Shuttered up and closed – the government shutdown was painful for many U.S. businesses. This was especially true for any business having to deal with FDA. FDA lost over 50% of its employees during the shutdown. Many of those furloughed were investigators and internal labs – the individuals and entities that most companies deal with on a daily basis.
According to Ben England, Founder and CEO of FDAImports.com, dealing with FDA – which is already strapped for resources – during a shutdown was nothing to look forward to, “Since our incorporation, we have never had to work with only an FDA skeleton staff of just a few individuals in each office. But we put our work into overdrive to ensure it didn’t slow down our clients’ expectations.”
You’d think in light of diminished government resources it would be difficult to get the government to act, but not for FDAImports.com. So what exactly did FDAImports.com get done for clients during the shutdown? Turns out, quite a lot:
- Obtained entry releases and rescinded refusals for clients ranging from small companies to multi-billion-dollar corporations;
- Obtained firms’ removal from Import Alert;
- Pushed FDA to take action on entry matters being held for several months;
- Convinced FDA to May Proceed entries that were held for FDA lab exam sampling;
And much more.
No matter what a company’s issue may be with FDA (and whether the government is shut down or not), any company dealing with FDA must ensure they discuss their matter with the right people within the Agency – the ones who know your issue. “There are only a handful of people who can understand the more complex regulatory issues that FDA addresses, such as OTC drug monograph issues or exemptions for adequate directions for use for Active Pharmaceutical Ingredients. Simply picking up the phone and being able to get the agency to act and think about your issue is not an easy task,” says Bill Nychis, a 40-year veteran of FDA regulation.
FDAImports.com got the right people at the Agency involved and put its advocacy and connections into play to ensure that clients were minimally effected by the government shutdown. Contact us today to learn more about how FDAImports.com can help and represent your company in front of FDA.
