Still Burned by the FDA

by on March 21, 2014 at 7:30 am in Economics, Law, Medicine | Permalink

Excellent piece in the Washington Post on the FDA and sunscreen:

…American beachgoers will have to make do with sunscreens that dermatologists and cancer-research groups say are less effective and have changed little over the past decade.

That’s because applications for the newer sunscreen ingredients have languished for years in the bureaucracy of the Food and Drug Administration, which must approve the products before they reach consumers.

…The agency has not expanded its list of approved sunscreen ingredients since 1999. Eight ingredient applications are pending, some dating to 2003. Many of the ingredients are designed to provide broader protection from certain types of UV rays and were approved years ago in Europe, Asia, South America and elsewhere.

If you want to understand how dysfunctional regulation has become ponder this sentence:

“This is a very intractable problem. I think, if possible, we are more frustrated than the manufacturers and you all are about this situation,”

Who said it? Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research! Or how about this:

Eleven months ago, in a hearing on Capitol Hill, FDA Commissioner Margaret A. Hamburg told lawmakers that sorting out the sunscreen issue was “one of the highest priorities.”

If this is high priority what happens to all the “low priority” drugs and medical devices?

The whole piece in the Washington Post is very good, read it all. I first wrote about this issue last year.

Addendum: See FDAReview.org for more on the FDA regulatory process and its reform.

Marie March 21, 2014 at 7:58 am

Sunscreen is, weirdly, potentially a very big oopsie for the FDA.

First because people are beginning to understand how much their skin absorbs the stuff and that it isn’t just a surface application (with some kinds), but more because vitamin D deficiency is starting to look like a main driver of a lot of disease. These two factors are both real and legitimate concerns (particularly the second) and also becoming very trendy.

What makes it big is that we’ve been told for years to slather the stuff on our kids. If there becomes a credible link between D deficiency in the youth and, say, MS or Hashimotos, even if it’s not definitive, that is going to be explosive.

Of course, reason would say that’s why we need either better sunscreens or a better look at the ones we have. But being the elephant in the mud, instead the FDA decides to just dig in its heels and stay put. Admitting a potential mistake is unthinkable, and you can’t correct a potential mistake easily without admitting it. And if you suggest it might be a mistake and then it turns out to have been hype, you look ridiculous. Best to just sit still.

And yeah, this means the medical devices out there for, for example, diabetes that I heard about being usefully used in Europe five years ago aren’t even on the radar here. There’s an insulin pump that makes one significant alteration — it turns off if your blood sugar is too low, so that you don’t keep pumping in insulin when you shouldn’t. That’s all, it just turns off. And of course it alarms, etc. so the user knows it is turning off. No go here.

Rahul March 21, 2014 at 9:05 am

I hate the FDA too, but I doubt if sunscreens are the best club to beat them with.

Take Tinosorb or Mexoryl or ecamsule: Epidimiologically what’s the best estimate of potential lives saved by using those over the many already FDA approved sunscreen APIs? So far as I can tell, improvements are marginal (if at all).

Also Ecamsule (L’Oreal) that used to sell at quite a premium & has recently come out of exclusivity, I think. Ideologically, I’m somewhat with the keep-FDA-away-from-meddling crowd; but I’m not convinced sunscreen is the issue to fight for. That’d just be doing pharma’s dirty work for them.

Jan March 21, 2014 at 9:34 am

Yet it is the EU that is clamping down on their device approval process due to safety concerns and loopholes they acknowledge need to be fixed. http://www.bloomberg.com/news/2013-09-24/medical-device-makers-see-eu-rules-slowing-u-s-approvals.html

In contrast to drug approvals, the vast majority of devices in the US are approved with minimal clinical data through a process called the 510k that is easily gamed.

Ryan March 21, 2014 at 11:25 am

Jan supplies a good article to read though it doesn’t necessarily shift the argument one way or another.

Jan March 21, 2014 at 12:11 pm

Whether we should have an FDA and how big it should be are arguments I do not expect to win with 90% of people. You have Alex and people like Marie (I think) who don’t believe in a government role in health care product regulation, or who will always argue for it to be smaller.

The point I guess is that one cannot hold up the EU as the ideal of regulation, as they are moving towards FDA on a number of fronts. But even that is irrelevant, people will next point to China, or Brazil, wherever: “They don’t regulate this stuff! They’re much faster. We can’t admit a mistake.”

Ryan March 21, 2014 at 1:15 pm

That was my interpretation of your original reply. I read these people slightly different than you Jan. I don’t read you as a ‘government will solve all of our problems type’ and I don’t think it’s fair for you to read Marie or Alex as ‘get rid of the government, and all of our problems would be solved.’ type.

The way I read these people is that they want to improve things at the margin — not do away with it entirely.

Jan March 21, 2014 at 1:31 pm

You may be right, I am lumping two somewhat dissimilar groups here: those who think FDA should not have the authority to require compliance and those who consistently think the government role in regulation should be lower. [Alex and Marie, if you are in fact neither of those, sorry if I am misreading you here!]

However, I would invite you to read the main policy solution espoused on FDA reform website linked in the original post. I read it as creating a system for “voluntary” FDA regulation. “A nexus of assurance is readily available without the FDA.”

Jim March 21, 2014 at 10:48 am

Last paragraph is technically incorrect, as the FDA finally approved that insulin pump (the 530G) last year and I am wearing one right now. They did take several years longer than the EU did, and will likely take several years longer to approve the next one (which will just reduce insulin flow when an accompanying sensor believes you to be heading low, rather than currently low).

