Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 27 August 2014 | By Alexander Gaffney, RAC
In March 2013, US President Barack Obama quietly signed into law the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), a biodefense bill which gave the US Food and Drug Administration (FDA) new authority to preemptively prepare for potential pandemics or biological threats.
But while the bill received little attention and even less congressional opposition at the time, an outbreak of Ebola in West Africa is now making the bill's passage—and FDA's authority—a campaign issue in Arkansas.
Under PAHPRA, FDA was given a host of new authorities and responsibilities meant to bolster the government's ability to respond to actual and potential health crises.
One of the most notable provisions of the law is one that allows FDA to temporarily authorize a medical product if the agency determines that an emergency is likely to occur—a "threat justifying emergency authorized use," to quote the legislation. Prior to the passage of the legislation, FDA could only grant an emergency use authorization (EUA) if a threat presently existed in the US, which legislators feared would leave the US slow to respond to emerging threats.
The law also allows FDA to grant EUAs to products without first ensuring that they meet current good manufacturing practice (CGMP) regulations.
Since the law's March 2013 passage, FDA has approved a small handful of medical products—all diagnostic tests intended to allow health officials to diagnose emerging diseases like the H7N9 influenza virus and the Middle East Coronavirus (MERS CoV).
Most recently, on 5 August 2014 the US Department of Health and Human Services announced that it had determined that "the Ebola virus presents a material threat against the US population sufficient to affect national security," allowing FDA to authorize the use of a diagnostic device for Ebola Zaire, the Department of Defense's EZ1 Real-Time RT-PCR Assay.
And with PAHPRA's role in helping to fight Ebola (more on that here), at least one legislator who voted against the bill is now finding himself in some trouble.
In Arkansas, a race for a seat in the US Senate has pitted Sen. Mark Pryor (D-Arkansas) again Rep. Tom Cotton (R-Arkansas), who voted against PAHPRAwhen it first passed the House of Representatives in 2013.
Pryor is now using that vote against Cotton. In a new political ad, "Emergency Response," Pryor's campaign said Cotton "voted against preparing America for pandemics like Ebola," referring to his vote on PAHPRA.
The ad is a highly unusual instance of healthcare product regulation—notwithstanding birth control—becoming a campaign issue.
Cotton, we should note, ultimately voted in favor of the bill once it had been passed by the Senate.
Tags: PAHPRA, Pandemic and All-Hazards Preparedness Reauthorization Act, Biodefense, Campaign Ad