feet?

Fri, 21 Apr 2017 13:00:00 -0400

As a neonatologist, I worry about patients with pulmonary hypertension. This unforgiving disease, sometimes seen after premature birth, can end with sudden death from constricting blood vessels in the lungs. One minute a baby in the neonatal ICU may be sleeping comfortably; moments later, doctors and nurses are giving chest compressions and rescue medications. A pulmonary hypertension crisis, as these frightening episodes are called, starts with a drop in the blood oxygen level. That drop triggers a monitor to beep. It's up to the nurse to hear the sound, come to the bedside and take action. The first and most effective step in stopping a pulmonary hypertension crisis is simple: Give oxygen. But a nurse caring for another patient might be delayed for 30 seconds, and the loss of that time can lead to brain injury or death. In an age of self-driving cars and 400-ton airplanes that can land themselves in blinding fog, it makes no sense that hospitalized patients are surrounded by lifesaving machinery that can be activated only by a person pressing a button or turning a knob. Modern transportation augments human judgment and reaction times with a computer's superior ability to continuously respond to dozens of fluctuating variables. Yet in medicine, safety remains stubbornly reliant on human intervention. FDA regulation impedes innovation My patients with pulmonary hypertension are often attached to a respirator with adjustable oxygen settings. The respirator sits inches below the monitor that indicates how much oxygen is in the blood. But the two machines can't communicate with each other. If they could, it would be possible to increase the flow of oxygen automatically the moment a crisis is detected. In 2009, engineers developed just this kind of closed-loop respirator and introduced it in several hospitals as part of a feasibility study. It increased the time premature babies spent at a safe oxygen level by more than two hours per day. But no biotechnology company has marketed the idea. There are other examples of automated systems with unrealized potential to save lives, and not just in the neonatal ICU. Software that scans an ECG for subtle heartbeat variability can identify patterns—undetectable to the human eye—that indicate an elevated risk of heart attack. Hospital beds that play audible feedback during an emergency promote more effective CPR. Yet patients are not benefiting because neither of these tools has been commercialized. Why haven't these innovations attracted the industry backing necessary to make them widely available? One reason is that the process of getting FDA approval for new devices—particularly those deemed "life-sustaining"—is often even more complicated and expensive than getting approval for drugs. In the Journal of Public Economics, Harvard Business School professor Ariel Dora Stern recently described how FDA hurdles discourage companies from investing in innovation. Often, the more profitable strategy is to wait for someone else to spend the time and money required to get approval for a new device, and then enter the market later with something similar that will face less scrutiny. Dr. Stern estimates that regulatory obstacles add an average of US$6.7 million to the cost of introducing a new medical device. For a company developing an ICU monitor, for instance, that will ultimately sell for less than $35,000 per unit, this up-front commitment can be prohibitive. A consequence is that small biotechnology firms (with annual revenue less than $500 million) rarely gamble on getting new inventions approved. Dr. Stern's paper notes that less than 17 percent of novel device applications to the FDA come from small companies. This is different from new drug applications, the majority of which origin[...]



FDA Loosens Its Shackles on 23andMe Personal Genomics Company

Thu, 06 Apr 2017 14:40:00 -0400

(image) Back in 2013 the regulators at the Food and Drug Administration basically shut down the burgeoning field of direct-to-consumer personal genomics when it ordered the genotype screening company 23andMe to stop testing new consumers for genetic health risks. Why? Because the regulators had ginned up some speculative scenarios in which, for example, a woman who tested positive for a deleterious BRCA breast cancer variant would run to her kitchen, grab a butcher knife, and lop off her breasts (I exaggerate slightly.) As a long time and happy 23andMe customer, I was particularly irked by the FDA's nonsensical decision to keep people in the dark about their genetic makeup.

Before the FDA brought its hammer down, 23andMe was developing a wonderful explanatory interface to help customers understand their genetic information. The company provided some insights on more than 200 health risks, drug responses, and inherited traits - and was adding more all of the time.

After 2013, the company was allowed to tell folks what their genes suggested about their ancestry and traits like dry earwax or the likelihood that their second toes are longer than their big toes. (As if anyone needs genetic tests to discern that information.) In their "wellness" reports, the company could inform customers about how their genes affect the speed with which they metabolize caffeine or their tolerance for milk.

Today, the company is announcing that the FDA is loosening its noose a bit and permitting it to tell customers some genetic risk information for ten different conditions, including late-onset Alzheimer's disease, Parkinson's disease, celiac disease and hereditary thrombophilia (harmful blood clots). As an early customer, the company had already provided me with some genetic insights with regard to all of these health risks, plus about 140 others.

Here's hoping that the Trump administration will roll back these unnecessary regulations and free up personal genome companies like 23andMe to provide Americans with access to their genetic information.

To find out what's genetically wrong with me, click over to SNPedia where I have posted the results of my 23andMe genotype screening tests for all to see.




