Making American Great Again–The FDA

by on November 15, 2016 at 7:19 am in Economics, Law, Medicine | Permalink

Does Donald Trump want to streamline the FDA and speed new drugs to patients? The Washington Post thinks that it can read the tea leaves:

A single sentence in President-elect Donald Trump’s health-care platform sends a strong hint to the drug and medical device industry that they may have an easier time getting their products on the market under his administration.

“Reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products,” his health plan states.

On the face of it, the bullet point may seem almost bland, but efforts to integrate patients’ preferences and encourage innovation often result in proposals aimed at speeding up the process for getting new medicines on the market by easing regulations. Critics argue that such efforts can erode standards that are in place to protect patients from drugs that don’t work and might even be harmful.

“The language … is industry code for deregulation and reducing of safety standards,” said Robert Weissman, president of Public Citizen, a consumer watchdog.

There is plenty of evidence that the FDA is too slow (see, for example, here, here, here and here) so I would support such a move. Senators Cruz and Lee proposed a reciprocity bill last term under which drugs approved in other developed countries would quickly be approved here; perhaps such a bill could find renewed interest in a Trump administration (Economists also support the idea of reciprocity.)

On the other hand, Trump has expressed support for Medicare being allowed to negotiate drug prices which is tantamount to price controls given the size of Medicare and that is potentially a disaster. Price controls could significantly reduce research and development in the pharmaceutical industry and end up greatly adding to the invisible graveyard. Trump’s advisers would seem to lean towards streamlining the FDA process rather than imposing price controls but it’s difficult to be certain.

1 Alan November 15, 2016 at 7:46 am

Our government had becometoo risk averse, this is the good side of the Trump phenomenon.

2 Alan November 15, 2016 at 7:47 am

The reciprocity deal is what I refer to above.

3 Travis Ormsby November 15, 2016 at 8:17 am

Hey, we’ll get a government that won’t abide by the 1st, 4th, 5th, or 8th amendments, promises to uproot millions of families (including US citizens), is committed to accelerating climate change, and is primarily motivated by white nationalist revanchism. But at least the FDA will be somewhat less risk averse. Maybe the trains will run on time too?

The headline for this series of articles should be “Disgustingly incompetent racist accidentally stumbles onto something worth doing, will insignificantly mitigate the harms he is responsible for”

4 Anon November 15, 2016 at 9:08 am

Look on the brighter side. Rise in status : Second Amendment

As Yeats put it in “The Second (amendment) Coming,”

“Things fall apart; the centre cannot hold; Mere anarchy is loosed upon the world.”

5 MOFO November 15, 2016 at 9:27 am

You guys should invest in some Xanax.

6 Alain November 15, 2016 at 10:34 am

How about they just leave? That would be my preference.

I do enjoy their anguish, but I would prefer that they post about their hurt little feelings in meme forum.

7 carlolspln November 15, 2016 at 9:42 pm

+ 1

8 collin November 15, 2016 at 9:09 am

On the other hand, Trump has expressed support for Medicare being allowed to negotiate drug prices which is tantamount to price controls given the size of Medicare and that is potentially a disaster.

I would agree with you on FDA and price controls but why not let our insurance companies and drug stores source their drugs from nations. We want free trade so companies who try to charge 50% more in the US than Canada than all the prescription distributors can source from Canada or Europe or Mexico. Let the free market compete here!!

9 Thiago Ribeiro November 15, 2016 at 9:49 am

You can’t because Big Pharma wouldn’t make as much money as it does now.

10 anon November 15, 2016 at 9:55 am

.. while Ryan is reported to be on an “end Medicare” tour.

I have no problem with moderate changes at the FDA, that is not extreme, it is not “end the FDA” or (another report) Secretary of State Giuliani.

The news seems a regression towards moderation in general, but not completely. There is still high uncertainty.

11 spencer November 15, 2016 at 10:15 am

If you try to import drugs from Canada it will still be the same company making and selling them. If imports from Canada became significant they would just restrict the supply to Canada or demand higher prices in Canada.

12 Alain November 15, 2016 at 10:37 am

The other countries are cheaper since they trample on property rights.

I know your don’t like the propert rights of others, but adults understand that they are necessary for incentives.

Sorry about your luck in the election. Losing the house, senate, and presidency hasn’t happened many times in the last 40 years, your team/clan/tribe must be full of horrible people. Sorry.

