Candidate Copout - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Candidate Copout
Fixing FDA lies in the hands of the government, but is the president-to-be paying attention?


Pharmaceutical Technology
Volume 32, Issue 1


Michelle Hoffman
At some point in this editorial, I may feel the need to utter something like "Surely the richest country in the world can find the resources to...." If you're sick of hearing that, you may choose to stop reading. But for the rest of you, I find myself wondering about the sorry state of the US Food and Drug Administration.

A scientific subcommittee appointed by FDA Commissioner Andrew von Eschenbach to study the agency's fitness, released a report in December that concluded "...science at the FDA is in a precarious position...and is not positioned to meet current or emerging regulatory responsibilities."

The subcommittee cited an imbalance between supply and demand: Essentially, the report said, "Resources have not increased in proportion to the [increased] demands. The result is that the scientific demands on the Agency far exceed its capacity to respond."

In response to this report and other criticisms of FDA's ability to ensure the safety of the nation's food and drug supply, the Associated Press reported that President George W. Bush, in an executive order, said that improvements would have to be made with existing resources. Surely, the richest country in the world can find the resources to ensure the safety of its food and drug supply.

In a previous editorial, I had to conclude that we didn't see Nobel Laureates on news shows, because the Prize is simply not a priority. Could it be that FDA is so underfunded because food and drug safety is also not a priority? Well, what better time to air national priorities than in the run-up to a national election? And who better to ask than the candidates for president? These people are—at the moment—exquisitely attuned to the public's priorities.

So, to find out, we got in touch with the press offices for all of the leading presidential candidates of both major parties. How do they feel about the current level of FDA funding? We asked. And, How do they feel about the way FDA is funded—in part, through user fees? Finally, If they were to become president, would they change these things and how?

You're probably wondering how they answered. So are we. Not a single one answered our request. (That's not exactly accurate. The Richardson campaign did send us an email thanking us for our interest in the candidate. But that's not really the kind of reply we were hoping for.)

I don't know why they didn't reply. I am aware that Pharmaceutical Technology is not the New York Times, and so maybe the press officers didn't feel compelled to respond to us. I actually hope that's the reason, because the other options are pretty frightening.

Perhaps the candidates know the FDA's in trouble, and they do have a solution but don't want to talk about it because issues related to the pharmaceutical industry are controversial and/or polarizing and therefore dangerous to the campaign. Or maybe they do know it's in trouble but don't have a solution. Finally, it's possible the candidates don't know FDA is in trouble—even the ones who have made healthcare an issue.

The candidates might reply if you, their constituents and potential voters, ask them. (If they do respond, please let us know what they said.) They still might respond to us, of course, and if they do, we'll post the replies online. But let's all hope they're thinking about this issue, because everyone in the pharmaceutical industry (not to mention everyone who takes drugs or eats) is.










Send your comments or story ideas to Editor-in-Chief Michelle Hoffman at

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here