No doubt, 2008 has been a rough year just about everywhere, with slings and arrows targeting everybody from an ambitious plumber to the president.  Somewhere in the middle is the US Food and Drug Administration (FDA), chartered by Congress to ensure the safety of our nation’s foods and medicines.  Thanks to FDA regulations, 21 new drugs have been approved in 2008 but many pharmaceutical-industry insiders say the FDA is dragging its bureaucratic feet, making the approval process take much longer than expected.

Many American consumers say caution is the best policy, especially after learning post-approval of the deadly consequences of the Merck-manufactured painkiller, Vioxx.  The instantly popular pain medication was removed from the market in 2004, years after first gaining FDA approval.  The general public, and many healthcare providers, assume a drug is both safe and effective once FDA approval has been granted but recent events have questioned that belief.

Industry analysts say even more drugs, at least 15 more of them, could have been ready for consumer use by now if only the FDA had acted faster when drug manufacturers submitted their latest drugs for approval.  Even so, both the FDA and the pharmaceutical industry agree the drug review process has become increasingly sophisticated, a characteristic that frequently slows the process.

And the FDA seems to be strengthening its criteria for approval, a situation acknowledged by Robert Clark, a vice president at Pfizer.  Clark said conversations and issues are tougher than they were 20 years ago, making it more difficult to guarantee investors that a new drug will achieve approval.

Deadlines are an issue that rankle Big Pharma, with industry leaders saying the FDA has become lax in maintaining its own timelines, established in the 1990s.  Full disclosure for 2008 is still unavailable but FDA officials have already said the agency won’t be meeting its goal of reviewing 90% of all drug applications in the allocated timelines.

Most new drugs undergo about 15 costly years of testing and development before presentation to the FDA for approval.  Marketing strategies and earnings projections are calculated according to the FDA review timeline.  Each month a timeline is missed, the pharmaceutical company and its investors lose money in missed sales.

Andrew von Eschenbach, current commissioner for the FDA, has had to defend the agency’s much-publicized handling of recent issues that range from tainted blood thinners to toxic chemicals in baby bottles to deadly contaminants in pet foods.  Von Eschenbach will relinquish his post on January 20, when the Obama Administration takes office, along with a new head of the FDA.

Bipartisan politics have been blamed for ills of every nature this past year and the Republican-appointed FDA commissioner has not escaped scrutiny.  Some industry leaders look to the new Democrat-controlled Congress and White House as an opportunity for optimism, with the hope that swifter action on the FDA’s part will now be possible.

Question for Medheadlines Readers:

What do you think about the time it takes to get a new drug approved for sale?  Does a more thorough review system prevent beneficial medications from quickly getting to patients who need them or is the biggest concern for the delay the delay in income gained by the pharmaceutical companies?

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