A Little Distracted, Are You, Merck?

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What's the only thing more embarrassing for a drugmaker than getting a "complete response letter" for a New Drug Application (NDA) from the Food and Drug Administration? Having the FDA refuse to file its NDA in the first place.

A "complete response letter" is sent after a review is complete and the FDA needs additional information before a drug can be approved. When the FDA refuses to file an NDA, the agency is essentially saying that the drugmaker doesn't have it together enough to get the application filled out correctly.

It usually happens to small drugmakers with less experience about what the agency wants. Acorda Therapeutics (Nasdaq: ACOR  ) , Cardiome Pharma (Nasdaq: CRME  ) , and Pharmacyclics, have all had their drug applications sent back after nothing more than a cursory review for completeness by the FDA.

But for it to happen to Merck (NYSE: MRK  ) , which has plenty of experience submitting NDAs over its long history, is really embarrassing. So embarrassing that the company snuck the announcement in its quarterly 10-Q, only saying that the FDA wants "additional manufacturing and stability data" for MK-0653C. Think Merck's regulatory department might be a little distracted, worrying about job cuts after the merger with Schering-Plough (NYSE: SGP  ) ?

The funny thing is, there seems to be little reason to rush MK-0653C's approval. The drug is a combination of Merck's (NYSE: MRK  ) Zetia and Pfizer's (NYSE: PFE  ) Lipitor. Combining cholesterol-lowering drugs from different classes is fairly common. Merck's Vytorin is a combination of its Zetia and Zocor, and Abbott Labs (NYSE: ABT  ) and AstraZeneca (NYSE: AZN  ) are working on a combination of their TriLipix and Crestor, respectively. But, as far as I know, Merck doesn't have a partnership with Pfizer, and it would probably have to wait until the patents expire in 2011 before selling the combination drug.

Then again, considering the glacial speed at which the FDA is moving these days, maybe it's never too early to start the drug approval process.

Is this a one-time slipup or a sign of bad things to come for Merck? Let us know what you think in Motley Fool CAPS. Make an out- or underperform call on these companies or post a pitch about where you think Merck is going. It's free, fun, and Foolish.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Pfizer is a recommendation of the Inside Value newsletter. The Fool's disclosure policy dots its t's and crosses its i's. Wait. Reverse that.

Read/Post Comments (4) | Recommend This Article (6)

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.

  • Report this Comment On November 04, 2009, at 8:12 AM, Stephanie2045 wrote:

    They had poisoned millions of girls with their aluminum

    adjuvants.(Gardasil/garbage)Why would anybody even look at a drug application from Merck?????????????

  • Report this Comment On November 04, 2009, at 9:05 AM, P1llman wrote:


    WebMD says Aluminum in vaccines is safe: <

    Why are you lying?

  • Report this Comment On November 04, 2009, at 9:13 AM, Stephanie2045 wrote:

    Look at the study from Shaw: Aluminum adjuvant causes

    motor neuron death. WebMD is not up to date in research.

    This is not a lie. Merck profits,there are over 16500

    adverse reactions reported,52 death.This is only 1-4%

    as most adverse cases will not make it to the database. Reporting is not mandatory.

  • Report this Comment On November 04, 2009, at 9:35 AM, P1llman wrote:

    The CDC's webpage on GARDASIL was updated on June 10, 2009:

    Current totals are:

    24,000,000 doses distributed

    13,758 VAERS adverse event reports (0.06%), but only 0.004% were deemed "serious".

    26 confirmed deaths (0.0001%) after administration, but there was no pattern to the deaths that would suggest that they were caused by GARDASIL.

    You had a 100 TIMES larger chance of being killed in a car accident in 2008 that you did by receiving the GARDASIL vaccine:

    37261 deaths/306,000,000 population = 0.012% deaths

    Why are you spreading unsubstantiated fear?

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