Marie March 21, 2014 at 11:45 am

Glad to hear I’m out of date, thanks much for the correction!

john personna March 21, 2014 at 11:59 am

A very good first post, Marie. I like it better than Alex’s rather superficial (pun intended!) endorsement of new chemicals on our skin. My approach, FWIW, is to use no sunscreen but to have my doctor look at my spots. Nothing interesting so far.

Jan March 21, 2014 at 12:47 pm

“People are beginning to understand.” Here’s the thing, FDA is tasked with keeping track of what the evidence is, how strong it is, and soliciting feedback from the public to help make determinations that balance medical product risk/benefit. The virtue of an agency whose job it is to do this stuff is they are concerned with what is “becoming very trendy.” At the same time, FDA is not tasked with generating the evidence on products. It can ask for evidence and require for companies to generate it if it does not yet exist. If they don’t produce convincing evidence, what should the regulatory decision be?

I admit FDA can delay decisions or take more risk averse paths to avoid accidents that harm people (and bring blame) and that sometimes they probably don’t fully account for the risk of lack of access to new products. It is a tough assessment to make and I bet they do come down on the side of caution more than they should. That said, I think they are focusing on the right things. It’s also impossible to do a full accounting on the number of lives saved and injuries avoided by preventing dangerous products from seeing the light of day.

JWatts March 21, 2014 at 7:59 am

The FDA appears to be broken and dysfunctional as an agency. And as you state Tyler, even if the FDA did manage to expedite the evaluation of sun screen it would almost certainly do it at the expense of other products awaiting approval.

It’s also noteworthy that the FDA is one of the largest such agencies in the world. The FDA has over 14,000 personnel and a budget of over $2.5 billion.

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM301553.pdf
http://www.genengnews.com/gen-news-highlights/senate-appropriations-approves-fda-budget-for-fy-2013/81246701/

The bigger the US government gets the less competent it appears to function.

Tom March 21, 2014 at 8:42 am

Well, it is performing regulatory functions for the largest national economy in the world. I would be interested in an even-handed study assessing the FDA, but simply citing its size and budget doesn’t quite get it whether it has capacity and effectiveness sufficient to the tasks we as a polity wish it to perform for us.

Norman Pfyster March 21, 2014 at 8:57 am

“As you state, Alex…”

Just think how much more the FDA could accomplish if it were adequately funded.

Jan March 21, 2014 at 10:21 am

FDA regulates 25% of every dollar spent in the US. $2.5 billion to regulate all that.

Meanwhile, the military budget is $664.84 billion. Yowza!

About half of the overall FDA program costs of ~$4.5 billion is paid by industry user fees. So a good chunk of the 14,000 staff are not primarily paid by tax dollars. I should also note that industry loves user fees. They have consistently lobbied for them to fund product review work.

Joe Torben March 21, 2014 at 10:44 am

Yes, but the military and the FDA are different. The FDA doesn’t provide a net value, but the military… well, no, I take that back.

BTW, suggesting that “industry fees” are not ultimately paid by consumers/tax payers is of course completely wrong. And yes, naturally the industry loves user fees and other practices that create greater economies of scale. How else would you expect the poor drug companies to fight competition from newcomers?

Jan March 21, 2014 at 11:35 am

Every dollar spent by any entity ultimately comes out of the pocket of someone who made that money by doing something that created value in the eyes of someone or something. We can have that discussion all day until we have fully described the circle of economics.

User fees are not ideal, but they speed review and approvals compared to the alternative: pretending Congress will fully fund FDA operations out of appropriations (because that might mean ending development of some super jet thing with a laser gun on it). They are a workaround that industry supports, so they are politically viable.

If someone or some small company develops a new drug or device that is valuable it will be bought out by one of those large companies lickety split, because there are always people with money interested in making more of it. The big companies and venture capital investors are much more efficient at safety testing and marketing — economies of scale and all.

Marie March 21, 2014 at 11:47 am

@JT,

“And yes, naturally the industry loves user fees and other practices that create greater economies of scale. How else would you expect the poor drug companies to fight competition from newcomers?”

Thank you for noting that.

Brandon March 21, 2014 at 3:10 pm

I’m not aware of too many areas where tax/fee/cost-of-business incidence is 100% on consumers.

Sean March 21, 2014 at 12:33 pm

Isn’t the FDA administrative in function? If so, I get ~$327k per employee. That seems high, even if you do take half out for facilities and equipment. Underfunding doesn’t appear to be an issue. Misallocation if funds, on the other hand, does.

Jan March 21, 2014 at 6:04 pm

And contracts for adverse event surveillance, etc.

But out of curiosity, where do you think the misallocation of funds is?

Sean March 21, 2014 at 9:34 pm

If we are agreed that half of the budget goes to payroll, which is very conservative considering most industry budgets have a labor component much higher than 50%. Still with this conservative labor cost estimate, the average payroll is a little north of $150K/employee. That seems very high for a mostly administrative function. That’s where I see the misallocation (we could debate the terminology here). They can get almost twice the current workforce with the same budget and not have real problems finding competent people.

Jan March 22, 2014 at 9:30 am

So there is an agency that many believe is underperforming. Paying them less is one option, but that will no doubt affect the quality of work and the staff that it can attract. Is that what we should do?

Many of the people there are scientists, the majority of which are PhD level and quite a few MDs. Here is a list of the types of jobs they are hiring for: https://www.usajobs.gov/JobSearch/Search/GetResults?Keyword=fda

The employees already no doubt make less money than people in industry with comparable backgrounds, and physicians definitely make less than they could outside the agency. I think this is really specialized work and you need people who know what they are doing. Believe me, they would pay people less if they could, but I don’t think it’s really an option.

Jan March 22, 2014 at 9:33 am

Also, I guess we can agree that regulatory agency is mostly administrative, but I think to many that term conjures paper pushing and secretaries, not scientists reviewing reams of clinical data and regulatory decision making.

