A disaster and emergency preparedness bill that would task the US Food and Drug Administration (FDA) with setting up new regulatory incentives and accommodations for medical countermeasures has passed both the House and Senate and has been presented to the president for his signature.
The bill, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013, was first introduced in the House on 18 January 2012, and passed four days later with broad bipartisan support in a 395-29 vote.
The bill then moved to the Senate, where it cleared both the Health, Education, Labor and Pensions Committee and the full Senate with unanimous support. However, the Senate version of the legislation made some minor wording changes, necessitating a re-vote by the full House.
That vote came on 4 March 2013, when the House voted again to approve the bill 370-28.
The bill has now been presented to President Barack Obama, whose office has not issued a signing statement regarding the bill, indicating that he is likely to sign it. Even if he were to veto the bill, both the Senate and House have enough votes to override such a veto.
Bill's Regulatory Provisions
As Regulatory Focus reported in February 2013, the bill contains a number of regulatory provisions with the potential to affect drug and device approvals, particularly those categorized as medical countermeasures. Companies will be able to solicit scientific advice from FDA through the use of new "regulatory management plans (RMPs)," which are intended to facilitate the development of medical countermeasures.
FDA is also afforded a number of incentives to dole out, including temporary approval of medical products in medical emergencies or any situation in which regulators encounter or expect to encounter a "threat justifying emergency authorized use."
In addition, FDA would be able to approve products without them first meeting current good manufacturing practice standards, extend expiration dates for stockpiled medical products, and waive Risk Evaluation and Mitigation Strategies (REMS) requirements during an emergency.