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A Faster Pathway to Drug Approvals

By Brian Orelli, PhD - Updated Apr 6, 2017 at 12:27PM

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Too bad it's a long shot.

File this under "awesome but unlikely to happen." A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority (EMA) onto the market in the U.S. before the Food and Drug Administration has approved the drugs.

A radical idea, for sure, but the proposal has some merit:

  • The EMA does a pretty good job of reviewing drugs.
  • Of the drugs looked at by the institute, and which both agencies approved, the European agency approved the drugs 97 days faster than its U.S. counterpart, on average.
  • Patients could get medications more quickly. More importantly for investors, companies could get revenue with equal speed.



Days between EU and U.S. approval


EPIX Pharmaceuticals






Pfizer (NYSE: PFE)



Takeda Pharmaceuticals



Eli Lilly (NYSE: LLY)


Source: Pacific Research Institute.

In fairness, the FDA did finish first for some of the drugs approved by both agencies: Celgene's (Nasdaq: CELG) Vidaza, Gilead Sciences' (Nasdaq: GILD) Ranexa, Shionogi and Johnson & Johnson's (NYSE: JNJ) Doribax, and BioMarin Pharmaceuticals' (Nasdaq: BMRN) Kuvan, for instance. Still, this proposal would allow the best of both worlds. Drugmakers could launch whether the FDA or the EMA approved the drug first.

The Pacific Research Institute concludes that a little friendly competition couldn't hurt, either. And if you think about it, the author may be on to something. The FDA has a monopoly on drug approvals in the U.S., and as we all know, it's easy to get complacent when there's a lack of competition.

Sure, the FDA has some checks on its speed. The Prescription Drug User Fee Act (PDUFA) provides goals for making decisions about drugs in a timely manner, but there's no real punishment that I know of if the agency doesn't meet those goals.

Furthermore, that goal may actually be counterproductive. So many drugmakers get their FDA approvals on the PDUFA date that one has to wonder whether the FDA is finishing early, but doesn't want to announce the approval before its deadline, for fear of the ramifications if unforeseen side effects appear. Detractors would no doubt point to the early approval as a sign that the FDA didn't spend long enough reviewing the drug.

On the flipside, sanofi-aventis' (NYSE: SNY) Jevtana, a cancer treatment where side effects aren't that important, received an approval less than three months after the company submitted its marketing application. While that's the exception, it shows that the agency can move quickly if it wants to.

Of course, it won't ever happen
Politicians who make the laws won't go for the Pacific Research Institute's proposal, because the idea of allowing other countries to exert their control in our territory is ridiculous. Or so the politicians would say. Plus, I doubt the FDA bureaucracy would stand still while someone took away its power, either.

You only need to point to a drug such as Sanofi's obesity drug Acomplia, which was approved in Europe, but turned down in the U.S. because of psychiatric side effects. The drug inhibits the same receptor that marijuana stimulates, thereby avoiding the munchies, but increasing depression, anxiety, and stress disorders in patients. The EU eventually revoked the drug.

But the point is still there
The chance that the Pacific Research Institute's proposal makes it anywhere is pretty slim. But it could actually stimulate discussion to get at the root of the problem. FDA approvals take way too long, and in some instances, the agency is more conservative than it needs to be. That hurts patients, drug companies, and investors alike.

The PDUFA was a good start, but maybe it's time to kick up the speed a notch.

Pfizer is a Motley Fool Inside Value selection. BioMarin Pharmaceutical is a Rule Breakers recommendation. Johnson & Johnson is an Income Investor choice, and Motley Fool Options has recommended buying calls on its shares. Try any of our Foolish newsletters today, free for 30 days.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.

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Stocks Mentioned

Eli Lilly and Company Stock Quote
Eli Lilly and Company
$304.61 (0.53%) $1.59
Sanofi Stock Quote
$45.20 (-7.11%) $-3.46
Pfizer Inc. Stock Quote
Pfizer Inc.
$49.95 (0.34%) $0.17
Johnson & Johnson Stock Quote
Johnson & Johnson
$170.67 (0.29%) $0.49
Celgene Corporation Stock Quote
Celgene Corporation
Gilead Sciences, Inc. Stock Quote
Gilead Sciences, Inc.
$63.14 (1.84%) $1.14
BioMarin Pharmaceutical Inc. Stock Quote
BioMarin Pharmaceutical Inc.
$96.00 (0.31%) $0.30

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

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