RZ0 March 21, 2014 at 8:10 am

All the more reason to cut the sequester FDA till they can get stuff done. Maybe add a mandate or two like the FSMA.

Brian Donohue March 21, 2014 at 8:55 am

I believe the sequester is on hold- it’s an election year silly, and talk of credit limits has been punted to 2015:

http://www.usdebtclock.org/

Apparently, we have found the limits of ‘austerity’- a $600 billion federal deficit.

Total government tax revenue (federal, state, local) will be more than $5.6 trillion this year. That works out to $17,500 per citizen, $70,000 for a family of four. Please wrap your brain around these numbers.

This is what government takes from us every year. Of course, they spend even more.

Jan March 22, 2014 at 9:36 am

And it is actually much too low for all the stuff people require government to do, mostly by statute. Please compare the tax revenue to other rich countries.

Mitch Berkson March 21, 2014 at 8:15 am

So which foreign sunscreen should I order?

carlospln March 21, 2014 at 2:46 pm

They have no idea. & the first time something like thalidomide is introduced, they’ll scream bloody murder that ‘the FDA missed it’.

http://en.wikipedia.org/wiki/Thalidomide

ummm March 21, 2014 at 8:16 am

The economist Milton Friedman has claimed that the regulatory process is inherently biased against approval of some worthy drugs, because the adverse effects of wrongfully banning a useful drug are undetectable, while the consequences of mistakenly approving a harmful drug are highly publicized and that therefore the FDA will take the action that will result in the least public condemnation of the FDA regardless of the health consequences.

http://en.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_Administration

Frederic Mari March 21, 2014 at 10:18 am

If that was true, how come any drug was ever approved? We should still be debating over penicilin…

mofo. March 21, 2014 at 10:25 am

because bias does not mean something is impossible.

chuck martel March 21, 2014 at 12:37 pm

Obviously. If someone decides not to drive to the hockey game because the roads are too icy, they’ll never know if they would actually have made it OK or been killed in a collision. The newspapers only mention the ones killed, not the ones who skipped the game and watched “Dancing with the Stars”.

Brenton March 22, 2014 at 1:28 am

Would take a damn good NHL lobbyist to convince me that attending a hockey game saves lives.

prior_approval March 21, 2014 at 8:26 am

But the dermatologist is ludicrous, and the final quote goes a long way in explaining why Americans have such a screwed up health care system – “I want the ultimate, perfect sunscreen for my patients,” he said. “No such perfect sunscreen exists yet. But these ingredients would help us get closer to that goal.”

And do note that one of the corporations leading this is BASF. With a BASF marketing person saying something almost as ludicrous as the above quote – “It definitely hurts how we approach development of new UV filters,” said Al Pearce, a personal care senior marketing manager for BASF, which owns several of the pending applications at FDA. “The U.S. market is one of the largest markets in the world. If it’s not open to new innovation, it’s extremely limiting.”

There is absolutely no way, as evidenced by the fact that BASF is happily selling its products to the rest of the world, that BASF is facing any restrictions in developing new UV filters. What BASF is facing is less potential profit because a large market is not open to it.

I truly understand why the Bartley J. Madden Chair in Economics at the Mercatus Center is interested in this subject. But such breathless Post reporting seems to even lack the capacity to understand how thoroughly this reads like a perfectly placed BASF position paper, without even this background – ‘German chemical giant BASF says that 50% of all ‘sun care’ products sold today contain its organic UV-A filters. Speaking at a press conference at the BASF headquarters in Ludwigshafen, Germany, Dietmar Hueglin, vice president for performance materials research, said that sun protection represented a remarkable success story for the company.

BASF launched a series of filters since the early 1990s, starting with Tinosorb S in 1992. Tinosrb M followed in 2003 and Uvinul A Plus in 2005.

Hueglin said that when BASF first moved into this area, there were no filters designed specifically to block UV-A radiation, which has wavelengths in the 320-400nm range and penetrates the skin more deeply than UV-B radiation. Until that point, skin protection products had focused on UV-B radiation (wavelengths in the 280-400nm range), which is the principal cause of skin reddening and sunburn. But in the last 20 years it became clear that both types of UV radiation increase the risk of permanent skin damage and, in particular, skin cancer.

It takes a long time – and considerable investment – to develop such filters, Hueglin said. Typically, six to eight years are needed to take a new compound to approval, and you are unlikely to see significant sales within a decade. For that reason, it’s important to keep the pipeline well stocked. Last year, BASF won approval for a new filter – called DP1 until a trade name is settled – which the company is planning to launch soon. Hueglin says the compound, which has a windmill structure with a 1,3,5-triazine group at the centre and three diphenyl blades, absorbs strongly in the shorter wavelength part of the UV-A range, something that hasn’t been seen before.’ http://www.rsc.org/chemistryworld/News/2012/March/BASF-UV-filter-sunscreen.asp

Though possibly, to be charitable to the Post, the reason might be the factual content being beyond its audience, as compared to illustrating just how self-serving the statement from a personal care senior marketing manager for BASF is.

dan1111 March 21, 2014 at 8:47 am

Yes, companies that develop drugs have an interest in the speed of the approval process. Duh. But the drug company was just one of many sources quoted in the article. If this is just industry propaganda, then why does the head of the FDA agree that it is a problem?

Norman Pfyster March 21, 2014 at 8:58 am

Regulatory capture.

dan1111 March 21, 2014 at 9:09 am

Janet Woodcock didn’t come from the pharmaceutical industry.

