Reauthorization of preparedness bill includes new provisions

The Pandemic and All-Hazards Preparedness Reauthorization Act of 2012 passed the House on Tuesday and, if signed into law, would include several new provisions, including a regulatory pathway for medical countermeasure approval.

H.R. 6672, which passed the House in a 395-29 vote, would create the Regulatory Management Plan Process that would give companies the ability to obtain scientific feedback and interactions about the development and regulatory review of eligible medical countermeasures. The RMP process could speed up interactions between biological medical countermeasure manufacturers and the U.S. Food and Drug Administration, Regulatory Focus reports.

PEPRA also includes a section on Emergency Use of Medical Products that gives government agencies broader regulatory authority over the approval, stockpiling and maintenance of medical products. The law would give the FDA the ability to approve a drug that went beyond its shelf life during a pandemic without the consequences of legal liability and enforcement action.

The proposed law would also allow federal authorities to stockpile unapproved drug products as long as they are not used prior to obtaining FDA approval. This gives the government the ability to stockpile products that are likely to be effective for a threat with no known treatment.

PEPRA would also enact new Risk Evaluation and Mitigation Strategies, allow for the FDA to be directly involved in interagency coordinating activities and let the FDA approve products that do not meet current good manufacturing practices on an emergency basis, Regulatory Focus reports.