Alexis Pellek
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For the second year in a row, PharmTech asked readers in an online poll what area of the pharmaceutical industry they think
will experience the most change in the upcoming year. Respondents said that for 2009, regulation policy and enforcement would
change the most (25%), followed by manufacturing equipment and processes (23%), and outsourcing and consulting services (17%).
These results differ slightly from what PharmTech readers thought about 2008, when outsourcing (33%) was the number 1 pick,
followed by regulation (23%) and information technology (15%). As it turned out, outsourcing was a big topic in 2008. Most
notably, there was Baxter's January recall of heparin products and the later discovery that the contaminated active ingredient
came from a supplier in China. Later in the year, news arose of the negative impact that last year's economic meltdown had
on the third-quarter reports of contract research and manufacturing organizations.
For 2009, readers seem to expect the most news and change in the area of regulation. As the Obama administration works with
new staff at FDA, we might see the agency take on topics such as increased oversight of direct-to-consumer advertising, more
implementation of quality systems, the development of a regulatory pathway for follow-on biologics, and an emphasis on foreign
inspections.
To cast your vote in our biweekly polls and to see the results of past questions, visit our poll archive at
http://PharmTech.com/polls.
Alexis Pellek is an assistant editor of Pharmaceutical Technology.
