Michael Causey, Editor & Publisher, eDataIntegrityReport.com
After years of budgetary neglect, malaise and a brain drain you could almost hear each time you passed the FDA’s exit on the Maryland side of the Washington, D.C. beltway, the FDA is hiring big time.
They are looking for medical officers, pharmacists, consumer safety officers, biologists, chemists, microbiologists, pharmacologists, statisticians and operations research analysts, among others.
And it’s not a moment too soon. It’s a challenge to get current FDAers to speak on the record about this issue. But off the record we’ve heard from mid-level folks and those higher up the org chart tell us time and time again that the agency is way understaffed — and it felt like the Bush Administration had it in a chokehold for nearly eight years.
“We need these people and we need them yesterday,” a senior FDA official told me this week.
The hiring push also suggests that the FDA in 2010 is going to be a lot more aggressive and proactive agency than the one we’ve been watching for most of this decade.
Need more proof? FDA’s Regional Food and Drug Director in San Francisco told a RAPS meeting in August that the agency planned to increase its foreign inspections by 100% over the next three years.
A Nobel Peace Prize notwithstanding, President Obama may be disappointing some of his supporters thus far in his presidency. But he’s keeping his promise to revitalize the FDA.
And the hiring push goes beyond the FDA, as an interesting front page article in the Oct. 13 Washington Post points out in the headline is a clue, “A Vigorous Push From Federal Regulators. Consumer, Workplace Agencies More Active.”
“The new regulators display a passion for rules and a belief that government must protect the public from dangers lurking at home and on the job – one more way the new White House is reworking the relationship between government and business,” says The Post article.
But even as we speculate that the FDA will conduct a lot more inspections next year, it’s important to remember something that’s not so likely to change, according to Roh. The most common drug GMP 483 items have been and probably will remain: Responsibilities and procedures of the Quality Control unit are not in writing, written procedures are not followed, control procedures not established, inadequate specifications, written procedures, and failure analysis.
Well, it’s nice to know that some things never change.
Dear Michael – Well how timely! And indeed the Agency gets to suggest that more of the same is not acceptable by issuing the anxiously awaited final guidance document “Guidance for Industry – Investigator Responsibilities – Protecting the Rights, Safety and Welfare of Study Subjects – October 2009” http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf
This document provides so much insight into not only what the regulations means, but also some great suggestions of what all these future audits will be “looking for”.
As someone who manages multiple sites running multiple studies we are excited to have this final word to help ensure the Investigators are living up the standards RxTrials places on them, the CRO and Sponsors and most of all the FDA. Together we can get it right and decrease the audit findings and ensure the public they are safe in our hands winning back their trust we have lost over the last few years.
Thanks for your commentary – well said!
Christine Pierre – RxTrials
I have also heard that the FDA is losing a lot of good qualified people who have been with the agency for years. The new hires are also being trained by those who are barely out of training themselves.
Regardless, the FDA has a long way to go before they are really up to speed. Simply adding people isn’t going to solve the problems in the industry. At least not right away.