Pharmaceutical regulation is getting tougher

by on November 1, 2014 at 2:19 am in Law, Medicine, Political Science | Permalink

From Diana Carew at the Progressive Policy Institute:

…the number of ‘restrictions’ on drug companies increased by 767, or 40% since 2000. This represents a substantial rise in the overall regulatory burden of pharmaceutical companies, which must allocate resources to ensure regulatory compliance. The word “restriction” refers to command clauses such as “shall” and “must,” as contained in sections of the Code of Federal Regulations related to the FDA.

The full study is here (pdf).

1 Ray Lopez November 1, 2014 at 4:16 am

Government is slowly strangling society. For money transfers, it’s very difficult for me to move money around without jumping through hoops. Be in Greece (the worse, for good reason, as there was a run on the banks a few years ago), the USA, Thailand (I’ve got stranded money there that I’ve abandoned) or the Philippines (rife with red tape…for some reason they insist on knowing your full middle name, and, btw, due to various laws they only allow one internet connection for a residence, you must get special permission or bribe somebody for more than one line for a non-business address).

Part of the Great Stagnation IMO. Government should get out of the way, strengthen their patent systems, offer prizes as AlexT and TC have mentioned, and watch society break free. But it’s hard for the Iron Triangle to dissolve itself.

2 Jan November 1, 2014 at 8:38 am

If this is something you feel passionately about, it looks like there a lot of countries with less regulation that you could look to. Just an idea. http://www.doingbusiness.org/rankings

3 Ray Lopez November 1, 2014 at 9:30 am

Nice list: the Philippines beats out the USA in “ease of getting electricity”, lol Meralco must be doing something right, despite all the brownouts!

4 JWatts November 3, 2014 at 3:05 pm

“ease of getting electricity”,

That’s seems like a weird metric that the US is doing “poorly” on. I’ve lived all over the Southeast, and I’ve generally never waited more than 24 hours to have electricity turned on for a building that had previously had it connected. And in the rural case, it took less than a week to get a pole dug and electricity run from the street to house.

Maybe, the slow down is in the permitting process? I waited a week this summer to have an electrical inspection for a basement room, because the chief inspector was on vacation and his assistant was slow.

5 Chip November 1, 2014 at 5:20 am

Is there any evidence that drugs were getting more unsafe to justify the increased regulations?

Was the cost – in terms of lives lost because of slower regulatory approval – considered when implementing a new regulation?

6 Ray Lopez November 1, 2014 at 6:07 am

@Chip – No and no. The one regulatory success of the US FDA is Thalidomide, which was actually over-the-counter before being pulled, hence arguably it was not the FDA that caused it to be withdrawn (see: http://en.wikipedia.org/wiki/Thalidomide). See also this apparently FDA hostile site: http://www.fdareview.org/

7 Floydthebarber November 1, 2014 at 7:45 am

How much of this is regulatory capture? It can’t be zero…

8 Slocum November 1, 2014 at 8:04 am

Regulatory capture is really not needed to explain this. The FDA is in the regulation business. Imposing more and tougher regulations means growth for the FDA (like selling more hamburgers means growth for McDonald’s). More and tougher regulations creates both a demand and justification for growing budgets. Streamlining and simplifying regulations (or even slowing the pace of regulatory churn) does the reverse — it gives regulators less to do. Anybody who has experience with the insanity of university ‘Institutional Review Boards’ has seen the same bureaucratic strangulation process in a local form.

9 Jan November 1, 2014 at 5:58 pm

FDA gets most of its money from user fees on industry, which is a terrible way to fund a regulator that oversees 25 cents of every dollar spent in this country. The government share of that budget is about $2billion per year. Please compare that to any other agency. Next, examine the total FDA budget amounts for the last few years. Come back and tell us what you find.

However, I totally agree about IRB’s. The federal agency that regulates human research proposed substantially relaxing those regulations years ago and got a ton of pushback. Hint, it wasn’t from other government agencies.

10 Jan November 1, 2014 at 8:22 am

Increased regulation is not necessarily bad, and in many cases it can both promote innovation and protect the public. Industry itself often requests this regulation. Simply counting the number of “restrictions” on companies is a flawed way to measure the impact of FDA oversight.

