Drug Safety Emphasis Did Not Slow FDA Drug Approvals in 2009

Posted by cdavenport on Thursday Jan 7, 2010 Under Drug Safety

New drugs cleared by the Food and Drug Administration (FDA) last year kept pace with 2008 and the number of “black box” warnings decreased, suggesting that the tougher approach to preclinical and clinical drug safety has not slowed approvals.

In the past year, the FDA also increased its use of “early communications,” a sign that the Agency is acting more quickly to address drug safety concerns.  Under the current “more transparent” policy, initiated in 2007, the FDA issues warnings to the public when it first begins looking at potential side effects with a drug, even if no direct link has been established.

The Agency has increased staff and is operating within its goal of taking 10 months to review regular drug applications and 6 months for review of priority applications.  Priority review is reserved for drugs that offer a major medical advancement or treat diseases with few alternate therapies.  FDA’s John Jenkins, the Office of New Drugs director, told executives at an industry conference last month that the FDA is reviewing roughly 85 percent of drug applications on time.

Sources: CNSNews.com and MSNBC.com

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4 Responses to “Drug Safety Emphasis Did Not Slow FDA Drug Approvals in 2009”

  1. John Burkhardt Says:

    Cynthia – nice summary; thanks for providing.

  2. Peter Honig Says:

    I think this is a simplistic ecologic analysis that does not completely tell the story of regulatory aversion to residual uncertainty around safety. The numbers of approvals need to be carefully scrutinized for comparability. The risk averse environment to primary care drugs is still extant even though there remain many unmet medical needs in this arena.

  3. cdavenport Says:


    No question this analysis is “light.” But given the number of compounds that the Agency sees per year, comparison of “apples to apples” and “oranges to oranges,” while preferable, is not always possible. There is also no means of telling which compounds were already under review and therefore only partially fell under the more stringent safety guidelines. In our current overly litigious society (primarily in the USA), I see no way around regulatory aversion to the omnipresent residual uncertainty around safety. The pharmaceutical industry as a whole needs to do a much better job of educating consumers of the risk:benefit balance. Maybe the evolution of personalized medicine will help consumers better appreciate our inherent individual differences.

    Thanks for joining the discussion!


  4. BrandInnovator Says:

    Thanks for the insightful post, Cynthia. To me, the numbers on NMEs (new molecular entity) approvals are bleak.

    FDA approved 26 new drugs in 2009.
    That’s barely better than the 25 in 2008.
    And there were only 18 in 2007 — the lowest number since 1983.

    Specifically, the FDA approved 7 biotech drugs and 19 traditional (i.e. small molecule) drugs last year. While the number of small-molecule drugs approved was comparable to the figures from recent years, the number of biotech drug approvals was up from 2 in 2007 and 4 in 2008.

    The issues, of course, go beyond the numbers.

    Some say “it isn’t just approvals it’s submissions.” Fewer big discoveries are coming out of the labs, and big pharma’s pipelines are dry.

    Others note the trend of “asking for more studies,” which is driven by safety concerns. This serves to not only delay many approvals, but also kills many submissions due to time and economic realities.

    Finally, there’s added conditions on approvals, like REMS programs and long negotiations with DDMAC and APLB for marketing and promotion.

    Let’s hope that the innovation increases, the clinical planning gets stronger, and the industry-agency communications gets clearer.

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