Rahul March 21, 2014 at 9:13 am

FYI, I think Woodcock is up for retirement in ~6 months.

prior_approval March 21, 2014 at 9:13 am

First, it wasn’t the director of the FDA, it was this person – ‘Dr. Woodcock has led many of FDA’s drug initiatives. She introduced the concept of risk management in 2000 as a new approach to drug safety. Since 2002, she has led the “Pharmaceutical Quality for the 21st Century Initiative,” FDA’s highly successful effort to modernize drug manufacturing and its regulation. In 2004, she introduced FDA’s “Critical Path” Initiative, which is designed to move medical discoveries from the laboratory to consumers more efficiently.

Most recently, Dr. Woodcock launched the “Safety First” and “Safe Use” initiatives designed to improve drug safety management within and outside FDA, respectively.’ http://www.fda.gov/AboutFDA/CentersOffices/ucm193984.htm

Her agreeing that it is a problem is the minimum she could do, considering her background of apparently being involved in this area for decades.

Though at least she didn’t turn Reaganeque, and say ‘mistakes were made.’ Though not tenured, I doubt she is too concerned about being fired at this point – she’s worked for the FDA for almost 3 decades.

And that point about Congress being responsible? It’s actually true – which is why having an article in the Post can be useful for the bottom line of a German company.

mofo. March 21, 2014 at 10:29 am

But the dermatologist is ludicrous, and the final quote goes a long way in explaining why Americans have such a screwed up health care system – “I want the ultimate, perfect sunscreen for my patients,” he said. “No such perfect sunscreen exists yet. But these ingredients would help us get closer to that goal.”

What, exactly is so ludicrous about that quote?

Rahul March 21, 2014 at 11:02 am

Don’t know about the quote, but have you seen the evidence as to how these ingredients would help us get closer to that goal? It’s super hazy at best.

It’s like paying $30 more for your yogurt cup because it claims to be 0.1% lower fat that the usual brand. Not to say that ought to stop someone from wasting his $30 but just saying.

Marie March 21, 2014 at 11:59 am

Yes, I think it’s a very valid argument that people should be able to spend their own money stupidly and that the government’s job is merely to keep the scales fair — in this case, make sure no claims are made that are unsubstantiated and would lead people to spend more money through deception.

But as you state well above, that’s pretty weak tea, better to criticize the FDA for the actually useful things they are stalling.

prior_approval March 21, 2014 at 12:43 pm

Well, let us just take that first sentence – “I want the ultimate, perfect sunscreen for my patients”

First, ultimate and perfect? For something that didn’t even exist for most of humanity’s existence? In part because staying out of the sun completely is already the ultimate and perfect way not to be exposed to the sun? With clothes running a fairly decent second, and remaining in shade as much as practical making a fine showing in third? Assuming, of course, that one is not already terrified by being outdoors on a sunny day because of all that deadly solar radiation, which is only imprefectly blocked by even the best sunscreens known to medical science.

Then that ‘for my patients’ – is this doctor really all that concerned about his patients (see above for free advice), or instead, does he care about his patients paying him?

And why is the word ‘perfect’ repeated after that first section? What would ‘perfect’ even mean in such a context? And for who? Is there really a quest for the perfect sunscreen (while not blaming a dermatologist for having a particular focus in this regard)? At least when looked at from the perspective that UVB is necessary to trigger vitamin D production in the skin. http://www.hsph.harvard.edu/nutritionsource/vitamin-d/

Which, to bring this full circle –

1. After finding the perfect sunscreen we also need

2. To find the perfect replacement for what UVB causes our bodies to produce

3. Leading to profits for those supplying both 1. and 2.

mofo. March 21, 2014 at 2:51 pm

This is a lame criticism even by your standards. Why shouldnt a dermatologist want a perfect sunscreen? Id say its hardly arguable that someone who’s job it is to help people take care of their skin would want a product that is perfectly suited to taking care of your skin. Apparently in your world that is an arguable, or even ludicrous concept for the following reasons:

1)This hasent existed in the past.
2)The shade
3)Clothes
4)The doctor might have a profit motive
5)The word ‘perfect’
6)Sunscreen might interfere with the production of Vitamin D

The first 5 are so thoroughly silly that they dont even merit a response. The last point, about vitamin D simply falls under the definition of ‘perfect’, i.e. the perfect sunscreen protects you from harmful UV while still allowing you to get the Vitamin D you need.

mofo. March 21, 2014 at 4:42 pm

Which, to bring this full circle –
1. After finding the perfect sunscreen we also need
2. To find the perfect replacement for what UVB causes our bodies to produce
3. Leading to profits for those supplying both 1. and 2.

Quell horror! Someone would make a profit from solving a problem? We cant have that!

Marie March 21, 2014 at 8:05 pm

I think the problem is with someone making a profit by solving a problem they created to make a profit.

Rahul March 22, 2014 at 4:09 am

@Marie

I agree with you in this case, but in general there could be acceptable scenarios: Say someone invented a miracle drug that totally prevented coronary thrombosis but the downside was it interfered with natural Vitamin D synthesis. It may still be worth for some high risk cohort to use miracle-drug & Vit-D supplements.

Marie March 22, 2014 at 11:49 am

@Rahul,

I think one of the things that is coming back in some corners of medicine is the idea that each person’s physiology has aspects that are unique, and that makes it very important that we allow people to individually balance benefits and risks, instead of doing so based on populations.

I don’t at all mind folks making money with D supplements and with sun screen. What I mind is federal interference that contributes to massive and unwarranted cultural coercion regarding sun screen followed by federal interference that contributes to massive and possibly warranted hysteria about vitamin D, and the combo of the two which means that perfectly intelligent people don’t consider getting more D by going outside without chemicals all over their faces.

if they choose to go outside with chemicals all over their faces, uncoerced, that’s dandy. I know folks prone to melanoma and skin disorders that certainly need it, and for them to be able to drink fortified milk or take supplements, that’s a win.

