Track the companies that matter to you. It's FREE! Click one of these fan favorites to get started: Apple; Google; Ford.



A Diabetic Compromise

Watch stocks you care about

The single, easiest way to keep track of all the stocks that matter...

Your own personalized stock watchlist!

It's a 100% FREE Motley Fool service...

Click Here Now

The Food and Drug Administration put Bristol-Myers Squibb (NYSE: BMY  ) and AstraZeneca (NYSE: AZN  ) in a predicament, but it looks like a compromise is going to resolve the issue. It'll cost the companies some money, but at least they'll get their diabetes drug, Onglyza, on the market.

The agency recently came up with new guidelines for diabetes drugs after heart issues were discovered with GlaxoSmithKline's (NYSE: GSK  ) Avandia. That's a reasonable move, except that there were drugmakers that had already completed their trials and submitted the results for approval.

So Bristol-Myers and AstraZeneca analyzed the trial data for Onglyza and couldn't find any sign that the drug was causing heart issues. But the FDA would rather see trials specifically designed to test hypotheses and doesn't really like post-hoc analysis -- ironic, as that's how Avandia's side effect was found. With that conundrum in mind, the agency sought counsel from its advisory panel yesterday.

The panel shrugged off the worries and said that the post-hoc analysis was good enough, voting 10-2 that the Onglyza data was sufficient to rule out unacceptable cardiac risk.

Sort of.

Panel members weren't completely convinced that there are no heart issues -- especially in patients most at risk, like the elderly -- so they unanimously voted to recommend that the FDA require Bristol-Myers and AstraZeneca to run post-marketing studies to specifically look for heart issues.

That's probably about the best the companies -- and Novo Nordisk (NYSE: NVO  ) , which has an advisory panel meeting today -- could have hoped for. Assuming the FDA follows the recommendation of the panel, Bristol-Myers and AstraZeneca can get on the market and start competing against Merck's (NYSE: MRK  ) Januvia.

With the FDA increasing its safety surveillance, I imagine phase 4 trials are going to become more common. Rather than fight them, companies should embrace them and be happy that the FDA is letting their drugs on the market before the studies are complete.

Our Foolishness is a guilt-free treat:

GlaxoSmithKline is an Income Investor recommendation. To see how dividend-paying stocks can offer both secure income and the opportunity for growth, take a free look at this newsletter with a 30-day trial. 

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

Read/Post Comments (0) | Recommend This Article (4)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 867248, ~/Articles/ArticleHandler.aspx, 10/25/2016 10:14:21 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated Moments ago Sponsored by:
DOW 18,222.99 -0.04 0.00%
S&P 500 2,150.35 -0.98 -0.05%
NASD 5,306.98 -2.85 -0.05%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

10/25/2016 9:58 AM
AZN $29.98 Down -0.11 -0.35%
AstraZeneca CAPS Rating: ****
BMY $49.65 Up +0.42 +0.85%
Bristol-Myers Squi… CAPS Rating: ****
GSK $40.44 Down -0.24 -0.59%
GlaxoSmithKline CAPS Rating: ***
MRK $61.17 Up +0.42 +0.69%
Merck and Co. CAPS Rating: ****
NVO $40.54 Down -0.27 -0.66%
Novo Nordisk CAPS Rating: *****