The social media regulations the authors lead off is an interesting case. FDA has regulated how companies market their drugs to doctors and the public for decades. Social media presented challenges because it was a new form of that communication. Companies have actually been begging FDA for this guidance because they wanted to know how they should apply existing standards to that medium.

The US and New Zealand are the only countries in which companies may directly market to consumers. So the FDA regs may technically contain a lot more specific restrictions on companies related to direct to consumer marketing than the EU countries, but that actually translates to _less_ regulation.

In another example, the ACA created a pathway for biosimilars (generic biologic medicines). Industry has been requesting more detailed regulations and guidance to implement this pathway, along with the additional certainty those provide. FDA is giving it to them.

A lot of new regulations, framed as “restrictions,” are related to programs created through FDA’s every-five-year user fee reauthorization legislation that are actually designed to allow markets to get to market more quickly through accelerated review or with less upfront study than they otherwise would. The tradeoff is often additional product marketing once on the market.

Finally, some data. Despite the perception of an unnecessarily high bar to market and onerous review processes, FDA approves drugs faster than both the EU and Canada. http://news.yale.edu/2012/05/16/drug-approval-race-us-fda-ahead-canada-europe

11 Jan November 1, 2014 at 8:27 am

Second to last paragraph should be “to allow products to get to market” and “is often additional product monitoring once on the market.”

12 Bill November 1, 2014 at 10:39 am

Jan, shhh, this site relies on ignorance to fan the flames against any and all regulation.

How dare you respond with fact based responses showing we have less regulation because we permit activities which are prohibited abroad.

13 Tom November 2, 2014 at 12:03 pm

Your comment does not comply with best practices. Desist or a fine may be imposed not exceeding $30,000, as well as a sentence not to exceed three years in prison.

14 Cohn November 1, 2014 at 11:54 am

OK … so what exactly makes the FDA bureaucrats smarter than everyone else in America about drugs ?
How is it they know “best”?

Are they extra special human beings carefully selected for FDA duties ?

Do they receive unique and intensive education, unavailable to other Americans ?

Are they especially selfless individuals immune to normal human foibles or self-interest?

Where do they actually find and hire these angelic FDA creatures ?

And who regulates Regulators ?

15 Bill November 1, 2014 at 12:27 pm

No, of course not, Glenn Beck knows all.

Never mind that you need a Ph.D in biochemistry or a Ph.D in biostatistics, or that industry groups also hire those folks to respond to proposed regulations.

Sometime why don’t you just look at the websites that post what types of applicants, and training, FDA hires and requires.

It aint an English degree.

16 chuck martel November 1, 2014 at 12:22 pm

“Companies have actually been begging FDA for this guidance because they wanted to know how they should apply existing standards to that medium.”

They would, when federal agencies can levy fines on businesses like the following: http://nailheadtom.blogspot.com/2014/09/faa-gets-half-million-dollars-for.html

“FDA approves drugs faster than both the EU and Canada.”

The next popular televised sport will be tortoise racing.

17 Jan November 1, 2014 at 3:40 pm

Yeah, FDA very rarely uses its authority to levy fines against companies or require products to be pulled off the market. Look into it. Their specialty is warning letters, which have no real consequences for companies.

18 Jan November 1, 2014 at 3:46 pm

The research showing FDA approved products faster its their peers in the EU came as a surprise to many who were pointing to the threat that companies would start to bring their products to market in more relaxed regulatory environments than the US. Turns out that FDA wasn’t so bad and companies didn’t actually start to do that. Also, FDA’s drug and device review times have significant;y decreased since the advent of user fees. So the agency is not only working faster than its peers, it is working faster than it has in the past.

19 Bill Reeves November 2, 2014 at 10:34 am

The Great Stagnation in a nutshell.

20 mpowell November 3, 2014 at 11:17 am

Am I missing something or is there more to this study than counting the number of ‘must’ or ‘shall’ command clauses in the federal regulations code? Because that is hardly any basis to make a solid conclusion from. If we want to understand what is going on in this kind of situation, we’re going to need better informed studies. The alternative is everyone simply confirms their priors. Fantastic.

Comments on this entry are closed.

Previous post:

Next post: