President Barack Obama has signed into law a new piece of legislation that would reauthorize and expand upon the US Food and Drug Administration's (FDA) authority to regulate and promote the development of medical countermeasures using innovative methods.
The signing of the law, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), was widely expected after the bill received broad-based and bipartisan support in both the House and Senate. The bill cleared the Senate on 4 March 2013, clearing its path for the president's signature on 14 March 2013.
In a statement, Sen. Tom Harkin (D-IA), chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee and a sponsor of the bill, said he was pleased the legislation had passed so easily.
"As often as we hear about gridlock in Congress, the enactment of PAHPRA is an example of a successful bipartisan legislative effort that will have real, positive impacts on our country's readiness to respond to public health threats," he said. "Increased coordination among federal, state, and local governments; consideration of the needs of at-risk individuals including children and people with disabilities; investments in medical countermeasure development and research; and stronger planning efforts mean that American families will be better protected from public health emergencies of all kinds."
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.
For our in-depth coverage of the legislation and its provisions, please see our 28 February 2013 article, "Bill Tasks FDA with Setting up New Regulatory Pathways."