13 Thiago Ribeiro November 15, 2016 at 11:09 am

Free trade ceases to be sold as a cure-all as soon as Big Business can’t make as much money as they can do by robbing Americans blind. It is the American Way. Any news here? Wall Street’s candidate was defeated, has Big Pharma’s candidate been elected? File under “problems of a two-party system”.

14 collin November 15, 2016 at 11:24 am

So our workers have to pay higher prices than Chinese or Canadian workers. That is we have to pay for all the ‘cost of research’ while Canadian, Mexican and Chinese benefit from not paying. And Trump won because he wants to end these free trade arrangements.

If you like NAFTA, this price discrimination is hurting the WWC and now they blame NAFTA. So this drug arrangement is going to hurt free trade.

15 Andrew November 15, 2016 at 3:57 pm

Actually adults understand that property rights are a means for creating incentives. Not the only means and therefore not “necessary”.

I’m sorry for your luck in the election too.

16 Dutch Boy November 15, 2016 at 7:03 pm

They lost the house and the Senate too? Someone told me they picked up seats in both chambers. Wrong, I guess.

17 Alain November 15, 2016 at 10:06 pm

Yep, wrong. Sorry!

Those seats are worth nothing. Sorry about your luck!

18 Tom DeMeo November 15, 2016 at 9:37 am

We could allow individual states to negotiate drug prices

19 Mark D November 15, 2016 at 10:28 am

Next stop–thalidomide! (Which, you may recall, had been approved in another developed country, Germany.)

20 dan1111 November 15, 2016 at 11:40 am

Drug companies are not going to be able to travel back in time and get drugs approved using 1950s era rules.

Also, the approval process is too restrictive precisely because harm caused by approved drugs is highly visible, while lost benefit from drugs that were not approved or not developed is invisible.

21 Seth November 15, 2016 at 12:16 pm

The “Pick 2” trade-off:
1.Cheap drugs.
2. Lots of new innovation.
3. Risk averse drug approval process.

You can’t have all three, unless another country is willing to subsidize the risk averse approval process, which fortunately for a lot of other countries with cheap drugs, the US does.

If the U.S. does manage to somehow successfully buy drugs at the lower prices they are available for in other countries, then we may lose #2 and we freeze ourselves into today’s treatments. It may not sound bad, until you realize that nobody now would be happy with the treatment options of 10, 20 or 50 years ago. So, we’d lose a lot of good future stuff.

22 Mark Thorson November 15, 2016 at 10:37 pm

No, more likely antineoplastons. Trump has squarely sided with the vaccines-cause-autism crowd, so it would be unsurprising if he also sides with other manifestations of quack medicine.

23 GoneWithTheWind November 15, 2016 at 10:30 am

Make the FDA do their job. Place a limit on the time a drug takes to go through the process. Let’s say six months, if the FDA does not approve or reject a drug within six months then it becomes available to the medical community to prescribe. Hold the FDA responsible if their approval process fails to catch a drug that causes harm.

24 Alain November 15, 2016 at 10:42 am

Anyway, onto the substance of the article Alex, this is great news. The scaling back of the regulatory machine of the last 8 years is going to produce huge gains. Maybe not in all fields, but it is likely/possible that there will be a couple of huge wins that will really benefit humanity.

The signature rollback of the Bush administration was the 2005 energy act, which allowed fracking to take off and which likely saved the world from insane oil prices and the resultant instability. This act by itself, did more for human welfare than all the acts of the previous and subsequent administrations. Yet, amazingly our media pays it no mind. Interesting …

25 Thiago Ribeiro November 15, 2016 at 11:12 am

“This act by itself, did more for human welfare than all the acts of the previous and subsequent administrations.”

Oh, God.

26 carlolspln November 15, 2016 at 9:46 pm

You must be new here, my Frenchified monikered friend.

Alex T. flies into paroxysms of rage whenever he spies the ‘three letter acronym’, in this case in the Jeff Bezos Morning Post.

For a sober adults take on the topic, let’s cross to Derek Lowe’s post today in “In the Pipeline”.

Oh, & Alex, please see in particular comments by Alan G & Stuart Buck below.

Pathetic.

27 Lord November 15, 2016 at 11:57 am

We would do well to have less innovation of $600 epi pens and other drugs and invest directly in it.