American Psychiatric Association Says Ketamine Can Treat Depression, But Don't Expect the FDA to Approve It

Tue, 21 Mar 2017 17:02:00 -0400

(image) The anaesthetic ketamine has been a popular party drug for decades due to its ability to put users in a blissful mood. Earlier this month, the American Psychiatric Association released a consensus statement acknowledging that the drug might also be a breakthrough treatment for severe depression.

The statement authors write that seven studies--all placebo-controlled, double-blind, and randomized--provide evidence that ketamine therapy is a "rapid and robust, albeit transient" response to severe clinical depression. The treatment is effective within hours, while conventional antidepressants generally take weeks to work. The transient nature of the drug, meanwhile, suggest it works best with twice-weekly dosing.

Ketamine hasn't been approved for treating depression, but Yale psychiatrist Gerard Sanacora succinctly explained to NPR why the drug's off-label status hasn't deterred him:

Sanacora says other doctors sometimes ask him, "How can you be offering this to patients based on the limited amount of information that's out there and not knowing the potential long-term risk?"

Sanacora has a simple answer.

"If you have patients that are likely to seriously injure themselves or kill themselves within a short period of time, and they've tried the standard treatments, how do you not offer this treatment?"

It certainly seems that the long-term risks of ketamine therapy, regardless of how severe they may be, are preferable to the short-term risk of a successful suicide attempt.

The APA paper closes with the hunch that "economic factors make it unlikely that large-scale, pivotal phase 3 clinical trials of racemic ketamine will ever be completed," which means patients with treatment-resistant depression who'd like to give ketamine a shot will need an appointment at one of a handful of clinics offering ketamine treatment. Or, they can apply for enrollment in a philanthropic or federally funded ketamine study, of which there don't appear to be many.

This is a rather strange fate for a drug that the APA says has "generated much excitement and hope for patients with refractory mood disorders and the clinicians who treat them," but it's also an indictment of the Food and Drug Administration's regulatory process. Ketamine is off patent, which means no pharmaceutical company is going to spend several million dollars per phase to get approval for a drug formulation that any company could turn around and sell, no matter how many lives it might save.




Scott Gottlieb: Trump's Nominee for Food and Drug Administration Commissioner

Mon, 13 Mar 2017 14:32:00 -0400

Products regulated by the Food and Drug Administration (FDA) account for about 20 cents of every dollar of annual spending by U.S. consumers, amounting to more than $2.4 trillion in annual consumption that includes medical products, food and tobacco. The agency regulates medicines, diagnostic tests, medical devices, food safety including those made from modern biotech crops and livestock, food labeling, and tobacco and nicotine products. What the agency's bureaucrats decide has signifcant impact on U.S. economic growth and the livelihoods of Americans. President Donald Trump has nominated physician and American Enterprise Institute scholar Scott Gottlieb to become commissioner of the agency. Gottlieb earlier served as deputy commissioner during the Bush administration. Gottlieb has long been a critic of FDA's increasingly risk-averse culture that is slowing down the approval of new medicines. Defenders of the agency often cite data suggesting that the agency approves new medicines faster than other drug approval agencies abroad. That is true if only the period of time after a drug maker has submitted its New Drug Application (NDA) for approval is taken into account. More consequentially, increasing FDA requirements for longer and more extensive clinical trials before the NDA is submitted has substantially lengthened the periods and raised the costs of getting new treatments from petri dishes to patients' bedsides. Consider that researchers at the Tufts University Center for the Study of Drug Development have estimated that in 1991 it cost $412 million (2013 dollars) to develop and obtain approval for a new pharmaceutical. Last year, they calculated that it now takes more than $2.5 billion, a six-fold increase. Gottlieb, who has been associated with venture capital side of medical innovation, will seek to change the agency's culture from the current highly precautionary approach to one that more readily recognizes that benefits always come with risks. Under his direction, the agency would likely exercise a lighter regulatory hand over the development of new medical apps and diagnostics while seeking to work out the best way to speed up the approval of novel therapeutics based on stem cells and gene-edting technologies like CRISPR. Gottlieb is keen to get generic drugs approved quickly in order to bring down prices for consumers. In an August 2016 op-ed in the Wall Street Journal, he noted it now takes more than 2 years for the agency to approve a generic drug application and that the costs had risen from $1 million in 2003 to over $15 million now. He added, "This means that a drug may not face brisk generic competition until it exceeds $25 million in annual revenue. Thanks to these changes, infrequently used generics—such as clomipramine for major depression—may now have only one competitor and cost as much as branded drugs." Gottlieb also cited research that estimated the FDA's proposed generic labeling rule would expose generic drug manufacturers, who supply 84 percent of all prescriptions, to failure-to-warn product liability lawsuits, costing more than $5 billion in 2017. That rule is supposed to be finalized in April. As commissioner, Gottlieb might be able to halt it. While not a radical reformer, Gottlieb clearly has a good understanding of how over-regulation has been slowing down innovation in medicines and foods.[...]