But when I take my kids in to the pediatrician, she asks me if they are wearing sun screen outside. Why? Because it’s on her checklist. And if I don’t lie (which I don’t), I get the Seinfeld mark in the records. On a related note, pediatricians will also ask you if you smoke (and if you smoke in the house), if the kids use helmets when riding their bikes every time, if you use a car seat every time, and if you have a gun in the house (and if you do, if it’s properly locked up).

charlie March 21, 2014 at 8:34 am

Usually, when someone cites a “highly technical” or “procedural” issue in an legal or adminstrative context, that is shorthand for “We don’t want to explain the other side of the argument to our readers.”

“In March 2013, manufacturers launched a new legislative-focused group known as the PASS Coalition, standing for Public Access to Sunscreens. The group said its aim is to bring together stakeholders—including FDA—to “Establish a framework for approval of the next generation of UV light active filters for over-the-counter (OTC) sunscreens.”

“The current pre-market review process needs to be reformed to ensure timely review and add transparency and predictability,” the group writes on its website.

The group noted that recent research indicated that as many as one in 10 people in the US will develop skin cancer in their lifetime, making access to more effective sunscreens all the more important.

The PASS Coalition is recommending that the TEA process be reformed and that FDA be given the resources it needs to process current and future applications.”

Special interests at work!

Thomas DeMeo March 21, 2014 at 8:37 am

I hope people understand that most of the problem here is with Congress. For the most part, the FDA and any other federal regulatory body has to deal with the system that was written into law, as well as the insane management and budgetary practices that have been imposed on it.

Nathan Goldblum March 21, 2014 at 8:42 am

Exactly.

Nick March 21, 2014 at 10:23 am

Yea, god forbid there be any democratically-elected oversight to these powerful, bureaucratic agencies control by unaccountable experts that essentially can write law through regulation with all their delegated authority.

Bob March 21, 2014 at 10:50 am

Oversight is great, but being good at oversight is not really in congress’ best interests.

Thomas DeMeo March 21, 2014 at 11:25 am

Nick- I am not arguing against removing Congressional oversight. I am saying that is where most of the reform must come from.

The FDA is huge and there are clearly some examples of terrible decision making. But for the most part, if you dig in and look the the process by which regulations get formed, it isn’t arrogant regulators throwing their weigh around, it is a grinding process of public comments and responses that can go on for many years.

chuck martel March 21, 2014 at 12:45 pm

Ninety-three point six percent of FDA employees rate their boss as an incompetent idiot.

Doug March 21, 2014 at 10:47 am

I’m sympathetic to this argument, but what undercuts it is the 23AndMe debacle. The FDA was under no Congressional mandate to act on personal genomic testing, yet enthusiastically flexed their authority for no reason whatsoever. That’s pretty hard evidence that the culture of FDA is primarily power-hungry.

mavery March 21, 2014 at 1:00 pm

Lord knows that why you go to work at the FDA. All of the POWER!

Michael Foody March 21, 2014 at 8:50 am

I share some skepticism about the specifics of the FDA but I see the mission of the organization as incredibly valuable. I know college educated people that buy homeopathic cures. Conditioner is sold based on its ability to gird your hair in CGI hexagons and because it has a benzene ring scented like pomegranates and those are, supposedly, good for a specific hair deficiency. People aren’t equipped to figure out what’s useful and what’s worse than nothing. The corners of life where FDA’s reach doesn’t extend are a frontier space of psuedoscience and huxterism. I don’t think a liberalized drug market would get us different results.

Roy March 21, 2014 at 8:56 am

Yet weirdly all that crap is occurring with the FDA in its current form…

Brandon March 21, 2014 at 10:05 am

Because they’re out of the FDA’s regulatory scope.

Nick March 21, 2014 at 10:27 am

So what? You should have the right to take whatever pseudo scientific, patently stupid garbage you want to put into your body. Not to mention, water doesn’t hurt people (ie homeopathy).

Rahul March 21, 2014 at 10:32 am

That’s fine as an ideologically consistent argument. Only that perhaps the majority doesn’t agree e.g. cocaine, heroin prohibition, no alcohol below 21, no euthanasia, absinthe bans (till recently) etc.

mofo. March 21, 2014 at 3:01 pm

So if the majority agreed to stomp your head in, you would be ok with that? Democratic is not synonymous with right, or just or smart.

Brandon March 21, 2014 at 3:12 pm

Just to clarify, I’m not arguing that homeopathy or juice diets or whatever dumb garbage people like to do along those lines should be regulated by the FDA.

John Donner March 21, 2014 at 5:23 pm

Libertarianism as moral aspergers.

Cliff March 21, 2014 at 9:44 am

To be fair, homeopathic “cures” are not going to hurt anyone, except in the wallet.

Rahul March 21, 2014 at 10:29 am

“Arsenic toxicity from homeopathic treatment.” J Toxicol Clin Toxicol. 2003;41(7):963-7.

“Use of a Homeopathic Preparation for “Infantile Colic” and an Apparent Life-Threatening Event” PEDIATRICS Vol. 125 No. 2 February 1, 2010 pp. e318 -e323

“Adverse effects of homeopathy: a systematic review of published case reports and case series” International journal of clinical practice 66.12 (2012): 1178-1188.

“Choking caused by a homeopathic drug In a previously healthy infant” Canadian Family Physician August 2013 vol. 59 no. 8 848-851

mavery March 21, 2014 at 1:02 pm

You forgot to mention all of the “benign” cases where folks take stuff that doesn’t work rather than getting real treatment.

