Regulatory crossroads

Bad news for Pfizer Inc. and Astra-Zeneca plc will force FDA to make precedent-setting decisions about safety and accelerated approvals, directly affecting patient access to new therapies and increasing the risk of developing new drugs in general.

PFE's Celebrex announcement on Friday immediately exacerbated the Vioxx furor, increasing pressure to remove more drugs from the market and potentially burying any consideration for patients - particularly those with osteoarthritis - who still need access to COX-2 drugs because therapeutic alternatives are virtually nil.

With the failure of AZN's Iressa to meet its confirmatory trial endpoints, also announced on Friday, the agency will be forced to decide whether to enforce the letter of the accelerated approval process, or to side with the clear demands of clinicians and patients for access to any drug that shows a signal of efficacy against cancer.

This pressure cooker comes at a time the agency's leadership is up in the air (see "The Leavitt Alone Approach," A5).

It is also unfortunate that these two cases each have tainted histories, making them less-than-ideal models for big decisions about risks and benefits of drugs to society.

Meanwhile, the pharma companies will have decisions to make, too, as the post-Vioxx fishbowl will make their decisions about each drug subject to extraordinary scrutiny. Indeed, on pharma's Black Friday, PFE lost $24.3 billion in market cap, finishing the week with a market cap of $193.9 billion. AstraZeneca (AZN; LSE:AZN, London, U.K.) fell 5.3 billion to a market cap of $62.8 billion (see "Big Pharma's Woes," A2)

Celebrex: A new

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