28 Sam November 15, 2016 at 12:13 pm

At some point are price controls justified if the monopoly granted to drug companies is way in their favor? I mean I know the better solution is to have more drugs make it through, but the “innovation” of things like epi-pens amounts to how well they can rent seek. Capping the price of an epi pen at 500 bucks by Medicare probably wouldn’t be much of a disincentive.

29 AlanG November 15, 2016 at 12:58 pm

What a crock of crap! I spent my working career in the drug regulatory affairs. Companies that have good data and submit complete applications get drugs approved on schedule. It’s just that simple. Priority drugs are reviewed in six months and usually approved at that point. The companies that have marginal data are the ones that are in trouble. this foreign approval idea has been around for a long time but the blunt fact is that data shows that first approvals occur in this country over 70% of the time. In addition, it’s always been difficult to determine which foreign approval agencies would qualify here. Certainly there is a lot of harmonization between the FDA and the European authorities on a lot of aspects of drug regulation.

As others have pointed out, it’s not the approval process that is the issue here but rather the cost of new therapies. Some of these are drugs with great potential while others offer only marginal gains yet the system pays for both. Perhaps our drug reimbursement system needs to be reformed to “pay for performance.”

30 John November 15, 2016 at 2:42 pm

So isn’t the other 30% worth looking at?

31 Dallas Weaver Ph.D. November 15, 2016 at 4:32 pm

For priority drugs, why even 6 mo for review if all the data is available? Non-priority can take years.

Every decision has an impact and a delay decision (I will get to that review next month) is a decision with impacts. A denial is a decision or demanding higher resolution in the results has impacts. Analysis of that delay, denial, and redo decisions must include the negative impacts on patients who don’t get treatment.

How many lives are lost or damaged from the delays, denials and redo’s must be included in the analysis.

A more dynamic approval process where once you have net positive data, you are tentatively approved while to expanded

32 Thiago Ribeiro November 15, 2016 at 1:12 pm

I say, arise, arise. Cast off the yoke of the moneyed interests! Overthrow your corporative masters and set the world on fire!.

33 Banned Norse Warrior November 15, 2016 at 1:54 pm

We are trying our best here in Portland. How is that strategy working out in Brazil? I hear you have been able to replace corrupt politicians with corrupt politicians, like in the other BRIC countries and former Soviet union countries.

34 Thiago Ribeiro November 15, 2016 at 3:36 pm

Corruption has suffered a decisive defeat. The president and the House Speaker (or Speaker of the House, I always forget which silly name you use) were deposed. The President of the Senate and the current president are under a strict investigation. Brazil is undergoing the most radical political investigation since the Stalinist Purges and is doing it under the emmpire of the Law, democratically. I am proud of the courage of the Brazilian people. We prevented our political system from becoming systematically corrupted like yours. Meanwhile, the FBI becomes a pretorian guard and the office-holders are in the pockets of Big Business. Sad.

35 John November 15, 2016 at 2:40 pm

An monopsony power in other institutions are not setting price controls? If we argue that perfect price discrimination by producers is an improvement over the one price profit maximization by a monopolist why should the intuition be the same when the roles are reversed? One might actually argue the latter is more consistent with the usual rationale for competitive markets — prices and profits driven the their reservation level and a maximized consumer surplus experience.

36 Stuart Buck November 15, 2016 at 2:44 pm

Contrary to Alex, the evidence more recently suggests that the FDA is approving just about everything, no matter how little evidence there is and no matter how marginal the benefit is. See Sarepta’s drug, for example, or think about the fact that the median cancer drug approved over roughly the past decade extends life by a mere 2.1 months. If we lower standards even further (a la the 21st Century Cures Act, also called the 19th Century Snake Oil Act by some experts), where does it stop? Do you want drugs approved in one week based on one patient’s testimony?

37 Stuart Buck November 15, 2016 at 9:33 pm

The FDA is quicker than Europe or Canada. http://www.nejm.org/doi/full/10.1056/NEJMsa1200223

38 Abelard Lindsey November 19, 2016 at 12:03 pm

Reverse the FDA’s current ban on the approval of effective anti-aging medicine and prioritize the development of a cure for aging.

“I set the goal for this nation, that we will have a cure for aging before the next decade is out”.

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