Cliff March 21, 2014 at 4:54 pm

I’m confused. By definition a homeopathic remedy has no active ingredient http://en.wikipedia.org/wiki/Homeopathy

sort_of_knowledgable March 21, 2014 at 7:08 pm

Diluted improperly or never meant to be homeopathic by classical definition but merely used as a marketing term, like natural.

Ragout March 21, 2014 at 9:28 am

Alex writes If this is high priority what happens to all the “low priority” drugs and medical devices?

The answer, apparently, is that they are approved much more speedily, because drugs and medical devices go through an entirely different process at the FDA. One of these new sunscreens has already been approved as a drug (marketed as “Ecamsule”).

To me, it makes sense that the FDA would have a different, slower, process for approving over-the-counter ingredients. Prescription drugs are usually only taken on a short-term basis, and their use always supposed to be monitored by a doctor. OTC ingredients like sunscreen will be used all day, every day by some people, so naturally it’s harder to prove they’re safe.

And of course, if Congress really thinks the FDA is wrong, they could simply pass a law directing the FDA to approve the new sunscreens.

Rahul March 21, 2014 at 1:55 pm

“Ecamsule has already been approved” while true, is actually a wee bit of an understatement. That drug has already expired exclusivity as well as patent protection.

So it’s almost time for cheap generic Ecamsule to enter the market now!

Ragout March 21, 2014 at 10:03 am

Just because other countries in Europe and elsewhere have approved the new sunscreens, why should I think the US is wrong not to approve them? Whenever I’ve gone to Europe, I’ve been appalled at the needless risks they allow, risks that would never be tolerated in America.

For example, a friend once tripped and fell over a step in the middle of a dimly-lit hallway. He didn’t expect a step in the middle of the hallway, because who would? The hallway was dimly-lit to save a few pennies on electricity (the lamp was on a timer and had to be switched on by anyone who wanted some light). I could multiply anecdotes like this. In my view, Europeans need a whole lot more more trial attorneys.

Mogden March 21, 2014 at 10:27 am

My God, the absolute horror of it all.

Ian Brown March 21, 2014 at 11:18 am

Has to be satire.

Ragout March 21, 2014 at 11:50 am

Several hundred thousand elderly people are hospitalized every year due to falls. Even if you think this is trivial (I don’t), it’s often trivial to reduce the risk of falls, and yet Europeans don’t take simple measures such as putting up warning signs. Since European regulators obviously deal badly with common, everyday risks such as falls, I see no reason to trust their drug regulators over American drug regulators.

chuck martel March 21, 2014 at 12:49 pm

But those darn Europeans have nationalized health care systems that can make those elderly fallers good as new in no time!

Doug March 21, 2014 at 10:55 am

Here’s a devious little plan to undermine the FDA, that I’d certainly pursue if I was a libertarian oriented billionaire like Peter Thiel. Offer a billion dollar X-Prize for anyone who discovers a truly novel antibiotic that isn’t manifestly toxic to humans. Then pay for Phase I safety testing which should cost on the order of $50 million or so. Then simply release the rights to the molecule under Creative Commons.

No drug company’s going to pay for the ~$500 million cost of Phase II and III efficacy testing. Yet with increasing antibiotic resistance there’s going to be massive demand for the product. Patients and doctors will obtain and prescribe the antibiotic on the grey market, and many will owe their lives to it. The public will realize that only safety testing should matter, especially with a coordinated media campaign to highlight the difference in cost and importance between safety and efficacy testing. It would undercut the FDA’s process in the same way that widespread marijuana use undercuts support for the drug war.

mavery March 21, 2014 at 1:06 pm

Here’s an idea: Instead of worrying about regulatory frameworks, how about you just create a novel antibiotic that isn’t toxic to humans? If you’ve got 1.05 billion to throw around, that seems like a great way to spend it.

Brandon March 21, 2014 at 3:14 pm

Then, a few years into this experiment, it’s discovered that this great new wonder drug has horrible side effects and doesn’t actually work all that well, something that would have been discovered in Phase II and III trials.

Cliff March 21, 2014 at 4:57 pm

Isn’t Phase I for side effects?

mulp March 21, 2014 at 11:00 am

Well, conservatives have long argued that fewer government workers means less government action and that means less bad stuff can be done by government.

So, conservatives don’t want anything bad to happen by the FDA approving new sunscreen ingredients because they will kill you because that’s Obama’s plan for change. Killing Americans.

Look at Obama’s nominee to Surgeon General – he says guns are the biggest health risk to kids and young adults. Everyone knows the way to live to age 100 is to be shot 10 times with cop killer bullets.

dan1111 March 21, 2014 at 11:31 am

“So, conservatives don’t want anything bad to happen by the FDA approving new sunscreen ingredients because they will kill you because that’s Obama’s plan for change. Killing Americans.”

I’m sure you wouldn’t just make something like this up. Could you please share with us the reference to conservatives who are saying this?

Jan March 21, 2014 at 12:16 pm

EU may be faster than us in sunscreen, but we kick their butts in drug approvals, cancer drugs in particular!
http://www.medicalnewstoday.com/articles/245585.php

It's Over March 21, 2014 at 12:19 pm

Hilarious that so many commenters cannot bring themselves to think that maybe the FDA shouldn’t take ten years to approve a sunscreen. Apparently Alex is being unreasonable. So many true believers!

I do not think that the FDA’s performance bodes well for DC’s ability to run our health care system.

dearieme March 21, 2014 at 12:24 pm

Are you familiar with the expression “They couldn’t organise a piss-up in a brewery”?

Norman Pfyster March 21, 2014 at 1:53 pm

No, but it does paint a picture!

prior_approval March 21, 2014 at 12:57 pm

‘Apparently Alex is being unreasonable.’

No, the holder of the Bartley J. Madden Chair in Economics at the Mercatus Center isn’t being unreasonable in the least, especially in light of the interests of the person responsible for the creation of that chair.

It is the article that is unreasonable – mainly because it is a dressed up plea for the world’s leading manufacturer and developer of UV protecting compounds to increase its profits by selling it latest patented products. Which is fine, actually – as long as one remembers that BASF is not interested in speeding up regulatory approval as a public health service, it is doing it for its own profit (goals of which there needs to be no conflict, of course. Well, as long as one ignores things like the history of Vioxx – ‘On September 30, 2004, Merck withdrew rofecoxib from the market because of concerns about increased risk of heart attack and stroke associated with long-term, high-dosage use. Merck withdrew the drug after disclosures that it withheld information about rofecoxib’s risks from doctors and patients for over five years, resulting in between 88,000 and 140,000 cases of serious heart disease’ http://en.wikipedia.org/wiki/Rofecoxib )

PL March 22, 2014 at 12:31 am

Is it so bad that companies that stand to profit something should advocate for it? Multinational support for elimination of CFC production came from the labs of DuPont, after all.

While Merck’s withholding of refecoxib’s adverse events is pretty bad, the extra attention paid to that specific selective COX-2 inhibitor lead to the realization that not only do other COX-2 inhibitors have such similarly awful side effect profiles, but even nonselective COX inhibitors (-1 and -2) like ibuprofen also do. No one ever ran such detailed investigations into those existing, legal drugs however.

Rahul March 22, 2014 at 10:59 am

Companies marketing their products upfront is a bit different than using a Cancer group front for lobbying.

Jan March 21, 2014 at 4:59 pm

Yeah, I totally get FDA sucks at some things. The commissioner of the agency gets that, and publicly admits it.

The reason some people think it’s unreasonable is that Alex uses this type of story (slower access to sunscreen, God forbid!) to plug his proposal to make FDA oversight voluntary, including for things like drugs and devices that could kill ya. That’s the thing.

Herb March 21, 2014 at 12:31 pm

Woe to the sunscreen lotion manufacturer. Not only are you doomed to produce an unnecessary and basically useless product, the FDA won’t let them do it with new and improved chemicals…I mean, “compounds.”

An even bigger problem than that, of course, is that another industry provides a better source of sun protection. And the FDA has no purview over clothing manufacturers….

Cliff March 21, 2014 at 4:58 pm

…putting on my burka…

Herb March 21, 2014 at 6:44 pm

I’m not that modest, so I just have a sombrero.

chuck martel March 21, 2014 at 12:57 pm

What about sunglasses? I wore out three pair on my trip to Phoenix last year.

Dan Lavatan March 21, 2014 at 2:47 pm

Products containing Bisoctrizole are available on eBay and in this case it seems the regulations aren’t really being enforced. If the FDA were serious about the ban it would need to target precursor chemicals and get the DEA and customs much more involved in enforcement. Does anyone really limit themselves to products they can buy at physical US retailers?

Brandon March 21, 2014 at 3:15 pm

I’d bet most people aren’t buying their sunscreen on eBay.

ezra abrams March 21, 2014 at 4:22 pm

all the active ingredient that comes from China, that has highly toxic contaminants that are absorbed thru the skin thanks to the cream base, who is responsible for the $$$ analytical chemistry QC (think CSI miami lab) needed ?

You do remember the Tryptophan diet supplement fiasco ??
http://en.wikipedia.org/wiki/Eosinophilia%E2%80%93myalgia_syndrome
http://responsibletechnology.org/gmo-dangers/health-risks/L-tryptophan/contaminants

or the designer heroin parkinson’s thing ?
http://en.wikipedia.org/wiki/Designer_drug

or Thalidomide ?

analytical chemistry QC (GC/Mass Spec, HPLC/MS, FTIR, etc etc – each of those acronyms is a 500,000 dollar instrument, and a highly trained person to maintain and run it

Cliff March 21, 2014 at 4:59 pm

What about all the people who died waiting for life-saving drugs to be approved?

Jan March 21, 2014 at 5:03 pm

Are you familiar with the numerous FDA programs that accelerate approval of and lower the threshold for required evidence of effectiveness (and sometimes safety) for products that meet unmet needs or treat serious conditions?

Rahul March 22, 2014 at 4:13 am

@Jan

In general I fault FDA less for slow approvals than for its role in keeping drugs more expensive in the US than the rest of the world. The damage that’s done because an American couldn’t afford an expensive drug (available much cheaper outside the US) is way higher (I feel) & more preventable than all the other faults people accuse FDA of.

Jan March 22, 2014 at 9:47 am

Any role the FDA has in drug costs is indirect. I don’t know how familiar you are with the US drug pricing policies, but government plays a very small role in trying to regulate prices compared to other countries. Medicare, the largest buy of prescription drugs is statutorily prohibited from negotiating drug prices with companies. However, Medicare is also statutorily required to cover drugs in many classes. State Medicaid departments, the program for the poor, may negotiate drug prices and there are some mandatory rebates, yet Medicaid is also required by law to cover any drug if medically necessary. These agencies are totally separate from FDA, an that is probably a good thing on balance.

The fastest rising cost center in drugs is biologics, and we will have generic versions of them much later than Europe due to the 12 year exclusivity law that Congress passed a few years ago when it created a biosimilars pathway at FDA. The pharmaceutical lobby is very powerful in America, so basically the US indirectly subsidizes the rest of the world by paying most the cost of developing new drugs, either through sky high prices or NIH-funded original research. It is endlessly argued that if we create policies to drive down drug costs, we will be stopping innovation, harming a strong US industry and killing jobs. FDA is not really the problem with costs, but they could always do better.

Jan March 22, 2014 at 9:50 am

Though I completely agree that drug costs are kept artificially high in the US and it is a big problem.

Rahul March 22, 2014 at 10:22 am

Let’s take an example: A drug costs ~$275 in the USA. Identical formulation outside USA can be sourced for ~$40. Same dose, same manufacturer, same formulation, same brandname even. Pristine, verifiable supply chain documentation. Third party lab analysis certifying quality.

Say I decide to import into USA, what regulator do I run afoul of? My impression is the FDA primarily (ok, indirectly enforced by customs inspectors), but correct me if I am wrong.

Jan March 22, 2014 at 11:23 am

Ok, I see what you are saying and you’re right that is an FDA law. But in short, buying drugs from abroad at lower prices as an individual consumer is illegal, but people do it all the time and nobody goes after them for it. So you can do it. The rationale for the law is that the US does not have the regulatory capacity to guarantee (re)imported drugs’ safety. Legal reimportation (buying safe US-manufactured drugs shipped abroad) of cheaper drugs has been advocated for a long time, mostly by seniors organizations and mostly before the Medicare prescription drug benefit was created in 2006. The drug companies vociferously opposed it, as you can imagine, and they have basically buried that as a policy option.

All that being said, a surprising number of people actually do buy drugs from abroad (something like 2 percent of people surveyed said they have done it. FDA actually has a policy of not prosecuting anyone buying the meds for their personal use. What the FDA has been doing is shutting down internet pharmacies that they know are selling counterfeit, substandard and dangerous products. I’m ok with that, but the reason have to do this in the first place is because the drug lobby doesn’t allow the US to put in place rational prescription purchasing policies.

Rahul March 22, 2014 at 11:34 am

@Jan:

But I think this is a HUGE problem. Perhaps the biggest problem the FDA is causing. Their turning a blind eye to consumers is hardly something to applaud the FDA for!

Americans would get hugely cheaper drugs if only FDA stopped preventing systematic, official, documented imports from abroad. The argument that we lack the regulatory capacity to guarantee imported drugs is a joke. Many API’s & formulations sold in the US get manufactured abroad anyways. And we are not even talking about allowing new companies into the market.

I strongly disagree with your assertion that FDA has no role in drug cost rise. It obviously does. If we had a “Federal Shirt Authority” that banned all imports, guess what would happen to shirt prices?

Rahul March 22, 2014 at 11:39 am

Also, FDA is the very reason these shady internet pharmacies selling counterfeit, substandard products thrive.

If FDA legalized imports, who’d buy from some flaky Chinese website when someone like Walmart or Target could manage the supply chain & cater to this huge suppressed market. FDA rules are the fundamental reason for this underground market to exist.

FDA’s mere turning a blind eye to individual imports without any checks on quality etc. endangers more people than if systematic, authorized, audited importers could service this market.

Jan March 22, 2014 at 12:27 pm

The issues you raise are legitimate concerns and I think your arguments are logical. But all of these are issues of the law, not FDA making poor decisions. There are two problems and one flows from the other. First, drug pricing policies in the US are totally irrational and it makes it tough for many people to get affordable meds. Second, people can’t get medications from abroad that they can trust, because it is illegal.

Both of these problems stem from the laws passed by Congress, and Congress has legal oversight of the execution of these laws. FDA must enforce these laws. FDA can’t unilaterally set up a drug reimportation program. Even the if the Administration was on board, Congress, industry and others would crucify them. You just can’t do this. I agree the resources could be marshaled to do such a program, but it would require a change in the statute and a formal budgeting process, and for Congress to explicitly appropriate money for this purpose. FDA is not allowed to spend its resources as it pleases, especially not industry user fees which about half of its budget.

Now FDA is not turning a blind eye to consumers because they think it is totally fine. They simply can’t prosecute everyone who buys some medicine from abroad. They couldn’t even find all these people if they wanted to. It’s like street drugs–it just isn’t efficient to focus on busting individual users, you go after the suppliers.

Jan March 22, 2014 at 12:32 pm

And my personal preference would be to change the real source of the problem, something that many countries have figured out: directly regulate drug prices. At the very least allow Medicare to leverage its market power to negotiate drug prices. There is a reason that drug prices are so high and people desire to import them from abroad. Allowing more of that would just be a band-aid.

Jan March 21, 2014 at 5:04 pm

Here’s some reading to get your started: http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm

“All the people who died waiting for life-saving drugs to be approved” is an absolute myth perpetuated by people who don’t know what they are talking about.

Seth Roberts March 21, 2014 at 7:43 pm

Alex may not know about a study recently done at a nursing home. The residents were divided into two groups: those who stopped taking all their drugs (I think each person was taking an average of something like 6 drugs) and those who continued taking their drugs. The ones who stopped taking their drugs lived considerably longer.

Given results like this, it is not so obvious that drug companies should be given more freedom.

PL March 22, 2014 at 12:37 am

But the increased activity of the FDA does not help keep people off drugs; presumably all of those persons in the nursing home are on FDA approved drug therapies. It is not so obvious that the FDA’s approval of those drugs that presumably increase mortality is supportive of its necessity.

Such research falls in line with “The House of God.”

Brenton March 22, 2014 at 2:28 am

In your example I think it would be far more relevant to look at who was prescribing those drugs rather than who approved them. I’ve been Rx’ed many drugs over the years that made me feel worse rather than better. That doesn’t mean those drugs should be banned.

Rahul March 22, 2014 at 11:01 am

Have a link?

Joshua Rogers March 26, 2014 at 6:22 am

Ah, the FDA. Still almost completely useless. Some things never change.

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