Drugs

New FDA Tools in Democrats’ Preparedness Bill

All 23 Democrats on the House Energy and Commerce Committee are sponsoring legislation to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA). The bill also includes new tools and authorities for FDA to use in dealing with drug shortages.

A statement from the committee Democrats (includes a link to the bill text) says the legislation reauthorizes key authorities intended to help the federal government respond to public health emergencies, including authorities within the Administration for Strategic Preparedness and Response, and workforce programs to ensure the healthcare system is prepared to respond to health security threats, as well as planning a national health security strategy for the future. It says the comprehensive bill also will improve communication and public health data sharing between states and the Centers for Disease Control (CDC) to ensure it can provide real-time guidance that reflects accurate data from states and localities. The Democrats say a Republican bill would undermine the CDC by leaving it without a permanent head at this time.

The Democrats’ bill increases funding levels for preparedness programs, including the Strategic National Stockpile and the Hospital Preparedness Program. It also increases funding for public health preparedness grants to ensure state and local public health agencies have the resources they need to properly respond to an emergency. The statement says the Republican bill “fails to increase any funding levels for existing programs over the levels appropriated for FY 2023.”

To help address drug shortages, the legislation provides for improved mandatory reporting of drug and medical device shortages, increased transparency in drug and active pharmaceutical ingredient manufacturing, new tools to support extended drug shelf-life during shortages, and recall authority to ensure dangerous products can be removed from the market quickly, the statement says.

The Democrats note that the Senate has reached a bipartisan agreement on PAHPA legislation that includes many of the provisions the House Democrats have been seeking, leaving only House Republicans who are not in agreement.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome