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Michelle Hoffman, editorial director of Pharmaceutical Technology.
With no economic relief in sight, industry, like all of us, is grappling with high-and new-costs.
What's old is new again, as the economy once more becomes the focus of America's anxieties. These days, when I tune into the news, I find myself listening to reports about how formerly middle class families are struggling to meet expenses for basic needs. Suddenly it seems that the "need" for a second home is supplanted by the more pressing need to meet the mortgage on the first home. Food is now prohibitively expensive for many people that previously didn't even check price tags. And the cost of health care and drugs weighs ever more heavily on people—even those with health insurance.
On a national level, the government has always struggled with national priorities in spending issues, but it seems to me that even the US government is now weighing the costs of meeting basic needs. Take for example, infrastructure, safe food, water, air, and drugs versus more high-ticket items such as war, space programs, and tax cuts.
Most of us are familiar by now with endless reports from within and outside the US Food and Drug Administration that the agency needs more funds to perform its job properly. And thankfully, Congress has responded by increasing appropriations for FDA activities. But there are other measures that will, in theory, improve the efficiency of drug manufacturing, measures that, in theory will also improve drug safety.
I'm thinking specifically of the quality-by-design initiative in which scientists get a handle on the basic physiochemical properties of drug ingredients in order to better predict how they'll move through the manufacturing line and come up with equipment and processes that rationally move ingredients through the line with a minimum of variability. But acquiring that physiochemical knowledge requires basic research that someone has to pay for.
Who should that someone be? If we ask drug companies to take on that expense, they may pass the costs onto consumers who already feel as though they pay too much for drugs. Should the government pay for that research? Should equipment manufacturers? I don't know the answers to these questions. But I would like to see a public discussion of them. And, without sounding like a broken record, I would like to hear our presumptive presidential candidates address these issues as they talk about the healthcare system.
Some of you may recall my editorial in the January 2008 issue of Pharmaceutical Technology, in which I had to report that—sadly—none of then contenders for the office of US President responded to my questions about their future plans for FDA. At that time, the editors decided to try again once we knew who would be the nominees from the major parties.
Of course, we won't know definitively who they are until later this summer, but in the interest of making our deadlines and being able to publish their answers before the general election, we have contacted the press offices of the two presumptive nominees: Senator John McCain (R-AZ) and Senator Barak Obama (D-IL). This time, instead of asking them to answer the editors' questions, we'd like them to answer yours.
We'll have an area set up on our website (pharmtech.com/Election2008) at which you can send us your questions, or, if you prefer, email them directly to me: email@example.com and we'll forward them to the candidates. Hopefully this time, we'll hear something back. Either way, you'll learn the outcome.
Michelle Hoffman is editor-in-chief of Pharmaceutical Technology, firstname.lastname@example.org